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-fa,Recall Event ID,Device Type,Product Code,Regulation Description,Medical Specialty,Review Panel,Submission Type,Trade Name/Product,Main Name,Recall Class,Date Posted,Year Posted,Recalling Manufacturer,Reason for Recall,FDA Determined Cause,Action,Consumer Instructions,Clean Quantity,Quantity in Commerce,Distribution,Recall Status,Termination Date,Time to Terminate,Merged Quantities,Fault Class,Failure Mode,Action Class,Action Category
Z-0206-2007,36690,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips",One Touch Ultra test strips,1,"January 05, 2007", 2007,Discount Diabetic Supply,Counterfeit-blood glucose test strips (manufacturer unknown),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit,The recalling firm notified its consignees of the problem and the recall by telephone on 10/19/2006. The firm followed this with a written notice on 10/30/2006.,N/A,240,240 units,"Nationwide distribution --- States of CA, TX, TN, GA, AL, and OK",Terminated,"December 22, 2009",1082,240,Not_Computer,N/A,N/A,N/A
Z-0339-2007,36693,Tube Tracheostomy And Tube Cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(K),"Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.",Smiths Bivona Adult Trach Tube,2,"January 05, 2007", 2007,"Smiths Medical ASD, Inc.","Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.",PRODUCTION CONTROLS: Process Control,Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.,N/A,197,197,"Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.",Terminated,"May 04, 2007",119,197,Not_Computer,N/A,N/A,N/A
Z-0452-2007,36774,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(K),"LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package,Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037",OneTouch SureStep Test Strips,2,"January 05, 2007", 2007,Lifescan Inc,"Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.",DESIGN: Device Design,"The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.",N/A,26398,"26,398 units (both recall numbers Z-0452/3-2007","Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.",Terminated,"November 27, 2007",326,26398,Not_Computer,N/A,N/A,N/A
Z-0450-2007,36728,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.",Bayer Advia 70 Hematology Analyzer,2,"January 05, 2007", 2007,Drew Scientific Group PLC,"System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.,N/A,545,545 units.,"Worldwide distribution ---- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.",Terminated,"March 10, 2008",430,844,Not_Computer,N/A,N/A,N/A
Z-0469-2007,36898,"Kit, Test, Pregnancy, Hcg, Over The Counter",LCX,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138)Note: (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick(2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.",Confirm Clearly Smart ,3,"January 05, 2007", 2007,"Mizuho USA, Inc.",False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.,N/A,"On November 14, 2006, Mizuho USA and SSL decided to cease further distribution of the product, and to contact SSL''s customers and ask them to return any unsold units. Mizuho USA informed SSL Americas by telephone.On November 21, 2006, SSL Americas sent Recall Notification Letters to each of its customers by US First Class, Certified, Return-receipt mail. The letter included a 'Fax Back' Notification to be use by the firm for recall effectiveness checks.",N/A,474000,"474,000 Kits",Worldwide-USA and Canada,Terminated,"May 23, 2008",504,474000,Not_Computer,N/A,N/A,N/A
Z-0266-2007,36863,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips,One Touch,1,"January 05, 2007", 2007,"Core Care Technologies, Inc",Counterfeit product (manufacturer unknown),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit,The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.,N/A,N/A,unknown,Nationwide.,Terminated,"June 06, 2007",152,N/A,Not_Computer,N/A,N/A,N/A
Z-0338-2007,36934,"Catheter, Flow Directed",DYG,Flow-directed catheter.,Cardiovascular,Cardiovascular,510(K),"Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75",SwanGanz Thermodilution VIP Catheter,2,"January 05, 2007", 2007,Edwards Lifesciences Technology SARL,"Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)",N/A,"Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A; to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.",N/A,1110,"1,110 units",Worldwide Distribution ----USA and countries of Columbia and Venezuela.,Open,N/A,N/A,1110,Not_Computer,N/A,N/A,N/A
Z-0444-2007,36306,"Ventilator, Continuous, Minimal Ventilatory Support,Facility Use",MNT,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),"Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD",Puritan Bennett KnightStar Ventilator,2,"January 09, 2007", 2007,Puritan Bennett Corporation,Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.,N/A,"Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.",N/A,7754,"7,754 (in US)","Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Open,N/A,N/A,7754,Not_Computer,N/A,N/A,N/A
Z-0449-2007,36706,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.",Bayer Advia 70 Hematology Analyzer,2,"January 09, 2007", 2007,Drew Scientific Group PLC,Flags and alerts on the user interface will not automatically transfering to the LIS.,N/A,Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available.,N/A,299,299 units.,"Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.-",Terminated,"March 10, 2008",426,844,Computer,N/A,N/A,N/A
Z-0293-2007,36392,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.",Terumo APS1Perfusion System,2,"January 09, 2007", 2007,Terumo Cardiovascular Systems Corp,An incorrect serial number was placed on one roller pump.,DESIGN: Labeling Design,"The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.",N/A,1,1,Worldwide-Michigan and Singapore.,Terminated,"February 01, 2007",23,3,Not_Computer,N/A,N/A,N/A
Z-0466-2007,36868,"Bit, Drill",HTW,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K),BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.,Bold/INIClip,2,"January 09, 2007", 2007,Integra LifeSciences Corp.,Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.,N/A,An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.,N/A,107,107 in US.,"Nationwide to distributors, hospitals and Integra Sales Reps.",Terminated,"April 16, 2008",463,107,Not_Computer,N/A,N/A,N/A
Z-0471-2007,36958,"Calculator/Data Processing Module, For Clinical Use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers",Beckman Coulter Expo 32 ADC,2,"January 09, 2007", 2007,Beckman Coulter Inc,The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.,N/A,"A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containing the same ratio parameter assignments. 2) Before running samples, open the protocol intended for use and open the Parameter Selection dialog box to ensure the correct ratio parameter assignments for numerator and denominator are selected. Make any necessary changes and save the protocol. 3) Run samples. (Letter was sent by US mail). A response form is included.",N/A,28,28 units,"Nationwide including the states of MA, AL, CO, MI, IN, MD, MO NY, PA, TX, AR, CA, NJ, FL, and TN",Open,N/A,N/A,28,Computer,N/A,N/A,N/A
Z-0454-2007,36821,"Enzyme Immunoassay, Phenobarbital",DLZ,Phenobarbital test system.,Toxicology,Toxicology,510(K),Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division,Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System,2,"January 09, 2007", 2007,Abbott Laboratories Inc.,Erratic elevated results and or the inability to calibrate due to imprecision.,N/A,"Abbott sent out a product recall letter on 9/26, 2006, to all consignees that received lot numbers 39074HW00, 41008HW00 and 42063HW00. The letter states that the firm has identified a Phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. Until the cause of this issue is identified, they have discontinued shipment of Phenobarbital reagent. It will be necessary to identity an alternate means for Phenobarbital testing during this time. AXSYM and TDxITDxFLx Phenobarbital are available as alternate testing options (consignee may contact the local sales person or Customer Service). Consignees also advised if they forwarded any of the Clinical Chemistry Phenobarbital lots listed above to another laboratory to provide a copy of the letter to their customer. If there are questions, they are advised to call Customer Service (US consignee) or local sales person (foreign consignee). Letter advises if user currently using or have inventory of lot number 39074HW00, expiration 9/30/06, to run two levels of quality control (QC) every 6 hours and be alert to QC trends. For those using or have inventory of lot numbers 41008HW00 & 42063HW00, they are advised to discontinue use of these lots and destroy them following laboratory procedures. Abbott will provide reimbursement for the destroyed kits. A customer reply form is provided.",N/A,162,Worldwide: Lot #41008HW00 - 162 kits; Lot #42063HW00 - 136 kits; Lot #39074HW00 - 150 Kits,"Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia",Open,N/A,N/A,162,Not_Computer,N/A,N/A,N/A
Z-0445-2007,36626,"Component, External, Limb, Ankle/Foot",ISH,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"SPS Blue Line Tube Clamp Adapters, Product No. BL120M",SPS Blue Line Tube Clamp Adapters,2,"January 10, 2007", 2007,Southern Prosthetic Supply Co.,"Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail",PRODUCTION CONTROLS: Process Control,"On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.",N/A,943,943 units,Nationwide,Terminated,"March 07, 2008",422,943,Not_Computer,N/A,N/A,N/A
Z-0299-2007,36624,"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",LGW,N/A,N/A,Neurology,PMA,"Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.",Advanced Bionics Precision Linear Leads,2,"January 10, 2007", 2007,Advanced Bionics Corporation,"A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006.The recall notification letters will instruct physicians to immediately return the unimplanted units.",N/A,18,18,Worldwide.,Open,N/A,N/A,18,Not_Computer,N/A,N/A,N/A
Z-0446-2007,36649,"Humidifier, Respiratory Gas, (Direct Patient Interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(K),"REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.",REMstar Heated Humidifier,2,"January 10, 2007", 2007,"Respironics, Inc.",AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device,N/A,"The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.",N/A,172000,"172,000 units","Worldwide Distribution ---- including USA and countries of Denmark, Austria, France, Canada, Netherlands, Japan, Hong Kong, Austrailia, Great Britain, Spain, Belgium, Germany, Poland, Ireland, Portugal, Saudia Arabia, Korea, Mexico, Finland, Taiwan, Philippines, Iceland, Brazil, Kuwait, New Zealand, Chile, India, Egypt, Norway, Turkey, Jordan, Thailand, Hungary, Russia, Peru, South Africia, Israel, Czech, Pakistan, Lebanon, Venezuela, Sweden, United Arab Emirates, Qatar, Slovakia, Bulgaria, Bermuda, and Colombia.",Terminated,"December 15, 2009",1070,172235,Not_Computer,N/A,N/A,N/A
Z-0467-2007,36871,"Bone Cement, Antibiotic",MBB,Polymethylmethacrylate (PMMA) bone cement.,Orthopedic,Orthopedic,510(K),Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.,Simplex P ,2,"January 10, 2007", 2007,Stryker Howmedica Osteonics Corp.,The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.,DESIGN: Labeling Design,A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary.,N/A,813,813 units,Nationwide,Terminated,"February 28, 2007",49,813,Not_Computer,N/A,N/A,N/A
Z-0468-2007,36883,"Component, External, Limb, Ankle/Foot",ISH,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007",REFlex VSP Prosthetic foot ,2,"January 10, 2007", 2007,Ossur,"Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot",PRODUCTION CONTROLS: Process Control,"By letter on Nov 9, 2006. An initial letter was sent to all involved customers stating the invoice number, the purchase order number and the original shipping date. The problem is explained and the detailed exchange process is outlined. Contact information is included (ref. enclosure 2.1). At the same time as the mailing, all customers are being contacted proactively by a customer service representative.",N/A,138,138 worldwide (86 in US),"Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.",Terminated,"May 28, 2008",504,138,Not_Computer,N/A,N/A,N/A
Z-0487-2007,36304,"System, Applicator, Radionuclide, Remote-Controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(K),"GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.",GammaMed 12it ,2,"January 11, 2007", 2007,Varian Medical Systems,Medical device for patient treatment does not meet electrical safety standards.,DESIGN: Labeling Design,The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.,N/A,1,1 unit,"Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.",Terminated,"May 18, 2007",127,1,Not_Computer,N/A,N/A,N/A
Z-0478-2007,36187,"Lift, Patient, Ac-Powered",FNG,AC-powered patient lift.,General Hospital,General Hospital,510(K),"Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US",Minstrel Patient Lift ,2,"January 11, 2007", 2007,"Arjo, Inc.",The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.,DESIGN: Device Design,"Arjo sent an Urgent Device Field Correction Recall letter dated 8/31/06 to all affected end users to the attention of the Administrator/Risk Manager via FedEx on the same date. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to fatigue failure of the pivot bolt. The accounts were advised that an Arjo Field Service Technician would contact them within five business days to schedule a visit to the account to perform an upgrade of their Minstrel lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6140.",N/A,76,76 lifts,Nationwide,Terminated,"October 16, 2008",644,76,Not_Computer,N/A,N/A,N/A
Z-0479-2007,36636,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits",BHM Kwiktrak Fixed Gate,2,"January 11, 2007", 2007,"Arjo, Inc.",The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.,DESIGN: Device Design,"Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that if the ceiling lift is moved too fast or too forcefully into a closed gate, the gate stopper can be damaged, causing its function to fail. One consequence can be that the gate may remain open, allowing the ceiling lift to pass through to the end of the track. The letters requested the customer to visually inspect their Kwiktrak Gate installation used with their Maxisky-600 Ceiling Lift to determine if there are any signs of impact or burr marks on the closed gate stopper. Illustrations of a damaged and normal gate stopper were included. The customers were requested to stop use of the Kwiktrak track system if any signs of impact or burr marks are found, and contact the Arjo Quality Department at 1-800-323-1245, ext. 6140 for special instructions. If no signs of damage were found, the customers were reminded to make sure that they manually drive the ceiling lift in a gentler manner to prevent damage to the gate stopper, making sure that all personnel using the ceiling lifts are properly trained. The accounts were informed that Arjo personnel will contact them in the next few weeks to install an improved system that will eliminate the risks of failure.",N/A,3,3 gate systems,"Michigan, Ohio and Illinois",Terminated,"January 09, 2010",1094,3,Not_Computer,N/A,N/A,N/A
Z-0480-2007,36740,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),"Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653",V.I.P Bird Gold ,2,"January 11, 2007", 2007,"Viasys Respiratory Care, Inc.",The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.,N/A,"On November 2, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On November 4, 2006, a product notification letter was mailed to all international customers via registed mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package.",N/A,1478,1478,"Worldwide including USA, Canada, Estonia, Belgium, Saudi Arabia, Brazil, Thailand, United Arab Emirates, Syria, Portugal, Jordan, Italy, Latvia, Hong Kong China, Ecuador, Jamaica, Dominican Republic, New Zealand, Australia, Czech Republic, Bolivia, Austria, Greece, United Kingdom (England), Turkey, Chile, Japan, India, Mexico, Uruguay, Algeria, Vietnam, Costa Rica, Ireland, Switzerland, Bahamas, Singapore, South Africa, Philippines, Spain, France, Peru, Lebanon, Taipei, Malaysia, Netherlands, South Korea, Israel & Slovak Republic",Terminated,"September 03, 2008",601,2017,Software,Device Operation,Software update,Software Update
Z-0457-2007,36849,"Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer",HRY,Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 1, sterile; Part number 1498-23-001.",Depuy Preservation UniCompartmental Knee ,2,"January 11, 2007", 2007,"Depuy Orthopaedics, Inc.",Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.,N/A,"The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.",N/A,558,558 for Recalls Z-0456-0465-2007,Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.,Terminated,"April 30, 2008",475,558,Not_Computer,N/A,N/A,N/A
Z-0482-2007,36802,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length",BHM Reacher for Portable Ceiling Lifts,2,"January 11, 2007", 2007,"Arjo, Inc.",The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.,N/A,"BHM sent recall letters to Arjo''s direct accounts on 11/13/06 via first class mail, informing them that fastening the carabineer to the exterior of the closed ring portion of the reacher is contrary to the manufacturer''s instructions and is an unsafe practice. The letters informed the users that Health Canada had received notification of an incident involving a reacher marketed by a competitor, and had conducted an investigation into all similar reachers available on the Canadian market. Enclosed with the letter was a copy of the BHM Reacher User''s Guide as well as a warning sticker that visually describes the safe method for connecting the carabineer to the reacher. The accounts were requested to place the warning stickers on their reachers, review the enclosed User''s Guide in detail, and ensure that all personnel using the reacher receive refresher training on its proper use and have access to the supplied User''s Guide. Once these measures have been completed, the account was requested to complete the enclosed response form and return it to BHM by fax, e-mail or mail.",N/A,886,886 reachers,Nationwide,Terminated,"January 19, 2010",1104,886,Not_Computer,N/A,N/A,N/A
Z-0488-2007,36889,"Radioimmunoassay, Luteinizing Hormone",CEP,Luteinizing hormone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500",ARCHITECT LH Reagent,2,"January 11, 2007", 2007,Abbott Laboratories MPG,"The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.",N/A,"Abbott initiated a field correction recall by letter dated 11/22/06 to all customers receiving the affected reagent. The accounts were informed of the elevated patient results with the affected lots of reagents. The accounts were requested to assess the inventory for the affected lots of reagents, discontinue use of the lots and destroy the remaining inventory of the lots, recording the number of kits on the customer reply form and faxing it to Abbott by 12/6/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.",N/A,2960,"2,960 kits","Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.",Terminated,"December 09, 2009",1063,2960,Not_Computer,N/A,N/A,N/A
Z-0483-2007,36928,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R",Colleague and Colleague CX Volumetric Infusion Pumps,2,"January 11, 2007", 2007,Baxter Healthcare Corp.,"Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.",N/A,"Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.",N/A,267317,"267,317 pumps","Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Open,N/A,N/A,347529,Hardware,Treatment/Delivery/Therapy,Reconfiguration,Other
Z-0489-2007,37010,"Plate, Fixation, Bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(K),"LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465",LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong,2,"January 11, 2007", 2007,Synthes,"Hole is malformed, leading to reduced construct strength.",DESIGN: Software Design,"All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.",N/A,11,11 units,"The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.",Terminated,"February 13, 2007",33,11,Not_Computer,N/A,N/A,N/A
Z-0485-2007,37003,"Warmer, Infant Radiant",FMT,Infant radiant warmer.,General Hospital,General Hospital,510(K),Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module,CosyCot,2,"January 11, 2007", 2007,Fisher & Paykel Healthcare Ltd,This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.,N/A,"Fisher & Paykel Healthcare commenced sending out Product Correction Notifications letter via U.S. Postal Service certified mail October 9, 2006. This Product Correction Notice explained the nature of the problem and include a reminder of the maximum recommended weight of accessories. Two FAX Response Forms were provided, Part A for initial receipt of the Product Correction Notice and Part B for confirmation of the completed upgrade.",N/A,273,273 units in US & 9 in Canada,Nationwide and Canada,Open,N/A,N/A,273,Not_Computer,N/A,N/A,N/A
Z-0476-2007,36973,"Prosthesis, Hip, Hemi-, Femoral, Metal",KWL,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),Howmedica Hip Fracture Stem SystemNo. 4 Femoral ComponentFenestratedSterile REF Catalogue #6942-0-040Made in Ireland,Howmedica HIp Stem,2,"January 13, 2007", 2007,Stryker Howmedica Osteonics Corp.,Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.,N/A,Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.,N/A,67,67 units,Nationwide,Terminated,"May 08, 2007",115,1657,Not_Computer,N/A,N/A,N/A
Z-0470-2007,36956,"Test, Time, Prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.",ProTimePro Microcoagulation System,3,"January 13, 2007", 2007,International Technidyne Corp.,Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.,DESIGN: Software Design,Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator''s manual.,N/A,1541,"1,541 units",Nationwide to health care professionals and ITC distributors,Terminated,"April 26, 2007",103,1541,Software,Output/Calculation,Update the manual,Other
Z-0354-2007,36731,Spinal Vertebral Body Replacement Device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(K),"TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system",TraXis Fixed Trial,2,"January 17, 2007", 2007,Abbott Spine,Tip of devices may dislodge while in use during surgery.,PRODUCTION CONTROLS: Process Control,All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.,Contact the recalling firm for information,76,76 units.,"Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus",Terminated,"October 11, 2007",267,142,Not_Computer,N/A,N/A,N/A
Z-0356-2007,36887,"Method, Nephelometric, Immunoglobulins (G, A, M)",CFN,"Immunoglobulins A, G, M, D, and E immunological test system.",Immunology,Immunology,510(K),Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.,Roche COBAS INTEGRA IGGT,2,"January 17, 2007", 2007,Roche Diagnostics Corp.,Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant Hemoglobin A1c assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 800 analyzer.,MISBRANDING: Labeling False and Misleading,Device correction letters dated 12/15/06 instructing users to perform an extra wash cycle between applications when using both the ALBT2 and IGGT cassettes on the COBAS INTEGRA 700 and 800 analyzers. The recall was extended to via device correction letters dated 2/28/07 instructing users to perform an extra wash cycle between applications when using both the A1C2 and IGGT cassettes on the COBAS INTEGRA 800 analyzer.,N/A,18905,"18,905",Nationwide.,Terminated,"April 23, 2008",462,18905,Not_Computer,N/A,N/A,N/A
Z-0353-2007,36713,"Enzyme Immunoassay, Valproic Acid",LEG,Neuroleptic drugs radioreceptor assay test system.,Toxicology,Toxicology,510(K),"ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.",ADVIA 2400 Chemistry System,2,"January 17, 2007", 2007,"Bayer Healthcare, LLC (Diagnostics Division)",Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.,DESIGN: Software Design,"On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.",N/A,1184,"1184 instruments total, all products","Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.",Open,N/A,N/A,1184,Not_Computer,N/A,N/A,N/A
Z-0455-2007,36831,"Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic",NAE,Hydrogel wound dressing and burn dressing.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.","HiZel, trayless, wound dressing, sterile ",2,"January 17, 2007", 2007,Embeem Inc.,"Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,Recall letters were sent out on 11/9/2006 to the retail level .,N/A,1258,"1,258 pieces",There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.,Terminated,"July 21, 2008",551,1258,Not_Computer,N/A,N/A,N/A
Z-0358-2007,36984,"Pump, Infusion, Elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(K),"I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742",ONQ PainBuster ,2,"January 18, 2007", 2007,I-Flow Corporation,The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.,N/A,"A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory.A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.",N/A,3475,3475,Nationwide,Terminated,"December 11, 2009",1058,3475,Not_Computer,N/A,N/A,N/A
Z-0357-2007,36655,"Laparoscope, General & Plastic Surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in the USA for: CRS Medical Diagnostics, Inc., Pewaukee, WI.",Fibrin analysis Catheter Testing System,2,"January 18, 2007", 2007,"Continental Medical Labs,Inc",Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.,DESIGN: Device Design,Consignee was notified by certified mail on 10/19/06.,N/A,840,840 kits,Product was distributed to one consignee located in Wisconsin,Terminated,"January 18, 2007",0,840,Not_Computer,N/A,N/A,N/A
Z-0343-2007,36785,"Dna Probe, Trichomonas Vaginalis",MJK,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K),"Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.",Welch Allyn PIC 50 Portable Monitor/Defibrillator,2,"January 19, 2007", 2007,"MRL, Inc., A Welch Allyn Company","Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.",N/A,"MRL sent Urgent Medical Device Recall letters dated 11/8/06 via certified mail on 11/15/06 to the direct accounts informing them of an intermittent connection between the J5 cable and its mating connector on a circuit board inside of the device that could result in a malfunction that could prevent or unacceptably delay the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units'' parts/serial numbers and were requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. Until their PIC 50 is serviced, the accounts were instructed to check the unit before each shift by using the self-test, which is automatically initiated by powering up the device. If the 'ECG Comm' error occurs during use, cycling the power off-on may clear the error. Even if power cycling clears the device, the accounts were instructed to contact Welch Allyn - MRL to obtain priority servicing of the affected unit. The accounts were also instructed to respond to the notification within 30 days by fax or mail, or by calling Welch Allyn - MRL Technical Support at 1-800-462-0777, to schedule their PIC 50 for preventative service. Welch Allyn will provide the accounts with a loaner PIC 50 after receiving the form with instructions to send back the PIC 50 in the same shipping box accompanying the loaner unit. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.",N/A,510,510 units,"Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emirates and the United Kingdom.",Terminated,"October 31, 2007",285,510,Hardware,Treatment/Delivery/Therapy,Repair,Repair
Z-0349-2007,36843,"Plate, Fixation, Bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(K),"DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.","DRLock Volar Plate Screw System, model DVR900",3,"January 19, 2007", 2007,OrthoHelix Surgical Designs Inc,"The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.",DESIGN: Device Design,The recalling firm contacted all consignees by phone on or about 8/3/06.,N/A,180,180,"The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and Crystal Clinic, Akron, OH.",Open,N/A,N/A,180,Not_Computer,N/A,N/A,N/A
Z-0364-2007,36991,"Test, Time, Prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(K),"i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24IVDAbbott Point of Care Inc.104 Windsor Center DriveEast Windsor, NJ 08520Product of Canada",iSTAT ,2,"January 23, 2007", 2007,Abbott Point of Care Inc.,Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.,N/A,Customers were notified by letter sent by regular mail on 12/13/2006.,N/A,24,"14,045 boxes of 24",Nationwide to hospitals and health care facilities,Terminated,"August 15, 2007",204,14045,Not_Computer,N/A,N/A,N/A
Z-0361-2007,37011,"Colorimetry, Salicylate",DKJ,Salicylate test system.,Toxicology,Toxicology,510(K),"Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892",Diagnostic Chemicals Limited,2,"January 23, 2007", 2007,"Diagnostic Chemicals, Ltd.","Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories",PRODUCTION CONTROLS: Process Control,For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.,No consumer action necessary,55,55 kits shipped to one customer,PA,Open,N/A,N/A,55,Not_Computer,N/A,N/A,N/A
Z-0362-2007,37071,"Instrument, Biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.",Suros ATEC Breast Biopsy System ,2,"January 23, 2007", 2007,Suros Surgical Systems Inc.,The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.,DESIGN: Labeling Design,Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.,N/A,1249,1249 handpieces,Nationwide.,Terminated,"May 04, 2007",101,1249,Not_Computer,N/A,N/A,N/A
Z-0363-2007,36256,"Assembly, Thigh/Knee/Shank/Ankle/Foot, External",KFX,External assembled lower limb prosthesis.,Physical Medicine,Physical Medicine,510(K),"Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.",Otto Bock Compact prosthetic knee joint,2,"January 25, 2007", 2007,"Bock,Otto,Orthopedic Ind,Inc","A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.",PRODUCTION CONTROLS: Process Control,"An Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced.",N/A,176,176,Nationwide.,Terminated,"November 26, 2008",671,176,Not_Computer,N/A,N/A,N/A
Z-0340-2007,36333,"Tubing, Pump, Cardiopulmonary Bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(K),"Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.",Medtronic Intersept Custom Tubing Pack,3,"January 25, 2007", 2007,Medtronic Perfusion Systems,An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.,N/A,"An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.",N/A,146,146,"Distributed in 6 states: CA, FL, IL, IN, LA and TN",Terminated,"February 03, 2007",9,146,Not_Computer,N/A,N/A,N/A
Z-0342-2007,36672,"Stimulator, Autonomic Nerve, Implanted For Epilepsy",LYJ,N/A,N/A,Neurology,PMA,"Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.",Cyberonics VNS Therapy System,2,"January 25, 2007", 2007,"Cyberonics, Inc","During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician",DESIGN: Software Design,Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.,N/A,7404,"7,404 Handheld PCs pre-programmed with software.","Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.",Terminated,"October 02, 2009",981,10942,Other,Output/Calculation,Instructions to avoid,Safety Notice/Insructions
Z-0372-2007,37089,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),Ventilator System SERVO-i V3.1 PC1777Maquet Critical Care,SERVOi ,2,"January 25, 2007", 2007,MAQUET Inc.,"Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.",N/A,971,"1, 970 units",Worldwide,Terminated,"April 11, 2008",442,1970,Other,Device Operation,Replace board,Remove or Replace
Z-0378-2007,37051,"Tube, Laryngectomy",KAC,"Ear, nose, and throat manual surgical instrument.",Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.",Bivona Laryngectomy Tube,3,"January 25, 2007", 2007,"Smiths Medical ASD, Inc.",The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.,N/A,117,117,"Worldwide, including USA, Canada, Netherlands and United Kingdom.",Terminated,"December 04, 2007",313,117,Not_Computer,N/A,N/A,N/A
Z-0350-2007,37023,"Controller, Temperature, Cardiopulmonary Bypass",DWC,Cardiopulmonary bypass temperature controller.,Cardiovascular,Cardiovascular,510(K),"Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine",Jostra Heater Cooler,2,"January 25, 2007", 2007,MAQUET Inc.,The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.,DESIGN: Software Design,Letters were mailed to customers on 11/10/2006 by Federal Express.,N/A,13,13 units,"Hospitals in CA, NC, FL, WY, NY and WV.S",Terminated,"February 05, 2007",11,13,Not_Computer,N/A,N/A,N/A
Z-0377-2007,37115,"Endoscopic Access Overtube, Gastroenterology-Urology",FED,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.",Cook Flexor DL,2,"January 25, 2007", 2007,"Cook Urological, Inc.","Lack of assurance of sterility, as the packages may not have been sealed.",PRODUCTION CONTROLS: Packaging Process Control,Consignees were notified via recall letter dated 1/5/07 and requested to return the product.,N/A,4,4,"Massachusetts, Maine, New Hampshire and Puerto Rico.",Terminated,"May 01, 2008",462,4,Not_Computer,N/A,N/A,N/A
Z-0376-2007,37097,"Calibrator, Secondary",JIT,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(K),"Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.",D10 Dual Program,2,"January 25, 2007", 2007,Bio-Rad Laboratories Inc,"The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.",PRODUCTION CONTROLS: Process Control,The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.,N/A,943,"900 kits, 43 sets distributed.","Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.",Terminated,"November 28, 2007",307,943,Hardware,Device Operation,Remove,Remove or Replace
Z-0373-2007,37121,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),"GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010",GE Centricity PACS RA1000 Workstation,2,"January 25, 2007", 2007,GE Healthcare Integrated IT Solutions,"The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.",DESIGN: Software Design,"GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.",N/A,198,198 units,"Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.",Terminated,"February 03, 2010",1105,198,Software,Display/Image,Software update,Software Update
Z-0368-2007,37012,"System, X-Ray, Angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(K),"Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).",Integris Allura,2,"January 25, 2007", 2007,Philips Medical Systems North America Co. Phillips,"Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.",DESIGN: Device Design,On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.,N/A,140,140 devices total,Units were distributed to hospitals and medical centers nationwide.,Open,N/A,N/A,140,Not_Computer,N/A,N/A,N/A
Z-0365-2007,37013,Surgeon'S Gloves,KGO,Surgeon's glove.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia",Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves,2,"January 25, 2007", 2007,Terang Nusa Sdn Bhd,Some of the packages labeled as latex-free actually contain latex gloves.,TRAINING: Employee Error,"Terang Nusa telephoned Medline Industries on 12/13/06 requesting them to retrieve the affected lot of size six gloves from their customers. Medline Industries notified their customers by letter dated 12/20/06, informing them of the possible latex gloves being labeled as the Neolon 2G Neoprene Surgical Gloves, and requesting them to inspect their inventories for the suspect size and lot of gloves. The accounts were instructed to complete the enclosed response questionnaire, indicating the amount of affected gloves found, and fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-359-1704.",N/A,43,43 cases,"Worldwide including USA, Canada, and Panama",Terminated,"August 12, 2009",930,43,Not_Computer,N/A,N/A,N/A
Z-0359-2007,36990,"Mesh, Surgical, Polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Bard Composix Kugel Hernia Patch-Large Oval with ePTFE , 5.4'' x 7.0''Product Number: 0010202",Davol Composix Hernia Patch ,1,"January 30, 2007", 2007,"Davol, Inc., Sub. C. R. Bard, Inc.",PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula,DESIGN: Device Design,"Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.",N/A,32581,"32,581 units",Nationwide,Open,N/A,N/A,49184,Not_Computer,N/A,N/A,N/A
Z-0375-2007,36922,"Staple, Implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)",Salute,2,"February 01, 2007", 2007,"Davol, Inc., Sub. C. R. Bard, Inc.",Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing,N/A,"Davol notified users by a first letter on 12/27/06 providng a introductory letter explaining the Enhanced Servicing Program and changes made to the IFU (re: servicing, tip inspection, end of wire, and test fire protocol). A second letter will issue to accounts to identifying the serial number to be serviced and returned to Davol.",N/A,4787,4787 (includes both types),"Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa.",Open,N/A,N/A,4787,Not_Computer,N/A,N/A,N/A
Z-0389-2007,37006,"Catheter, Biliary, Diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.,Protege GPS Biliary Stent System,3,"February 01, 2007", 2007,"Ev3, Inc",Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.,TRAINING: Employee Error,"Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.",N/A,2,2,"IL, PA",Terminated,"February 03, 2007",2,2,Not_Computer,N/A,N/A,N/A
Z-0381-2007,36963,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046.,Terumo APS 1,2,"February 01, 2007", 2007,Terumo Cardiovascular Systems Corp,"Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.",DESIGN: Software Design,"Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.",N/A,35,35,Nationwide.,Terminated,"June 11, 2007",130,35,Software,Output/Calculation,Software update,Software Update
Z-0390-2007,37019,"Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass",DTL,"Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.",Cardiovascular,Cardiovascular,510(K),"ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242",ACS,2,"February 01, 2007", 2007,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,Specific lots of the .096' and .115' RotatingHemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch,PRODUCTION CONTROLS: Packaging Process Control,"On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.",N/A,24365766,"6090751 - 791 devices, 6090752 - 656 devices, 6091151 - 381 devices, 6091152 - 132 devices","Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.",Open,N/A,N/A,1960,Not_Computer,N/A,N/A,N/A
Z-0393-2007,37021,"Filter, Intravascular, Cardiovascular",DTK,Cardiovascular intravascular filter.,Cardiovascular,Cardiovascular,510(K),"G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J",G2,2,"February 01, 2007", 2007,Bard Peripheral Vascular Inc,This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.,PRODUCTION CONTROLS: Process Control,"Recall letters were sent to all consignees via Federal Express overnight delivery with signature receipt required on December 20, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV). Customers will be asked to immediately remove product from inventory and isolated from use and contact BARD for return authorization. All returned product will be destroyed.",N/A,5761,5761 units,"Worldwide including USA, Australia, and Canada",Terminated,"October 23, 2008",630,5885,Not_Computer,N/A,N/A,N/A
Z-0395-2007,37126,"Catheter, Intravascular, Diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific brand iLab¶_ Ultrasound Imaging System, for intravascular use;Model Number(s): iLab120lNS, iLab2401NS, Distributed by and Manufactured by:Boston Scientific Corporation IVUS, Technology Center,47201 lakeview Parkway, Fremont, CA 94538",Boston Scientific iLab ,2,"February 01, 2007", 2007,Boston Scientific Target,"The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.",N/A,"A customer notification was sent December 1, 2006 indicating the need for the correction.","Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",24,24 units,Nationwide and Portugal.,Terminated,"December 05, 2007",307,24,Hardware,Treatment/Delivery/Therapy,Correction,Repair
Z-0397-2007,37143,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Portrait¶_ PSR3 System, an electro-surgical device used in dermatological applications",Portrait ,2,"February 01, 2007", 2007,Rhytec Inc.,Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz,DESIGN: Labeling Design,Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.,N/A,234,234 units,"Canada, Australia, Brazil, Korea",Open,N/A,N/A,234,Software,Output/Calculation,Software update,Software Update
Z-0398-2007,36458,"Dressing, Wound, Drug",FRO,N/A,N/A,General & Plastic Surgery,510(K),Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.,Mucotrol,2,"February 07, 2007", 2007,Belcher Pharmaceuticals Inc.,Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.,N/A,Consignees were notified of recall via letter dated 09/25/2006.,N/A,1097,1097 bottles,Nationwide.,Terminated,"July 22, 2008",531,1097,Not_Computer,N/A,N/A,N/A
Z-0421-2007,36967,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"Desktop Pro¶_ R6.0 & R6.1, Linear Medical Accelerator.",Desktop Pro Linear Medical Accelerator,3,"February 07, 2007", 2007,"Elekta, Inc.",Unexpected Diaphragm movement when manual field size modifications are not saved.,N/A,Consignees were notified by letter on/about 11/23/2006.,N/A,37,37 units,"Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .",Terminated,"May 14, 2008",462,37,Not_Computer,N/A,N/A,N/A
Z-0416-2007,36996,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.",ARCHITECT i2000SR Processing Module,2,"February 07, 2007", 2007,"Abbott Laboratories, Inc","The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.",DESIGN: Device Design,"Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.",N/A,648,648 units.,"Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.",Terminated,"September 24, 2007",229,705,Hardware,Device Operation,Instructions to verify,Safety Notice/Insructions
Z-0417-2007,37065,"Thyroglobulin, Antigen, Antiserum, Control",DDC,Thyroid autoantibody immunological test system.,Immunology,Immunology,510(K),"Access¶_ Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890",Access,2,"February 07, 2007", 2007,Beckman Coulter Inc,Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.,N/A,"A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.",N/A,474,474 units,Nationwide and Canada,Open,N/A,N/A,474,Not_Computer,N/A,N/A,N/A
Z-0382-2007,37001,"Catheter, Percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.",Mach 1 Guide Catheter,2,"February 07, 2007", 2007,Boston Scientific,"Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.",N/A,3,3,Nationwide.,Terminated,"June 28, 2007",141,51,Not_Computer,N/A,N/A,N/A
Z-0396-2007,37139,Ocular Peg,MQU,Eye sphere implant.,Ophthalmic,Ophthalmic,510(K),"Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted.The affected model which is the subject of this recall comes with the flat peg.",Ocular Motility Peg system,2,"February 07, 2007", 2007,Integrated Orbital Implants Inc,"The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.",DESIGN: Process Design,"All domestic customers were notified by phone call on 12//20/2006 which was followed up with a fax and the letter sent registered mail. Internationally, customers were notified by fax, email and mail.Customers were instructed to check their inventory of the product by lot number and visual inspection. They were instructed to isolate the affected inventory. They were provided with alternate instructions on how to use the product as it is, if needed. They were provided with a reply card to complete and fax back to the company. They were instructed that when replacement product becomes available, they will be contacted to arrange for the exchange of the affected product.",N/A,234,234,"Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.",Terminated,"July 12, 2007",155,234,Not_Computer,N/A,N/A,N/A
Z-0400-2007,37024,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),Triathlon X3 CR Tibial Bearing InsertSize #7 - 11MMRef # 5530-G-7112011-09Howmedica Osteonics Corp.,Triathlon,2,"February 08, 2007", 2007,Stryker Howmedica Osteonics Corp.,"A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.",PRODUCTION CONTROLS: Packaging Process Control,Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.,N/A,24,24 units,Nationwide and Canada.,Terminated,"February 21, 2007",13,47,Not_Computer,N/A,N/A,N/A
Z-0411-2007,37066,"Orthosis, Spinal Pedicle Fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(K),"Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA",Rocker Reducer,2,"February 08, 2007", 2007,Medtronic Sofamor Danek Instrument Manufacturing,"Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.",PRODUCTION CONTROLS: Process Control,"The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device.",N/A,58,58 units,"Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.",Terminated,"July 16, 2007",158,58,Not_Computer,N/A,N/A,N/A
Z-0410-2007,37057,"Knife, Ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Beaver¶_ Mini-Blade, Mini/Bulk 69, Catalog Number: 374823",BD Beaver,2,"February 08, 2007", 2007,Becton Dickinson and Company,Product sterility may be compromised due to incomplete package seal,PRODUCTION CONTROLS: Process Control,"On 12/26/2006 BD Medical, Ophthalmic Systems mailed a recall notification letter to US Distributors and US OEM''s. Customers are instructed to return any affected products to BD for a replacement. On 1/10/07, the firm expanded the recall to additional lots. Those lots are noted with an asterisk.",N/A,43600,"43,600 units","Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.",Open,N/A,N/A,664050,Not_Computer,N/A,N/A,N/A
Z-0420-2007,37083,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part #722593 CXP Analysis Software Kit V2.1, 5 Network User PackPart #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1, 15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0, Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack; Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643 CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.",CXP Analysis Software,2,"February 08, 2007", 2007,Beckman Coulter Inc,Two workflow scenarios associated with renaming regions may produce incorrect results.,N/A,"A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.",N/A,200,200 units nationwide,Nationwide & Canada,Open,N/A,N/A,623,Computer,N/A,N/A,N/A
Z-0414-2007,37162,"Laparoscope, General & Plastic Surgery, Reprocessed",NLM,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.",AutoSuture ,2,"February 08, 2007", 2007,"Ascent Healthcare Solutions, Inc.",The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.,PRODUCTION CONTROLS: Reprocessing Controls,The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.,N/A,1566,1566,Nationwide,Terminated,"October 31, 2008",631,1566,Not_Computer,N/A,N/A,N/A
Z-0412-2007,36154,Ventricular (Assisst) Bypass,DSQ,N/A,N/A,Cardiovascular,PMA,"Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588",Thoratec Dual Drive Console,2,"February 10, 2007", 2007,Thoratec Corp,The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.,DESIGN: Device Design,The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.,N/A,331,331,Worldwide,Terminated,"April 18, 2008",433,331,Not_Computer,N/A,N/A,N/A
Z-0379-2007,37099,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),Ventilator System Servo-i V3.1Maquet Critical CarePC1771,Maquet Critical Care Ventilator System ,2,"February 10, 2007", 2007,MAQUET Inc.,The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator,DESIGN: Device Design,"Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going.",N/A,2436,"2,436 units",Worldwide,Terminated,"March 23, 2009",772,2436,Not_Computer,N/A,N/A,N/A
Z-0432-2007,36490,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",Terumo APS 1,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,"A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as zero, even when the battery is fully functional.",N/A,"Consignees were sent a letter dated 11/10/06 informing them of the nature of the issues and that the firm would contact them to schedule a service call to install the software upgrade package. The software upgrade installation began at customers on 10/16/06, prior to issuance of the letter to consignees.",N/A,489,489,"Worldwide distribution ---- including USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,696,Software,Alarm/Message,Software update,Software Update
Z-0436-2007,36491,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100.,Terumo APS 1,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.,DESIGN: Software Design,Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.,N/A,683,683,"Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,1379,Software,Alarm/Message,Software update,Software Update
Z-0438-2007,36494,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.",Terumo Advanced Perfusion System,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,"The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.",DESIGN: Software Design,Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.,N/A,1399,"1,399","Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,3350,Computer,N/A,N/A,N/A
Z-0493-2007,36496,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States).,Terumo APS 1,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,"The pump may lose communication with the central control monitor, causing the monitor to display a service message ""System Computer Needs Service"" and to become non-operational.",DESIGN: Software Design,Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.,N/A,50,50,"Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,3743,Computer,N/A,N/A,N/A
Z-0494-2007,36498,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110.,Terumo APS 1,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.,DESIGN: Software Design,Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.,N/A,806,806,"Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,806,Software,Alarm/Message,Software update,Software Update
Z-0437-2007,36492,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041.,Terumo APS 1,2,"February 14, 2007", 2007,Terumo Cardiovascular Systems Corp,"The large roller pump may experience false ""overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump.",DESIGN: Software Design,Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.,N/A,1951,"1,951 units","Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",874,1951,Software,Alarm/Message,Software update,Software Update
Z-0477-2007,36932,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan",Life Scan One Touch Ultra,1,"February 14, 2007", 2007,"Matrix Distributors, Inc.",Counterfeit Test Strips (manufacturer unknown),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit,Matrix Distributors contacted by telephone those pharmacies to which they had shipped the affected lots. These call were conducted from 10/9 to 10/13/2006. A follow-up letter was issued to the pharmacies extending the recall to the user level.,N/A,800,800 units,Product was distributed to 96 pharmacies throughout the United States.,Terminated,"January 07, 2008",327,800,Not_Computer,N/A,N/A,N/A
Z-0500-2007,36925,"Apparatus, Autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(K),Atrium Express Dry Seal Chest Drain with Sterile Fluid Path PackageModel Number: 4050-170N,Atrium,2,"February 15, 2007", 2007,Atrium Medical Corporation,Chest drainage tubing incorrectly assembled and may disconnect from patient during use,PRODUCTION CONTROLS: Process Control,Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.,N/A,49,49 cases ( 294 units),"Nationwide, including CA, and PA.",Terminated,"November 27, 2007",285,49,Not_Computer,N/A,N/A,N/A
Z-0380-2007,36241,Full-Montage Standard Electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(K),"NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.",NicoletOne monitoring system version 5.20 software,3,"February 15, 2007", 2007,Nicolet Biomedical Div of Viasys Healthcare,"A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.",DESIGN: Software Design,"An Advisory Notice, dated August 25, 2006, was sent to all affected customers. The notice described the issues, states to discontinue use of 5.20.1038 software until updated 5.21.1039c software is installed.",N/A,75,75,"Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.",Open,N/A,N/A,75,Software,Output/Calculation,Software update,Software Update
Z-0504-2007,36855,"Table, Radiographic, Tilting",IXR,Radiologic table.,Radiology,Radiology,510(K) Exempt,"Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.",Stille Sonesta Video Fluoroscopy Table 6210,2,"February 15, 2007", 2007,"Stille-Sonesta, Inc",Bolts may back out of their joints causing the back section of the table to tilt.,PRODUCTION CONTROLS: Process Control,Notifications letters sent to consignees on 11/20/06. Users are instructed to check the bolts located under the table. The Notice includes instructions with pictures for checking the bolts and tightening them if necessary. Stille AB has developed a kit for replacing the bolt that is involved and will send a service engineer out to the site to do the replacement.,N/A,66,66 units.,Nationwide.,Terminated,"June 20, 2007",125,66,Not_Computer,N/A,N/A,N/A
Z-0506-2007,37028,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the obese population (BMI",GE LightSpeed RT16 CT Scanner System ,2,"February 15, 2007", 2007,GE Healthcare,"When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced.",DESIGN: Software Design,"A Product Safety Advisory Notice, dated December 8, 2006, was issued to all customers informing them of the safety issue and production correction. Customers are advised to operate the CT cradle as intended with the system''s electronic controls. If a critical need arises to release the cradle during a radiation therapy simulation scan, they are advised to independently verify patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software update will be installed to correct this problem by a GE representative.",N/A,22,22 units,"Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.",Terminated,"November 30, 2007",288,1278,Computer,N/A,N/A,N/A
Z-0425-2007,37085,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172",Sara Active Sling Wide,2,"February 15, 2007", 2007,"Arjo, Inc.","There is the potential for the slings to come apart, potentially allowing injury to the patient.",PRODUCTION CONTROLS: Process Control,"Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.",N/A,16,16 slings,Nationwide,Terminated,"September 02, 2008",565,95,Not_Computer,N/A,N/A,N/A
Z-0501-2007,37002,Sirolimus Test System,NRP,Sirolimus test system.,Toxicology,Toxicology,510(K),"IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA",IMx Sirolimus Reagent Pack,2,"February 15, 2007", 2007,Abbott Laboratories MPG,The sirolimus values may shift higher after storage at 2-8¶_C or after one freeze/thaw cycle of specimens.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,Abbott initiated a field correction recall by letter dated 8/11/06 to all customers receiving the affected reagent. The accounts were informed of the shift in sample values after storage at 2-8*C or with freeze thaw of specimens with the affected lots of reagents. The accounts were requested to review the revised sample handling information included in the attachment to the letter with their laboratory personnel and retain a copy of the letter and attachment for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.,N/A,2800,"2,800 kits","Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealand, Norway, Italy, Portugal, Spain, Greece, Panama, Hungary, Slovakia, Russia, Romania, Cyprus, Germany, Lithuania, Saudi Arabia, Jordan, Israel, Lebanon, Kuwait, Oman, Qatar, UAE, Egypt, Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Argentina, Brazil, El Salvador, Canada, Ireland, United Kingdom, Sweden, Netherlands, Belgium, France, Austria, Czech Republic, and Switzerland",Terminated,"January 18, 2008",337,2800,Not_Computer,N/A,N/A,N/A
Z-0510-2007,37180,Powered Laser Surgical Instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display",Candela Corporation Vbeam Aesthetica Laser System,2,"February 15, 2007", 2007,Candela Laser Corporation,Internal component may overheat causing the possibility of risk of fire or smoke,DESIGN: Software Design,Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.,N/A,474,474 laser systems total (all models),"Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico",Terminated,"May 01, 2007",75,474,Not_Computer,N/A,N/A,N/A
Z-0427-2007,37113,"Lenses, Soft Contact, Extended Wear",LPM,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,510(K),"O¶_Optix¶_ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).",OOptix (lotrafilcon B) Soft Contact Lenses,2,"February 15, 2007", 2007,Ciba Vision Corporation,Reduced Ion Permeability,N/A,Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.,N/A,11.4,11.4 million lenses,"Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany",Terminated,"March 21, 2008",400,11400000,Not_Computer,N/A,N/A,N/A
Z-0514-2007,37191,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(K),"OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.",Imageintensified fluoroscopic xray system.,2,"February 15, 2007", 2007,"GE OEC Medical Systems, Inc",Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.,DESIGN: Device Design,"Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.",N/A,425,425 units,"Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.",Open,N/A,N/A,702,Not_Computer,N/A,N/A,N/A
Z-0428-2007,37182,"Catheter, Peritoneal",GBW,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations:a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit",Taut Intraducer Peritoneal Catheter,2,"February 15, 2007", 2007,"Taut, Inc.","Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.",DESIGN: Packaging Design/Selection,"Taut sent Urgent Medical Device Recall letters dated 1/19/07, via UPS over night, on the same date, informing them that the two lots of catheters may have package seals that are not intact. Customers were instructed to check their stocks for the affected lots, remove any found and return all affected product immediately. The PI-128 is also a component of the System One Comprehensive Lap CBDE Kist, catalog number 50000, which is a convenience kit. The customer is being instructed to remove the PI-128, Intraducer Peritoneal Catheter contained in the System Once Comprehensive Lap CBDE Kit in the eight kit lots listed, and return the PI-128 catheters. All other components of the kit may be used. As the PI-128, Intraducer Peritoneal Catheter, can also be ordered as a replacement component, the customer is also being instructed to check all opened System One Comprehensive lap CBDE kits, regardless of lot number, to ensure that it does not contain the impacted PI-128 lots. The customers were requested to complete and return the enclosed Acknowledgment & Stock Status Form, which includes an option to obtain replacement product for the PI-128, immediately faxing it back to Linda Todd at 919-433-4986. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.",N/A,5769,"5,769 catheters","Worldwide, including USA, Guam, Australia, Iceland and Italy",Terminated,"August 12, 2009",909,5769,Not_Computer,N/A,N/A,N/A
Z-0430-2007,37009,"Lens, Multifocal Intraocular",MFK,Intraocular lens.,Ophthalmic,Ophthalmic,PMA,AcrySof¶_ ReSTOR¶_ Intraocular Lens,AcrySof ReSTOR Intraocular Lens,2,"February 15, 2007", 2007,"Alcon Laboratories, Inc",Intraocular lenses exposed to extreme temperatures while in storage.,N/A,"The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.",N/A,10,10 units,Nationwide.,Terminated,"April 09, 2008",419,15,Not_Computer,N/A,N/A,N/A
Z-0502-2007,37192,"System, Hypothermia, Intravenous, Cooling",NCX,Thermal regulating system.,Cardiovascular,Neurology,510(K),"Alsius Cool Line Catheter, Model CL-2295A",Alsius Cool Line ,2,"February 15, 2007", 2007,Alsius Corporation,Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.,PRODUCTION CONTROLS: Process Control,"Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.",N/A,77,77,"Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland",Terminated,"June 22, 2007",127,202,Not_Computer,N/A,N/A,N/A
Z-0505-2007,36866,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),"LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.","LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil",2,"February 15, 2007", 2007,USA Instruments Incorporated,The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.,TRAINING: Employee Error,"Customers were notifed by certified letter, dated 11/28/06.",N/A,250,250 units,Nationwide.,Open,N/A,N/A,250,Not_Computer,N/A,N/A,N/A
Z-0519-2007,37263,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),"The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.",Large grid biopsy plate,2,"February 15, 2007", 2007,USA Instruments Incorporated,The packaging used for the Breast Biopsy plate may exhibit small holes or tears.,TRAINING: Employee Error,"The recalling firm notified consignees via certified letter, dated 1/31/07.",N/A,2200,Approximately 2200 units for all products being recalled,"Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.",Open,N/A,N/A,2200,Not_Computer,N/A,N/A,N/A
Z-0422-2007,36722,"System, Imaging, Pulsed Doppler, Ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(K),"iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)",iE33 Ultrasound System,2,"February 17, 2007", 2007,"Philips Ultrasound, Inc.",Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode),DESIGN: Software Design,"On 11/2/06 the firm sent a letter dated October 31, 2006 to their customers. The letter explains the problem and states that new software is being released and will be available sometime in November. Customer service representatives will visit consignees to upgrade their units. The firm later determined they sent letters out to consignees that did not have affected units. Those consignees will be notified the week of 11/20/06 to disregard the previous letter.",N/A,619,"619 domestic units, 706 international units",Worldwide,Terminated,"July 14, 2009",878,619,Software,Output/Calculation,Software update,Software Update
Z-0499-2007,37215,"Transport Systems, Anaerobic",JTX,Microbiological specimen collection and transport device.,Microbiology,Microbiology,510(k),"Anaerotest;Microbiology ,50 test strips1.15112Store dry and tightly closed.Store at + 15 C to +25CMerck IVD64271 Darmstadt, Germany",Anaerotest,3,"February 17, 2007", 2007,EMD Chemicals Inc,Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present,DESIGN: Packaging Design/Selection,A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.,Contact the recalling firm for information,800,800 packages of 50 strips each.,"Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.",Terminated,"June 06, 2008",475,808,Not_Computer,N/A,N/A,N/A
Z-0423-2007,36974,"Filler, Bone Void, Calcium Compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(K),"OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc",OsSatura TCP ,3,"February 22, 2007", 2007,Teknimed SA,The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Teknimed notified IsoTis OrthoBiologics via electronic recall letter dated August 31, 2006. IsoTis was instructed to notify their consignees of this field correction and they were asked to be responsible for identifying and making any corrections necessary at the medical user level. Teknimed supplied the correct IFU to IsoTis so that they could perform a field correction of the affected product. October 1, 2006 IsoTis OrthoBiologics sent their consignees a recall notification that included the IsoTis notification letter, a copy of the Teknimed recall letter, IsoTis Field Correction Instruction Sheet and replacement TCP IFU's for the affected lots.",N/A,1681,1681 units,Nationwide,Terminated,"April 23, 2012",1887,1681,Not_Computer,N/A,N/A,N/A
Z-0525-2007,37120,"Lamp, Surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.",Skytron Infinity series (also called Astro series) minor surgery light,2,"February 22, 2007", 2007,"Skytron, Div. The KMW Group, Inc","If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.",DESIGN: Device Design,The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.,N/A,5000,"5,000 for all models.",Nationwide and Canada.,Terminated,"November 18, 2009",1000,5000,Not_Computer,N/A,N/A,N/A
Z-0520-2007,37213,"Dilator, Esophageal",KNQ,Esophageal dilator.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105",Quantum TTC Biliary Balloon Dilation Catheter,2,"February 22, 2007", 2007,Cook Endoscopy,"The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.",TRAINING: Employee Error,Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.,N/A,12,12 units,"Worldwide, including NY and TX in USA, Australia, Canada and India.",Open,N/A,N/A,12,Not_Computer,N/A,N/A,N/A
Z-0548-2007,37231,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741",Symbia S Series SPECT System with a Pinhole Collimator,2,"February 23, 2007", 2007,"Siemens Medical Solutions USA, Inc.","Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.",DESIGN: Software Design,"Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.",N/A,16,16 units,"Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.",Terminated,"November 30, 2007",280,27,Software,Device Operation,Software update,Software Update
Z-0554-2007,37349,"Table, Operating-Room, Electrical",GDC,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450",Cmax Surgical Table,2,"February 23, 2007", 2007,Steris Corporation,"A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A certified letter was sent to all affected consignees on February 6, 2007 notifying them of the issue and informing them of the recall and the replacement of the affected tables with new tables.",N/A,46,46 tables,USA and Canada,Terminated,"September 11, 2009",931,46,Not_Computer,N/A,N/A,N/A
Z-0536-2007,36864,"Calibrator, Multi-Analyte Mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(K),"Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252",Diagnostic Chemicals Limited,3,"February 27, 2007", 2007,"Diagnostic Chemicals, Ltd.","Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct",PRODUCTION CONTROLS: Packaging Process Control,"Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.",N/A,38,38 kits,Nationwide.,Terminated,"May 14, 2007",76,38,Not_Computer,N/A,N/A,N/A
Z-0522-2007,37005,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13,Optetrak,2,"February 27, 2007", 2007,"Exactech, Inc.",The outside profile on this manufactured lot of devices is oversized and does not meet specifications.,TRAINING: Employee Error,Letter dated 12/08/06. The firm representative retrieved all four devices from the field.,N/A,4,4 units,Distributed to one hospital in New York.,Open,N/A,N/A,4,Not_Computer,N/A,N/A,N/A
Z-0521-2007,37067,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.",Stryker TOM,2,"February 27, 2007", 2007,Stryker Leibinger USA,"Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.",PRODUCTION CONTROLS: Process Control,Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions.,N/A,26,26,Nationwide.,Terminated,"June 04, 2008",463,26,Not_Computer,N/A,N/A,N/A
Z-0523-2007,37077,"Detector And Alarm, Arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(K),"Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.",Ultraview SL Command Module/Multiparameter input module,2,"February 27, 2007", 2007,"Spacelabs Healthcare, Incorporated","Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.",DESIGN: Software Design,"On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.",N/A,1347,1347 devices; 1067 domestic and 280 international,Nationwide and worldwide.,Open,N/A,N/A,1347,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0542-2007,37014,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01",LifeShield OmniFlow Primary I.V. Pump Set,2,"February 27, 2007", 2007,Hospira Inc.,The tubing can separate from the set at the filter inlet post.,PRODUCTION CONTROLS: Process Control,"Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.",N/A,7656,"7,656 sets",Nationwide.,Terminated,"March 24, 2008",391,7656,Not_Computer,N/A,N/A,N/A
Z-0546-2007,37252,"Transmitters And Receivers, Physiological Signal, Radiofrequency",DRG,Radiofrequency physiological signal transmitter and receiver.,Cardiovascular,Cardiovascular,510(K),"LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223",Life Sync Leadwear Disposable,2,"February 27, 2007", 2007,GMP Companies/Lifesync Corporation,"When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.",PRODUCTION CONTROLS: Process Control,"The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers.Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.",N/A,272,272 cases,Nationwide,Terminated,"July 27, 2009",881,272,Not_Computer,N/A,N/A,N/A
Z-0543-2007,37104,"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(K),"Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 10 FR, 17.5 cm (7'') long; Catalog no. L7350.",Terumo perfusion cannulae,3,"February 27, 2007", 2007,Terumo Cardiovascular Systems Corp,"The cannula connector is an incorrect size: It is actually 1/4"" by 3/8"" instead of the correct 1/4"" by 1/4"".",PRODUCTION CONTROLS: Process Control,Consignee was notified via telephone on 12/7/06 and returned the product.,Contact the recalling firm for information,50,50,Pennsylvania.,Terminated,"December 05, 2007",281,60,Not_Computer,N/A,N/A,N/A
Z-0537-2007,36988,"Introducer, Catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(K),"Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS",PREFACE,2,"February 28, 2007", 2007,"Biosense Webster, Inc.","Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.",N/A,"Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter.On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office.For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed.For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.",Contact the recalling firm for information,4565,4565,"Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.",Terminated,"June 25, 2009",848,32317,Not_Computer,N/A,N/A,N/A
Z-0550-2007,37289,"Apparatus, Hemoperfusion, Sorbent",FLD,Sorbent hemoperfusion system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437",Clark Biocompatible Hemoperfusion,2,"February 28, 2007", 2007,Clark Research and Development Inc,Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions,PRODUCTION CONTROLS: Process Control,The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.,N/A,15,15,Nationwide,Terminated,"July 17, 2007",139,292,Not_Computer,N/A,N/A,N/A
Z-0344-2007,36711,"Accessories, Soft Lens Products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(K),"COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution(Japan only)",COMPLETE MoisturePLUS & COMPLETE Amino Moist,2,"March 01, 2007", 2007,"Advanced Medical Optics, Inc.","Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.",PRODUCTION CONTROLS: Equipment Maintenance,"Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.",N/A,3125885,"182,678 units for all US products, 2,943,207 units worldwide","Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.",Terminated,"February 17, 2010",1084,3125885,Not_Computer,N/A,N/A,N/A
Z-0535-2007,36605,"Introducer, Catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(K),"FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.",FastCath,2,"March 01, 2007", 2007,St. Jude Medical / Daig Division,Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.,PRODUCTION CONTROLS: Process Control,The affected customers were notified on 10/5/06 by letter.,N/A,40,40 Units,Nationwide.,Terminated,"May 25, 2007",85,40,Not_Computer,N/A,N/A,N/A
Z-0564-2007,37153,"Knife, Ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"Alcon Custom-Pak¶_, part #11148-02, containing BD Beaver¶_ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.",CustomPak Surgical Packs,2,"March 01, 2007", 2007,"Alcon Laboratories, Inc","Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.",N/A,"Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.",N/A,65,65 custom surgical packs.,"Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.",Terminated,"June 06, 2007",97,206,Not_Computer,N/A,N/A,N/A
Z-0545-2007,37160,"Radioassay, Vitamin B12",CDD,Vitamin B12test system.,Clinical Chemistry,Clinical Chemistry,510(K),Sample Management System software for in vitro diagnostic testingProduct # 030102-03,SMS,2,"March 01, 2007", 2007,Siemens Medical Solutions Diagnostics,"Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.",DESIGN: Software Design,A recall communication was sent on 1/15/2007 to all customers by fax.,N/A,87,87 units,"Worldwide, including USA, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and United Kingdom.",Terminated,"January 18, 2008",323,87,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0565-2007,37234,"Diluent, Blood Cell",GIF,Blood cell diluent.,Hematology,Hematology,510(K),"CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.",Abbott Diagnostics CELLDYN Diluent/Sheath Reagent,3,"March 01, 2007", 2007,Abbott Laboratories,"Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.",N/A,"Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.",N/A,652,652 (20 L. each) cubitainers,"Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.",Terminated,"November 28, 2007",272,652,Not_Computer,N/A,N/A,N/A
Z-0547-2007,37307,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count,One Touch,1,"March 03, 2007", 2007,Safety & Supplies Co. Inc.,Counterfeit product (manufacturer unknown),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit,"A recall notification was sent on February 1, 2007 via first class mail to all customers.",N/A,N/A,Unknown,Nationwide to pharmacies.,Terminated,"June 08, 2007",97,N/A,Not_Computer,N/A,N/A,N/A
Z-0582-2007,37248,"Syringe, Piston",FMF,Piston syringe.,General Hospital,General Hospital,510(K),BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle1 ml 29g 1/2'' (0.33mm x 13 mm)Re-Order No. 305282U-100 insulinLot 6073436,BD Integra ,2,"March 03, 2007", 2007,Becton Dickinson & Company,The needle becomes detached from the hub/syringe,DESIGN: Process Design,"Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm.",N/A,247824,"247,824 units",Nationwide,Terminated,"July 24, 2007",143,247824,Not_Computer,N/A,N/A,N/A
Z-0566-2007,37287,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)",COULTER LH 700 Series,2,"March 06, 2007", 2007,Beckman Coulter Inc,There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.,N/A,"A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version.Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.",N/A,1893,1893 units in the US; 94 units to Canada,Nationwide and Canada,Open,N/A,N/A,1893,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0574-2007,37170,Ventricular (Assisst) Bypass,DSQ,N/A,N/A,Cardiovascular,PMA,AB5000 Console Circulatory Support SystemCatalog Number: 0015-0000,Abiomed,2,"March 07, 2007", 2007,"Abiomed, Inc.",Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.,PRODUCTION CONTROLS: Manufacturing Material Removal,Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.,N/A,55,55 units,"Worldwide, including USA, Japan, Germany, Australia, and Mexico.",Terminated,"February 07, 2008",337,55,Not_Computer,N/A,N/A,N/A
Z-0567-2007,37250,"Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Wright Medical Technology, Gladiator¶_ Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head",Gladiator Bipolar,2,"March 07, 2007", 2007,Wright Medical Technology Inc,Product specification failure which could result in improper locking of the cup onto the femoral head.,PRODUCTION CONTROLS: Process Control,"The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.",N/A,10,10 units,Nationwide and Japan,Terminated,"January 15, 2009",680,90,Not_Computer,N/A,N/A,N/A
Z-0576-2007,37298,"Instrument, Microsurgical",GZX,Microsurgical instrument.,Neurology,Neurology,510(K),"AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.",AccuGuide,3,"March 07, 2007", 2007,"Medtronic Xomed, Inc.","A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.",PRODUCTION CONTROLS: Packaging Process Control,"Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock.Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.",N/A,48,48 boxes,Nationwide,Terminated,"January 17, 2009",682,48,Not_Computer,N/A,N/A,N/A
Z-0413-2007,37070,"Analyzer, Enzyme, For Clinical Use",JJI,Enzyme analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,PMA,"ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21","ARCHITECT i System Assay CDROM, U.S. Version 21.0",3,"March 08, 2007", 2007,Abbott Laboratories MPG,The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.,DESIGN: Labeling Design,"On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.",N/A,51,51 affected analyzers,Nationwide,Terminated,"December 09, 2009",1007,51,Computer,N/A,N/A,N/A
Z-0583-2007,37079,"Tubing, Pump, Cardiopulmonary Bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(K),Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.,Intersept Custom Tubing Pack,3,"March 08, 2007", 2007,Medtronic Perfusion Systems,"One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.",DESIGN: Device Design,"There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.",N/A,17,17,Illinois,Terminated,"February 24, 2008",353,17,Not_Computer,N/A,N/A,N/A
Z-0577-2007,37314,"Catheter, Continuous Flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(K),"EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WAPackaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150",EKOS EndoWave(TM) Infusion System Drug Delivery Catheter,2,"March 08, 2007", 2007,Ekos Corp,Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.,PRODUCTION CONTROLS: Process Control,"On 2/9/07 the firm faxed and sent via certified return receipt an URGENT: Device Recall letter to their consignees. The letters requested to immediately examine stock and segregate all recalled products. In addition, the firm''s representatives will contact, via phone or visit, each of the consignees. Product is to be returned to the firm.",N/A,446,446 distributed,Nationwide.,Terminated,"May 07, 2008",426,446,Not_Computer,N/A,N/A,N/A
Z-0596-2007,37369,"Instrument, Surgical, Disposable",KDC,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set.",JariTrak Table Clamp,3,"March 08, 2007", 2007,"J. Jamner Surgical Instruments, Inc.","The JariTrak Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals.",DESIGN: Device Design,"On 11/14/06, an ""URGENT-PRODUCT NOTIFICATION"" letter (dated 11/14/06) and accompanying Fax Back Form were sent via Certified Mail Return Receipt Requested, to each customer that purchased or was supplied with the 206-160 Table Clamp. The letter instructs each surgical instrument coordinator (user) to review the inventory of 206-160 JariTrak"" Table Clamps at the facility. The letter also provides instructions for the proper installation of the clamp to the bed rail. The customer is also asked to complete the Fax Back Form and fax it to back to Customer Service. J. Jamner Surgical Instruments, Inc. (J. Jamner) will replace any Table Clamps at the request of the customer. J. Jamner will account for all Fax Back replies and product returns. A second notification letter will be sent to any non-responding customers. Table Clamps returned from customers and from J. Jamner's inventory will be returned to the manufacturer, Koros USA Inc. or be destroyed by J. Jamner.",N/A,30,Domestic: 30 units,Nationwide,Terminated,"January 10, 2008",308,30,Not_Computer,N/A,N/A,N/A
Z-0580-2007,37394,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier),Lifeline AEDDefibtech Sentry ,1,"March 08, 2007", 2007,"Defibtech, LLC","Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be ""unable"" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.",DESIGN: Software Design,"Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded. Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, theircustomers, and direct accounts shall return to Defibtech documentation confirming unitsoftware upgrade was completed..Press was issued by the firm on March 6, 2007.",N/A,22197,"22,197 units","Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.",Open,N/A,N/A,22233,Software,Alarm/Message,Software update,Software Update
Z-0578-2007,37389,"System, X-Ray, Angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(K),"AXIOM Artis MP, Angiographic x-ray system, model number 5904466","AXIOM Artis MP XRay System, Model number 5904466",2,"March 08, 2007", 2007,"Siemens Medical Solutions USA, Inc",C-arm gantry could rapidly descend without command during use.,DESIGN: Device Design,"In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.",N/A,62,62 units,The products were shipped to medical facilities nationwide.,Terminated,"May 05, 2009",789,70,Not_Computer,N/A,N/A,N/A
Z-0597-2007,37393,"Catheter, Peripheral, Atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(K),"ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.",ThromCat ,2,"March 08, 2007", 2007,Kensey Nash Corp,Face seal may wear excessively and cause particulate matter.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.",N/A,165,165 units,Nationwide.,Terminated,"June 12, 2007",96,165,Not_Computer,N/A,N/A,N/A
Z-0575-2007,37270,"Introducer, Catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(K),"StarClose Vascular Closure System (Clip Applier & Exchange System),Catalog Number: 14677;Product is manufactured by:Abbott Vascular Inc.,400 Saginaw Drive,Redwood City, CA 94063",StarClose ,2,"March 08, 2007", 2007,"Abbott Vascular, Inc.","Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.","Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",97952,"97,952 units","Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.",Terminated,"February 26, 2008",355,97952,Not_Computer,N/A,N/A,N/A
Z-0604-2007,37068,"Catheter, Biliary, Diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100",Boston Scientific Endoscopic Biliary Endoprosthesis,2,"March 13, 2007", 2007,Boston Scientific Corporation,Guidewire restriction during use (excessive adhesive in the guidewire lumen),DESIGN: Process Design,"On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.",N/A,8511,"8,511 for Recalls Z-0604-0609-2007","Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.",Terminated,"December 12, 2007",274,8511,Not_Computer,N/A,N/A,N/A
Z-0588-2007,37346,"Laparoscope, General & Plastic Surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.","FRAZIER Surgical Suction Instrument, 8 French",2,"March 13, 2007", 2007,Conmed Corporation,Firm was made aware of instances where the sterile barrier of the instruments had been compromised.,PRODUCTION CONTROLS: Packaging Process Control,"On 11/10/06, ConMed Corp. sent ""URGENT: DEVICE RECALL"" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.",N/A,711245,"711,245 units",Worldwide,Open,N/A,N/A,7401479,Not_Computer,N/A,N/A,N/A
Z-0594-2007,37356,Fibrin Split Products,GHH,Fibrinogen/fibrin degradation products assay.,Hematology,Hematology,510(K),"Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide10 plastic pipettesWampole LaboratoriesInverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.",Clearview Simplify ,2,"March 13, 2007", 2007,Inverness Medical Professional Diagnostics,Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.,N/A,Recall notification letters were sent to all customers on 2/14/07 by first class mail.,N/A,382,382 kits,"Worldwide, including USA, Puerto Rico, and Canada.",Terminated,"May 08, 2007",56,382,Not_Computer,N/A,N/A,N/A
Z-0595-2007,37363,"Reagents,Specific,Analyte",MVU,Analyte specific reagents.,Pathology,Hematology,510(K) Exempt,"Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001;The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.",Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set,3,"March 13, 2007", 2007,Abbott Molecular,The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.,PRODUCTION CONTROLS: Environmental Control,"Abbott Molecular telephoned and/or sent recall letters to the Abbott FISH accounts on 12/22/06, advising them that an unexpected signal pattern with the Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 Probe was observed, confirmed and identified as a result of contamination in a subset of vials of D13S319 /CEP 12/13q34 from lot number 79500. This contamination results in 10 FISH signals in each normal cell (4 SO, 4 SG, 2 SA) rather than the expected 6 FISH signals in each normal cell (2 SO, 2 SG, 2 SA). The customers were advised that lot 80178 was also being included in the recall, and were requested to review the information carefully and assess the risk to their patient population; discontinue and destroy any unused product immediately; complete and return the enclosed reply form; review the information with laboratory personnel; and communicate the information to health care providers served in cases where the affected product were used and reported. Abbott Molecular provided replacement product for that product destroyed, upon receipt of the reply form. Any questions were directed to Abbott Molecular Technical Service at 800-553-7042, option 2.",N/A,109,109 probe sets,"Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.",Terminated,"April 17, 2008",401,109,Not_Computer,N/A,N/A,N/A
Z-0614-2007,37404,"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901,Gyrus ACMI,2,"March 13, 2007", 2007,Gyrus ACMI Corporation,Product sterility may be compromised due to failure of the tray seal packaging,PRODUCTION CONTROLS: Packaging Process Control,Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .,N/A,184,184 boxes (5 units/box),"Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.",Terminated,"February 24, 2008",348,722,Not_Computer,N/A,N/A,N/A
Z-0616-2007,37479,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),"The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment.",iSite PACS,2,"March 13, 2007", 2007,Stentor Inc A Phillips Medical Systems Co.,A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.,DESIGN: Software Design,The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.,N/A,54,54 units,"Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.",Terminated,"December 03, 2007",265,54,Software,Display/Image,Notification,Safety Notice/Insructions
Z-0610-2007,37147,"Cannula, Trocar, Ophthalmic",NGY,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.",Alcon Trocar Cannula Replacement Plug,3,"March 13, 2007", 2007,"Alcon Research, Ltd",Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.,PRODUCTION CONTROLS: Packaging Process Control,"Recalled by letter on January 22, 2007.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",15,15 units.,Nationwide- Hospitals in MD and MN.,Terminated,"September 24, 2010",1291,15,Not_Computer,N/A,N/A,N/A
Z-0617-2007,36962,"Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(K),Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.,Sarns Terumo perfusion,2,"March 14, 2007", 2007,Terumo Cardiovascular Systems Corp,Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.,N/A,"Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.",N/A,2696,2696,"Woldwide, including USA, Canada, and Mexico",Terminated,"June 19, 2008",463,2696,Not_Computer,N/A,N/A,N/A
Z-0621-2007,37423,"Culture Media, Selective And Differential",JSI,Selective culture medium.,Microbiology,Microbiology,510(K) Exempt,"Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.",Remel MacConkey Agar w/Sorbitol,2,"March 14, 2007", 2007,"Remel, Inc.",False negative results for sorbitol fermenting bacteria such as E. Coli 0157.,N/A,Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.,N/A,704,694/10-pack boxes,Nationwide.,Terminated,"March 06, 2008",358,694,Not_Computer,N/A,N/A,N/A
Z-0620-2007,37362,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7553",Baxter Vented Paclitaxel Set,2,"March 14, 2007", 2007,Baxter Healthcare Corp.,Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.,PRODUCTION CONTROLS: Process Control,"Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837.",N/A,200309,"200,309 units","Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.",Terminated,"March 17, 2008",369,215886,Not_Computer,N/A,N/A,N/A
Z-0627-2007,37422,"Device, Intravascular Catheter Securement",KMK,Intravascular catheter securement device.,General Hospital,General Hospital,510(K) Exempt,"StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.",StayFix,2,"March 15, 2007", 2007,"Merit Medical Systems, Inc",Sterility of some units may be compromised due to damaged packaging.,PRODUCTION CONTROLS: Packaging Process Control,Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.,N/A,195001,"195,001 units","Worldwide, including USA, France, Germany, and United Kingdom.",Open,N/A,N/A,250808,Not_Computer,N/A,N/A,N/A
Z-0631-2007,37442,"Port & Catheter, Implanted, Subcutaneous, Intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(K),"Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200,",Vaxcel Implantable Chest Ports with PASV Valve Technology,2,"March 15, 2007", 2007,Boston Scientific Corp,Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.,DESIGN: Packaging Design/Selection,"On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.",Contact the recalling firm for information,42,Domestic - 42,Nationwide,Terminated,"November 26, 2007",256,236,Not_Computer,N/A,N/A,N/A
Z-0637-2007,37102,"Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days",FOZ,Intravascular catheter.,General Hospital,General Hospital,510(K),COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum¶_ Glide¶_ Antimicrobial Catheter with EZ--Pass¶_ Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.,Cook Antimicrobial Catheter ,2,"March 16, 2007", 2007,"Cook, Inc.",These catheters do not include the proximal sidehole as required by the specification.,PRODUCTION CONTROLS: Process Control,Consignees were notified by phone on 1/2/07 and instructed to return the product.,Contact the recalling firm for information,100,100,"Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.",Terminated,"December 05, 2007",264,100,Not_Computer,N/A,N/A,N/A
Z-0612-2007,37272,"Stabilizer,Heart",MWS,Cardiovascular surgical instruments.,Cardiovascular,Cardiovascular,510(K) Exempt,"Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100",Guidant ACROBAT Vacuum Stabilizer,2,"March 16, 2007", 2007,Guidant Cardiac Surgery,Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.,MISBRANDING: Labeling False and Misleading,"The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.",N/A,57691,"57,691 units distributed total","Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.",Terminated,"December 04, 2007",263,57691,Not_Computer,N/A,N/A,N/A
Z-0639-2007,37450,"Diluent, Blood Cell",GIF,Blood cell diluent.,Hematology,Hematology,510(K),"CELL-DYN 4000 Diluent/Sheath Reagent,List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA",CELLDYN 4000 ,2,"March 16, 2007", 2007,Abbott Laboratories,Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"On May 12, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.",N/A,6893,"6,893 units","Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.",Terminated,"May 01, 2007",46,6893,Not_Computer,N/A,N/A,N/A
Z-0636-2007,36685,N/A,N/A,N/A,N/A,N/A,510(K),"Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)","Brilliance CT System, Big Bore Configuration.",2,"March 17, 2007", 2007,Philips Medical Systems (Cleveland) Inc,"Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.",DESIGN: Software Design,Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.,N/A,17,17 units,"Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.",Open,N/A,N/A,17,Software,Output/Calculation,Software update,Software Update
Z-0640-2007,37444,"Diluent, Blood Cell",GIF,Blood cell diluent.,Hematology,Hematology,510(K),"CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA",CELLDYN ,2,"March 17, 2007", 2007,Abbott Laboratories,Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed.",N/A,9800,"9,800 units","Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore.",Terminated,"May 01, 2007",45,9800,Not_Computer,N/A,N/A,N/A
Z-0632-2007,36872,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015",FloGard 6201 Volumetric Infusion Pumps,2,"March 20, 2007", 2007,Baxter Healthcare Corp.,"There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.",DESIGN: Device Design,"Baxter sent the 11/27/06 Urgent Device Correction letter to all Flo-Gard Volumetric Infusion Pump customers, to the attention of the Vice President of Nursing and the Biomedical Engineer, via first class mail to alert them to the potential for non-detection of, and no alarm for, upstream occlusion under specific conditions for Flo-Gard Volumetric Infusion Pumps if the occlusion occurs above a flexible chamber (such as a drip chamber, Buretrol or blood filter), and to provide the addendum to the operator manual to address these specific conditions. The letters included the mitigations and risks associated with each of the conditions that could potentially cause this situation. This information was included in the letter, as well as the Operator''s Manual Addendum, which Baxter requested to attach a copy to all Flo-Gard Operator''s Manuals in their facility. Baxter instructed the customers to share this information with all staff members, services and facilities that use Flo-Gard pumps. Any questions were directed to Baxter''s Global Technical Services at 1-800-843-7867, prompt 2. Although Baxter previously notified customers on 3/5/99 that they would no longer support or service the Flo-Gard 6200 and 6300 devices as of 12/1/99, these product codes were included in this letter due to a similar potential for this issue. Should the customer still have these 6200 or 6300 devices in their possession, Baxter recommended that they be taken out of service due to obsolescence of the appropriate components. The accounts were requested complete the enclosed reply form acknowledging receipt of the letter and dissemination of the information to their staff.",N/A,177468,"177,468 pumps","Worldwide including USA, Puerto Rico, Argentina, Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Honduras, India, Indonesia, Ireland, Italy, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Singapore, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.",Terminated,"January 19, 2010",1036,219566,Not_Computer,N/A,N/A,N/A
Z-0497-2007,37150,"Saliva, Artificial",LFD,N/A,N/A,Dental,510(K),"Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio",Salivart Oral Moisturizer,2,"March 20, 2007", 2007,Gebauer Company,Microbial Contamination-certain lots of product failed USP,N/A,"The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.",N/A,34545,"34,545 cans","The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers). A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code: 06BB002",Terminated,"December 17, 2007",272,34545,Not_Computer,N/A,N/A,N/A
Z-0638-2007,37318,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),"VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.",Viasys Vela Adult/Pediatric Lung Ventilator,2,"March 20, 2007", 2007,"Viasys Respiratory Care, Inc.dba Bird Products",The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.,N/A,"On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks.",N/A,878,878,"Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.",Terminated,"September 18, 2008",548,878,Software,Device Operation,Software update,Software Update
Z-0642-2007,36979,"Wire, Guide, Catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a 'pulse-spray' or 'slow weep' technique. Order No. REF: 46-193 (M001461930).",Katzen (TM) Infusion Wire,3,"March 21, 2007", 2007,Boston Scientific,"Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.",PRODUCTION CONTROLS: Process Control,"An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.",Contact the recalling firm for information,10,10 units,"US only to: FL, GA, IN, NY.",Terminated,"July 20, 2007",121,10,Not_Computer,N/A,N/A,N/A
Z-0626-2007,37106,"Pad, Heating, Powered",IRT,Powered heating pad.,Physical Medicine,Physical Medicine,510(K) Exempt,HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No. HP-500 (UPC 031262003652).,HoMedics Thera P heating pad,1,"March 21, 2007", 2007,"HoMedics, Inc.","Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.",PRODUCTION CONTROLS: Process Control,Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.,N/A,292108,"292,108 of all models",Nationwide and Canada.,Terminated,"January 04, 2010",1020,292108,Not_Computer,N/A,N/A,N/A
Z-0644-2007,37141,"System, Blood Culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(K),"BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA",BacT/VIEW C.30a Software update (P/N 5145151),2,"March 22, 2007", 2007,"bioMerieux, Inc.",Bottle data is not sent to BacT/ALERT 3D instrument.,N/A,"A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.",N/A,1233,1233 disks,"Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.",Terminated,"December 08, 2009",992,1233,Not_Computer,N/A,N/A,N/A
Z-0643-2007,37133,"System, Blood Culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(K),"BacT/ALERT¶_ FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704",BacT/ALERT FA Culture Bottles.,2,"March 22, 2007", 2007,"bioMerieux, Inc.",Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.,N/A,Consignees were notified by letter on/about 01/12/2007.,N/A,2136,2136 cases (100 bottles per case),"Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.",Terminated,"December 08, 2009",992,2136,Not_Computer,N/A,N/A,N/A
Z-0556-2007,37322,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(K),"OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.",OEC 9800 ,2,"March 22, 2007", 2007,"GE OEC Medical Systems, Inc","During routine service, a cover may have been installed without the required proper lead shielding.",PRODUCTION CONTROLS: Packaging Process Control,Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.,N/A,11,11 units of all models,"Nationwide to AL, AZ, IA, OH, TX, VA, and WV.",Terminated,"June 26, 2007",96,11,Not_Computer,N/A,N/A,N/A
Z-0645-2007,37390,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.",ADVIA Centaur CP System,2,"March 22, 2007", 2007,Siemens Healthcare Diagnostics,"Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.",DESIGN: Software Design,"A Support Bulletin was sent by e-mail to all affected Bayer HealthCare LLC Branches on 11/09/06 in order to inform them of the issue and to provide them with instructions for this field correction. Two Customer Bulletins were prepared and sent by e-mail to Bayer HealthCare LLC Branches on 11/09/06 both in the US and outside the US for communication with the affected customers. The first bulletin advised customers of the problem and the corrective action. A Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The second Customer Bulletin describes an optional alternative mitigation, which requires a Bayer representative to go to the customer site to implement.",N/A,306,"306 units: 101- Domestic, 205 - Foreign",Worldwide,Open,N/A,N/A,306,Not_Computer,N/A,N/A,N/A
Z-0646-2007,37473,"Radioimmunoassay, Thyroid-Stimulating Hormone",JLW,Thyroid stimulating hormone test system.,Clinical Chemistry,Clinical Chemistry,510(K),Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.,Thyrotest TSH POC Rapid membrane test,3,"March 22, 2007", 2007,ThyroTec Inc,Positive control showed little or no positive line.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.",N/A,484,484 units,Nationwide.,Terminated,"June 04, 2007",74,484,Not_Computer,N/A,N/A,N/A
Z-0641-2007,37477,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED)Catalog Numbers: M3860A/M3861A/M3840A/M3841A,HeartStart FR2,2,"March 22, 2007", 2007,Philips Medical Systems,"Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"On 02/28/2007 the firm sent letters via return receipt to all domestic and foreign customers. The letter advises the customer of the issue and if the user encounters the problem, to press the button again with additional force. In addition, the firm sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock' buttons firmly.",N/A,9099,9099 units,"Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.",Open,N/A,N/A,9099,Hardware,Treatment/Delivery/Therapy,Update manual,Other
Z-0656-2007,37366,"Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass",DTW,Cardiopulmonary bypass level sensing monitor and/or control.,Cardiovascular,Cardiovascular,510(K),"Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.",Terumo Perfusion System 8000 ,2,"March 27, 2007", 2007,Terumo Cardiovascular Systems Corp,The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.,N/A,36,36,"Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.",Terminated,"June 19, 2008",450,83,Not_Computer,N/A,N/A,N/A
Z-0653-2007,37376,"Appliance, Fixation, Spinal Intervertebral Body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only",Colorado 2 Anterior Plate,2,"March 27, 2007", 2007,Medtronic Sofamor Danek USA Inc,Bone screws may pull though the plate.,PRODUCTION CONTROLS: Process Control,"Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.",N/A,1407,1407 units,"France, Germany, Italy, UK, and Tunisia. No US distribution.",Terminated,"August 11, 2007",137,1700,Not_Computer,N/A,N/A,N/A
Z-0651-2007,37069,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522.",NexGen,2,"March 28, 2007", 2007,Zimmer Inc.,"The device was cut to an incorrect angle, which may result in an incorrect bone cut.",PRODUCTION CONTROLS: Process Control,Product was removed from customer location during visit on 10/10/2006.,N/A,1,1,One medical facility in Michigan.,Terminated,"December 04, 2007",251,1,Not_Computer,N/A,N/A,N/A
Z-0660-2007,37436,"System,Surgical,Computer Controlled Instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(K),"8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA",EndoWrist,2,"March 28, 2007", 2007,"Intuitive Surgical, Inc.","The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.",DESIGN: Software Design,"The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.",N/A,8,8,"Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.",Terminated,"November 28, 2007",245,8,Other,Device Operation,Return,Remove or Replace
Z-0652-2007,37347,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.,syngo Dynamics ,2,"March 28, 2007", 2007,"Siemens Medical Solutions, USA, Inc",The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.,DESIGN: Software Design,"Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.",N/A,71,71,Nationwide.,Terminated,"April 30, 2008",399,71,Software,Output/Calculation,Software update,Software Update
Z-0667-2007,36947,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).,superDimension Bronchus System,2,"March 29, 2007", 2007,"SuperDimension, Inc.","The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.",N/A,"An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.",N/A,2000,"Up to 2,000 each Locatable Guide Kit and Extended Working Channel","Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.",Terminated,"November 20, 2008",602,2074,Not_Computer,N/A,N/A,N/A
Z-0663-2007,37232,"Probe, Radiofrequency Lesion",GXI,Radiofrequency lesion probe.,Neurology,Neurology,510(K),"RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271",Smith & Nephew,1,"March 29, 2007", 2007,"Smith & Nephew, Inc. Endoscopy Division",Product is non-sterile but labeled incorrectly as sterile.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007.",N/A,338,338 units,"Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.",Terminated,"January 18, 2008",295,497,Not_Computer,N/A,N/A,N/A
Z-0675-2007,37365,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.",Trabecular Metal Reverse Shoulder System ,2,"March 29, 2007", 2007,Zimmer Inc.,The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Zimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer.,N/A,21,21,"California, Ohio and Texas.",Terminated,"May 04, 2007",36,21,Not_Computer,N/A,N/A,N/A
Z-0668-2007,37384,"Device, Neurovascular Embolization",HCG,Neurovascular embolization device.,Neurology,Neurology,510(K),"Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0,Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Corporation, Neurovascular Division, Fremont, CA",Matrix2 ,2,"March 29, 2007", 2007,Boston Scientific Target,The product may be missing the temperature indicator label on the inner pouch.,PRODUCTION CONTROLS: Packaging Process Control,"The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.",N/A,57,57 units,"Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.",Terminated,"November 27, 2007",243,57,Not_Computer,N/A,N/A,N/A
Z-0670-2007,37431,"System,Surgical,Computer Controlled Instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(K),"Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA",Da Vinci S Surgical System,2,"March 29, 2007", 2007,"Intuitive Surgical, Inc.","Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.",PRODUCTION CONTROLS: Process Control,The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.,"Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",24,24 units,Nationwide.,Terminated,"December 05, 2007",251,24,Not_Computer,N/A,N/A,N/A
Z-0669-2007,37405,"Susceptibility Test Discs, Antimicrobial",JTN,Antimicrobial susceptibility test disc.,Microbiology,Microbiology,510(K),"BD¶_ Sensi-Disc¶_ Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***",SensiDisc,2,"March 29, 2007", 2007,Becton Dickinson & Co.,Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. The recalling firm received customer reports of false susceptibility results.,TRAINING: Employee Error,"The recalling firm ceased distribution of the product on 01/15/07 and subsequently notified US distributors by faxed letter and international consignees by e-mail on 02/19/07. The notification advised distributors to discontinue and return remaining inventory for replacement. The consignees were instructed to return the accompanying response form indicating inventory counts for credit. The notice also requested distributors to provide within three days the end-user lists of those receiving the product for subsequent direct notification by the recalling firm. The notification to consignees was initiated on 02/22/07 by overnight courier. The consignee notification advised that the product will give false susceptible results when testing with the identified QC organism using the Kirby Bauer method. Consignees were instructed to immediately discontinue use and return prouct identified by lot 6167435, EXP 06/30/08 and reply by returning the enclosed response form. The firm recommended to end users, primarily laboratory and testing facilities, that patient isolates yielding susceptible results with the identified lot of Ticarcillin Sensi-disc which had not been tested with the QC organism, be retested and the physicians notified.",N/A,538,528/10 packs,"Worldwide, including USA, Australia, Canada, Hong Kong, Philippines, Belgium, Japan, Mexico, Singapore, Chile, India, and Venezuela.",Terminated,"July 09, 2007",102,528,Not_Computer,N/A,N/A,N/A
Z-0661-2007,37452,"System, Imaging, Pulsed Doppler, Ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(K),"MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer",MicroMaxx LAP Transducer,2,"March 29, 2007", 2007,"Sonosite, Inc.",Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.,DESIGN: Device Design,On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected.,N/A,6,6 Devices,"Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.",Terminated,"June 01, 2007",64,6,Not_Computer,N/A,N/A,N/A
Z-0672-2007,37533,"Device, Irrigation, Ocular Surgery",KYG,Ocular surgery irrigation device.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618",Visitec,3,"March 29, 2007", 2007,Becton Dickinson and Company,"Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)",PRODUCTION CONTROLS: Packaging Process Control,BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.,Contact the recalling firm for information,1500,1500 units,Nationwide.,Terminated,"March 05, 2008",342,1500,Not_Computer,N/A,N/A,N/A
Z-0673-2007,37600,"Instrument, Biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.",Prostate Biopsy Needle ,2,"March 29, 2007", 2007,Remington Medical Inc.,Pouches were not sealed prior to sterilization.,PRODUCTION CONTROLS: Packaging Process Control,Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.,N/A,192,192 units,Nationwide.,Terminated,"May 11, 2007",43,192,Not_Computer,N/A,N/A,N/A
Z-0665-2007,37568,"Catheter, Percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(K),"Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.",Cook ATB Advance PTA Dilatation Catheter,2,"March 29, 2007", 2007,"Cook, Inc.","Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.",PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified via telephone on 2/28/07 and instructed to return the product.,N/A,20,20 units,"Illinois, North Carolina and South Carolina.",Terminated,"May 29, 2007",61,20,Not_Computer,N/A,N/A,N/A
Z-0671-2007,37490,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.",LIFEPAK,2,"March 29, 2007", 2007,"Medtronic Emergency Response Systems, Inc.",LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.,DESIGN: Software Design,"Firm sent letters on 03/02/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK CR Plus devices. The firm advised consignees to upgrade their devices' software, and indicated that each consignee will be provided a user-installable software upgrade for their device(s) within 45 days.",N/A,13835,"13,835 units","Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.",Open,N/A,N/A,13835,Software,Alarm/Message,Software update,Software Update
Z-0704-2007,31058,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body),InstaTrak 3500 Plus system,2,"March 30, 2007", 2007,"GE OEC Medical Systems,Inc",Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.,DESIGN: Software Design,"Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2.",N/A,91,91 systems (version 5.1 software),"Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada",Open,N/A,N/A,91,Software,Output/Calculation,Software update,Software Update
Z-0684-2007,37168,"Lithotriptor, Electro-Hydraulic",FFK,Electrohydraulic lithotriptor.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .,EMS Lithocast Ultra Ultrasound Handpiece ,2,"March 30, 2007", 2007,E.M.S. - Electro Medical Systems SA,Handpiece may become dislodged causing cable damage and possible electric shock.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"EMS Lyon, France (manufacturer) notified the single US Distributor by letter to contact their accounts and return device for replacement. Boston Scientific, Natick, Ma conducted the sub-recall by letter dated 4/22/05 to all USA accounts.",No consumer action necessary,160,160 units,Nationwide,Open,N/A,N/A,160,Not_Computer,N/A,N/A,N/A
Z-0685-2007,37247,Endoscope And/Or Accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),Plicator EPS Plication SystemCatalog Number: 160-01128R,NDO Surgical Plicator EPS,2,"March 31, 2007", 2007,"NDO Surgical, Inc.",Device arm may fail to open after being deployed and require surgical intervention to remove,DESIGN: Device Design,NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.,N/A,9,9 units,"Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.",Terminated,"December 12, 2007",256,9,Not_Computer,N/A,N/A,N/A
Z-0686-2007,37277,N/A,N/A,N/A,N/A,N/A,N/A,"Aspyra, Inc. CyberMED Version 2.1 Pharmacy Software",CyberMED Version 2.1 Pharmacy SoftwareAspyra,2,"March 31, 2007", 2007,"Aspyra, Inc.",Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient.,N/A,"Current customers were mailed a Recall Letter January 31,2007 explaining the issue and informing the customers of an upcoming CyberMED Version 2.1 maintenance software release to correct the potential issue. A fax-back Acknowledgement of Receipt form was sent with the Recall Letter.",N/A,10,10,"Nationwide to: CA, GA, IN, MI, MN, MS, NC, ND, & OK",Open,N/A,N/A,10,Software,Output/Calculation,Software update,Software Update
Z-0687-2007,37291,"Device, Thermal Ablation, Endometrial",MNB,N/A,N/A,Obstetrics/Gynecology,PMA,"HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)",Boston Scientific Thermal endometrial ablation system,2,"March 31, 2007", 2007,Boston Scientific Corporation,Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment,DESIGN: Software Design,"Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.",N/A,57,57 units,"Worldwide-USA, UK, Denmark, Italy, and France",Terminated,"December 12, 2007",256,83,Hardware,Treatment/Delivery/Therapy,Return,Remove or Replace
Z-0695-2007,37306,"Dialyzer, High Permeability With Or Without Sealed Dialysate System",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.",Gambro Prismaflex,2,"March 31, 2007", 2007,"Gambro Renal Products, Inc.","Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)",DESIGN: Device Design,Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.,N/A,153,153 units (Domestic),"Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.",Open,N/A,N/A,153,Not_Computer,N/A,N/A,N/A
Z-0700-2007,37462,"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",LGW,N/A,N/A,Neurology,PMA,"The Precision Implantable Pulse Generator, Model Number SC-1110",Precision Spinal Cord Stimulation System,3,"March 31, 2007", 2007,Advanced Bionics Corp,The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.,DESIGN: Software Design,March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry. .,N/A,57,5 unimplanted devices; 52 implanted devices,Nationwide including Puerto Rico,Open,N/A,N/A,57,Software,Output/Calculation,Upgrade wireless RF telemetry,Repair
Z-0699-2007,37403,Endoscope And/Or Accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),Boston Scientific SpyGlass CameraRef Number: 4610 UPN M00546100,Boston Scientific SpyGlass Camera,2,"March 31, 2007", 2007,Boston Scientific Corporation,"A teal ""bloom""/ glare on the subject image during high light conditions.",DESIGN: Device Design,Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.,N/A,12,12 units,"Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .",Terminated,"November 15, 2007",229,152,Not_Computer,N/A,N/A,N/A
Z-0706-2007,37453,"Diluent, Blood Cell",GIF,Blood cell diluent.,Hematology,Hematology,510(K),"CELL-DYN 3200 Diluent/Sheath Reagent,List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA",CELLDYN 3200 ,2,"April 03, 2007", 2007,Abbott Laboratories,Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.",N/A,27411,"27,411 units","Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.",Terminated,"May 01, 2007",28,27411,Not_Computer,N/A,N/A,N/A
Z-0701-2007,37596,"Instrument, Surgical, Disposable",KDC,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.",Scanlan MobinUddin Vein Holder,2,"April 03, 2007", 2007,Scanlan International Inc,Incorrectly assembled by manufacturer,N/A,"The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.",N/A,35,35 units domestically ( 70 units to OUS),"Worldwide distribution --- USA including states of IN, MO and country of Japan",Terminated,"June 27, 2007",85,35,Not_Computer,N/A,N/A,N/A
Z-0707-2007,37632,"System, Test, Vitamin D",MRG,Vitamin D test system.,Clinical Chemistry,Clinical Chemistry,510(K),"1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA","DiaSorin 1,25Dihydroxyvitamin D RIA Kit ",3,"April 03, 2007", 2007,Diasorin Inc.,"Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Product recalled by letter dated 6/01/2006.,N/A,715,715,"Worldwide Distribution-USA including states of UT, CO, IL, NY, NV, MI, NC, MN, VA, GA, CA, KS, VT, CT and IN, and Countries of Canada, Sweden, Germany, Belgium, Italy, France, Norway, Australia, South Korea, Taiwan, Israel, New Foundland, India, China, Brazil, Austria, Saudi Arabia, and Spain",Terminated,"June 25, 2007",83,715,Not_Computer,N/A,N/A,N/A
Z-0703-2007,37615,"Prosthesis, Penile",FAE,Penile rigidity implant.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN",AMS DURAII Distil Tips,2,"April 03, 2007", 2007,American Medical Systems,Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.,N/A,"The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.",N/A,5,5 devices,Nationwide,Terminated,"June 27, 2007",85,5,Not_Computer,N/A,N/A,N/A
Z-0708-2007,37454,"Diluent, Blood Cell",GIF,Blood cell diluent.,Hematology,Hematology,510(K),"CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA",CELLDYN Sapphire and CELLDYN 4000 ,2,"April 03, 2007", 2007,Abbott Laboratories,High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites.",N/A,56075,"56,075 units","Worldwide Distribution-USA including states of AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV and Countriers of Argentina, Australia, Brazil, Hong Kong, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, and Venezuela.",Terminated,"November 28, 2007",239,56075,Not_Computer,N/A,N/A,N/A
Z-0713-2007,37018,"Device, Pasteurization, Hot Water",LDS,Medical washer.,General Hospital,General Hospital,510(K) Exempt,"ThermaSure Medical Device Drying Cabinet, series 1000",ThermaSure,2,"April 04, 2007", 2007,Cenorin,Potential for user to receive an electrical shock.,DESIGN: Device Design,Letter dated 12/20/2006 notifying customers of potential shock hazard under certain fault conditions and that a corrective action upgrade is being developed.,N/A,8,8 units,Worldwide.,Terminated,"November 09, 2007",219,159,Not_Computer,N/A,N/A,N/A
Z-0714-2007,37358,"Dressing, Wound, Drug",FRO,N/A,N/A,General & Plastic Surgery,510(k),"ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625",ProWick Shoulder Postoperative Dressing and Cold Therapy System,2,"April 04, 2007", 2007,Integra Biotechnical LLC,"During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.",N/A,"An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.'.",N/A,1769,1769,Nationwide,Open,N/A,N/A,1769,Not_Computer,N/A,N/A,N/A
Z-0710-2007,37597,"Bandage, Liquid",KMF,Liquid bandage.,General Hospital,General & Plastic Surgery,510(K),"Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.",SeaClens Wound Cleanser,2,"April 04, 2007", 2007,Coloplast Corp Skin Care Div,Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The initial consignees of the product were contacted and notified of the recall February 14, 2007. The consignees were asked to contact their customers immediately and return all product to the manufacturer.",N/A,654,"654 boxes, 12 bottles per box for a total of 7,848 bottles",Nationwide.,Terminated,"June 25, 2007",82,654,Not_Computer,N/A,N/A,N/A
Z-0715-2007,37507,"Accessories, Solution, Ultrasonic Cleaners For Lenses",LYL,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(K),"Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu¶_ Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz","Bausch & Lomb ReNu MultiPurpose Solution, Equate MultiPurpose Solution and Target Brand MultiPur",2,"April 04, 2007", 2007,Bausch & Lomb Inc,A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.,N/A,1.5,1.5 million units,"Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.",Terminated,"January 09, 2008",280,15000000,Not_Computer,N/A,N/A,N/A
Z-0716-2007,37642,N/A,N/A,N/A,N/A,N/A,N/A,QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.,QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface,2,"April 04, 2007", 2007,Pulse Biomedical Inc,No 510(k) marketing clearance for the product,N/A,"On 3/5/07, the recalling firm telephoned their customers to inform them of the problem and the need to return to the product. As a follow up to the telephone calls a letter dated 3/5/07 was sent via certified mail.",N/A,8,8 units,"The product was shipped to four direct customers in CA, NY, TN and US military (Cuba). The product was also shipped to Chile, Greece, and the Netherlands",Terminated,"August 29, 2007",147,8,Not_Computer,N/A,N/A,N/A
Z-0674-2007,37188,"Compressor, Air, Portable",BTI,Portable air compressor.,Anesthesiology,Anesthesiology,510(K),Medical Air Compressor Model #8413419,Drager Medical Air Compressor,2,"April 05, 2007", 2007,"Draeger Medical, Inc.",Compressors not providing sufficient supply pressure to connected medical ventilator,PRODUCTION CONTROLS: Process Control,"The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.",N/A,67,67 units,Nationwide.,Terminated,"June 15, 2007",71,67,Not_Computer,N/A,N/A,N/A
Z-0718-2007,37486,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.",CADD Prizm,3,"April 05, 2007", 2007,"Smiths Medical MD, Inc.",The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.,TRAINING: Employee Error,"All consignees who have received the affected CADD-Prizm PCS II ambulatory infusion pumps and the CADD-Prizm VIP System ambulatory infusion pumps were contacted via telephone by February 1, 2007. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths Medical MD in order for the problem to be corrected.",N/A,27,27,Nationwide.,Terminated,"May 25, 2007",50,27,Software,Device Operation,Remove,Remove or Replace
Z-0719-2007,37598,"Syringe, Piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 30ml Syringe Luer-Lok tipSterileBD, Franklin Lakes, NJMade in USA",BD,2,"April 05, 2007", 2007,Becton Dickinson & Company,"The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.",PRODUCTION CONTROLS: Process Control,"Distributors were sent recall notification letters on February 1, 2007Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.",No consumer action necessary,332400,"332,400 units",Nationwide.,Terminated,"July 19, 2007",105,332400,Not_Computer,N/A,N/A,N/A
Z-0722-2007,37334,"Phosphomolybdate (Colorimetric), Inorganic Phosphorus",CEO,Phosphorus (inorganic) test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20",N/A,2,"April 05, 2007", 2007,Abbott Laboratories Inc.,Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L),N/A,"A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.",N/A,87722,"42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide","Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica",Open,N/A,N/A,1665,Not_Computer,N/A,N/A,N/A
Z-0721-2007,37638,"System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy",MEQ,N/A,N/A,Gastroenterology/Urology,PMA,Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.,Uroglogix Targis,2,"April 05, 2007", 2007,"Urologix, Inc.","The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.",PRODUCTION CONTROLS: Packaging Process Control,"A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.",N/A,21,21,Nationwide and the Netherlands.,Terminated,"May 25, 2007",50,117,Not_Computer,N/A,N/A,N/A
Z-0705-2007,37167,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27,ABL800 Series analyzer with FLEXQ module ,2,"April 06, 2007", 2007,Radiometer America Inc,In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.,DESIGN: Software Design,"Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.",N/A,64,"64 in U.S. & 1,281 to foreign accounts","Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark",Open,N/A,N/A,64,Software,Output/Calculation,Software update,Software Update
Z-0728-2007,37446,"Radioimmunoassay, Estradiol",CHP,Estradiol test system.,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500",ARCHITECT Estradiol Reagent,3,"April 07, 2007", 2007,Abbott Laboratories,A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.,N/A,"Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.",Contact the recalling firm for information,1944,"1,944 kits","Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Chile, Uruguay, Argentina, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.",Terminated,"January 09, 2008",277,1944,Not_Computer,N/A,N/A,N/A
Z-0723-2007,37383,"Device, Microtiter Diluting/Dispensing",JTC,Microtiter diluting and dispensing device.,Microbiology,Microbiology,510(K) Exempt,"Hamilton brand Disposable Precision Tips,Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada",Hamilton Disposable Precision Tips,2,"April 07, 2007", 2007,Hamilton Co,"Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting.",N/A,"The firm initiated its recall on January 30, 2007. The initial notification was sent via certified mail and e-mail. Subrecalls will be conducted by the distributor.",N/A,37,37 cases,Nationwide (via a single distributor in New Jersey),Terminated,"November 28, 2007",235,37,Not_Computer,N/A,N/A,N/A
Z-0724-2007,37582,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),Smith & Nephew Suture Passer 12 inchPart Number: 7209166,Smith & Nephew Suture Passer,2,"April 07, 2007", 2007,"Smith & Nephew, Inc. Endoscopy Division",Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot becleaned adequately following use.,DESIGN: Device Design,"Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.",N/A,304,"12, 292 units for all recalls Z-0724-0726-07","World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway",Terminated,"July 14, 2008",464,12292,Not_Computer,N/A,N/A,N/A
Z-0727-2007,37641,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K),"Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.",Sunrise MedicalHoyer Advance Patient Lifts,2,"April 07, 2007", 2007,Joerns Healthcare Inc.,Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).,PRODUCTION CONTROLS: Process Control,Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement.,N/A,581,581 units,"Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada.",Terminated,"October 07, 2010",1279,581,Not_Computer,N/A,N/A,N/A
Z-0733-2007,37465,"Enzyme Immunoassay, Amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(K),"Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA",BioRad TOX/See ,2,"April 10, 2007", 2007,Bio-Rad Laboratories Inc,The product may produce a faint line which could be interpreted as a false negative test result .,DESIGN: Device Design,"The firm intends to contact its subsidiary distributors and sales staff via Fax (Feb 12, 2007) and phone call. In addition, the recall notification will be posted on the firm's intranet site. Customers are instructed to destroy recalled product following standard laboratory practices.",N/A,177,177 Kits,Worldwide distribution --- USA and countries of Australia and Italy.,Terminated,"February 04, 2008",300,177,Not_Computer,N/A,N/A,N/A
Z-0735-2007,37585,Drug Metabolizing Enzyme Genotyping Systems,NTI,Drug metabolizing enzyme genotyping system.,Toxicology,Toxicology,510(K),"AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.",AmpliChip CYP450 ,2,"April 11, 2007", 2007,"Roche Molecular Systems, Inc.","The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the ""Other Materials Required"" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)"" . The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.",MISBRANDING: Labeling False and Misleading,"A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I. .",Contact the recalling firm for information,89,89,"World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary",Terminated,"August 23, 2007",134,218,Not_Computer,N/A,N/A,N/A
Z-0730-2007,37628,"Catheter, Biliary, Diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Flexxus¶_ Endoscopic Biliary Stent, 7.5 Fr10 mm diameter x 60 mm lengthItem Number: LXB10060",Flexxus,2,"April 11, 2007", 2007,"Conmed Endoscopic Technologies, Inc.",Blue safety clip incorrectly placed on the stent may prevent deployment,TRAINING: Employee Error,ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.,N/A,1,1 UNIT,"Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.",Terminated,"May 15, 2007",34,12,Not_Computer,N/A,N/A,N/A
Z-0737-2007,37602,"Test, Time, Prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(K),CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).,Coaguchek ,2,"April 11, 2007", 2007,Roche Diagnostics Corp.,The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.,PRODUCTION CONTROLS: Process Control,All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.,N/A,10,10,"Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.",Terminated,"June 13, 2007",63,10,Not_Computer,N/A,N/A,N/A
Z-0736-2007,37599,"Enzyme Immunoassay, Digoxin",KXT,Digoxin test system.,Toxicology,Toxicology,510(K),"Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.",COBAS Integra DIG,2,"April 13, 2007", 2007,Roche Diagnostics Corp.,"The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.",N/A,A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.,N/A,4735,"4,735",Nationwide.,Terminated,"June 12, 2008",426,4735,Not_Computer,N/A,N/A,N/A
Z-0694-2007,37687,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),"BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only","BioHorizons 0.050 Hex Driver, Long",3,"April 13, 2007", 2007,BioHorizons Implant Systems Inc,Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Letters and replacement drivers were sent to the consignees (both domestic and abroad) on 3/12/2007 explaining the problem and requesting that the consignee discard the instrument and use the replacement. They were delivered via United Parcel Service (UPS) 3rd day package delivery.,N/A,436,436 units,"Worldwide Distribution -- USA and countries of Canada, Norway, Australia, Spain, Brazil, Pakistan, Israel, Latvia, Japan, Columbia, Thailand, Turkey, Italy, South Korea, India, Taiwan, Ukraine, Russia, United Arab Emirates, Saudi Arabia, Hong Kong, Romania, UK, Kuwait, and Lithuania",Terminated,"September 04, 2007",144,1366,Not_Computer,N/A,N/A,N/A
Z-0744-2007,37254,"Calibrator, Multi-Analyte Mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(K),Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.,Mega Diagnostics Alcohol Standard ,3,"April 14, 2007", 2007,Mega Diagnostics,Potential for microorganism growth in the alcohol standard.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product .,N/A,6,6 units,Country of Indonesia,Open,N/A,N/A,18,Not_Computer,N/A,N/A,N/A
Z-0746-2007,37427,"Port & Catheter, Implanted, Subcutaneous, Intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(K),"Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific MEDI-TECH (617) 972-4000/(800) 225--3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.",Vaxcel Implantable Vascular Access System ,2,"April 14, 2007", 2007,Boston Scientific Corp,Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error),PRODUCTION CONTROLS: Process Control,"Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.",N/A,5,5,"NY, CA, MD, WA, TN.",Terminated,"April 23, 2007",9,27,Not_Computer,N/A,N/A,N/A
Z-0748-2007,37606,"N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin",JNO,Trypsin test system.,Clinical Chemistry,Clinical Chemistry,510(K),"DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)",DiaSorin TRYPSIK,3,"April 14, 2007", 2007,Diasorin Inc.,Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay),N/A,The consignees & distributors were notified by letter on 2/15/07 . The Distributors are instructed to forward the notification to the customers who have received the affected products. A response form will be requested from the customers.,N/A,100,100 kits,"Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.",Terminated,"July 15, 2007",92,100,Not_Computer,N/A,N/A,N/A
Z-0747-2007,37528,"Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)",LOM,N/A,N/A,Microbiology,PMA,"VITROS¶_ Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.",VITROS Immunodiagnostics Products HBsAg Reagent Pack,2,"April 14, 2007", 2007,Ortho-Clinical Diagnostics,Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.,N/A,"On 2/01/07, all US end-user consignees who received the VITROS HBsAg Reagent Packs, were informed of this issue by Federal Express overnight letter, and informed that they may continue to use their current lot of VITROS HBsAg Reagent Pack providing that they followed the instructions in the letter. INSTRUCTIONS: Please do the following if you choose to continue using sodium citrate and/or EDTA plasma collection tubes: - Do not freeze samples collected in sodium citrate or EDTA plasma collection tubes prior to processing the assay. - Process samples collected into sodium citrate plasma tubes within 12 hrs. of collection. -Continue to perform supplemental testing to confirm all HBsAg results that repeat as 'Borderline' or 'Reactive', as directed in the Package Insert. - Complete and return the attached Confirmation of Receipt Form upon receipt of this notification. - Forward the information in this notification if you have distributed the product outside your facility.",N/A,4125,"Cat. #6801322 (1 Reagent Pack box per sales unit): 11,761 units; Cat. #6802450 (5 Reagent Pack boxes per sales unit): 4125 units",Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.,Open,N/A,N/A,15886,Not_Computer,N/A,N/A,N/A
Z-0749-2007,37698,"System, X-Ray, Mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),"Mobilett XP, mobile X-ray system, Model number 1818454",Mobilett XP,2,"April 19, 2007", 2007,"Siemens Medical Solutions USA, Inc",Mounting bolts for tank fork assembly and collimator flange may become loose.,DESIGN: Device Design,"Siemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.",N/A,186,186 units,The products were shipped to medical facilities nationwide.,Terminated,"August 07, 2007",110,227,Not_Computer,N/A,N/A,N/A
Z-0754-2007,37742,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"RITA¶_ Starburst¶_ MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816",RITA StarBurstMRI SemiFlex ,2,"April 19, 2007", 2007,"Rita Medical Systems, Inc.",The product may have a cracked tray which can compromise the sterility of the product.,N/A,"Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.",N/A,2021,2021 devices,"Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.",Terminated,"January 20, 2010",1007,5103,Not_Computer,N/A,N/A,N/A
Z-0761-2007,37518,Full-Montage Standard Electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(K),"Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)",Ceegraph/Sleepscan Netlink Traveler,2,"April 20, 2007", 2007,Bio-Logic Systems Corp,Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.,DESIGN: Device Design,"On 2/26/07, Bio-logic Systems shipped replacement batteries, marked with part number 520-LIBAT4-3 and a label reading 'THIS SIDE OUT', and a new battery compartment cover with a label inside the cover to clarify the correct installation of the battery to each of the affected customers. The accounts were requested to remove and replace the old batteries, part 520-LIBTA4-2, and compartment covers, and return the old batteries and covers to Bio-logic Systems in the enclosed pre-paid shipping container, along with the completed accounting form.",N/A,130,"130 battery packs (112 domestic USA, 18 foreign)","Worldwide, USA , Canada, China, Hong Kong, India and Israel.",Terminated,"August 26, 2008",494,130,Battery,Physical Safety Hazards,Replace battery,Remove or Replace
Z-0731-2007,37189,"Conserver, Oxygen",NFB,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(K),DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder,DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder ,2,"April 21, 2007", 2007,Sunrise Medical,Cylinder could lose oxygen at high pressure after the filling process,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.,N/A,4169,"4,169 units (Z-0731/0732-2007)",Worldwide-original shipments to distributors/dealers USA and Canada.,Terminated,"August 27, 2009",859,4169,Not_Computer,N/A,N/A,N/A
Z-0765-2007,37281,"Instrument, Vitreous Aspiration And Cutting, Ac-Powered",HQE,Vitreous aspiration and cutting instrument.,Ophthalmic,Ophthalmic,510(K),"Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.",Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter,2,"April 21, 2007", 2007,Bausch & Lomb Inc,The cutter probe tip breaks during use.,DESIGN: Device Design,"On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply card.",No consumer action necessary,5825,"32,190 units of Catalog No: CX 5825","Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands",Terminated,"April 07, 2009",717,50800,Not_Computer,N/A,N/A,N/A
Z-0767-2007,37759,"Blade, Scalpel",GES,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.",Miltex Stainless Steel Disposable Scalpel,2,"April 21, 2007", 2007,"Miltex, Inc.",Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex),PRODUCTION CONTROLS: Process Control,The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall.,N/A,400,400 boxes,"Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA.",Terminated,"August 07, 2007",108,400,Not_Computer,N/A,N/A,N/A
Z-0756-2007,37495,"Electrode, Electrodcardiograph, Multi-Function",MLN,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K),"PADPRO ADULT Radiotranslucent Pad w/Zoll¶_ connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502.",PADPRO DULT Radiotranslucent Pad w/Zoll connector,2,"April 24, 2007", 2007,Conmed Corporation,Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.,PRODUCTION CONTROLS: Packaging Process Control,"On 3/08/07, ""URGENT DEVICE RECALL"" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.",N/A,9712,9712 pairs,"Worldwide, including USA, Canada, Romania, Chile, and Belgium",Open,N/A,N/A,10632,Not_Computer,N/A,N/A,N/A
Z-0760-2007,37607,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),"Puritan Bennett 840 Ventilator System, Catalogue Numbers:4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP(Note: the Xs indicate any combination of alpha characters which specify option and language packs)",Puritan Bennett 840 Ventilator System,2,"April 24, 2007", 2007,Nellcor Puritan Bennett,"In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.",DESIGN: Software Design,"The correction will extend to the end user. All users will be contacted by mail or through personal contact. In the U.S., all customers were mailed the 'Urgent Device Correction' letter along with a serial number listing of those units which records show were consigned to them beginning on March 12, 2007. The customer communication informs customers of the issue and provides instruction for continued safe use of the device pending the correction.",N/A,3756,3756,"Worldwide, including USA, ARGENTINA, AUSTRALIA,BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, EGYPT,FRANCE, GERMANY, GREECE, GUATEMALA, IRAN,IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN,KOREA, LEBANON, MEXICO, MOROCCO, NICARAGUA, PANAMA, POLAND, PUERTO RICO, ROMANIA, RUSSIA,SINGAPORE, SOUTH AFRICA, SPAIN, TURKEY, UK,& YUGOSLAVIA",Open,N/A,N/A,3756,Hardware,Device Operation,Correction,Repair
Z-0759-2007,37604,"Joint, Knee, External Limb Component",ISY,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).",Medipro OP4,2,"April 24, 2007", 2007,Medi Manufacturing Inc,Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Each consignee was contacted by phone on 8/11/2006. A follow up letter was sent to consignees on 8/11/2006 providing details on who to contact and how to return the affected devices for replacement. A self addressed, stamped response form was included to be completed and returned to Medi.",N/A,8,8 units,Nationwide.,Open,N/A,N/A,8,Not_Computer,N/A,N/A,N/A
Z-0755-2007,37691,"Test, Antigen, Nuclear, Epstein-Barr Virus",LLM,Epstein-Barr virus serological reagents.,Microbiology,Microbiology,510(K),"DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285",ETIEBNAG,3,"April 24, 2007", 2007,Diasorin Inc.,A lot to lot inconsistency was noted on kits of ETI EBNA G.,DESIGN: Device Design,"All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product.",N/A,203,203,Nationwide and Canada.,Terminated,"July 15, 2007",82,203,Not_Computer,N/A,N/A,N/A
Z-0769-2007,37760,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),Magnetom Espree System with OR Table,Magnetom Espree System with OR Table,2,"April 26, 2007", 2007,"Siemens Medical Solutions USA, Inc",If table top is not seated properly it can lock up/stick.,DESIGN: Device Design,"The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.",N/A,3,3 units,The product was shipped to medical facilities in NY and TX.,Terminated,"August 07, 2007",103,3,Not_Computer,N/A,N/A,N/A
Z-0768-2007,37590,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096",Medfusion 3500 ,2,"April 26, 2007", 2007,"Smiths Medical MD, Inc.","Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.",DESIGN: Software Design,Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.,N/A,23519,"23,519","Nationwide, Canada, and Italy.",Open,N/A,N/A,23519,Software,Device Operation,Notification,Safety Notice/Insructions
Z-0758-2007,37591,"Laryngoscope, Rigid",CCW,Rigid laryngoscope.,Anesthesiology,Anesthesiology,510(K),"Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; Distributed by Teleflex Medical, Research Triangle Park, NC 27709; catalog number 005852300",Rusch MRI Conditional Fiber Optic Laryngoscope Kit,2,"May 02, 2007", 2007,Teleflex Medical,The MRI Battery is out of specification for its magnetic content.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Teleflex telephoned the account on 3/1/07, and faxed them a follow-up recall letter on the same date. The account was informed that the batteries did not meet specification, and was requested to check the batteries in the laryngoscope kit shipped to them for the affected battery lot numbers, and return the affected batteries to Teleflex for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.",N/A,1,1 kit,Georgia,Terminated,"May 03, 2007",1,1,Not_Computer,N/A,N/A,N/A
Z-0773-2007,36826,"System, Blood Culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(K),"BacT/ALERT Classic System Software, Blood Culturing System",BacT/ALERT ,2,"May 03, 2007", 2007,"bioMerieux, Inc.",Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.,N/A,"Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.",N/A,10790,"10790 units, total for all models","Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.",Terminated,"December 08, 2009",950,10790,Software,Output/Calculation,Corrective Action Notification,Repair
Z-0779-2007,37762,"Reagent, Russel Viper Venom",GIR,Russell viper venom reagent.,Hematology,Hematology,510(K),American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic,American Diagnostica Inc.,2,"May 03, 2007", 2007,"American Diagnostica, Inc.",Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.,N/A,249,249 kits,"Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.",Open,N/A,N/A,249,Not_Computer,N/A,N/A,N/A
Z-0778-2007,37719,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),GEM Premier 4000 Laboratory Analyzer,Instrumentation Laboratory GEM Premier,2,"May 03, 2007", 2007,Instrumentation Laboratory Co.,Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result,DESIGN: Software Design,Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07.,N/A,210,210,"Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden",Open,N/A,N/A,210,Not_Computer,N/A,N/A,N/A
Z-0780-2007,37510,"Accessories, Operating-Room, Table (Kit)",FWZ,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.",Doro Adapter,2,"May 04, 2007", 2007,Orthopedic Systems Inc,"Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of ""Tercite"", which is blue.",DESIGN: Component Design/Selection,A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.,"Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",8,8 units distributed.,"The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.",Terminated,"December 06, 2007",216,8,Not_Computer,N/A,N/A,N/A
Z-0770-2007,37702,"Accessories, Cleaning, For Endoscope",FEB,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.",83 Miniflex with accesory crate,2,"May 04, 2007", 2007,"Custom Ultrasonics, Inc.",The device was marketed without a 510k,N/A,"On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.",Contact the recalling firm for information,4,4 units,"Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.",Terminated,"November 05, 2007",185,4,Not_Computer,N/A,N/A,N/A
Z-0772-2007,37747,"Walker, Mechanical",ITJ,Mechanical walker.,Physical Medicine,Physical Medicine,510(K) Exempt,"Lumex¶_ Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.",Lumex,2,"May 05, 2007", 2007,Graham Field Atlanta,The caster bolt stem/screw may loosen over time causing the wheel to come off.,DESIGN: Device Design,"Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.",N/A,13300,"13,300 units","U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo",Terminated,"January 12, 2010",983,13300,Not_Computer,N/A,N/A,N/A
Z-0771-2007,37813,"Transducer, Ultrasonic, Diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(K),"Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.","Nemio XG SSA580A, Diagnostic Ultrasound System",2,"May 05, 2007", 2007,Toshiba American Med Sys Inc,"Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.",DESIGN: Software Design,"Notification letters were sent to customers on December 19, 2206. Customers were instructed to avoid using Scale Graph function with live images, and instructed to call up the Scale Graph after images are frozen. Customers were informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.",N/A,37,37,"Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.",Open,N/A,N/A,37,Software,Physical Safety Hazards,Software update,Software Update
Z-0782-2007,37819,"Camera, Television, Endoscopic, Without Audio",FWF,Surgical camera and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.",Sopro Camera Control Unit,3,"May 05, 2007", 2007,"Smith & Nephew, Inc Endoscopy Division",Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT),N/A,Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.,N/A,25,25 units.,"Foreign Distribution Only-No U. S. A. distribution International distribution to: Argentina, Austria, Australia, Belgium, Brazil, China, Columbia, Denmark, Dubai, France, Germany, Greece, Italy, India, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Turkey and United Kingdom.",Terminated,"September 02, 2008",486,102,Not_Computer,N/A,N/A,N/A
Z-0783-2007,37855,"Set, I.V. Fluid Transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(K),"B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.",B. Braun HyperFormer Pump Dispensing Set,2,"May 05, 2007", 2007,"B. Braun Medical, Inc.",The integrity of the sterile product barrier may be compromised,PRODUCTION CONTROLS: Packaging Process Control,"An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.",N/A,180,180 units,"Nationwide distribution --- including states of GA, MA, OH, and TX",Terminated,"August 07, 2007",94,180,Not_Computer,N/A,N/A,N/A
Z-0789-2007,37437,"Prosthesis, Penis, Inflatable",JCW,Penile inflatable implant.,Gastroenterology/Urology,Gastroenterology/Urology,PMA,"AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.",AMS 700 Penile Prothesis,2,"May 09, 2007", 2007,American Medical Systems,The carton labeling does not match the product packaged inside.,PRODUCTION CONTROLS: Packaging Process Control,AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.,"Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",10,10,"Worldwide, including USA, Canada and England.",Terminated,"February 24, 2008",291,26,Not_Computer,N/A,N/A,N/A
Z-0790-2007,37780,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, Irving, TX.",ARCHITECT i2000 Processing Module,2,"May 09, 2007", 2007,"Abbott Laboratories, Inc","If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.",N/A,Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.,Contact the recalling firm for information,N/A,n/a,"Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, UAE, United Kingdom. No US distribution.",Terminated,"September 25, 2007",139,N/A,Not_Computer,N/A,N/A,N/A
Z-0793-2007,37854,"Lenses, Soft Contact, Daily Wear",LPL,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,PMA,"CIBASoft¶_ Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.",CIBASoft Visitint,2,"May 09, 2007", 2007,Ciba Vision Corporation,Base curve of the lenses do not meet specification.,TRAINING: Employee Error,"Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.",N/A,22,22 lenses,Nationwide.,Terminated,"March 13, 2008",309,22,Not_Computer,N/A,N/A,N/A
Z-0784-2007,37105,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),"GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.",Engstrom Carestation ,2,"May 10, 2007", 2007,"Datex - Ohmeda, Inc",There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.,DESIGN: Software Design,Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.,"Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",446,446,"GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY.",Terminated,"October 16, 2008",525,446,Software,Display/Image,Software update,Software Update
Z-0777-2007,37710,"Tubes, Vials, Systems, Serum Separators, Blood Collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(K),"BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.",SafetyLok Blood Collection Set,2,"May 10, 2007", 2007,Becton Dickinson & Company,The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.,PRODUCTION CONTROLS: Process Control,"Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.",N/A,147200,"147,200 units",Nationwide and Canada.,Terminated,"July 25, 2007",76,147200,Not_Computer,N/A,N/A,N/A
Z-0795-2007,37805,"Mesh, Surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(K),Gynecare PROLIFT Total Pelvic Repair SystemPFRT01EthiconDeutschland,PROLIFT,2,"May 10, 2007", 2007,"Ethicon, Inc.",The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01),PRODUCTION CONTROLS: Process Control,"Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.",N/A,160,160 units to US,Nationwide,Terminated,"March 04, 2008",299,160,Not_Computer,N/A,N/A,N/A
Z-0794-2007,37837,"Filter, Intravascular, Cardiovascular",DTK,Cardiovascular intravascular filter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572",MediTech Stainless Steel Greenfield Vena Cava Filter,3,"May 10, 2007", 2007,Boston Scientific,"One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.",TRAINING: Employee Error,Consignees were notified by letter (10/06/2006) which was accompanied by a Reply Verification Letter. All consignees were asked to cease use of product upon receipt of the letter and to fax the Reply Verification Letter to recalling firm and return product to firm.,N/A,24,24 units,Nationwide.,Open,N/A,N/A,24,Not_Computer,N/A,N/A,N/A
Z-0797-2007,37064,N/A,N/A,N/A,N/A,N/A,N/A,"Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4MSU2FUS",Maxi Move Patient Lift with Scale,2,"May 11, 2007", 2007,"Arjo, Inc.","The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.",PRODUCTION CONTROLS: Process Control,"Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/5/07 to the end user accounts who received the affected lifts, advising them of the potential for the hanger bar assembly to detach. They were informed that an Arjo Field Service Technician would call them within five business days to schedule the time for him to visit and perform the inspection and correction to the lifts involved. If they did not hear from the technician within that time, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140. The accounts were also requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter.",N/A,10,10 lifts,Nationwide,Terminated,"September 02, 2008",480,284,Not_Computer,N/A,N/A,N/A
Z-0801-2007,37893,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),"Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243",Biohorizons 3.0mm Overdenture Implant System,3,"May 11, 2007", 2007,BioHorizons Implant Systems Inc,Dental implant system is missing ball attachment system.,PRODUCTION CONTROLS: Packaging Process Control,Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.,N/A,34,34 units,Worldwide distribution ---- USA and country of Italy,Terminated,"August 11, 2007",92,34,Not_Computer,N/A,N/A,N/A
Z-0800-2007,37635,"Material, Tooth Shade, Resin",EBF,Tooth shade resin material.,Dental,Dental,510(K),"3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.",Rely X ,2,"May 11, 2007", 2007,3M Espe Dental Products,"Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.",N/A,"All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.",N/A,99,99,"Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.",Terminated,"February 24, 2008",289,99,Not_Computer,N/A,N/A,N/A
Z-0805-2007,37007,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.",GE LightSpeed Computed Tomography,2,"May 15, 2007", 2007,GE Healthcare,Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.",N/A,21,21,"Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam",Open,N/A,N/A,1817,Not_Computer,N/A,N/A,N/A
Z-0810-2007,37761,"Radioimmunoassay, Parathyroid Hormone",CEW,Parathyroid hormone test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.",Roche PTH,2,"May 16, 2007", 2007,Roche Diagnostics Corp.,Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.,N/A,The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.,N/A,14503,"14,503",Nationwide.,Terminated,"June 11, 2008",392,14503,Not_Computer,N/A,N/A,N/A
Z-0811-2007,37865,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),"Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.",MicroMiniplant ,3,"May 16, 2007", 2007,Biomet 3i,"The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.",DESIGN: Device Design,Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.,No consumer action necessary,362,362 units,"Distributed worldwide, including USA, Spain and the Netherlands.",Terminated,"November 18, 2008",552,362,Not_Computer,N/A,N/A,N/A
Z-0812-2007,37868,"Instrument, Coagulation, Automated",GKP,Coagulation instrument.,Hematology,Hematology,510(K),STA Compact and STA Compact CTFor in vitro Diagnostic Use OnlyIn vitro diagnostic analyzerDiagnostica StagoFrance,STA Compact ,2,"May 16, 2007", 2007,"Diagnostica Stago, Inc.","Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.",N/A,"A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007.",N/A,693,693 units,Product was distributed to hospitals and laboratories nationwide.,Terminated,"December 10, 2007",208,693,Not_Computer,N/A,N/A,N/A
Z-0815-2007,37653,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System,EXCITE,2,"May 18, 2007", 2007,GE Medical Systems LLC,To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.,DESIGN: Software Design,"The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.",N/A,30,30 units,"Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.",Terminated,"February 24, 2008",282,30,Software,N/A,Software update,Software Update
Z-0816-2007,37838,N/A,N/A,N/A,N/A,N/A,510(K),"Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.",Cranex Tome panoramic xray ,2,"May 18, 2007", 2007,"Instrumentarium Dental, Inc.",There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.,DESIGN: Device Design,"A recall letter, dated 04/28/2006, was sent to affected customers . The letter describes the issue, and requests that no patient operation is permitted until the unit is checked by authorized service technician. If the service technician noted wear of the screw, the assembly was replaced.",N/A,9,9,"Worldwide, including USA, Canada, Bermuda, and Colombia.",Terminated,"February 24, 2008",282,9,Not_Computer,N/A,N/A,N/A
Z-0814-2007,37136,"System, Blood Culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),"BacT/VIEW¶_ Software, all versions. in vitro diagnostic database software.",BacT/ALERT Classic (Only) with BacT/VIEW Software,2,"May 18, 2007", 2007,"bioMerieux, Inc.",BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.,N/A,"A customer notification was sent on/about December 19, 2006. Customers will be sent a new BacT/VIEW software version C.30b QTR 1 2007.",N/A,1233,1233 units,"Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.",Terminated,"December 08, 2009",935,1233,Software,Device Operation,Software update,Software Update
Z-0817-2007,37852,Ph Buffer,JCC,General purpose reagent.,Pathology,Pathology,510(K),"Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark",Medtronic,3,"May 22, 2007", 2007,Medtronic Neuromodulation,Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Customers were sent a recall notice, a customer detail sheet for this product lot, and a reply form to be used when returning the suspect bottles. Distributor was provided with a formatted templates to be used in recalling the supsect bottles from their customers and instructions on how to manage the returns and ship the bottles back to Medtronic.",N/A,238,238,Nationwide.,Terminated,"March 02, 2008",285,238,Not_Computer,N/A,N/A,N/A
Z-0821-2007,37848,"System, X-Ray, Mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(K),"Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI",Definium AMX 700 ,2,"May 22, 2007", 2007,GE Medical Systems LLC,When using the Tech Switch on exposures,DESIGN: Device Design,"Visit to each consignee beginning December 21, 2006.",N/A,6,6 units,"Product was distributed in the following states: MS, NE, NJ, and, TX",Terminated,"February 24, 2008",278,6,Not_Computer,N/A,N/A,N/A
Z-0709-2007,37385,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;",Precision Link Software ,2,"May 23, 2007", 2007,"Abbott Diabetes Care, Inc.","If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.",DESIGN: Software Design,"Firm initiated its recall on 12/21/2006. The firm provided customer letters with additional information (eg. flyer or insert) to customers that they had addresses for via fedex. In addition, the product notification was posted on the firm's internet website. Further, a flyer is to be included as a supplement to the user manual.",N/A,67601,"67,601 units","Worldwide Distribution: USA as well as abroad to Argentina, Aruba, Australia, Austria, Bahamas, Belgium, Canada, Colombia, Croatia, Curacao, Czech/Slovak Republics, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Latvia, Lithuania/Estonia (Baltics), Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Portugal, Saudi Arabia, Serbia, Bulgaria/Macedonia, Singapore, Slovenia, South Africa, Spain, St. Maarten, Sweden, Switzerland, Turkey, UK and Venezuela.",Open,N/A,N/A,67601,Other,Output/Calculation,User manual update,Other
Z-0822-2007,37843,"Antigens, Cf (Including Cf Control), Influenza Virus A, B, C",GNX,Influenza virus serological reagents.,Microbiology,Microbiology,510(K),BinaxNOW Influenza A&B; 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper,BinaxNOW,2,"May 23, 2007", 2007,"Binax, Inc. dba IMPD",Tip of the foam swab could detach from the shaft causing injury to the patient.,N/A,Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical.,N/A,2688,2688 kits,Nationwide and Japan.,Terminated,"September 08, 2008",474,13934,Not_Computer,N/A,N/A,N/A
Z-0495-2007,36980,"Instrument, Vitreous Aspiration And Cutting, Ac-Powered",HQE,Vitreous aspiration and cutting instrument.,Ophthalmic,Ophthalmic,510(K),"Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY.",Bausch & Lomb Lightning High Speed Vitrectomy Cutter,2,"May 24, 2007", 2007,Bausch & Lomb Inc,The cutter tip could break during a procedure,DESIGN: Device Design,Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.,"Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.",8289,"Cat. CX4804 - 3,485 Cutter Tips","Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands.",Terminated,"April 07, 2009",684,17840,Not_Computer,N/A,N/A,N/A
Z-0813-2007,37871,"Syringe, Piston",FMF,Piston syringe.,General Hospital,General Hospital,510(K),BD 5ml Syringe Luer-Lok TipBulk Sterile Convenience PakLatex Free,Becton Dickinson,2,"May 24, 2007", 2007,Becton Dickinson & Company,"Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.",N/A,"Recall communications were sent on April 2, 2007 and May 3, 2007 by UPS second day air to all direct consignees and potential customers.",N/A,174300,"174,300 units",Nationwide.,Terminated,"August 09, 2007",77,174300,Not_Computer,N/A,N/A,N/A
Z-0827-2007,37903,"Oxygenator, Cardiopulmonary Bypass",DTZ,Cardiopulmonary bypass oxygenator.,Cardiovascular,Cardiovascular,510(k),Endura No-React Dural Substitute 2 cm x 10 cm,Endura NoReact ,1,"May 24, 2007", 2007,Integra LifeSciences Corp.,"Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t",N/A,"On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.",N/A,12736,"12,736 for all recalls Z-0827-0832-2007",Nationwide Distribution to hospitals and medical centers,Terminated,"September 24, 2008",489,12736,Not_Computer,N/A,N/A,N/A
Z-0808-2007,37756,"Suture, Nonabsorbable, Synthetic, Polypropylene",GAW,Nonabsorbable polypropylene surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'.Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' .Product is also distributed under two private labels, Webster Veterinary and Butler. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'.Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.",Polypro; Webpro; Promend,2,"May 24, 2007", 2007,C P Medical,Potential for sterility of product to be compromised. Suture package seals incomplete or missing.,PRODUCTION CONTROLS: Packaging Process Control,"On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.",N/A,1332,1332 suture packets,"Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa.Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution.Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.",Terminated,"August 01, 2008",435,15049,Not_Computer,N/A,N/A,N/A
Z-0838-2007,37900,"Needle, Hypodermic, Single Lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(K),BD AutoShield Pen Needle (Re order Number : 329300),BD AutoShield Pen Needle,2,"May 24, 2007", 2007,Becton Dickinson & Company,Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage),DESIGN: Labeling Design,"April 23, 2007, Recall letters were sent via UPS 2nd day air and/or hand delivered to all direct consignees and potential customers of the product.",N/A,496200,"496,200 units","Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.",Terminated,"April 16, 2008",328,496200,Not_Computer,N/A,N/A,N/A
Z-0820-2007,37873,"Immunoassay Method, Troponin Subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(K),"VITROS¶_ Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK",VITROS Immunodiagnostic Products Troponin I Reagent Pack,1,"May 26, 2007", 2007,Ortho-Clinical Diagnostics,Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.,N/A,"On 4/27/07, Ortho-Clinical Diagnostics in Rochester, NY, notified the end users of the recall of the product by phone, fax, and FedEx overnight letter. Clinical labs in possession of these lots have been contacted by OCD, and were instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. Replacement product has been provided to clinical labs with the affected product lots. Clinical laboratories with questions may contact the company at 1-800-421-3311. On 4/27/07, OCD foreign affiliates were informed of this action by e-mail and instructed to inform their customers who received these reagent packs of this issue. Ortho-Clinical Diagnostics in Raritan, NJ, issued a nationwide press release on 5/04/07.",N/A,11387,"Lot 3151: 1,750 units, Lot 3170: 3,316 units","Worldwide-including USA, Canada, and Bermuda",Open,N/A,N/A,5066,Not_Computer,N/A,N/A,N/A
Z-0833-2007,37701,"Dressing, Wound, Drug",FRO,N/A,N/A,General & Plastic Surgery,510(K),"TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.",TriActiv FX Embolic Protection System 7F,2,"May 31, 2007", 2007,Kensey Nash Corp,Insufficient wire sealing,PRODUCTION CONTROLS: Process Control,"On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.",N/A,427,427 kits,"Worldwide, including USA and Germany.",Terminated,"August 30, 2007",91,547,Not_Computer,N/A,N/A,N/A
Z-0819-2007,37856,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.,Horizon Pump Metriset Burette Set,2,"May 31, 2007", 2007,"B. Braun Medical, Inc.",Secondary infusion backs up into primary container.,DESIGN: Device Design,The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.,N/A,2.5,2.5 million for all products,Nationwide and Canada.,Terminated,"April 22, 2008",327,25000000,Not_Computer,N/A,N/A,N/A
Z-0845-2007,37902,"Stopcock, I.V. Set",FMG,Intravascular administration set.,General Hospital,General Hospital,510(K),"Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.",Large Bore Male Luer for use in Fluid Administration Sets.,2,"May 31, 2007", 2007,"Merit Medical Systems, Inc.",Male luer in fluid administration sets may crack due to inadequate molding process,PRODUCTION CONTROLS: Process Control,Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.,N/A,400,400 units,"CA, IL, NJ, NY. No military, government or foreign distribution.",Terminated,"May 05, 2008",340,41251,Not_Computer,N/A,N/A,N/A
Z-0854-2007,37605,Excimer Laser System,LZS,N/A,N/A,Ophthalmic,PMA,LADAR6000 Excimer Laser System,LADAR6000,1,"June 05, 2007", 2007,"Alcon Refractive Horizons, Inc.","Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated)",N/A,"Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.",Contact the recalling firm for information,102,102,"Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada",Open,N/A,N/A,102,Other,Physical Safety Hazards,Remove,Remove or Replace
Z-0869-2007,37723,Solid State X-Ray Imager (Flat Panel/Digital Imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(K),GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System),GE Healthcare Innova 4100/4100 IQ,2,"June 05, 2007", 2007,General Electric Med Systems LLC,Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen,DESIGN: Software Design,"A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.",N/A,70,70,"Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.",Terminated,"October 21, 2008",504,144,Software,Output/Calculation,Software update,Software Update
Z-0889-2007,37886,"Catheter, Nephrostomy",LJE,N/A,N/A,Gastroenterology/Urology,510(k),Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon;Part Number: M0064501110,Boston Scientiific PCNL ,2,"June 05, 2007", 2007,Boston Scientific Corporation,Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.,N/A,15,15 kits,"Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad",Terminated,"December 12, 2007",190,15,Not_Computer,N/A,N/A,N/A
Z-0890-2007,37997,"System, Digital Image Communications, Radiological",LMD,Medical image communications device.,Radiology,Radiology,510(K),Sienet MagicStore. Radiological Digital Image Communications System,Sienet Magicstore ,2,"June 05, 2007", 2007,"Siemens Medical Solutions USA, Inc",System could crash and result in data loss.,N/A,"The recalling firm issued a Safety Advisory letter to their customers (May 2, 2007) to inform them of the problem. A company representative will be contacting the customers to arrange for replacement of the RAID component.",N/A,19,19 units,"The products were shipped to medical facilities in CA, CO, FL, MS, NH, NJ, NY, and WA.",Terminated,"September 17, 2008",470,19,Other,Device Operation,Replace component,Remove or Replace
Z-0873-2007,37793,Endoscope And/Or Accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Light Source 300 Watt Xenon Lamp used in the following models:Viking EndoSite Xenon, Model 8050-1 andBoston Scientific Spyglass 300W Light Source (M00546190)",Viking ,2,"June 06, 2007", 2007,"Vision Systems Group, A Div of Viking Systems","Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure",PRODUCTION CONTROLS: Packaging Process Control,Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.,N/A,4,4,Nationwide to CA and NC,Terminated,"June 07, 2007",1,4,Not_Computer,N/A,N/A,N/A
Z-0896-2007,37806,"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(K),"Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S.",Surge Medical Solutions Retrograde Cardioplegia Cannula,2,"June 06, 2007", 2007,"Surge Medical Solutions, LLC","The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.",PRODUCTION CONTROLS: Process Control,Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.,N/A,2211,"2,211 for all Recalls Z-0892-0904-2007","Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.",Terminated,"March 10, 2009",643,2211,Not_Computer,N/A,N/A,N/A
Z-0906-2007,37857,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark;",c.cam ,2,"June 06, 2007", 2007,"Siemens Medical Solutions USA, Inc.","Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.",DESIGN: Device Design,"Important Safety Notice letters dated 4/30/07 on Siemens letterhead were sent to the end users, informing them of the potential risk that the c.cam chair may bend or break under heavy load. They were told that a Siemens service representative will contact them within the next few days to arrange the repair of the chair at no cost to the end user. To ensure the chair does not become damaged, SIemens recommended that the c.cam not be used for patient scanning until the update has been performed on the chair. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens' office at: 1-800-888-7436 (USA).",N/A,413,413 cameras,"Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal.",Terminated,"January 09, 2009",583,413,Not_Computer,N/A,N/A,N/A
Z-0905-2007,37811,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,N/A,"FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA.",FramelessArray software,2,"June 06, 2007", 2007,Varian Medical Systems Oncology Systems,"Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments",DESIGN: Software Design,"The recalling firm notified consignees by certified letter on 03/14/07. The notification was flagged as ""Urgent Medical Device Correction"" and advised end users that a localization error may occur when using the FramelessArray and affect its accuracy for Frameless treatments. Users were instructed to verify software in the devices and if running FramelessArray version 1.0, to discontinue use of the software when Stereotactic Radiosurgery plans are transfered via DICOM RT. The notification offered that firmware would be upgraded during scheduled service visit.",N/A,178,178 devices,"Worldwide : The software was distributed to direct accounts in the US and internationally distributed to accounts in Canada, Australia and Spain.",Terminated,"July 03, 2008",393,178,Software,Treatment/Delivery/Therapy,Firmware update,Software Update
Z-0891-2007,37309,"Detector And Alarm, Arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(K),"GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)",CIC Pro System,2,"June 06, 2007", 2007,General Electric Medical Systems Information Technology,Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .,DESIGN: Software Design,"GE Healthcare sent a certified letter titled ""Urgent Medical Device Correction"" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.",Contact the recalling firm for information,5190,"5,190 Units",Nationwide,Open,N/A,N/A,5190,Software,Alarm/Message,Software update,Software Update
Z-0872-2007,37792,"Accessories,Arthroscopic",NBH,Arthroscope.,Orthopedic,Orthopedic,510(K) Exempt,"Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810.","Smith & Nephew, Well Leg Holder",3,"June 06, 2007", 2007,"Smith & Nephew, Inc Endoscopy Division",The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.,PRODUCTION CONTROLS: Process Control,Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.,N/A,12,12,"Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK",Terminated,"June 16, 2008",376,12,Hardware,Device Operation,Replace,Remove or Replace
Z-0841-2007,37876,"Heart-Valve, Allograft",MIE,N/A,N/A,Cardiovascular,Contact ODE,"CryoValve, Pulmonary Valve & Conduit",CryoValve,2,"June 07, 2007", 2007,"CryoLife, Inc.",Donor tissue was released prior to information received regarding a pericardial effusion.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife.,N/A,1,1 tissue,"AZ, CO",Terminated,"December 31, 2007",207,1,Not_Computer,N/A,N/A,N/A
Z-0856-2007,37538,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.,Precision Xtra Blood Glucose monitoring system,3,"June 07, 2007", 2007,"Abbott Diabetes Care, Inc.",The front button covers may detach from the meter.,PRODUCTION CONTROLS: Process Control,"The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.",N/A,300,approximately 300 lots,Product was distributed worldwide.,Terminated,"April 04, 2008",302,300,Not_Computer,N/A,N/A,N/A
Z-0861-2007,37665,"Ventilator, Non-Continuous (Respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(K),"Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1694: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;","Hudson RCI Infant Nasal CPAP Cannula, Size 4",2,"June 07, 2007", 2007,Teleflex Medical,"The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.",PRODUCTION CONTROLS: Process Control,"Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.",N/A,13530,"13,530 for all products","Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela",Terminated,"November 16, 2009",893,13530,Not_Computer,N/A,N/A,N/A
Z-0862-2007,37782,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,PMA,"Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146",BHR Acetabular Cup W/ Impactor,2,"June 07, 2007", 2007,Smith & Nephew Inc,The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.,PRODUCTION CONTROLS: Packaging Process Control,The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.,N/A,1,1 unit,Europe. No domestic distribution.,Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-0839-2007,37821,N/A,N/A,N/A,N/A,N/A,510(K),"Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.",Silver Speed Hydrophilic Guidewire,2,"June 07, 2007", 2007,EV3 Neurovascular,Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.,N/A,"A recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires.",N/A,2120,2120,"Worldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and United Arab Emirates",Open,N/A,N/A,2120,Not_Computer,N/A,N/A,N/A
Z-0840-2007,37849,"Image, Illumination, Fiberoptic, For Endoscope",FFS,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.",Endoscope light source.,2,"June 07, 2007", 2007,"Smith & Nephew, Inc Endoscopy Division","Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.",PRODUCTION CONTROLS: Process Control,"Notification sent 04/09/07 via FedEx to distribution centers, sales reps and user facilities. Users asked to send light source to Smith & Nephew GMBH Service Center in Germany for repair (contact Ute Dieling at +49 (0) 7462-208-313).",N/A,67,67 units.,"Product sent to distributors in Argentina, Austria, Chile, Denmark, Dubai, France, Greece, Hong Kong, India, Italy, Japan, Korea, Malaysia, Norway, South Africa, Spain, Sweden and United Kingdom. No US distribution.",Terminated,"September 02, 2008",453,67,Battery,Device Operation,Repair,Repair
Z-0868-2007,37826,"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Profemur¶_ R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.","Profemur R, Revision Hip system, Proximal Body (part),",2,"June 07, 2007", 2007,Wright Medical Technology Inc,The titanium plasma coating was found to have missing fragments.,PRODUCTION CONTROLS: Process Control,The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.,N/A,4,4 units,"Nationwide, Puerto Rico, & Japan",Terminated,"June 30, 2008",389,22,Not_Computer,N/A,N/A,N/A
Z-0913-2007,37775,Solid State X-Ray Imager (Flat Panel/Digital Imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(K),GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.).,GE Healthcare Innova ,2,"June 09, 2007", 2007,General Electric Med Systems LLC,"Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely.",DESIGN: Device Design,"Consignees were contacted via a letter ""Urgent: Safety Notice"" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction.",Contact the recalling firm for information,201,201,"Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.",Open,N/A,N/A,446,Not_Computer,N/A,N/A,N/A
Z-0916-2007,37788,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(K),AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.,AcuMatch MSeries Straight and Curved Fluted Stem Segments.,2,"June 09, 2007", 2007,"Exactech, Inc.","The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.",PRODUCTION CONTROLS: Packaging Process Control,"The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product.",N/A,6,6,World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.,Open,N/A,N/A,6,Not_Computer,N/A,N/A,N/A
Z-0917-2007,37795,"Radioimmunoassay, Tobramycin",KLB,Tobramycin test system.,Toxicology,Toxicology,510(K),"Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)",Roche Online TDM Tobramycin,2,"June 09, 2007", 2007,Roche Diagnostics Corp.,"Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.",PRODUCTION CONTROLS: Process Control,Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.,N/A,474,474 total (Z-0917-0918-2007),"International Distribution ONLY-Australia, Canada and Germany.",Terminated,"April 30, 2008",326,474,Not_Computer,N/A,N/A,N/A
Z-0920-2007,37796,"Enzyme Immunoassay, Valproic Acid",LEG,Neuroleptic drugs radioreceptor assay test system.,Toxicology,Toxicology,510(K),"Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.",Roche VALP2,2,"June 09, 2007", 2007,Roche Diagnostics Corp.,Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.,PRODUCTION CONTROLS: Process Control,Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.,N/A,992,992,Nationwide.,Terminated,"December 17, 2007",191,1654,Not_Computer,N/A,N/A,N/A
Z-0926-2007,37984,"Lancet, Blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"NeatNick Sweeping Action Heel Lancet -Full-Term-Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100)",NeatNick,2,"June 09, 2007", 2007,Hawaii Medical LLC,"Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient",N/A,"Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.",N/A,286376,"286,376 units",Nationwide,Terminated,"July 22, 2008",409,344434,Not_Computer,N/A,N/A,N/A
Z-0925-2007,37864,"Dna Probe, Trichomonas Vaginalis",MJK,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K),LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.,LIFEPAK 20 Defibrillator/monitor,2,"June 09, 2007", 2007,"Medtronic Emergency Response Systems, Inc.","White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.",DESIGN: Software Design,"On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.",N/A,859,859 units,Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.,Open,N/A,N/A,859,Software,Device Operation,Software update,Software Update
Z-0922-2007,36616,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.,EP Healing abutment,2,"June 14, 2007", 2007,Biomet 3i,Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.,PRODUCTION CONTROLS: Packaging Process Control,Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.,N/A,N/A,N/A,Worldwide.,Terminated,"December 30, 2008",565,N/A,Not_Computer,N/A,N/A,N/A
Z-0933-2007,37818,"Catheter, Coronary, Atherectomy",MCX,N/A,N/A,Cardiovascular,510(K),"St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.",St Jude Medica CPS Direct SL ,2,"June 14, 2007", 2007,St Jude Medical CRMD,Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.,PRODUCTION CONTROLS: Process Control,"By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves.The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.",N/A,14000,"14,000","Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.",Open,N/A,N/A,14000,Not_Computer,N/A,N/A,N/A
Z-0855-2007,37570,"Immunoassay Method, Troponin Subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064",ARCHITECT STAT TroponinI Reagent,1,"June 14, 2007", 2007,Abbott Laboratories MPG,"False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL",N/A,Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of,N/A,9438,"9,438 kits","Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago.",Terminated,"July 16, 2008",398,9438,Not_Computer,N/A,N/A,N/A
Z-0739-2007,37767,"Collimator, Automatic, Radiographic",IZW,Diagnostic x-ray beam-limiting device.,Radiology,Radiology,Enforcement Discretion,"Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system.",Philips Automatic Collimator or Beam Limiting Device,2,"June 14, 2007", 2007,Philips Medical Systems North America Co. Phillips,The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 CFR,N/A,Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.,N/A,6,6,"Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.",Terminated,"November 15, 2010",1250,6,Not_Computer,N/A,N/A,N/A
Z-0960-2007,37671,"Mesh, Surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip.",Synovis PetriStrips Dry with Veritas Collagen Matrix (PSDV),2,"June 15, 2007", 2007,Synovis Surgical Inovation Div. of,Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.,N/A,Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.,N/A,1722,1722,"Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI",Terminated,"February 24, 2008",254,3902,Not_Computer,N/A,N/A,N/A
Z-0934-2007,37847,"Stimulator, Electrical, Implanted, For Parkinsonian Tremor",MHY,N/A,N/A,Neurology,PMA,"Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604",Medtronic DBS ,2,"June 15, 2007", 2007,Medtronic Neuromodulation,Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).,PRODUCTION CONTROLS: Process Control,"Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.",N/A,31,31 kits,"Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.",Terminated,"February 24, 2008",254,31,Not_Computer,N/A,N/A,N/A
Z-0936-2007,37869,Wearable Automated External Defibrillator,MVK,N/A,N/A,Cardiovascular,PMA,"Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.","LifeVest:Electrode Belt component of the LifeVest Wearable Defibrillator, Product number 10A0889A01",2,"June 15, 2007", 2007,Zoll Lifecor Corporation,The electrodes do not properly release conductive gel,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Patients currently using the product should continue to do so while the product removal is underway. Product replacements will begin with the belts currently in the possession of the sales reps. By replacing these first any new patients will be receiving new or refurbished belts with new Therapy Electrodes that have not been exposed to methanol. As patients complete their use of the LifeVest and return their device to the firm the belt's refurbishment process will include replacement of all 3 Therapy Electrodes. The firm expects this process to be completed in approximately 3 months based on the average use of time and current production capabilities. The process may take an additional month for devices distributed overseas. Physicians with active patients were notified via letter sent certified mail on 5/3/07. Long term use patients (patients using the device longer than 3 months) will be notified of the product removal via telephone and follow up letter. Each long term patient will be provided with a replacement belt. They will be instructed to return their existing belt in the same shipping box. Due to the low residual risk no notification is planned for short term use patients. Prescribing physicians have the option to notify their patients if they choose to do so.,N/A,944,944 belts,"Worldwide: The product was shipped to patients in AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV. The product was also shipped to Germany, United Kingdom, Italy, Spain, France, and Denmark.",Terminated,"March 06, 2008",265,944,Not_Computer,N/A,N/A,N/A
Z-0921-2007,37774,"Scale, Patient",FRW,Patient scale.,General Hospital,General Hospital,510(K) Exempt,"IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC",IMS Patient scale,2,"June 19, 2007", 2007,"Integrated Measurement Systems, Inc.","Patient Scale may become detached, which can cause a patient to fall and result in injury.",DESIGN: Device Design,"The scale manufacturer, IMS, in conjunction with the lift manufacturer, Joerns Healthcare (previously Sunrise Medical), will initiate a field fix strategy consisting of shipping replacement 4-point cradles without scales, for use until a replacement can be designed, tested and validated. Joerns will utilize their Customer Service Help Line (1-800-826-0270) on behalf of IMS, to inform customers of the voluntary field correction, address any questions regarding the IMS scale field fix strategy and to provide additional information on return of affected IMS Patient Scales. Customers were notified by telephone beginning on January 30, 2007.",N/A,149,149 units,Worldwide,Terminated,"March 02, 2008",257,149,Not_Computer,N/A,N/A,N/A
Z-0937-2007,37905,"Dilator, Esophageal",KNQ,Esophageal dilator.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.",ConMed Esophageal Dilator,2,"June 19, 2007", 2007,"Conmed Endoscopic Technologies, Inc.","Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.",PRODUCTION CONTROLS: Process Control,"Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.",N/A,68,68 units.,"Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.",Terminated,"July 30, 2010",1137,3262,Not_Computer,N/A,N/A,N/A
Z-0950-2007,37918,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX.",ARCHITECT i2000,2,"June 19, 2007", 2007,"Abbott Laboratories, Inc","One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem",DESIGN: Software Design,"Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.",Contact the recalling firm for information,170,170 units.,"Worldwide distribution, including: USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guetamala, Honduras, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, Trinidad/Tobago, Uruguay, and Venezuela.",Terminated,"March 19, 2008",274,3344,Computer,N/A,N/A,N/A
Z-0959-2007,37994,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"Biomet 3 i, Disposable Twist Drills, Model Number DT2715.",Disposable Twist Drills ,2,"June 19, 2007", 2007,Biomet 3i,The depth indicator laser line markings on the drills are too faint for clinicians to read during use.,PRODUCTION CONTROLS: Process Control,Each domestic consignee was contacted on 5/14/07 by phone using a prepared script. A follow up letter was then faxed to each consignee. International consignees were contacted by email followed by a faxed letter. Each consignee was instructed to examine their inventory for the recalled product. They were requested to complete and fax back a response form to Biomet and to return any affected product.,N/A,147,147,"World Wide: USA states including: NY, MA, MD, NJ, IL, DE, RI, CA, MI, VA, KS and fL. Internationally to Brazil, Germany, France, Great Briton Japan, Greece and Italy.",Terminated,"September 11, 2009",815,147,Not_Computer,N/A,N/A,N/A
Z-0935-2007,37863,"Humidifier, Respiratory Gas, (Direct Patient Interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(K),"HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM",Humidiflow ,2,"June 20, 2007", 2007,Porous Media Corporation,The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient),DESIGN: Device Design,"Customers were notified via a letter dated April 26, 2007. The letter describes the problem and product. Included with the letter, is a correction kit and installation instructions. The letter also urges the consignee to take an action to fill the attached form to confirm that the new intake filter restaint has been installed.",No consumer action necessary,178,178,"WORLDWIDE DISTRIBUTION: USA including states of GA, MO, FL, UT, CO, TX, MT, MN, PA, OH, AL, SC, VA, KY, IA, MA, TN, IL, NM, UT, NJ, IN, and WI, and countries of CANADA, MEXICO, and JAPAN.",Open,N/A,N/A,178,Not_Computer,N/A,N/A,N/A
Z-0836-2007,36484,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),LIFEPAK CR Plus defibrillator,LIFEPAK CR Plus,2,"June 21, 2007", 2007,"Medtronic Emergency Response Systems, Inc.",Premature battery depletion due to electrical component failure,N/A,"Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.",N/A,13741,"Total of CR Plus 13,741 units worldwide; amount does not include units distributed to Japan.","Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.",Open,N/A,N/A,14747,Not_Computer,N/A,N/A,N/A
Z-0955-2007,37919,"Catheter, Embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(K),"Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).",Possis AngioJet XMI Catheter Rapid Exchange ,3,"June 21, 2007", 2007,"Possis Medical, Inc",Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.,TRAINING: Employee Error,"Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.",N/A,45,45,"Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.",Terminated,"July 15, 2007",24,114,Not_Computer,N/A,N/A,N/A
Z-0957-2007,37953,N/A,N/A,N/A,N/A,N/A,510(K),"BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ",BD Microtainer Tube ,3,"June 21, 2007", 2007,Becton Dickinson & Company,"Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).",PRODUCTION CONTROLS: Process Control,"Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.",N/A,142800,"142,800 worldwide","Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia",Terminated,"August 15, 2007",55,142800,Not_Computer,N/A,N/A,N/A
Z-0967-2007,37493,"Sterilant, Medical Devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(K),Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.,Steris QFC1728 and QFC1729 Quick Connects ,2,"June 21, 2007", 2007,Steris Corp,The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope,DESIGN: Component Design/Selection,"On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product.",N/A,146,146,"Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Qatar.",Open,N/A,N/A,146,Not_Computer,N/A,N/A,N/A
Z-0956-2007,37948,"Test, Factor V Leiden Mutations, Genomic Dna Pcr",NPQ,Factor V Leiden DNA mutation detection systems.,Hematology,Hematology,510(k),MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.,MagNA Pure LC Total Nucleic Acid,2,"June 22, 2007", 2007,Roche Diagnostics Corp.,"False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.",DESIGN: Labeling Design,"Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks.",N/A,4201,"4,201",Nationwide.,Terminated,"December 17, 2009",909,4201,Not_Computer,N/A,N/A,N/A
Z-0971-2007,36955,"Ventilator, Non-Continuous (Respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(K),"Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.",FlexiFix Nasal Mask,2,"June 27, 2007", 2007,Fisher & Paykel Healthcare Inc,"Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use.In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat",N/A,Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock.The firm will supply consignees with replacement product as determined from completed faxback information.The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out.Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.,N/A,815239,"815,239 total for all models, all lots",Nationwide,Open,N/A,N/A,815239,Not_Computer,N/A,N/A,N/A
Z-0981-2007,37950,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),Gyroscan MRI,Gyroscan,2,"June 27, 2007", 2007,Philips Medical Systems North America Co. Phillips,"Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.",N/A,"On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.",Contact the recalling firm for information,293,293 units,"Units were distributed throughout the US to 1,078 hospitals and medical centers.",Open,N/A,N/A,1372,Not_Computer,N/A,N/A,N/A
Z-0968-2007,37300,"Clip, Implantable",FZP,Implantable clip.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.",Medtronic UClip,2,"June 27, 2007", 2007,Medtronic Cardiac Surgery Technologies,"Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.",TRAINING: Employee Error,"Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a ""Recall Certificate"" acknowledging the receipt of this information.",N/A,187,"187 (US 155, OUS 32)",Nationwide and Canada.,Terminated,"February 24, 2008",242,187,Not_Computer,N/A,N/A,N/A
Z-0985-2007,37965,"System, Imaging, Pulsed Doppler, Ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(K),"Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software",Aplio ,2,"June 27, 2007", 2007,Toshiba American Med Sys Inc,When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.,DESIGN: Software Design,"Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.",N/A,260,260,Nationwide,Open,N/A,N/A,305,Software,Display/Image,Software update,Software Update
Z-0740-2007,38120,"Device, Irrigation, Ocular Surgery",KYG,Ocular surgery irrigation device.,Ophthalmic,Ophthalmic,510(K) Exempt,"Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures.",Disposable Bimanual Irrigation and Aspiration Handpiece Set:,2,"June 27, 2007", 2007,Oasis Medical Inc,Plastic shavings are coming from the producthandle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.,PRODUCTION CONTROLS: Process Control,"An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the RecallNotification Letter are instructions: ""In addition, if you may have further distributed this product,please identify your customers and notify them at once of thisproduct recall. Your notification to your customers may beenhanced by induding a copy of this recall notification letter.This recall should be carried out to the user level. Yourassistance is appreciated and necessary to prevent anyinconvenience."".",N/A,3050,3050 total for all item numbers,"Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.",Open,N/A,N/A,3050,Not_Computer,N/A,N/A,N/A
Z-0977-2007,37764,"Enzyme Immunoassay, Cortisol, Salivary",NHG,Cortisol (hydrocortisone and hydroxycorticosterone) test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.",Roche Cortisol reagent,2,"June 28, 2007", 2007,Roche Diagnostics Corp.,"The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.",N/A,The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.,N/A,6051,6051,Nationwide.,Terminated,"June 11, 2008",349,6051,Not_Computer,N/A,N/A,N/A
Z-0976-2007,37651,"System, X-Ray, Mammographic",IZH,Mammographic x-ray system.,Radiology,Radiology,510(K),"Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.",Diamond Mammographic XRay System,2,"June 28, 2007", 2007,General Electric Med Systems LLC,GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.,DESIGN: Device Design,"A Product Safety Notification, dated 05/24/07, was sent to Hospital Administrators, Managers of Radiology and Radiologists. This letter describes the safety issue, instructions to continue the use of the product and states that the device will be corrected by GE Healthcare service engineers.",N/A,106,106,"Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.",Terminated,"February 24, 2008",241,106,Not_Computer,N/A,N/A,N/A
Z-0980-2007,37872,"Staple, Implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope.","Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03",2,"June 28, 2007", 2007,Ethicon Endo-Surgery Inc,"The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomplete staple formation or cut line.",PRODUCTION CONTROLS: Process Control,"The recalling firm sent a recall letter dated 04/02/07 to foreign consignees and a second letter dated 04/03/07 to their United States consignees. The letter asks that the customers: 1) Examine their inventories for the presence of the affected product and remove it from inventory if found; 2) Complete the Business Reply Form and fax it to Stericycle their representative and 3) Return all affected product in order to received credit, along with the completed Business Reply Form in the box identified with a pre-printed UPS shipping label supplied by the recalling firm.",N/A,23966,"23,966 units","Worldwide, including USA and Canada.",Terminated,"December 09, 2009",895,23966,Not_Computer,N/A,N/A,N/A
Z-0978-2007,37803,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.",LINAC aka FastPlan Treatment Planning Sysytem,2,"June 28, 2007", 2007,Varian Medical Systems Inc,A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.,N/A,The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.,N/A,80,80 devices,The medical devices were distributed to medical centers nationwide and worldwide.,Open,N/A,N/A,80,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0598-2007,36399,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",Terumo APS 1,2,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,"The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.",DESIGN: Software Design,"Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.",N/A,485,485 of both model numbers,"Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.",Terminated,"June 23, 2009",724,485,Battery,N/A,Replace components,Remove or Replace
Z-0602-2007,37049,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",Terumo APS 1,3,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,The power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor),PRODUCTION CONTROLS: Process Control,The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when replacement components become available.,N/A,534,534 of both model numbers,"Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.",Terminated,"August 04, 2009",766,534,Hardware,N/A,Replace power suply,Remove or Replace
Z-0601-2007,37017,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.",Terumo APS 1,2,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,"The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.",DESIGN: Device Design,The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.,N/A,1484,"1,484 of both models","Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Mexico, Malaysia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.",Terminated,"July 07, 2009",738,1484,Not_Computer,N/A,N/A,N/A
Z-0929-2007,37241,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",Terumo APS 1,2,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,"System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when replacement components become available.,N/A,416,416 for both models,"Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.",Terminated,"July 07, 2009",738,416,Hardware,Device Operation,Replace components,Remove or Replace
Z-0924-2007,37244,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.",Terumo APS 1,3,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.,DESIGN: Device Design,"The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.",N/A,525,525 total for both models,"Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.",Terminated,"June 11, 2008",347,525,Not_Computer,N/A,N/A,N/A
Z-0932-2007,37242,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.",Terumo APS 1,3,"June 30, 2007", 2007,Terumo Cardiovascular Systems Corp,"The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.",DESIGN: Component Design/Selection,The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.,N/A,1982,1982 total for both models distributed,"Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.",Terminated,"February 23, 2008",238,1982,Not_Computer,N/A,N/A,N/A
Z-0852-2007,38279,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(K),"GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.",GE OEC 2800 mobile Fluoroscopic xray system,2,"June 30, 2007", 2007,"GE OEC Medical Systems, Inc",X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.,PRODUCTION CONTROLS: Packaging Process Control,Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.,N/A,25,25 units,"Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.",Open,N/A,N/A,575,Not_Computer,N/A,N/A,N/A
Z-0738-2007,38233,"System, X-Ray, Stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(K),"Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.",Kodak Direct View DR 7500 System,2,"June 30, 2007", 2007,"Carestream Health, Inc.",The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).,MISBRANDING: Labeling False and Misleading,"On 2/21/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR 7500 Systems. (3) Kodak will supplement the Kodak DR 7500 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard. Kodak has reported that the CAP was completed as of 5/07/07.",Return product to place of purchase for a full refund,28,Domestic: 28 units,"Nationwide: CO, IL, MI, MN, MS, NY, OK, PA, SC, TN, WA",Terminated,"June 29, 2007",-1,28,Not_Computer,N/A,N/A,N/A
Z-0975-2007,37526,"Tube, Collection, Capillary Blood",GIO,Capillary blood collection tube.,Hematology,Hematology,510(K) Exempt,"SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.","SafeClinitubes, REF 942892.",2,"July 03, 2007", 2007,Radiometer America Inc,The clinitubes are not able to be filled due to contamination with silicone during production.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The firm notified their customers of this recall with a letter dated 6/22/2006. The letter informs the customers of the problem with the affected lots of SafeCLINITUBES and asks that the customers discard any remaining boxes of affected product on-site. The recall letter is accompanied by a FAX FORM (response form) which the customer is asked to complete in order to request replacement product to be sent to their individual locations.,N/A,175,175 boxes,Nationwide and Canada.,Open,N/A,N/A,175,Not_Computer,N/A,N/A,N/A
Z-0928-2007,38272,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.",OEC Miniview 6800 Mobile fluoroscopic xray system,2,"July 03, 2007", 2007,"OEC Medical Systems, Inc",X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures,DESIGN: Labeling Design,Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals.,N/A,811,811 systems,"Worldwide; USA including VA facilities in AK, CA, ID, MD, MI, NY and OR. Military distribution to CA, CO, CT, FL, GA, KS, LA, MS, OH, OK, TX, VA and Iraq. Foreign distribution to Austria, Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.",Terminated,"June 02, 2008",335,811,Not_Computer,N/A,N/A,N/A
Z-0979-2007,37834,"Test, Time, Prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(K),"STA Neoplastine CI Plus (10), (cat. 0667).12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).",STA,3,"July 03, 2007", 2007,"Diagnostica Stago, Inc.","Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.",N/A,"Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.",N/A,170,170 units,Nationwide.,Terminated,"November 30, 2009",881,170,Not_Computer,N/A,N/A,N/A
Z-0853-2007,37746,"Test, Qualitative And Quantitative Factor Deficiency",GGP,Factor deficiency test.,Hematology,Hematology,510(k),"STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.",STA Liatest,2,"July 03, 2007", 2007,"Diagnostica Stago, Inc.","A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Customers were notified on March 13, 2007 by letter, first class mail.",N/A,1098,"1,098 units",Hospitals and laboratories Nationwide,Terminated,"January 16, 2009",563,1098,Not_Computer,N/A,N/A,N/A
Z-1041-2007,37969,"Calculator/Data Processing Module, For Clinical Use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.",ACCELERATOR APS System,2,"July 03, 2007", 2007,"Abbott Laboratories, Inc","Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.",DESIGN: Device Design,Firm notified consignee via letter on 05/15/07. Consignee informed of potential for injury and advised that a label would be affixed to the device lid by an Abbott representative.,N/A,1,1 unit.,Device distributed to a hospital in UT.,Terminated,"November 27, 2007",147,1,Not_Computer,N/A,N/A,N/A
Z-1006-2007,37832,"Ventilator, Non-Continuous (Respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(K),"ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.",ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator,2,"July 03, 2007", 2007,Resmed Corporation,"S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke).",DESIGN: Device Design,"ResMed began to broadly distribute information regarding the recall on 4/23/2007. A press release was issued on 4/23/2007 with information regarding the recall and information was posted at ww.resmed.com/s8program. The firm is providing a Consignee notification package and press release to include(1) specific device names subject to the recall and affected serial numbers; specific information to be provided in each package to the end-customer. The specific information to the end user customers will include: (1) specific device names subject to the recall; (2) affected serial numbers; (3)continuing use and safety information; and (4) contact information for requesting additional details. Patients are advised that they may continue to use their S8 flow generators until a replacement unit is provided. ResMed is instructing patients, sleep labs, and hospitals to continue using the device, placing it on a hard clean surface, with a clear area around the device. ResMed intends to replace the affected products with either a new device or a device in which the affected components have been replaced.",N/A,300000,"300,000","Worldwide, USA, Canada, and Mexico.",Open,N/A,N/A,300000,I/O,Device Operation,Replace device,Remove or Replace
Z-0958-2007,37957,"Fluorescent Immunoassay, Theophylline",LER,Theophylline test system.,Toxicology,Toxicology,510(K),"IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test.This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.",IMx Theophylline Reagent Pack In Vitro Test,2,"July 03, 2007", 2007,"Abbott Diagnostic International, Ltd.","A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).",N/A,"An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records.",N/A,17,17 Kits,"Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore",Open,N/A,N/A,17,Not_Computer,N/A,N/A,N/A
Z-1001-2007,38118,"Glucose Dehydrogenase, Glucose",LFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(K),Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.,Ascensia Contour Diabetes Care System,1,"July 03, 2007", 2007,Bayer Healthcare LLC,Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.,PRODUCTION CONTROLS: Process Control,"The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.",N/A,16,16-Canadian Units only are affected,Canada.,Terminated,"November 30, 2007",150,16,Other,Output/Calculation,Return,Remove or Replace
Z-0987-2007,37888,"System, Imaging, Pulsed Doppler, Ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(K),HD11XE Diagnostic Ultrasound System,HD11,2,"July 03, 2007", 2007,Philips Medical Systems,"Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib",DESIGN: Software Design,On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.,N/A,219,219 units in US and 347 units distributed internationally,Worldwide.,Open,N/A,N/A,219,Software,Device Operation,Software update,Software Update
Z-0717-2007,38248,"System, X-Ray, Stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(K),"Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.",Kodak Direct View DR3000 System,2,"July 03, 2007", 2007,"Carestream Health, Inc.",The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).,DESIGN: Labeling Design,"On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.",N/A,7,"Domestic: 7 units, Canada: 2 units","FL, NY, MO, MI, TX, and Canada",Terminated,"July 02, 2007",-1,9,Not_Computer,N/A,N/A,N/A
Z-1010-2007,38170,"Holder, Head, Radiographic",IWY,Radiographic head holder.,Radiology,Radiology,510(K) Exempt,"BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A",BrainLAB Target Positioner for Leksell Headring,2,"July 03, 2007", 2007,Brainlab AG,Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.,DESIGN: Software Design,"BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.",N/A,7,7 units,"Ohio, Washington and France",Terminated,"February 24, 2008",236,7,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0988-2007,37954,"Sensor,Electro-Optical(For Cervical Cancer)",MWM,N/A,N/A,Obstetrics/Gynecology,PMA,MediSpectra Luma Cervical Imaging SystemModel Number: 3-02600,MediSpectra ,3,"July 03, 2007", 2007,Medispectra Inc.,Power supply may fail and render the unit inoperable.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,MediSpectra notified users by telephone on 5/15/07 and follow-up letter. Users are requested to select a date for field servce to replace the power supply.,N/A,8,8 units,"AZ, CA, FL, & NY.",Terminated,"July 09, 2007",6,8,Battery,Device Operation,Replace power supply,Remove or Replace
Z-0887-2007,37692,"Dna Probe, Trichomonas Vaginalis",MJK,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K),Batteries used with the LIFEPAK 20 defibrillator/monitor,N/A,2,"July 04, 2007", 2007,"Medtronic Emergency Response Systems, Inc.",Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.,DESIGN: Device Design,Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.,N/A,3002,3002,Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.,Open,N/A,N/A,29420,Not_Computer,N/A,N/A,N/A
Z-0966-2007,37929,"Wheelchair, Powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(K),"Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS.",Invacare Storm TDX Power Wheelchair,2,"July 04, 2007", 2007,Invacare Corporation,Software error may permit the chair to recline too far.,DESIGN: Software Design,"The recalling firm sent a recall letter dated March 19, 2007. The recalling firm also posted information regarding the recall on their website.",N/A,227,227 devices,Nationwide and Canada.,Open,N/A,N/A,227,Software,Physical Safety Hazards,Notification,Safety Notice/Insructions
Z-0991-2007,37968,"Ventilator, Emergency, Powered (Resuscitator)",BTL,Powered emergency ventilator.,Anesthesiology,Anesthesiology,510(K),"Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport.",Pneupac VR1,2,"July 04, 2007", 2007,"Smiths Medical PM, Inc.",Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.,DESIGN: Device Design,"Distriblutors and end users were contacted by phone (May 10 - May 24, 2007) and end users were additionally sent a Safety Action Bulletin May 21, 2007. The Bulletin was used as a script.",Contact the recalling firm for information,93,93,Nationwide.,Terminated,"October 10, 2008",464,93,Not_Computer,N/A,N/A,N/A
Z-0997-2007,38130,"Knife, Ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A","Premier Edge MVR 20g Microsurgical Knife, Angled",2,"July 04, 2007", 2007,Oasis Medical Inc,"This voluntary recall has been initiated due to the product puncturing the packingduring rough handling. Once the packaging is damaged, the product is no longersterile as labeled.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in theRecall Notification Letter are instructions: ""In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."".",N/A,N/A,N/A,"Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.",Terminated,"September 25, 2009",814,N/A,Not_Computer,N/A,N/A,N/A
Z-0994-2007,38116,"Syringe, Piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).",Biomet Graft Preparation System,3,"July 04, 2007", 2007,"Biomet, Inc.",The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.,DESIGN: Device Design,Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.,Contact the recalling firm for information,5,5 to Europe,"Worldwide, including USA, Chile, Italy, Spain and United Kingdom.",Terminated,"December 05, 2007",154,51,Not_Computer,N/A,N/A,N/A
Z-1005-2007,37367,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).",Terumo perfusion,2,"July 07, 2007", 2007,Terumo Cardiovascular Systems Corp,"Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.",DESIGN: Component Design/Selection,"As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem.",N/A,728,728 pumps of all models,"Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.",Terminated,"December 12, 2007",158,728,Hardware,Device Operation,Correction,Repair
Z-1000-2007,37587,"Pulse Generator, Permanent, Implantable",NVZ,N/A,N/A,Cardiovascular,PMA,"Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. T-Series software VSF07/VSF08 Version 1.2. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands",Viatron TSeries Dual Chamber pacemakers ,2,"July 07, 2007", 2007,Medtronic Inc. Cardiac Rhythm Managment,"Pacing rate: Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.",DESIGN: Software Design,Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.,N/A,6259,"6,259","within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.",Terminated,"October 16, 2008",467,10553,Software,Treatment/Delivery/Therapy,Programmer Software update,Software Update
Z-1007-2007,37944,"Pump, Infusion, Insulin",LZG,Infusion pump.,General Hospital,General Hospital,PMA,"Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722",Medtronic MiniMed Paradign Insulin Infusion Pumps,2,"July 07, 2007", 2007,Medtronic MiniMed,"Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi",N/A,"Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.",N/A,334000,"334,000 Paradigm insulin pumps (approx)","Worldwide: USA, US Virgin Islands, Antigua, Australia, Austria, Bahamas, Bahrain, Bermuda, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.",Open,N/A,N/A,334000,Not_Computer,Treatment/Delivery/Therapy,Update manual,Other
Z-1044-2007,37733,Solid State X-Ray Imager (Flat Panel/Digital Imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(K),GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System),GE Healthcare Innova 3100/ 3100 IQ,2,"July 10, 2007", 2007,General Electric Med Systems LLC,"Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury.",DESIGN: Device Design,"A ""GE Healthcare Urgent: Safety Notice"" dated January 24, 2007 was sent to consignees describing the product, problem, safety instructions, product correction and contact information.",N/A,168,168,"Worldwide, including USA, Guam, Canada, Australia, China, India, Japan, Korea, Malaysia, New Zealand, Algeria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Jordan, Morocco, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Syria, Turkey, and United Kingdom.",Terminated,"October 21, 2008",469,373,Computer,N/A,N/A,N/A
Z-0888-2007,37870,"Tubes, Gastrointestinal (And Accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Patrol enteral pump set with piercing pin, list #520540.",Patrol ,2,"July 10, 2007", 2007,Ross Products Division Abbott Laboratories,The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.,PRODUCTION CONTROLS: Process Control,"The recalling firm sent a recall letter dated April 27, 2007 to all customers.",N/A,1042050,"1,042,050 units",Nationwide,Open,N/A,N/A,1042050,Not_Computer,N/A,N/A,N/A
Z-0877-2007,37996,"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(K),"Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.",Terumo TenderFlow Pediatric Arterial Cannulae,2,"July 10, 2007", 2007,Terumo Cardiovascular Systems Corp,The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).,PRODUCTION CONTROLS: Process Control,Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.,N/A,100,100,Nationwide.,Terminated,"July 07, 2009",728,912,Not_Computer,N/A,N/A,N/A
Z-1047-2007,37769,"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",NIK,N/A,N/A,Cardiovascular,PMA,"CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.", CONTAK RENEWAL 3,2,"July 11, 2007", 2007,Boston Scientific CRM Corp,Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.,PRODUCTION CONTROLS: Process Control,"An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.",N/A,18571,"18,571","Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.",Terminated,"March 02, 2008",235,73008,Not_Computer,N/A,N/A,N/A
Z-1025-2007,37887,"Enzyme Linked Immunoabsorbent Assay, Rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,PMA,"AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064",AxSYM Rubella IgG Reagent Pack,2,"July 11, 2007", 2007,Abbott Laboratories,Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.,N/A,"Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing samples again, the user must perform a probe crash recovery following the procedure in the Operations Manual. If necessary, they need to replace the probe. If a probe crash recovery is not performed, subsequent results may be impacted. The customers were requested to retain a copy of the letter for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.",N/A,2811,"2,811 packs","Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.",Terminated,"May 18, 2008",312,28061,Not_Computer,N/A,N/A,N/A
Z-1008-2007,37977,"Motor, Drill, Pneumatic",HBB,Pneumatic cranial drill motor.,Neurology,Neurology,510(K),"Anspach Single Use, Sterile Bone Cutting Burrs",Anspach cutting burrs,2,"July 11, 2007", 2007,"The Anspach Effort, Inc.",The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.,N/A,"The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.",N/A,1962123,"1,962,123","World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.",Terminated,"January 17, 2009",556,1962123,Not_Computer,N/A,N/A,N/A
Z-0992-2007,38052,"Catheter, Embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(K),"Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EOev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USATHE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a ""Snare Catheter"" and a pouch labeled ""Amplatz Goose Neck Snare"".Snare Catheter",Amplatz Goose Neck Snare Kit,2,"July 11, 2007", 2007,"Ev3, Inc",Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.,TRAINING: Employee Error,"Letter May 18, 2007.",N/A,23,23 units,"Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.",Terminated,"October 17, 2008",464,23,Not_Computer,N/A,N/A,N/A
Z-1045-2007,38072,"Unit, Cryosurgical, Accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical SystemsReference: 900218,Wallach Cryotip,2,"July 11, 2007", 2007,"Wallach Surgical Devices, Inc.",The tip may separate from the probe.,DESIGN: Device Design,Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product.,N/A,315,315 units,"Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania",Open,N/A,N/A,329,Not_Computer,N/A,N/A,N/A
Z-1067-2007,37920,"Visual, Pregnancy Hcg, Prescription Use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(K),"AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use.",AxSYM Total BhCG Reagent,2,"July 12, 2007", 2007,"Abbott Diagnostic International, Ltd.",An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.,N/A,11530,11530 kits,"Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.",Open,N/A,N/A,30275,Not_Computer,N/A,N/A,N/A
Z-1075-2007,38062,"Ventilator, Non-Continuous (Respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(K),"AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Cardinal Health, McGaw Park, IL 60085; cat. 006900",AirLife nCPAP System Driver,2,"July 12, 2007", 2007,Cardinal Health,"Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.",N/A,"Cardinal Health sent the accounts recall letters dated 6/1/07 via UPS next day delivery, which listed the catalog number and affected serial numbers of the CPAP Driver, and informed them that under certain isolated conditions, the CPAP Driver may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance. Customers have experienced this under the following conditions: 1) air inlet pressure is greater than O2 pressure by 5 to 10 psi and 2) FiO2 settings less than 45%. Separate recall letters were sent to those accounts who had filed complaints of O2 Calibration Errors, stating that their device will be replaced by the end of June, 2007; those accounts who purchased the devices, but had not reported O2 Calibration Errors, stating that a Cardinal Health representative will upgrade the firmware on the devices at their facility by the end of August, 2007; and those accounts who had had demonstration units in their possession, advising them to notify their sales representative if any of the conditions mentioned in the letter occurred. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their possession, and were advised that they would be contacted by a Cardinal Health representative to arrange for the replacement/service of their drivers. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.",N/A,48,48 units,Nationwide.,Terminated,"December 12, 2007",153,48,Software,Alarm/Message,Firmware update,Software Update
Z-1076-2007,38115,"Joint, Knee, External Limb Component",ISY,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Ossur Total Knee Model Number 2100, external knee prosthesis.",Ossur Total Knee ,2,"July 12, 2007", 2007,Ossur,"Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.",PRODUCTION CONTROLS: Process Control,"On 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement.Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact each of those consignees. Upon receipt of this list, Ossur will then communicate the recall information directly to these consignees.",N/A,44,44,Nationwide.,Terminated,"May 28, 2008",321,44,Not_Computer,N/A,N/A,N/A
Z-1071-2007,37921,"Calibrator, Secondary",JIT,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(K),"NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***",NEFA Standard ,3,"July 12, 2007", 2007,"Wako Chemicals USA, Inc.",Diagnostic reagent for clinical laboratory testing was incorrectly labeled.,DESIGN: Labeling Design,The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction.,N/A,94,94 cartons,"Worldwide, including USA, Germany and Canada.",Terminated,"July 24, 2007",12,94,Not_Computer,N/A,N/A,N/A
Z-0990-2007,38339,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(K),"GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.",Mobile fluoroscopic xray unit.,2,"July 12, 2007", 2007,"GE OEC Medical Systems, Inc",The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.,DESIGN: Software Design,Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.,N/A,4,4 units,"Worldwide, including USA, France, Singapore, Sweden, and Switzerland.",Open,N/A,N/A,26,Computer,N/A,N/A,N/A
Z-1074-2007,38048,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C;/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C;/D",Clinac,2,"July 12, 2007", 2007,Varian Medical Systems Inc,The wedge tray may slip out of the Clinac interface mount during gantry rotation.,PRODUCTION CONTROLS: Process Control,"The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.",N/A,209,209 units,"Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, Switzerland, UAE, and UK.",Open,N/A,N/A,209,Not_Computer,N/A,N/A,N/A
Z-1077-2007,38169,"Light, Operating, Dental",EAZ,Dental operating light.,Dental,Dental,510(K) Exempt,"DCI Equipment Track Mount Light Assembly, 110v",DCI ,2,"July 12, 2007", 2007,Dental Equipment LLC,Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.,N/A,On 5/1/07 the dental office contacted the manufacturer via telephone regarding the incident. On 5/2/07 the firm's service representative visited the dental office and replaced the lights.,N/A,4,4 dual track lights,The lights were distributed to one distributor in NY who in turn distributed the lights to one dental office.,Terminated,"July 12, 2007",0,4,Not_Computer,N/A,N/A,N/A
Z-1042-2007,38016,"System, Test, Blood Glucose, Over The Counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(K),"OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)",OneTouch Ultra Test strip,2,"July 13, 2007", 2007,Lifescan Inc,"Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.",DESIGN: Device Design,March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.,N/A,77,"~33 million vials (25 strips per vial in the US, ~19 million worldwide.","Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.",Terminated,"August 15, 2008",399,52000000,Not_Computer,N/A,N/A,N/A
Z-1011-2007,38220,"Suture, Absorbable, Synthetic, Polyglycolic Acid",GAM,Absorbable poly(glycolide/l-lactide) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek¶_, TOPS ASSY P/P SLING, Catalog #84414323",Bondek Sutures ,2,"July 17, 2007", 2007,Teleflex Creek Dr,Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.",N/A,1920,1920 units total for all types of sutures,"Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany",Terminated,"March 14, 2008",241,1920,Not_Computer,N/A,N/A,N/A
Z-1091-2007,38219,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9163","Colleague 3, 3 CX and 3 CXE Volumetric Infusion Pumps",1,"July 18, 2007", 2007,Baxter Healthcare Corp.,"A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.",DESIGN: Software Design,"Baxter telephoned the direct accounts on 6/20-21/07, informing them that Baxter has received multiple reports of newly upgraded Colleague Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion. These reported events occurred during user programming with all three channels simultaneously infusing fluids. In all cases, the pump stopped the infusions and both an audible and visual alarm notification were activated. The accounts were requested to immediately remove the affected triple channel pumps, identified by two attached hangtags entitled ""Battery"" and ""Power On"", from service. The accounts were informed that their Baxter representative would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps, if available. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867. Baxter sent follow-up Urgent Product Recall letters dated 6/22/07.",Contact the recalling firm for information,4512,"4,512 pumps","Worldwide, including USA, Canada, Australia, Belgium, New Zealand, South Africa, Thailand, and Singapore.",Open,N/A,N/A,4512,Software,Treatment/Delivery/Therapy,Remove,Remove or Replace
Z-1093-2007,38019,"Accessories, Soft Lens Products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA",COMPLETE Amino Moist MultiPurpose Solution ,1,"July 19, 2007", 2007,"Advanced Medical Optics, Inc.","In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.",N/A,"On Friday, May 25, 2007 at 11:16 ET, AMO issued a press release to the market related to the voluntary recall of AMO's COMPLETE MoisturePLUS TM Multi-Purpose Solution from the market. Similar press releases, specific to the geographic regions, were issued in the other markets beginning on Saturday, May 26, 2007.A copy of the United States press release is present on the AMO website (www.amo-inc.com) and was forwarded to the FDA for posting on the FDA web site. In addition, the FDA also completed a press release related to the AMO recall and it is available on the FDA web site.Regulatory agency notifications in all markets affected outside the United States were initiated beginning on Monday, May 28. Beginning on Thursday, May 31, AMO (via Stericycle) distributed RetaiI Customer notification packages via overnight UPS delivery to the 485 customer accounts in the United States.",Contact the recalling firm for information,3794990,"3,794,990 units in Japan (57,252,581 Worldwide)","Worldwide including USA, Canada, Europe, Japan, China and various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines).",Open,N/A,N/A,31602188,Not_Computer,N/A,N/A,N/A
Z-1056-2007,37728,"Enzyme Immunoassay, Methotrexate",LAO,N/A,N/A,Toxicology,510(K),"TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution.",TDx/TDxFLx Methotrexate II,3,"July 20, 2007", 2007,"Abbott Diagnostic International, Ltd.","Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.",N/A,"The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records.",N/A,1026,"1,026","World wide Distribution : USA including states of AR, CA, CO, CT, DE, FL,GA, ID, IL, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NJ, NY, NC,NV, OH, SC, PA, RI, TN, TX, UT, WA, WI, WV, Hawaii, Washington DC, and Puerto Rico. Countries of :Canada, Mexico, Venezuela, Columbia, Chile, Brazil, Germany, Japan, Hong Kong, Australia and New Zealand",Open,N/A,N/A,1026,Not_Computer,N/A,N/A,N/A
Z-1115-2007,38055,"Catheter, Peripheral, Atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(K),ThromCat Thrombectomy Catheter System. Catalog number 63000-01,ThromCat Thrombectomy Catheter System Catalog number 6300001.,2,"July 23, 2007", 2007,Kensey Nash Corp,Defective component (power supply),PRODUCTION CONTROLS: Process Control,New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.,N/A,11,11 units,"Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.",Terminated,"August 29, 2007",37,11,Not_Computer,N/A,N/A,N/A
Z-1116-2007,38105,"Catheter, Flow Directed",DYG,Flow-directed catheter.,Cardiovascular,Cardiovascular,510(K),"Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.",B Braun Thermodilution Right Heart Catheters,2,"July 23, 2007", 2007,"B. Braun Medical, Inc.",Cracks at the Catheter Tip,N/A,"On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan.",N/A,4695,"4,695",International ONLY- Japan,Terminated,"October 31, 2007",100,4695,Not_Computer,N/A,N/A,N/A
Z-1118-2007,38194,"Scale, Patient",FRW,Patient scale.,General Hospital,General Hospital,510(K) Exempt,Liko Universal Sling Bar 450 R2R Product NUmber: 3156095,Like Universal Sling Bar,2,"July 23, 2007", 2007,"Liko, Inc.",Sling bar may have a center bolt break at the adapter while in use,DESIGN: Device Design,Liko Inc notified distributors and end users by letter on 6/13/07.,N/A,3,3 units,Nationwide,Open,N/A,N/A,25,Not_Computer,N/A,N/A,N/A
Z-1090-2007,38154,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.",Medtronic Performer CPB,2,"July 23, 2007", 2007,Medtronic Perfusion Systems,Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB)),DESIGN: Device Design,"There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update.",N/A,24,24 units,"Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.",Terminated,"March 02, 2008",223,24,Hardware,Device Operation,Repair,Repair
Z-1089-2007,38128,"Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(K),BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200),BCI Advisor,2,"July 23, 2007", 2007,"Smiths Medical PM, Inc.","Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.",N/A,57,57,"International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel",Terminated,"October 29, 2008",464,57,Other,Device Operation,Repair,Repair
Z-1063-2007,37881,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.",ALFA II Modular Femoral Revision Stem,2,"July 23, 2007", 2007,"Encore Medical, Lp",Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.,DESIGN: Device Design,"Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.",N/A,3,3 units.,"Product distributed to surgical centers in CT, KS and MO.",Terminated,"July 25, 2007",2,7,Not_Computer,N/A,N/A,N/A
Z-1119-2007,38354,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),"Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W",Biomedicare Implantium Fixtures,2,"July 23, 2007", 2007,"Biomedicare, Inc.","Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.",PRODUCTION CONTROLS: Process Control,The firm initiated the recall notification with telephone calls to all consignees on 06/30/2007. Recall letters with attached Recall Response Form were mailed to all customers on 06/30/2007 by certified US mail. Customers were asked to examine their inventory and immediately remove all Implantium Fixtures from their inventory and quarantine until arrangements could be made for product return.,N/A,8844,"8,844 units","In US to AZ, CA, IL, TX & WA. Internationally to Turkey",Open,N/A,N/A,8844,Not_Computer,N/A,N/A,N/A
Z-1060-2007,37778,"Refrigerant, Topical (Vapocoolant)",MLY,N/A,N/A,Physical Medicine,510(K),"Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)","Gebauer""s Topical anesthetic skin refrigerant",2,"July 23, 2007", 2007,Gebauer Company,Mold contamination,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm sent a recall letter dated April 17, 2007 to all customers.",N/A,905,905 cans of product,Nationwide,Terminated,"November 30, 2009",861,41499,Not_Computer,N/A,N/A,N/A
Z-1099-2007,37982,"Staple, Implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(K),Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60,Power Linear Cutter Reusable Digital Loading Units with Reloads,2,"July 24, 2007", 2007,"Power Medical Interventions, Inc",Malfunction - improper staple formation,DESIGN: Device Design,"The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.",N/A,9,9 units,"The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany",Terminated,"August 29, 2007",36,9,Not_Computer,N/A,N/A,N/A
Z-1095-2007,36812,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),ABL 800 FLEX series blood gas analyzers containing software version 5.24.,ABL 800 FLEX analyzers,3,"July 24, 2007", 2007,Radiometer America Inc,"Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem",DESIGN: Software Design,"The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will be coming out and making a software upgrade to these systems within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and completed by each customer in order to verify that the alert notification has been received and that the staff members responsible for operating and maintaining the analyzer(s) on-site have been informed of this situation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Removal, and Decontamination programs have been made.",N/A,464,464,The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada.,Open,N/A,N/A,481,Software,Output/Calculation,Software update,Software Update
Z-1100-2007,38075,"Light, Surgical, Accessories",FTA,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile).",Sunnex,2,"July 24, 2007", 2007,Sunnex Inc.,"Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.",DESIGN: Device Design,"Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users.",N/A,346,346 lamps,Nationwide,Terminated,"January 06, 2009",532,376,Not_Computer,N/A,N/A,N/A
Z-1098-2007,37961,"Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)",LOM,N/A,N/A,Microbiology,PMA,ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.,Architect AUSAB Calibrators,2,"July 24, 2007", 2007,"Abbott Diagnostic International, Ltd.","During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.",N/A,All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form,N/A,393,393,Nationwide and Puerto Rico,Open,N/A,N/A,2134,Not_Computer,N/A,N/A,N/A
Z-1102-2007,38206,"System, Immunomagnetic, Circulating Cancer Cell, Enumeration",NQI,Immunomagnetic circulating cancer cell selection and enumeration system.,Immunology,Pathology,510(K),"Cell Search Circulating Tumor Cell Kit (Epithelial)Veridex LLC, a Johnson & Johnson CompanyIVDVeridex, LLC33 Technology DriveWarren, NJ 07059 USA1-877-VERIDEX USA",Veridex,3,"July 24, 2007", 2007,"Veridex, LLC",An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.",N/A,468,Lot 0036: 468 kits; Lot 0036A: 197 kits,"The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J; affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.",Terminated,"December 06, 2007",135,665,Not_Computer,N/A,N/A,N/A
Z-1086-2007,38267,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),SPI EASY Abutment. Endosseous dental implant abutment.,SPI EASY Abutment,3,"July 24, 2007", 2007,"Thommen Medical, AG",The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.,TRAINING: Employee Error,Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.,N/A,84,84,Nationwide.,Terminated,"May 12, 2008",293,84,Not_Computer,N/A,N/A,N/A
Z-1085-2007,38261,"Guide, Needle, Surgical",GDF,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument.Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the ""Distributed by...."", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024",4Closure Surgical Fascia ,2,"July 24, 2007", 2007,Synovis Surgical Inovation Div. of,"There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.",N/A,1,1box (4 untis),Nationwide.,Open,N/A,N/A,63,Not_Computer,N/A,N/A,N/A
Z-0240-2008,38256,"Tank, Holding, Dialysis",FIN,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006",HillRom VersaCare,2,"July 24, 2007", 2007,"Hill-Rom, Inc.","False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle.",DESIGN: Device Design,"The firm notified consignees via an Urgent Device Correction letter dated 11/12/07 informing them of the problem and informed them they would be receiving upgrade kits which they could have their qualified personnel install themselves following video instructions also provided, or they could contact Hill-Rom for assistance.",N/A,47013,"43,731 beds total for both models were distributed; 3,282 have been corrected to date.","Worldwide, including USA, Argentina, Australia, Brazil, Canada, Dominican Republic, Emirate of Sharjah, England, Greece, Indonesia, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Selangor, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates and Venezuela.",Terminated,"October 22, 2010",1186,40449,Not_Computer,N/A,N/A,N/A
Z-1104-2007,38313,"System, Test, Anticardiolipin Immunological",MID,Multiple autoantibodies immunological test system.,Immunology,Immunology,510(K),"american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¶_ aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.",IgG ELISA Kit,2,"July 24, 2007", 2007,Louisville Apl Diagnostics Inc,Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.,PRODUCTION CONTROLS: Process Control,Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.,N/A,45,45,Product distributed to a single direct account in CT.,Terminated,"November 27, 2007",126,80,Not_Computer,N/A,N/A,N/A
Z-1110-2007,37273,"Oxygenator, Cardiopulmonary Bypass",DTZ,Cardiopulmonary bypass oxygenator.,Cardiovascular,Cardiovascular,510(K),"Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN",Medtronic Intersept ,2,"July 26, 2007", 2007,Medtronic Perfusion Systems,Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.",N/A,11,11 units,Nationwide: Distributed to states of CO and PA,Terminated,"November 01, 2007",98,11,Not_Computer,N/A,N/A,N/A
Z-1108-2007,38325,Ventricular (Assisst) Bypass,DSQ,N/A,N/A,Cardiovascular,PMA,Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system,Thoratec TLCII Portable VAD driver,1,"July 27, 2007", 2007,Thoratec Corp,"Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Medical Device Recall letters, dated June 08, 2007, were issued to consignees, with instructions to take the following actions: 1) check the current number of service hours on all units. 2) do not use TLC-II drivers exceeding 1500 hours until they are serviced by thoratec. 3) note the indicated hours on the product inventory form and return the form to Thoratec. 4) ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures. The firm is also arranging for the return and servicing of all affected drivers, with highest priority to those drivers already exceeding 1500 hours of life. A July 19, 2007, Press Release was issued by the firm.",Contact the recalling firm for information,378,378 drivers,"Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.",Terminated,"July 17, 2008",356,378,Not_Computer,N/A,N/A,N/A
Z-1109-2007,38342,Ventricular (Assisst) Bypass,DSQ,N/A,N/A,Cardiovascular,PMA,Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.,Thoratec Paracorporeal Ventricular Assist Device,1,"July 27, 2007", 2007,Thoratec Corp,Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths,PRODUCTION CONTROLS: Error in Labeling,"The firm has issued an Urgent Medical Device Correction notice dated March 30, 2007, to all VAD customers alerting them to the hazard. The letter instructs them that a Thoratec representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs them to dispose of any expired original design caged tip atrial cannula and to 1) not use the black collet and nut with any current design VAD, 2) make sure that all current patients using PVADs are using the appropriate collet nut, and 3) provide a copy of the product safety bulletin to all outlying hospitals and/or physicians that may be following patients implanted with PVADs and provide contact information with the acknowledgement form.",Contact the recalling firm for information,2484,"2,484 units","Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.",Terminated,"April 24, 2008",272,2484,Not_Computer,N/A,N/A,N/A
Z-1111-2007,38221,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063",Baxter FloGard 6201 Volumetric Infusion Pumps,1,"July 28, 2007", 2007,Baxter Healthcare Corp.,Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.,TRAINING: Employee Error,"Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing.*** Baxter expanded the recall and telephoned the direct accounts starting on 7/30/07, informing them that the electrical safety testing may not have been performed on their Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required electrical safety and all functional verification testing. Follow-up recall letters were sent to the accounts on 8/7/07 reiterating the telephone conversations and providing a list affected pump serial numbers to be removed from service and returned to Baxter for testing. They were also requested to report any malfunction or adverse event related to the Colleague or Flo-Gard Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176. ****Recall 2 Extension******* Baxter expanded the recall for a second time via letter on 8/20/07 and telephone calls starting on 8/21/07, informing the direct accounts that Baxter's investigation found documentation inconsistencies by three more of their service technicians, representing the possibility of incomplete testing and/or documentation by these technicians who serviced Colleague infusion pumps at the account's facility. Without complete and properly do.",N/A,49,49 units,"Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming",Terminated,"March 16, 2010",962,2013,Not_Computer,N/A,N/A,N/A
Z-1105-2007,37614,"Stripper, Vein, External",DWQ,External vein stripper.,Cardiovascular,Cardiovascular,510(K),"Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.",TRIVEX,3,"August 02, 2007", 2007,"Smith & Nephew, Inc Endoscopy Division",Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.,N/A,274,274 units.,"Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.",Terminated,"August 02, 2007",0,274,Not_Computer,N/A,N/A,N/A
Z-1107-2007,37963,"Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus",MZP,N/A,N/A,Microbiology,510(K),"Amplilink Software Versions 1.1, 1.3, 1.4, 2.41COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0",Amplilink,2,"August 02, 2007", 2007,"Roche Molecular Systems, Inc.","For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.",DESIGN: Software Design,Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.,N/A,5806,"5,806 total",Nationwide to hospitals and laboratories.,Terminated,"February 18, 2010",931,5806,Computer,N/A,N/A,N/A
Z-1020-2007,38225,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set","Gemini, Alaris",2,"August 02, 2007", 2007,Cardinal Health 303 Inc DBA Alaris Products,"It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.k.a. Flo-Stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. The over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practi",N/A,"The field action will consist of a mailing and will be conducted through consignees (distributors) in the affected countries as well as direct customers for all IV Administration sets intended for use with Gemini Infusion Pumps and Alaris/Medley Pump modules. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management at each facility. Distributors will be sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their customers as requested. The domestic letters (direct customers and distributors) were mailed beginning on June 18, 2007 to all of the affected accounts via US Postal Service Certified Mail.",N/A,N/A,N/A,"Worldwide including USA, Argentina, Australia, Bahrain, Belgium, Canada, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malta, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Serbia/Montenegro, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad &Tobago;, United Kingdom, United Arab Emirates, Uruguay & Venezuela.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1021-2007,38230,"Keratome, Ac-Powered",HNO,Keratome.,Ophthalmic,Ophthalmic,510(K),"Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO.The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.",Zyoptix XP Epi Separator,2,"August 02, 2007", 2007,Bausch & Lomb Inc,Reports have been received of stromal incursions after use of the product.,N/A,"The firm notified their customers via telephone between 6/8-12/07. During the call, the customer was informed reports had been received of stromal incursions and they were to quit using the product and return it.",Contact the recalling firm for information,253,243/10-pouch cartons,"Distribution was limited to ""key"" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.",Terminated,"April 28, 2009",635,272,Not_Computer,N/A,N/A,N/A
Z-1078-2007,38215,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013",Alaris,2,"August 03, 2007", 2007,Cardinal Health 303 Inc DBA Alaris Products,The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.,PRODUCTION CONTROLS: Process Control,"Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007.The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.",N/A,4248,"4,248 sets (59 boxes)",Nationwide.,Open,N/A,N/A,4248,Not_Computer,N/A,N/A,N/A
Z-1148-2007,38232,Hepatitis Viral B Dna Detection,MKT,N/A,N/A,Microbiology,PMA,"biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)",LIFEPAK 500,2,"August 04, 2007", 2007,"Medtronic Emergency Response Systems, Inc.","Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.",DESIGN: Software Design,"On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.",N/A,59996,"59,996 devices",Worldwide,Open,N/A,N/A,59996,Not_Computer,N/A,N/A,N/A
Z-1132-2007,37640,"Computer, Diagnostic, Programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(K),"GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.",MacLab,2,"August 07, 2007", 2007,General Electric Medical Systems Information Technology,"GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.",DESIGN: Software Design,"Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.",N/A,1513,1513 (1067 US and 446 OUS),"Worldwide, including USA, Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Pakistan, Panama, Puerto Rico, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Kingdom, and Venezuela.",Terminated,"March 02, 2008",208,2909,Software,Device Operation,Software update,Software Update
Z-1137-2007,37878,"Antisera, Immunoperoxidase, Chlamydia Spp.",LKH,Chlamydia serological reagents.,Microbiology,Microbiology,510(k),"Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.",MIKA Speed Block,3,"August 07, 2007", 2007,"Encore Medical, Lp",Complaints received that device used to prepare femur to receive femoral implant would split during surgery.,PRODUCTION CONTROLS: Process Control,"Firm sent notification letter to consignees on 08/25/2006, along with replacement speedblocks. Consignees asked to trade out old speedblocks with the replacements.",Contact the recalling firm for information,24,24 units.,Product distributed to direct accounts in USA and one consignee in Japan.,Terminated,"March 27, 2008",233,24,Not_Computer,N/A,N/A,N/A
Z-1151-2007,38121,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)",Biomet Magnum Straight Insert Handle,2,"August 07, 2007", 2007,"Biomet, Inc.",The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.,PRODUCTION CONTROLS: Process Control,"On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.",N/A,94,94,"World wide: USA, Australia, and Finland.",Terminated,"December 12, 2007",127,94,Not_Computer,N/A,N/A,N/A
Z-1127-2007,38234,"Instrument, Coagulation, Automated",GKP,Coagulation instrument.,Hematology,Hematology,510(k),Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer.P/N 280000,IL,2,"August 07, 2007", 2007,Instrumentation Laboratory Co.,"ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.",DESIGN: Device Design,Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.,N/A,94,94,Nationwide.,Open,N/A,N/A,94,Not_Computer,N/A,N/A,N/A
Z-1142-2007,38223,"Pump, Infusion, Enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(K),"The Companion ClearStar Pump System, for enteral feeding.",The Companion ClearStar Pump System,2,"August 07, 2007", 2007,Ross Products Division Abbott Laboratories,The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.,DESIGN: Device Design,Consignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007.,N/A,27814,"27,814","Worldwide, including USA and Canada.",Open,N/A,N/A,27814,Not_Computer,N/A,N/A,N/A
Z-1130-2007,38373,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),"Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.",Cleaning probe,3,"August 07, 2007", 2007,"GE OEC Medical Systems, Inc",Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.,DESIGN: Device Design,Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.,N/A,67625,"67,625 units","Worldwide, including USA, Canada and France.",Open,N/A,N/A,67625,Not_Computer,N/A,N/A,N/A
Z-1128-2007,38239,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),Philips Medical HeartStartXL Defibrillator/MonitorModel : M4735A,HeartStart XL,2,"August 07, 2007", 2007,Philips Medical Systems,The ECG signal may become unusable to assess patient condition and need for therapy.,DESIGN: Device Design,"Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.",N/A,312,312 units,"Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.",Open,N/A,N/A,312,Not_Computer,N/A,N/A,N/A
Z-1129-2007,38341,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.",Curlin,2,"August 07, 2007", 2007,Curlin Medical Llc,The Administration Sets may leak at the reservior bag.,PRODUCTION CONTROLS: Process Control,"A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels.A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels.",N/A,305,"25, 280","One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109",Terminated,"May 28, 2008",295,25280,Not_Computer,N/A,N/A,N/A
Z-1149-2007,38289,"Component, External, Limb, Ankle/Foot",ISH,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.",VS1000 Senator,2,"August 07, 2007", 2007,Applied Composite Technology,Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.,PRODUCTION CONTROLS: Process Control,On 06/20 and 06/21/2007 all recipients of the affected Senators were notified by telephone. They were asked to return all suspect prostheses for replacement. Follow-up emails and fax letters (6/21/07) were also sent.,N/A,97,97 units,"Worldwide Distribution- USA including states of CA, CO, FL, IL, MI, MN, MS, NC, NY, OR, PA, SC, TN, TX, VA, WA. VA facilities in CA and MI. Foreign distribution to Australia, Canada, Germany, Russia, South Africa, South Korea, and UK.",Terminated,"June 05, 2008",303,97,Not_Computer,N/A,N/A,N/A
Z-1143-2007,38226,"Tube, Tracheal (W/Wo Connector)",BTR,Tracheal tube.,Anesthesiology,Anesthesiology,510(K),"Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia",Microcuff ,2,"August 08, 2007", 2007,Kimberly-Clark Corporation,The tubes may kink during use which may impede or prevent ventilation.,N/A,"Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.",N/A,4376,4376 cases (43760 units/total for both products),"Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.",Terminated,"June 12, 2008",309,4376,Not_Computer,N/A,N/A,N/A
Z-1141-2007,38222,"Pump, Infusion, Enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(K),Embrace Enteral Pump,Embrace Enteral Pump,2,"August 08, 2007", 2007,Ross Products Division Abbott Laboratories,Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.,PRODUCTION CONTROLS: Process Control,Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.,N/A,9600,"9,600 units",The product was distributed throughout the US.,Open,N/A,N/A,9600,Not_Computer,N/A,N/A,N/A
Z-1147-2007,38358,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.,ISOLOC,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,"When the ISOLOC (Version 4.2) profile distance unit is set to ""centimeter"" and the user clicked the ""back"" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.",DESIGN: Software Design,"Software to fix the described problems was written and customers contacted by e-mail on 05/31/2005, that a software patch, titled 05312005 was available on the firm's internet website.",N/A,85,85,"Worldwide, including USA, Korea, Spain, and UK.",Open,N/A,N/A,85,Software,Output/Calculation,Software update,Software Update
Z-1146-2007,38355,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.,ISOLOC,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.,DESIGN: Software Design,Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.,N/A,141,141 copies,"Customers in USA, Korea, Spain and UK.",Open,N/A,N/A,141,Software,Display/Image,Software update,Software Update
Z-1153-2007,38361,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.",ISOLOC,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,"When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.",DESIGN: Software Design,"Software to fix the described problem was written and customers contacted by e-mail on 04/11/2005, that a software patch, titled 04112005, was available to their customers on the firm's internet website.",N/A,84,84,"Worldwide, including USA, Korea, Spain, and UK.",Open,N/A,N/A,84,Software,Display/Image,Software update,Software Update
Z-1145-2007,38319,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.",Image guided radiation treatment software.,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,"Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to ""Anatomic Landmark"" setting.",DESIGN: Software Design,"Software to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.",N/A,132,132,"Nationwide, Korea, Spain, and UK.",Open,N/A,N/A,132,Software,Alarm/Message,Software update,Software Update
Z-1154-2007,38363,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.",ISOLOC,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,"When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.",DESIGN: Software Design,"Software to fix the described problem was written and customers contacted by e-mail on 12/30/2004 that a software patch, titled 12302004 was available to their customers on the firm's internet website.",N/A,79,79,"Worldwide, including USA, Korea, Spain, and UK.",Open,N/A,N/A,79,Software,Display/Image,Software update,Software Update
Z-1152-2007,38360,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.,ISOLOC,2,"August 08, 2007", 2007,Northwest Medical Physics Equipment Inc,"When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.",DESIGN: Software Design,"Software to fix the described problems was written and customers contacted by e-mail on 04/28/2005, that a software patch, titled 04282005, was available on the firm's internet website.",N/A,84,84,"Worldwide, including USA, Korea, Spain, and UK.",Open,N/A,N/A,84,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1072-2007,37952,"Test, Qualitative And Quantitative Factor Deficiency",GGP,Factor deficiency test.,Hematology,Hematology,510(K),"STA Liatest Free Protein SFor in vitro diagnostic use.2-8 degrees CDistributed in the USA by:Diagnostica Stago, Inc.5 Century DriveParsippany, NJPhone 800-abc coag1 - 6 x 5 ml Buffer2 - 6 x 6 ml Latex",STA Liatest,3,"August 09, 2007", 2007,"Diagnostica Stago, Inc.",Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.,N/A,"Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled "" Recall notice, Open Immediately"".",N/A,365,365 units,Medical facilities nationwide,Terminated,"October 13, 2010",1161,365,Not_Computer,N/A,N/A,N/A
Z-1073-2007,37999,"Lithotriptor, Electro-Hydraulic",FFK,Electrohydraulic lithotriptor.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),Gyrus CyberWand Ultrasonic Lithotripter System includes:CW-USLS CyberWand USL System CW-USLT CyberWand USL TransducerCW-USLRBP CyberWand USL Renal/Bladder Probe SetCW-USLTT CyberWand USL Transducer Sterilization Tray,Gyrus CyberWand,2,"August 09, 2007", 2007,Gyrus ACMI Corporation,Sterilization Instructions not adequate for sterilizing.,N/A,"Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.",N/A,53,53 units,Nationwide and Canada.,Terminated,"May 25, 2010",1020,53,Not_Computer,N/A,N/A,N/A
Z-1157-2007,38005,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"The ClearGlide EVH small with Scissors.The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors.Datascope Cardiac AssistSterileManufactured for:Datascope Cardiac Assist15 Law DriveFairfield, NJ 07004",Precision Bipolar Device ClearGlide EVH ,2,"August 09, 2007", 2007,Datascope Corporation,"Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.",N/A,"Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened.Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.",N/A,549,549,"Worldwide, including USA, Belgium, the Netherlands, and Germany.",Terminated,"March 04, 2008",208,1671,Not_Computer,N/A,N/A,N/A
Z-1160-2007,38112,"Catheter, Intravascular, Diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEXBoston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391221, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX",Impulse Flextrusion,3,"August 09, 2007", 2007,Boston Scientific Corporation,Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.,PRODUCTION CONTROLS: Process Control,"Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.",N/A,233,233,"Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.",Terminated,"December 19, 2007",132,468,Not_Computer,N/A,N/A,N/A
Z-1155-2007,38366,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.",ISOLOC ,2,"August 09, 2007", 2007,Northwest Medical Physics Equipment Inc,"When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.",DESIGN: Software Design,"Software to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.",N/A,83,83,"Worldwide, including USA, Korea, Spain, and UK.",Open,N/A,N/A,83,Software,Output/Calculation,Software update,Software Update
Z-1161-2007,38117,"Stent, Carotid",NIM,N/A,N/A,Cardiovascular,PMA,"Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA",Nexstent Carotid Stent and Monorail Delivery System,2,"August 09, 2007", 2007,Boston Scientific Corporation,Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.,DESIGN: Device Design,"On May 1, 2007, Boston Scientific initiated a Customer Notification worldwide. On May 21, 2007 Boston Scientific expanded this field action to a recall/removal status for Germany. Affected customers were notified in Germany on May 24, 2007.",N/A,2487,2487,"Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland.",Terminated,"March 02, 2008",206,2487,Not_Computer,N/A,N/A,N/A
Z-1162-2007,38283,"Stylet For Catheter, Gastro-Urology",EZB,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038"", 145 cm; sterile; Order/Ref number 638413.",Cook PTFE Wire Guide ,2,"August 09, 2007", 2007,"Cook Urological, Inc.","Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.",PRODUCTION CONTROLS: Process Control,Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.,N/A,100,100,Nationwide and Canada.,Terminated,"November 25, 2009",839,100,Not_Computer,N/A,N/A,N/A
Z-1131-2007,38244,"Catheter, Embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(K),"Possis AngioJet XVG Thrombectomy Sets,Model/Order # 105042-001, Sterilized with Ethylene Oxide,Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)",AngioJet XVG Thrombectomy Catheter,2,"August 10, 2007", 2007,"Possis Medical, Inc",Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.,PRODUCTION CONTROLS: Process Control,"A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.",N/A,194,194,"AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV",Terminated,"March 02, 2008",205,194,Not_Computer,N/A,N/A,N/A
Z-1163-2007,38309,"Wheelchair, Powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(K),"Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays)","Quickie Rhythm, Quickie Groove, and Quickie Zippy ZBop",2,"August 14, 2007", 2007,Sunrise Medical Inc,The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.,DESIGN: Device Design,"Firm contacted consignees by phone and mailed May 1, 2007, Urgent Medical Device notification letters.",N/A,229,229 Enhanced Display units (affecting 220 wheelchairs),Product was distributed Worldwide.,Terminated,"March 25, 2008",224,229,Not_Computer,N/A,N/A,N/A
Z-1150-2007,38458,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.,Bayonet Electrosurgical Pencil,2,"August 14, 2007", 2007,Zinnanti Surgical Design LLC,"Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised",PRODUCTION CONTROLS: Packaging Process Control,The recalling firm issued an Urgent Medical Device Recall Letter dated 7/24/07 to its single wholesaler requesting recall and sub-recall to all their consignees.,N/A,868,"8, 860 units",Nationwide,Terminated,"March 07, 2008",206,8860,Not_Computer,N/A,N/A,N/A
Z-1166-2007,38209,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42"" Tubing - Blue, List #P4291",Orbit 90,2,"August 16, 2007", 2007,"ICU Medical, Inc.",The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.,PRODUCTION CONTROLS: Process Control,"Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical.",Contact the recalling firm for information,26361,"26,361 units","VA, OH, TX, CA, GA",Open,N/A,N/A,26361,Not_Computer,N/A,N/A,N/A
Z-1167-2007,38217,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"VITROS¶_ 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS¶_ Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.","VITROS 5,1 FS Chemistry System",2,"August 16, 2007", 2007,Ortho-Clinical Diagnostics,"Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS¶_ Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabi",DESIGN: Software Design,"On 5/17/07, OCD informed its foreign affiliates of the field correction by e-mail, and instructed them to inform their customers who received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents of this issue. On 5/18/07, all US OCD direct customers and end-use customers of consignees that received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents, were informed of the ""field correction"" by US Postal Service letter, provided with a new Assay Data Disk (ADD #5465), and were instructed to load it and recalibrate these assays, if necessary.",N/A,598,"Domestic: 604, International: 598",Nationwide and Worldwide,Open,N/A,N/A,1202,Software,Output/Calculation,Software update,Software Update
Z-1165-2007,38035,"Lancet, Blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200",One Touch SureSoft Lancing Device,2,"August 16, 2007", 2007,Lifescan Inc,Lancet tip may not fully retract and cause needle stick and exposure to used lancets.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.",Contact the recalling firm for information,632,632 cartons (200 units per carton),Product was distributed nationwide to distributors and wholesale dealers.,Terminated,"December 03, 2007",109,632,Not_Computer,N/A,N/A,N/A
Z-1169-2007,38352,"Station, Pipetting And Diluting, For Clinical Use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.",Microlab F.A.M.E. reagent containers,2,"August 16, 2007", 2007,Hamilton Co,Some product containers may be leaking.,PRODUCTION CONTROLS: Process Control,"The firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.",Contact the recalling firm for information,797,797 boxes,"Product was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.",Terminated,"December 21, 2007",127,797,Not_Computer,N/A,N/A,N/A
Z-1172-2007,38096,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names ""Bath Helper"" and ""Shower Helper"" , Sisus Corporation, Santa Cruz, CA 95062.","""Shower Helper"" and ""Bath Helper""",2,"August 17, 2007", 2007,The Sisus Corporation,"Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.",DESIGN: Device Design,"On 6/8/2007, a letter was sent to all dealers and each direct account customer/user followed by a phone call to ensure the notification letter was received. Customers were instructed to discontinue use of the devices pending receipt of modification kits/ instructions to be shipped priority overnight. The firm plans to call customers/dealers to support them with the installations and ensure smooth implementation. Dealers were instructed to conduct recall to the user level.",N/A,100,approximately 100 units have been distributed.,"Nationwide Distribution including states of PA, TX, NY, MI, AL, FL, CA, OH, CT, WA, MD, OR, NC, NH, VT, IL, CO, HI, LA, GA, TN, OK, MA, KS, SC, ME, GA, MN, IN, and DE.",Terminated,"August 19, 2008",368,100,Not_Computer,N/A,N/A,N/A
Z-1175-2007,38396,"System, Test, Anticardiolipin Immunological",MID,Multiple autoantibodies immunological test system.,Immunology,Immunology,510(K),"APhL¶_ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).",APhL HRP IgG & IgM ELISA Kit,2,"August 17, 2007", 2007,Louisville Apl Diagnostics Inc,Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.,PRODUCTION CONTROLS: Process Control,Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.,Contact the recalling firm for information,29,29 test kits (ea. kit containing 1 IgG and 1 IgM test kit),"World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.",Terminated,"October 11, 2007",55,70,Not_Computer,N/A,N/A,N/A
Z-1171-2007,38042,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Abbott Laboratories Diagnostics Division",CELLDYN 1700 Hematology Analyzer,2,"August 18, 2007", 2007,Abbott Laboratories,"Abnormal results may not be ""flagged"" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)",DESIGN: Software Design,"The firm initially sent reports (Product Information Letters) of this issue to the field on May 7, 2007. The firm sent a notice with customer notification response form on May 16, 2007 (Product Correction Letter). In addition, product information letters are being packed with the instruments accessory kit and quality control products used with the Cell-Dyn 1700 system.",N/A,4197,"4,197 units total (both models)","WORLDWIDE: Product was distributed nationwide to all 50 states, as well as worldwide to Anguilla, Argentina, Australia, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Malaysia, Mexico, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.",Open,N/A,N/A,4197,Computer,N/A,N/A,N/A
Z-1173-2007,38359,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),"ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company",Radiometer Copenhagen ABL77 Cal Pack,2,"August 18, 2007", 2007,Sendx Medical Inc,Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.,DESIGN: Process Design,"A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261.All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.",Contact the recalling firm for information,69,69,"Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.",Open,N/A,N/A,69,Not_Computer,N/A,N/A,N/A
Z-1184-2007,38409,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit.",Arizant Healthcare Ranger Blood/Fluid Warming Set,2,"August 18, 2007", 2007,"Arizant Healthcare, Inc","Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.",PRODUCTION CONTROLS: Packaging Process Control,All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.,N/A,12000,"12,000","Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.",Terminated,"March 02, 2008",197,97710,Not_Computer,N/A,N/A,N/A
Z-1187-2007,38167,"Fluorescence Polarization Immunoassay, Carbamazepine",LGI,Neuroleptic drugs radioreceptor assay test system.,Toxicology,Toxicology,510(K),XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01,XSYSTEMS Quinidine Calibrators,2,"August 22, 2007", 2007,"Abbott Diagnostic International, Ltd.",Controls Out of Range/Specification.,N/A,"May 31, 2007, Product Correction Letter to Customers were instructed to: ""Revise the expiration date for all lots identified in the customer letter. ""Discontinue use of the expired lots, and discard the material according to their laboratory procedures. ""An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.",N/A,250,250,"Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS",Open,N/A,N/A,729,Not_Computer,N/A,N/A,N/A
Z-1178-2007,38251,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"PhaSeal, Protector 14, Item No. P14, US Order No. 21320",PhaSeal Intravascular Administration Set,2,"August 22, 2007", 2007,"Carmel Pharma, Inc.",Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.",N/A,6.1,6.1 million for Z-1178-1181-2007 recalls,Product was distributed throughout the US and Canada,Open,N/A,N/A,6100000,Not_Computer,N/A,N/A,N/A
Z-1191-2007,38351,"Catheter, Electrode Recording, Or Probe, Electrode Recording",DRF,Electrode recording catheter or electrode recording probe.,Cardiovascular,Cardiovascular,510(K),"Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0",Polaris Dx Diagnostic Catheter,3,"August 22, 2007", 2007,Boston Scientific Corp,"Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).",N/A,"The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it.",Contact the recalling firm for information,30,30 units,Product was distributed to 3 consignees in Florida and Tennessee.,Terminated,"November 27, 2007",97,30,Not_Computer,N/A,N/A,N/A
Z-1174-2007,38384,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K),"EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.",EasyLink Informatics System ,2,"August 22, 2007", 2007,"Dade Behring, Inc.",Sample ID and Patient results could be associated with the wrong patient,N/A,The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.,Contact the recalling firm for information,72,72 units,"Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.",Terminated,"November 07, 2007",77,72,Software,Output/Calculation,Software update,Software Update
Z-1189-2007,38433,"Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer",MBD,N/A,N/A,Orthopedic,510(K),"BacT/ALERT¶_ FN Culture Bottles, Product Number 259793",BacT/ALERT FN Culture Bottles,2,"August 22, 2007", 2007,"bioMerieux, Inc.",Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.,N/A,Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.,N/A,2403,"2,403 cases (100 bottles per case)","Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom",Terminated,"December 08, 2009",839,2403,Not_Computer,N/A,N/A,N/A
Z-1193-2007,38031,"Sterilizer, Steam",FLE,Steam sterilizer.,General Hospital,General Hospital,510(k),"Amsco Century Medium Steam Sterilizer (26"" x 37.5"") (660 x 950mm).",Century Medium Sterilizer,2,"August 23, 2007", 2007,Steris Corp,The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.,PRODUCTION CONTROLS: Process Control,"By telephone 3/22/2007, customers were instructed to cease using the product and a service technician would be dispatched immediately to repair the unit.",N/A,78,78,"Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.",Terminated,"September 28, 2010",1132,78,Not_Computer,N/A,N/A,N/A
Z-1194-2007,38462,"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.",Zimmer Anatomical Shoulder Glenoid,2,"August 23, 2007", 2007,Zimmer Inc.,The package actually contains a knee patellar implant.,PRODUCTION CONTROLS: Process Control,"The firm notifed the distributor via letter dated 6/25/07, and sent by email, to retrieve the product from their customers and to return the product.",N/A,10,10,Maryland.,Terminated,"December 05, 2007",104,10,Not_Computer,N/A,N/A,N/A
Z-1190-2007,38324,"System, Imaging, Pulsed Echo, Ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(K),"Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)",Volcano s5 Imaging System,3,"August 23, 2007", 2007,Volcano Corporation,"During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.",DESIGN: Device Design,"The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.",Contact the recalling firm for information,351,351 units worldwide,"Product was distributed to health care facilities nationwide and to distributors in Europe (via subsidiary), Japan (via subsidiary), Latin America and Asia (third party distributors).",Terminated,"June 03, 2008",285,351,Not_Computer,N/A,N/A,N/A
Z-1196-2007,38172,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),"ABL80 FLEX Analyzer, Model #393-839",ABL80 FLEX Analyzer,2,"August 25, 2007", 2007,Sendx Medical Inc,There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.,DESIGN: Device Design,"The recall was initiated 3/27/2007. All distributors were notified via the Radiometer FAN (field action notice) system which provides a communication mechanism for these types of actions. The notice advises that there have been a few reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer which occurs when excessive pressure builds within the waste line. To prevent any spraying of fluids from the waste drain a check valve has been added to the waste tubing, between the waste drain and the waste pump which allows fluids to flowin one direction thus making it impossible to spray fluids out the waste drain. The letter further advises that all analyzers shipped from SenDx on or after March 16, 2007 will include this check valve. All analyzers already in the field must be updated to include this check valve. Distributors are to distribute a copy of the Customer Advisory Letter associated with this case to all their customers and update all ABL80 analyzers to include the waste drain check valve as per the instructions that accompany the check valve. The Advisory Letter informs the customer of the problem and the new waste drain check valve and provides precautionary instructions such as appropriate hand, eye, face and clothing shields. In addition, it advises that the analyzer should never be used if there is any indication of a waste drain occlusion or blockage. The most typical indication of an occlusion or blockage is fluid overflowing out of the waste drain.",N/A,334,334 units worldwide,"Class II Recall - Worldwide Distribution --- USA including state of Ohio, and countries of Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, The Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, New Zealand, Canada, and Denmark.",Open,N/A,N/A,334,Not_Computer,N/A,N/A,N/A
Z-1197-2007,38382,"Cannula, Ophthalmic",HMX,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K),"Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2"". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.",Atkinson Retrobulbar Anesthesia Needles,3,"August 25, 2007", 2007,"Alcon Research, Ltd",Mislabeled: boxes actually contained Tri-Fact needles,PRODUCTION CONTROLS: Packaging Process Control,"The recalling firm telephoned the hospital on 7/11/07 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm issued a recall letter via FedEx on 7/11/07. The firm's representative is making arrangements to pick up the recalled product.",N/A,2,2 boxes,CA.,Terminated,"August 28, 2007",3,2,Not_Computer,N/A,N/A,N/A
Z-1202-2007,37904,"Enzyme Immunoassay, Digoxin",KXT,Digoxin test system.,Toxicology,Toxicology,510(K),Abbott AxSYM System Digoxin III Reagent Pack,Abbott AxSYM System Digoxin III Reagent Pack ,2,"August 29, 2007", 2007,"Abbott Diagnostic International, Ltd.","Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.",N/A,"On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.",N/A,2579,"2,579 kits","Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.",Open,N/A,N/A,2579,Not_Computer,N/A,N/A,N/A
Z-1200-2007,38322,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),Abbott CELL-DYN 3700 Hematology Analyzer,CELLDYN 3700 Hematology Analyzer,2,"August 29, 2007", 2007,Abbott Laboratories,"The product failed electrostatic discharge testing, which could result in product failure.",DESIGN: Device Design,Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.,N/A,3429,"3,429 units, all models","Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.",Terminated,"June 19, 2008",295,3429,Not_Computer,N/A,N/A,N/A
Z-1201-2007,38350,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),"ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863",ABL8O FLEX,2,"August 29, 2007", 2007,Sendx Medical Inc,"The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice.Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.,Contact the recalling firm for information,165,165 software upgrade CDs,"In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom",Open,N/A,N/A,165,Software,Output/Calculation,Software update,Software Update
Z-1218-2007,38512,"Collimator, Manual, Radiographic",IZX,Diagnostic x-ray beam-limiting device.,Radiology,Radiology,510(K),"PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois","PCS125 Swivel Collimator, Model F100",2,"August 29, 2007", 2007,Summit Industries Inc.,The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.,DESIGN: Process Design,"The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.",N/A,3034,3034 for all units,"Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.",Terminated,"March 18, 2010",932,3034,Not_Computer,N/A,N/A,N/A
Z-1195-2007,38349,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.",Varian OnBoard Imager,2,"August 29, 2007", 2007,Varian Medical Systems Inc,Patient positioning errors may occur because of mechanical variations during product installation.,PRODUCTION CONTROLS: Process Control,"The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.",N/A,291,291 units,"Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.",Terminated,"August 12, 2010",1079,291,Not_Computer,N/A,N/A,N/A
Z-1204-2007,39374,"Kit, Surgical Instrument, Disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.09, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Ortho Ba",DeRoyal ,2,"August 29, 2007", 2007,DeRoyal Lafollette,Packaging failure. Lack of sterility assurance,PRODUCTION CONTROLS: Packaging Process Control,"Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product.",N/A,2023,2023 cases,Nationwide,Terminated,"June 12, 2008",288,2135,Not_Computer,N/A,N/A,N/A
Z-1206-2007,38898,"Implant, Malar",LZK,N/A,N/A,General & Plastic Surgery,510(K),"Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.",Silhouette Malar Implant,2,"August 29, 2007", 2007,Spectrum Designs Inc,"The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.",DESIGN: Labeling Design,The firm initiated the recall on 06/15/2007 by contacting their customers by telephone. The firm followed-up by sending recall letters via FedEx or certified mail with signature confirmation to each direct account who received the recalled product on 06/18/2007.,N/A,15,15 pairs (left/right),Nationwide.,Open,N/A,N/A,15,Not_Computer,N/A,N/A,N/A
Z-1211-2007,39147,"Stent, Coronary",MAF,N/A,N/A,Cardiovascular,PMA,"Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951",Guidant MultiLink RX Vision,2,"August 29, 2007", 2007,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.,PRODUCTION CONTROLS: Process Control,"The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.",N/A,43,43 units,Nationwide,Open,N/A,N/A,43,Not_Computer,N/A,N/A,N/A
Z-1213-2007,38306,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA","Reserve, Cassette, CADD, 100ml, yellow, mdl 2100, 21710024",2,"August 30, 2007", 2007,"Smiths Medical MD, Inc.","Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax ""Attachment 1"" form in regard to affected product inventory to Smiths Medical MD.",Contact the recalling firm for information,8555,8555 boxes,"Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel,Austria, and Switzerland.",Open,N/A,N/A,153798,Not_Computer,N/A,N/A,N/A
Z-1207-2007,38308,"Stimulator, Nerve, Transcutaneous, For Pain Relief",GZJ,Transcutaneous electrical nerve stimulator for pain relief.,Neurology,Neurology,510(K),"Avazzia Tennant Biomodulator¶_; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.",TENS Device,3,"September 01, 2007", 2007,"Avazzia, Inc",Plastic Cases may crack due to manufacturing by the supplier not meeting specifications,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement.",N/A,134,134 units.,"Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California",Terminated,"April 04, 2008",216,278,Not_Computer,N/A,N/A,N/A
Z-1182-2007,38400,"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(K),"Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central StationModels: M3145, M3150, M3154, M3155, M3169",Philips Intellivue Central Station Software,2,"September 05, 2007", 2007,Philips Medical Systems,"Incorrect Patient Assignment: the information center will in most cases be associated with the ""incorrect"" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring)",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Philips Medical Systems issued a letter notification dated July 2007 "" Urgent Device Correction"". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.",N/A,76,76 units,"Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK",Open,N/A,N/A,76,Software,Output/Calculation,Software update,Software Update
Z-1203-2007,38428,"Gas-Machine, Anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Kion Anesthesia WorkstationMaquet Critical Care ABSE-171-95 Solna, Sweden",Kion Anesthesia Workstation ,2,"September 07, 2007", 2007,MAQUET Inc.,Overcharging of batteries and the release of acid fumes,TRAINING: Employee Error,"Safety Alert letters were sent out by FedEx tracking.A Service Express letter will be sent out emphasizing that only qualified batteries must be used in KION equipment and will list all qualified battery types.A Field Action - update of existing operating manuals will include warning on battery charging on KION. This action is currently scheduled to start 9/1/07 and be completed in US by 10/1/07. After FDA consultation the recalling firm issued a 9/5/2007 URGENT DEVICE CORRECTION Letter stating that KION will visit consignees and replace batteries older than three years, verify that the batteries are ones of the approved type, and verify battery condition.",N/A,9,9 units in US,"Nationwide: 2 units at the National Institute of Health in Bethesda, MD and 7 units at Oconee Regional Medical Center, Milledgeville, GA",Terminated,"December 07, 2007",91,9,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-1219-2007,39362,N/A,N/A,N/A,N/A,N/A,N/A,"Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia",Biogel Skinsense,2,"September 08, 2007", 2007,"Molnlycke Health Care, Inc",Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.",N/A,6000,"6,000 pair","Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI",Terminated,"March 17, 2010",921,6000,Not_Computer,N/A,N/A,N/A
Z-1234-2007,44721,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, ""Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***"".",MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit),2,"September 13, 2007", 2007,Philips Medical Systems (Cleveland) Inc,The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.,DESIGN: Device Design,"On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians.",N/A,491,491,"Worldwide, including, USA, Canada, China, Italy, Russia, Brazil, Belgium, Germany, Austria, Australia, Netherlands, France, Korea, Denmark, Israel, England, Argentina, Mexico, Spain, Yemen, Greece, Egypt, Japan, UAE, & Chile.",Open,N/A,N/A,491,Not_Computer,N/A,N/A,N/A
Z-1232-2007,38635,"Lipase-Esterase, Enzymatic, Photometric, Lipase",CHI,Lipase test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30",Lipase,2,"September 18, 2007", 2007,Abbott Laboratories Inc.,Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.,N/A,The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase.,N/A,7260,7260,"Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.",Open,N/A,N/A,7602,Not_Computer,N/A,N/A,N/A
Z-1222-2007,38439,Single (Specified) Analyte Controls (Assayed And Unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(K),"ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL 60064, list 6C27-05",ARCHITECT Prolactin MasterCheck,2,"September 18, 2007", 2007,Abbott Laboratories,The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.,N/A,"Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will contain updated storage and handling conditions of the ARCHITECT Prolactin MasterCheck. They were requested to check their inventory to see if they have any remaining inventory of lot number 82900M. If they know the date the lot was received or the date it was thawed, they may continue to use the ARCHITECT Prolactin MasterChecks if it has been stored at 2 to 8 degrees C unopened for less than 30 days. If the material has been stored at 2 to 8 degrees C for greater than 30 days or they do not know the number of days it has been thawed, they were instructed to discard the material. Reimbursement for discarded kits will be provided based on information provided in the Customer Reply form. Until labeling is updated, it will be necessary to use an alternate material for verification of sensitivity, calibration linearity, and the reportable range of the ARCHITECT Prolactin assay. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits, and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. The accounts were requested to complete and fax back the customer reply form, acknowledging the receipt and understanding of the correction letter. Customers outside of the U.S., were requested to contact their local customer support representative.",N/A,57,57 kits,Nationwide and Canada.,Terminated,"May 18, 2008",243,57,Not_Computer,N/A,N/A,N/A
Z-1221-2007,38983,"Implant, Endosseous, Root-Form",DZE,Endosseous dental implant.,Dental,Dental,510(K),"Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.",LTX XP Miniplant,2,"September 18, 2007", 2007,Biomet 3i,"The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.",PRODUCTION CONTROLS: Process Control,"International customers were contacted first by e-mail , then by fax letter 08/03/2007.",N/A,240,240 (120 each model / lot),"Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.",Terminated,"September 11, 2009",724,240,Not_Computer,N/A,N/A,N/A
Z-1220-2007,38348,"Labware, Assisted Reproduction",MQK,Assisted reproduction labware.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(K),"IVF Pasteur Pipettes, glass, cotton plugged, length 9"", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***",IVF Pasteur Pipettes,2,"September 18, 2007", 2007,"Humagen Fertility Diagnostics, Inc.",Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.,Contact the recalling firm for information,160,160 boxes,"The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel.",Terminated,"October 29, 2007",41,160,Not_Computer,N/A,N/A,N/A
Z-1192-2007,38630,"Ventilator, Continuous, Facility Use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(K),Newport HT50 Ventilator (all Models),Newport HT50,2,"September 19, 2007", 2007,Newport Medical Instruments Inc,"Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.",N/A,"An Important Medical Device Correction Letter was issued on September 14, 2007 as a short term fix. The firm has submitted a long term correction as a supplement to its 510 K which is pending review by FDA.",N/A,8160,"8,160","Worldwide including USA, Algeria, Argentina, Armenia, Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote D' Ivoire, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Liechtenstein, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, New Zealand, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, Venuzuela, Yemen, and Zambia",Open,N/A,N/A,8160,Battery,Device Operation,Repair,Repair
Z-1224-2007,39415,"Pump, Infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(K),"Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161",Baxter Colleague CX Infusion Pumps,1,"September 19, 2007", 2007,Baxter Healthcare Corp.,Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.,TRAINING: Employee Error,"The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.",N/A,42,42 pumps,Florida and California,Terminated,"February 21, 2008",155,42,Not_Computer,N/A,N/A,N/A
Z-1223-2007,39368,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),"Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)",Welch Allyn AED 20 Defibrillator,1,"September 19, 2007", 2007,"Welch Allyn Protocol, Inc","Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a ""Defib Comm"" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.",DESIGN: Device Design,On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to those customers.,Contact the recalling firm for information,1637,"1,637 devices","Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.",Open,N/A,N/A,1637,Other,Treatment/Delivery/Therapy,Return,Remove or Replace
Z-1226-2007,38399,"Needle, Hypodermic, Single Lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(K),"ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe30 gauge x 5/16"" length, for subcutaneous injection of insulin.",ReliOn,2,"September 20, 2007", 2007,Becton Dickinson & Company,"Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.",PRODUCTION CONTROLS: Packaging Process Control,"Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.",Contact the recalling firm for information,644500,"644,500 units",Nationwide.,Terminated,"June 03, 2008",257,644500,Not_Computer,N/A,N/A,N/A
Z-1228-2007,38546,"Dialyzer, High Permeability With Or Without Sealed Dialysate System",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"NxStage Cartridge Express, CAR-170, for hemodialysis.",NxStage,2,"September 20, 2007", 2007,"NxStage Medical, Inc.",Potential for dialysate leaks from the cartridge during treatment.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.",N/A,12085,"12,085 cases",Nationwide,Terminated,"September 13, 2010",1089,12085,Not_Computer,N/A,N/A,N/A
Z-1225-2007,38424,Full-Montage Standard Electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(K),"BMSI ""MicroJack"" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.",BMSI MicroJack,2,"September 20, 2007", 2007,Nicolet Biomedical Div of Viasys Healthcare,"The BMSI ""MicroJack"" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.",PRODUCTION CONTROLS: Process Control,"VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters ""Viasys HealthCare Urgent Medical Device Field Correction (Recall)"" were sent 7/17/07 to both domestic and international customers.",Contact the recalling firm for information,2102,2102,"Worldwide, including USA, ISRAEL, LITHUANIA, RUSSIA, FRANCE, IRELAND, UNITED KINGDOM , SPAIN, YEMEN, JAPAN, TAIWAN, KOREA, CHINA, SAUDI ARABIA, HONG KONG, INDIA, COLOMBIA, BRAZIL, GERMANY, CANADA, DENMARK, ITALY, MEXICO, and THAILAND.",Open,N/A,N/A,2102,Not_Computer,N/A,N/A,N/A
Z-1236-2007,39386,"Saline, Vascular Access Flush",NGT,Intravascular catheter.,General Hospital,General Hospital,510(K),Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.,Normal Saline 10ml in 12ml Syringe,2,"September 20, 2007", 2007,"B. Braun Medical, Inc.",Particulate matter in product.,PRODUCTION CONTROLS: Process Control,"The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.",Contact the recalling firm for information,1292520,"1,292,520 units",The products were shipped to distributors nationwide.,Terminated,"April 01, 2008",194,1325760,Not_Computer,N/A,N/A,N/A
Z-1230-2007,38623,"System, Suction, Lipoplasty",MUU,Suction lipoplasty system.,General & Plastic Surgery,General & Plastic Surgery,510(K),"5mm x 30cm Hollow ""Golf"" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.","5mm X 30cm Hollow ""Golf"" Tip Ultrasonic Aspiration Probe",3,"September 20, 2007", 2007,"Mentor Texas, Inc","Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow ""Golf"" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Firm notified consignees by letter on July 27, 2007.",N/A,4,4 units,"Nationwide, including VA, IN, CA, and IL.",Terminated,"April 04, 2008",197,4,Not_Computer,N/A,N/A,N/A
Z-1237-2007,39413,"System, Test, Vitamin D",MRG,Vitamin D test system.,Clinical Chemistry,Clinical Chemistry,510(K),"25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.",DiaSorin,3,"September 20, 2007", 2007,Diasorin Inc.,25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.,TRAINING: Employee Error,Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.,N/A,117,117 kits,"Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.",Terminated,"October 17, 2008",393,117,Not_Computer,N/A,N/A,N/A
Z-1229-2007,38621,"Catheter, Hemodialysis, Non-Implanted",MPB,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.",BARD Access Systems ,2,"September 20, 2007", 2007,"C.R. Bard Access Systems, Inc",Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.,PRODUCTION CONTROLS: Process Control,Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.,N/A,7225,7225 units,"Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).",Terminated,"April 25, 2008",218,7225,Not_Computer,N/A,N/A,N/A
Z-1009-2007,37978,"Stretcher, Wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales)",Stryker stretcher,2,"September 21, 2007", 2007,Stryker Medical Div. of Stryker Corporation,"The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consignees were notified of the problem via letter dated 5/7/07 instructing them to immediately unplug the affected stretchers with scales, affix a warning label enclosed with the letter to the power cord of stretchers with scales, and that they will be contacted so that the firm can schedule a visit to upgrade all affected stretchers. A second notification letter was issued on August 7, 2007 to cover all 1550 stretchers with and without scales.",N/A,39,"1,048 (1009 in the U.S. plus 39 international)","Worldwide: USA, Latin America, Mexico and Spain.",Terminated,"June 11, 2008",264,39,Not_Computer,N/A,N/A,N/A
Z-1240-2007,38472,Oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(K),"BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc", BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor,3,"September 21, 2007", 2007,"Smiths Medical PM, Inc.",Phantom pacer spikes caused by a damaged resistor.,N/A,"Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.",N/A,178,178,"World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.",Terminated,"October 31, 2008",406,178,Not_Computer,N/A,N/A,N/A
Z-1241-2007,38814,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Duracon Total Knee Modular Femoral Component;Non-Porous Right Medium Assembly, Product No. 6632-0-325",Duracon Total Knee Modular Femoral ,3,"September 21, 2007", 2007,Stryker Howmedica Osteonics Corp.,Loose fixation pegs: One lot of femoral components may have loose fixation pegs.,N/A,"Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.",N/A,3,"3 total, 2 in USA","Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.",Terminated,"July 07, 2009",655,3,Not_Computer,N/A,N/A,N/A
Z-1239-2007,38406,"Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(K),"Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430",Stryker Radius Locking Caps,2,"September 21, 2007", 2007,Stryker Spine,Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod,N/A,Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.,N/A,123,"1,300 in US, 123 in Italy","Worldwide- USA: Distributed to Stryker Branches/Agencies in MA, NY, NC. IN, MI, OK, TX,CO, AZ, WI, KS, CA, OR and hospitals in NC IN, MI, MO. KS, TZ, AZ, CA. OR and WA and Country of Italy",Terminated,"December 11, 2007",81,1423,Not_Computer,N/A,N/A,N/A
Z-1256-2007,37874,"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Reverse Shoulder Prosthesis (RSP) device component; RSP Stem; Device manufactured by Encore Medical, L.P., Austin, TX 78758.",Reverse Shoulder Prosthesis device components,2,"September 25, 2007", 2007,"Encore Medical, Lp","Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as ""custom devices"" by the manufacturer did not meet the definition of ""custom devices"" and were, therefore, unapproved devices.",N/A,Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.,N/A,120,120 units.,"Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.",Terminated,"March 27, 2008",184,678,Not_Computer,N/A,N/A,N/A
Z-1124-2007,44899,"Kit, Surgical Instrument, Disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024",Laser Level Transmitters,2,"September 25, 2007", 2007,K Tek,"Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.,N/A,21,21 units,Nationwide,Terminated,"December 10, 2008",442,1008,Not_Computer,N/A,N/A,N/A
Z-1231-2007,38624,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Triathlon X3 Total Stabilizer + Tibial InsertFor use with Triathlon Universal Baseplates, knee prosthesis. #5 13mmStryker Orthopaedics",Triathlon X3 ,2,"September 25, 2007", 2007,Stryker Howmedica Osteonics Corp.,"Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.",N/A,"Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.",N/A,14,14,"Product distributed to 5 hospitals in GA, OH, MN, TX.",Terminated,"December 05, 2007",71,14,Not_Computer,N/A,N/A,N/A
Z-1227-2007,38485,"Tubing, Pump, Cardiopulmonary Bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(K),"Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.",Medtronic Intersept ,2,"September 25, 2007", 2007,Medtronic Perfusion Systems,Medtronic Custom Tubing Packs might have open header bag seals.,PRODUCTION CONTROLS: Process Control,Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information.,Contact the recalling firm for information,853,853 packs,Nationwide.,Terminated,"October 10, 2008",381,853,Not_Computer,N/A,N/A,N/A
Z-1212-2007,39420,"System,Planning,Radiation Therapy Treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h)",The Pinnacle3 Radiation Therapy Planning System ,2,"September 25, 2007", 2007,"Philips Nuclear Medicine, Inc.",Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction,N/A,"All customers will receive an August 21, 2007, Customer Advisory Notification letter notifying them of the issue and the steps required to avoid the issue. Return receipts will be tracked. This is a short-term fix, a long term software fix will be issued shortly by the firm.",Contact the recalling firm for information,1407,"1,407","Worldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Country of CANADA",Open,N/A,N/A,1407,Software,Display/Image,Software update,Software Update
Z-1243-2007,44739,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.,Cerner Millennium RadNet Auto Launch Study and Auto Launch Report,2,"September 25, 2007", 2007,Cerner Corp,Defects in the Auto Launch functionality make it possible for a mismatch of patient data.,N/A,"The recalling firm initiated recall via telephone on 8/23/07 to their customers who had the 2007 version in their production environment, explained the reason for recall, and informed them they should turn off the affected functionality. The firm posted details of the situation on their website in two different documents (referred to as a Priority Review Flash), one dated 8/29/07 and the other dated 8/31/07. The 8/31/07 document was also mailed to their customers via certified mail on 9/4/07.The corrected software (EP28822 ver.1) was made available to the firm's clients on 9/7/07 via their website. Beginning 9/18/07, workarounds were discussed via telephone with the clients who had downloaded the software correction which contained a new bug that affected the dictation file. A new software correction to fix the dication file problem was posted on the recalling firm's website on 9/28/07 for clients to download and validate. A Priority review Flash #PR07-0176-2 client notification dated 10/4/07 was also posted on their website and mailed via certified mail return receipt.",N/A,9,Downloaded by 9 customers nationwide.,"Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.",Terminated,"November 29, 2007",65,9,Software,Output/Calculation,Software update,Software Update
Z-1262-2007,38950,General Surgery Tray (Kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.",Merit Medical Surgical Convenience Kits,2,"September 25, 2007", 2007,"Merit Medical Systems, Inc",Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.,PRODUCTION CONTROLS: Packaging Process Control,"An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their consignees.",Contact the recalling firm for information,16333,"16,333 units",Nationwide,Open,N/A,N/A,16333,Not_Computer,N/A,N/A,N/A
Z-1087-2007,38633,"System, X-Ray, Stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(K),"GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.",Proteus XR/a Radiographic System,2,"September 25, 2007", 2007,General Electric Med Systems LLC,Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.",N/A,22,22 units,"Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA",Terminated,"December 11, 2007",77,22,Not_Computer,N/A,N/A,N/A
Z-0911-2007,44910,"System, X-Ray, Angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(K),Philips Omni Diagnost Eleva,Omni Diagnost Eleva,2,"September 25, 2007", 2007,Philips Medical Systems North America Co. Phillips,"Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.",DESIGN: Software Design,"On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.",N/A,14,14 units,Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.,Open,N/A,N/A,6141,Not_Computer,N/A,N/A,N/A
Z-0764-2007,37844,"System, X-Ray, Mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(K),"Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.",Practix 300,2,"September 25, 2007", 2007,Philips Medical Systems North America Co. Phillips,"X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007.,N/A,9,9 units,Nationwide: Distributed to Puerto Rico.,Terminated,"September 16, 2010",1087,11,Not_Computer,N/A,N/A,N/A
Z-1242-2007,38459,"Stimulator, Cranial Electrotherapy",JXK,Cranial electrotherapy stimulator.,Neurology,Neurology,510(K),HealthPax Cranial Electrotherapy Stimulator,HealthPax Cranial Electrotherapy Stimulator,3,"September 26, 2007", 2007,"Health Directions, Inc",Peak voltage test result not in acceptable limits.,N/A,The recalling firm sent a recall letter 07/30/2007 to all their customers. The letter indicated that it is necessary to return the product for testing and the device will either be returned or if necessary replaced. Each unit will be tested with an oscilloscope device to determine whether it meets or fails design specifications. The recalling firm will reimburse shipping costs.,N/A,212,212 units,"Worldwide, including USA, Canada, Ireland, and India.",Terminated,"June 03, 2008",251,212,Hardware,N/A,Replace,Remove or Replace
Z-0014-2007,37567,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.",Brilliance CT ,2,"September 26, 2007", 2007,Philips Medical Systems (Cleveland) Inc,"A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.",DESIGN: Software Design,"The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.",N/A,20,20,"Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.",Terminated,"October 05, 2010",1105,90,Software,Output/Calculation,Software update,Software Update
Z-1261-2007,38815,"Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp.,325 Corporate DriveMahway, NJ 07430",Trident PSL Acetabular Shell;,2,"September 26, 2007", 2007,Stryker Howmedica Osteonics Corp.,Dimensional anomaly,TRAINING: Employee Error,"Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express.",N/A,1220,"1,220 units","Worldwide -USA, Romania, Chile and Brazil.",Terminated,"January 18, 2008",114,1220,Not_Computer,N/A,N/A,N/A
Z-1244-2007,38069,"System,Surgical,Computer Controlled Instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(K),"Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086","daVinci Surgical System Model IS1200, A4.3 SW level",2,"September 26, 2007", 2007,"Intuitive Surgical, Inc.","Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.",DESIGN: Software Design,"As of 9/7/2007, Intuitive Field Service Engineers have performed the upgrade via service visit on 292 of 293 U.S. systems listed on the affected sites list. A notification letter that the upgrade has been performed was left with each site after the upgrade has been completed. The firm's distributors received advance notice of the upgrades 9/13/2007.",Contact the recalling firm for information,405,405,"Worldwide, including USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.",Terminated,"July 02, 2008",280,405,Software,Device Operation,Software update,Software Update
Z-0555-2007,39378,"Cabinet, Table And Tray, Anesthesia",BRY,"Anesthetic cabinet, table, or tray.",Anesthesiology,Anesthesiology,510(K) Exempt,"Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA",Pyrxis Anesthesia System 3500,2,"September 26, 2007", 2007,Cardinal Health 303 Inc DBA Alaris Products,"System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.",N/A,"The field action consisted of phone calls and a mailing conducted to all customers for the Pyxis Anesthesia System 3500 beginning on 08/13/2007. The customers will be notified by registered return receipt mail by Recall Notifications dated August 14, 2007. Separate letters will be sent to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix and a long-term fix of the software will be issued shortly.",N/A,369,369,"Nationwide to Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, New Jersey, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, and Wyoming.",Open,N/A,N/A,369,Software,Device Operation,Software update,Software Update
Z-1263-2007,44702,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),"Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts.",Altaire Shoulder Coil,2,"September 26, 2007", 2007,Hitachi Medical Systems America Inc,Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"On 7/30/07, Hitachi sent a Device Correction letter via courier with receipt tracking to all affected customers outlining the risk of overheating of the cable balun assembly and subsequent risk of patient/operator injury. The letter notifies customers that (1) Hitachi will be contacting them in the future to schedule an on-site visit for replacement of the Altaire Shoulder Coil; (2) the replacement will begin in September, 2007 and continue until all affected coils are replaced; and (3) customers that have noticed overheating of the cable balun assembly are urged to notify Hitachi for immediate replacement service.",N/A,273,273,"Nationwide: U.S. A. to include: AL, AR, AZ, CA, CO, CT, DE, FL, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WY.",Terminated,"October 05, 2010",1105,273,Not_Computer,N/A,N/A,N/A
Z-1245-2007,38301,"System,Surgical,Computer Controlled Instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(K),"daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.",daVinci S Surgical System IS2000,2,"September 26, 2007", 2007,"Intuitive Surgical, Inc.",Product may malfunction and fail to start up on AC power.,PRODUCTION CONTROLS: Process Control,"As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).",Contact the recalling firm for information,38,38 units,"Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.",Terminated,"December 03, 2007",68,38,Other,Device Operation,Replace component,Remove or Replace
Z-1238-2007,38372,"System/Device, Pharmacy Compounding",NEP,Intravascular administration set.,General Hospital,General Hospital,510(K) Exempt,"Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.",ExactaMix 2400 ,1,"September 27, 2007", 2007,Baxa Corporation,A software defect could allow up to 50mL of extra volume being added to a TPN solution.,DESIGN: Software Design,"All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.",N/A,30,30 units,"Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK",Terminated,"December 07, 2007",71,30,Software,Treatment/Delivery/Therapy,Conversion back to previous version,Software Update
Z-1267-2007,38634,"Staple, Implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(K),Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic)Item Numbers: 0113036-Product Code 9113036-(Refurbished),Davol,2,"September 27, 2007", 2007,"Davol, Inc., Sub. C. R. Bard, Inc.",Malformed constructs (straight shots) may form causing injury to user/patient,DESIGN: Device Design,"Davol issued recall letter notification on 7/16/07 via Federal Express. Sales of the disposable cartridges ceased July 31, 2007. Cartridges will not be requested to be returned to Davol. Customer requests to return cartridges will be managed on an account-by-account basis. A reminder Second Letter issued July 23,2007 as a follow-up to the letter of July 16, 2007.The second stage will be a series of three letters to customers following the cessation of disposable cartridge sales and to recall the re-usable handles. A Stock Status form will be provided to customers to inventory the product which they are returning.The Stock Status form will be used to document the handles being returned. In the event that the customer cannot locate one or more handles. All handles will be returned to Cranston and will be dispositioned. Account verification for the number of handles returned from the account will be performed. No verification testing will be performed on returned handles unless a formal complaint has been registered for a handle.",Contact the recalling firm for information,4242,"4,242 shafts","Worldwide-USA and Canada, Austria, Switzerland, Spain, Sweden, United Kingdom, Italy,Portugal, Greece,Holland, South Africa, Israel, Japan, Belgium, Denmark, Finland, France, and Germany",Open,N/A,N/A,195104,Not_Computer,N/A,N/A,N/A
Z-0676-2007,37498,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(K),"OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.",OEC 9900 Elite,2,"September 28, 2007", 2007,"GE OEC Medical Systems, Inc","During routine service, primary and/or secondary collimators may not have been properly reinstalled.",PRODUCTION CONTROLS: Process Control,Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.,N/A,19,19 units,Nationwide and Germany.,Open,N/A,N/A,1975,Not_Computer,N/A,N/A,N/A
Z-1088-2007,44936,Solid State X-Ray Imager (Flat Panel/Digital Imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(K),"GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.",GE Innova 2100IQ ,2,"September 28, 2007", 2007,GE Healthcare,The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).,PRODUCTION CONTROLS: Labeling Mix-Ups,"Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.",N/A,161,161,"World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.",Open,N/A,N/A,161,Not_Computer,N/A,N/A,N/A
Z-0035-2008,44827,"Agent, Tooth Bonding, Resin",KLE,Resin tooth bonding agent.,Dental,Dental,510(K),"Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.",Heraeus Kulzer GLUMA Comfort Bond Desensitizer,3,"October 02, 2007", 2007,"Heraeus Kulzer Inc., Dental Products Division","The material may solidify in the bottle, and thus be rendered unusable.",DESIGN: Process Design,Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.,N/A,1236,"1,236",Nationwide and Canada.,Terminated,"March 12, 2008",162,1972,Not_Computer,N/A,N/A,N/A
Z-0005-2008,38449,"Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(K),"PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.",PathFinder Bone DrillAwlTap,2,"October 02, 2007", 2007,Abbott Spine,Tip of PathFinder surgical instrument broke during procedure.,DESIGN: Device Design,Firm notified sales representatives with an approved phone script on 7/18/2007.,N/A,11,11 units,Nationwide.,Terminated,"April 02, 2008",183,11,Not_Computer,N/A,N/A,N/A
Z-0013-2008,39369,"Blade, Scalpel",GES,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Shelf Pack:Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.Unit Package:Contents of unopened or undamaged package guaranteed sterile;After use place product in a puncture resistant container and dispose properly.Becton DickinsonBecton Dickinson Acute CareFranklin Lakes, NJ 07417",BardParker RibBack ,3,"October 02, 2007", 2007,Becton Dickinson & Company,Complaints received of rust on the blades of BD Bard-Parker Surgical blades.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,Urgent recall letters were sent out 8/10/2007 via UPS second day air.,N/A,56700,"56,700",Nationwide.,Terminated,"March 07, 2008",157,60726,Not_Computer,N/A,N/A,N/A
Z-0007-2008,38494,Single (Specified) Analyte Controls (Assayed And Unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(K),"4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.",AIAPack BHCG Calibration Verification Test Set,3,"October 03, 2007", 2007,Tosoh Bioscience Inc,Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Letter, dated July 2, 2006. Immediately examine inventory and quarantine product. If product was further distributed, the direct accounts are to notify their customers including a copy of the original recall letter and Notification of Recall response card.",N/A,47,47 Boxes,Nationwide.,Terminated,"October 07, 2010",1100,47,Not_Computer,N/A,N/A,N/A
Z-0003-2008,38430,"Test, Urea (Breath Or Blood)",MSQ,Campylobacter fetusserological reagents.,Microbiology,Microbiology,510(K),"BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.",BreathTek ,2,"October 04, 2007", 2007,"Meretek Diagnostics, Inc.","Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.",MISBRANDING: Labeling False and Misleading,Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.,N/A,92,92 units,Nationwide.,Terminated,"November 26, 2007",53,92,Not_Computer,N/A,N/A,N/A
Z-0006-2008,38484,"Absorber, Carbon-Dioxide",BSF,Carbon dioxide absorber.,Anesthesiology,Anesthesiology,510(K) Exempt,"GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.",EZchange Module ,2,"October 04, 2007", 2007,"Datex - Ohmeda, Inc",Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"Because this issue only occurs when the Disposable Multi Absorber is used in conjunction with EZchange Module, they have contacted all EZchange Module customers. It is critical to contact these customers specifically, rather than all customers shipped Disposable Multi Absorbers as this may cause unwarranted confusion with customers who do not have the EZchange Module. Consignees were sent an letter dated 7/19/2007 describing the product and problem. The letter lists a number of interim actions to implement with the anesthesia systems.",N/A,389070,"389,070","Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and Venezuela.",Open,N/A,N/A,389070,Not_Computer,N/A,N/A,N/A
Z-0008-2008,38894,"Injector And Syringe, Angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(K),"CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)",CVI (Cardiovascular Innovations) ,2,"October 04, 2007", 2007,"Lemaitre Vascular, Inc.",Sterility of device may be compromised due to breach in sterile barrier.,DESIGN: Packaging Design/Selection,"The firm issued a ""Adivsory Notice"" to accounts 7/18/07, advising them to examine inventory and remove product with defective packaging. The firm issued an updated notification dated 9/24/07 advising users to return recalled lots instead of conducting an examination of the product at the user site.",N/A,7860,"7,860 units","Worldwide, including USA, Canada, Netherlands, and Germany.",Terminated,"September 08, 2008",340,7860,Not_Computer,N/A,N/A,N/A
Z-0034-2008,39412,"System, Test, Anticardiolipin Immunological",MID,Multiple autoantibodies immunological test system.,Immunology,Immunology,510(K),"APhL¶_ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).",APhL HRP IgG & IgM ELISA Kit,3,"October 04, 2007", 2007,Louisville Apl Diagnostics Inc,Product mislabeled; outer container labeled with incorrect lot number.,DESIGN: Process Design,Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.,N/A,3,3 test kits (each kit containing 1 IgG and 1 IgM test kit),Product was shipped to a distributor in Canada.,Terminated,"October 24, 2007",20,3,Not_Computer,N/A,N/A,N/A
Z-0015-2008,39389,"Enzymatic Method, Ammonia",JIF,Ammonia test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.",Ammonia Liquid Stable Reagent,3,"October 04, 2007", 2007,Thermo Fisher Scientific,Method is susceptible to positive interference from endogenous ALT in patient samples.,DESIGN: Device Design,"The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.",N/A,6882,"6,882 units","Worldwide, including USA, Ecuador, and Canada.",Terminated,"December 18, 2007",75,6882,Not_Computer,N/A,N/A,N/A
Z-0057-2008,44933,"Sterilant, Medical Devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(K),"ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.",ONQ PainBuster with OnDemand ,2,"October 06, 2007", 2007,I-Flow Corporation,"Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.",PRODUCTION CONTROLS: Process Control,"An Important Recall Notification Letter was faxed to affected customers on March 27, 2007. Affected customers were notified of the recall, the reason for recall, and instructed to immediately quarantine any remaining inventory. A Customer Response (and Fax back) form was included with the Recall Notification. Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. Replacement product will be sent out as applicable.",Contact the recalling firm for information,2587,"2,587 units","Worldwide, USA and Australia",Terminated,"October 07, 2009",732,2587,Not_Computer,N/A,N/A,N/A
Z-0009-2008,38951,"Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer",HRY,Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"EPIK¶_ KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.",EPIK KNEE SYSTEM Angled Insert Impactor,2,"October 10, 2007", 2007,"Encore Medical, Lp","Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.",DESIGN: Device Design,Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.,N/A,5,5 units.,"Products distributed to direct accounts in CA, FL and MD.",Terminated,"March 10, 2008",152,5,Not_Computer,N/A,N/A,N/A
Z-0014-2008,39382,"Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USACatalog #P1174",BHIA,2,"October 10, 2007", 2007,Pml Microbiologicals Inc.,Plates manufactured without vancomycin. Possibility for false resistant results.,PRODUCTION CONTROLS: Process Control,On 4/23/07 the firm began contacting customers via fax and telephone.,N/A,640,"640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)","lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center.lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribution center.",Open,N/A,N/A,640,Not_Computer,N/A,N/A,N/A
Z-0011-2008,39367,"Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/MLMicrobiological media plates,Brain Heart Infusion Agar (BHIA),2,"October 10, 2007", 2007,Pml Microbiologicals Inc.,Marketed a regulated product without a 510(k).,PREMARKET APPROVAL: No Marketing Application,"Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.",N/A,1205,1205 plates distributed in US; 1040 distributed in Canada,"US, Puerto Rico, & Canada",Open,N/A,N/A,1205,Not_Computer,N/A,N/A,N/A
Z-0039-2008,39419,"Instrument, Coagulation, Automated",GKP,Coagulation instrument.,Hematology,Hematology,510(K),"STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.",STA Compact and STA Compact CT,2,"October 11, 2007", 2007,"Diagnostica Stago, Inc.",Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.,DESIGN: Process Design,Recall notification letters were mailed to consignees on 7/30/07 by first class mail.,N/A,41,41 units installed,Nationwide.,Terminated,"December 17, 2007",67,41,I/O,Output/Calculation,N/A,Other
Z-0037-2008,38371,"Stimulator, Electrical, Implantable, For Incontinence",EZW,Implanted electrical urinary continence device.,Gastroenterology/Urology,Gastroenterology/Urology,PMA,Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.,Interstim for Urinary Control,2,"October 11, 2007", 2007,Medtronic Neuromodulation,A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .,DESIGN: Software Design (Manufacturing Process),"Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.",Contact the recalling firm for information,1885,1885,Nationwide and the Netherlands.,Terminated,"October 08, 2010",1093,1885,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0041-2008,44791,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.",PEMView,3,"October 11, 2007", 2007,Naviscan PET Systems,"Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line.1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema",DESIGN: Software Design (Manufacturing Process),"Telephone notification regarding issues #1 and #2 were carried out on August 1 and 2, 2007 and included instructions for a validated work-around to avoid the software issues. Written notifications with these same validated work-around instructions were sent on August 2, 2007 via certified mail. Customers were notified that Naviscan has identified a potential safety issue with all versions of PEM View Software.Issue #3 was identified after the notification to customers for issues #1 and #2. Telephone notification regarding issues #3 was carried out via telephone and certified mailing beginning August 16, 2007. Customers were informed that Naviscan is preparing software to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure they thoroughly understand the issues and the recommended procedure to prevent these issues from occurring. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159 or service@navsicanpet.com.",N/A,19,19 units,Nationwide.,Terminated,"May 14, 2008",216,19,Software,Output/Calculation,Software update,Software Update
Z-0038-2008,38511,"Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(K),Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.,accessory to ABL800 Flex,2,"October 11, 2007", 2007,Radiometer America Inc,Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.,DESIGN: Process Design,"By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.",N/A,289,289 pieces,Product was distributed throughout the United States and Canada.,Open,N/A,N/A,289,Not_Computer,N/A,N/A,N/A
Z-0055-2008,39383,"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",LGW,N/A,N/A,Neurology,PMA,"Precision Implantable Pulse Generator (IPG), Model Number SC-110",Precision Implantable Pulse Generator,2,"October 12, 2007", 2007,Advanced Bionics Corp,Mislabeled: Product labeled with the incorrect shelf-life information.,PRODUCTION CONTROLS: Labeling Mix-Ups,"There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.",N/A,1,1 unit affected,MD,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-0040-2008,44740,"Stimulator, Electrical, Implantable, For Incontinence",EZW,Implanted electrical urinary continence device.,Gastroenterology/Urology,Gastroenterology/Urology,PMA,Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.,Interstim for Urinary Control,2,"October 12, 2007", 2007,Medtronic Neuromodulation,"Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).",DESIGN: Software Design (Manufacturing Process),"Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.",Contact the recalling firm for information,1885,1885,Nationwide and the Netherlands.,Terminated,"October 08, 2010",1092,1885,Software,Alarm/Message,Notification,Safety Notice/Insructions
Z-0056-2008,39408,"Injector And Syringe, Angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(K),"Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.",Angiomat Illumena ,2,"October 13, 2007", 2007,Mallinckrodt Inc,"Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv",DESIGN: Device Design,"On 9/20/2007, a notification was sent from Mallinckrodt to all direct accounts via certified mail. The notification details the potential for mis-synchronization of injection parameters if the main and auxiliary consoles are simultaneously programmed. The notification reminds end-users that simultaneous programming should not be performed and to ensure it is not performed, a notification label (provided in the notification) is to be affixed on both consoles of the injector system. Once the label is affixed to the system, end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1) for the injector system's product manual that emphasize the separation between programming of the main and auxiliary consoles. Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-888-744-1414, menu option 1 and then menu option 2.",Contact the recalling firm for information,176,176,"Worldwide to include:U.S.A. states of - AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, & WI. and Foreign countries of Argentina, Belgium, Brazil, Canada, Germany, Japan, Singapore, & Zambia.",Terminated,"August 17, 2010",1039,176,Other,Device Operation,Update manual,Other
Z-0002-2008,38369,"Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use",LXG,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.",FP1000 Cell Preparation System ,2,"October 16, 2007", 2007,Beckman Coulter Inc,Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.,DESIGN: Labeling Design,"A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.",N/A,9,9 in the U.S.; 1 in Canada,"Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.",Open,N/A,N/A,9,Not_Computer,N/A,N/A,N/A
Z-0061-2008,44942,Wearable Automated External Defibrillator,MVK,N/A,N/A,Cardiovascular,PMA,Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).,Battery Pack portion of the LifeVest device,3,"October 18, 2007", 2007,Zoll Lifecor Corporation,Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.,DESIGN: Device Design,Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.,N/A,2006,2006 packs,"The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.",Terminated,"June 13, 2008",239,2006,Battery,N/A,Replace,Remove or Replace
Z-0043-2008,44909,"Lead, Atomic Absorption",DOF,Lead test system.,Toxicology,Toxicology,510(K),"ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704ACatalog Number: 70-7142",ESA LeadCare,3,"October 18, 2007", 2007,"Esa Biosciences, Inc.",Level 1 and Level 2 Control values were incorrectly assigned.,DESIGN: Process Design,ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Viallabel for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.,N/A,2,2 kits,Nationwide and United Kingdom.,Terminated,"March 25, 2008",159,367,Not_Computer,N/A,N/A,N/A
Z-0046-2008,44940,"Lancet, Blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Microtainer Safety Flow Lancets; BlueSterile Use once and Discard;1.9mm Blade Length;1.0 mm Blade Width;Becton Dickinson Vacutainer SystemsBecton dickinson and COmpany;Franklin Lakes, NJ 07417",Microtainer Safety Flow Lancets,2,"October 18, 2007", 2007,Becton Dickinson & Company,Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.,DESIGN: Process Design,Recall communication issued on or about 9/28/2007.,N/A,4349000,"4,349,000 units","Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.",Terminated,"January 15, 2008",89,7803000,Not_Computer,N/A,N/A,N/A
Z-0066-2008,38739,"Keratome, Battery-Powered",HMY,Keratome.,Ophthalmic,Ophthalmic,510(K),"BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)",BD Microkeratome K3000 and K4000,2,"October 23, 2007", 2007,Becton Dickinson and Company,Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea,DESIGN: Component Design/Selection,"BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.",N/A,256,256 units,Worldwide,Open,N/A,N/A,256,Not_Computer,N/A,N/A,N/A
Z-0058-2008,44938,"Bag, Bile Collecting",EXF,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.","Remington Medical, Inc, (RMI) Urinary Drainage Bag",2,"October 23, 2007", 2007,Remington Medical Inc.,"Sterility, inadequate -- Pathway may not be sterile as labeled.",PRODUCTION CONTROLS: Process Control,Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007. They were instructed to quarantine all affected product in inventory. If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter.,N/A,45000,"45,000 units","Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY.",Terminated,"April 06, 2009",531,45000,Not_Computer,N/A,N/A,N/A
Z-0101-2008,44810,"Sterilant, Medical Devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(K),"Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.",Steris Quick Connects (QC) QFC1728 and QFC1729,2,"October 24, 2007", 2007,Steris Corporation Hopkins Facility,Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.,DESIGN: Component Design/Selection,"STERIS has contacted affected direct accounts by phone to notify direct accounts of the recall. On 9/28/2007, STERIS will mail a recall notification to all affected direct accounts via certified mail. The notification informs direct accounts that STERIS representatives will be visiting direct accounts to retrieve affected products and provide replacements. Where direct accounts further distribute, STERIS representatives will inform the direct accounts to contact their sub-accounts and facilitate exchange of affected product for replacement product. Replacement product will be available beginning November 1, 2007.",N/A,391,391 Quick Connects,"Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain",Terminated,"September 28, 2010",1070,391,Not_Computer,N/A,N/A,N/A
Z-0033-2008,39402,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,PMA,"Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.","Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup ",2,"October 25, 2007", 2007,Smith & Nephew Inc,The carton label may not reflect the correct size of the acetabular cup.,PRODUCTION CONTROLS: Packaging Process Control,The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.,N/A,1,1 unit,"Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.",Terminated,"February 02, 2010",831,177,Not_Computer,N/A,N/A,N/A
Z-0062-2008,44751,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),"HeartStart XL Defibrillator/Monitor, Model: M4735A",HeartStart XL ,2,"October 25, 2007", 2007,Philips Medical Systems,"Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.",DESIGN: Packaging Design/Selection,Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.,N/A,147,147 boards,"Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany",Open,N/A,N/A,147,Not_Computer,N/A,N/A,N/A
Z-0072-2008,44780,"Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Trident PSL HA Cluster Acetabular Shell;Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp.325 Corporate Drive;Mahwah, NJ 07430;A subsidiary of Stryker Corp.Sterile, Made in USA.",Trident PSL ,2,"October 25, 2007", 2007,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.",PRODUCTION CONTROLS: Process Control,"Recall notification letters were sent out on August 30, 2007 with return receipt.",N/A,142,142 units,Product was distributed nationwide and one unit to Brazil.,Terminated,"September 05, 2008",316,142,Not_Computer,N/A,N/A,N/A
Z-0067-2008,45403,Implantable Cardioverter Defibrillator (Non-Crt),LWS,N/A,N/A,Cardiovascular,PMA,"Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.",Medtronic Sprint Fidelis Lead,1,"October 25, 2007", 2007,Medtronic Inc. Cardiac Rhythm Managment,"Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of",DESIGN: Component Design/Selection,"A press release was issued by Medtronic on 10/15/2007. An FDA Statement was also issued on 10/15/2007. An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians. The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic. This letter describes background information, performance and recommendations. Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. An Important Patient Information letter was addressed to Medtronic Heart Device Patients. Both letters can be found on Medtronic's website at www.medtronic.com/fidelis. Return of product will be achieved with the assistance of Medtronic Representatives.",N/A,235000,"235,000 for all models","Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.",Open,N/A,N/A,235000,Not_Computer,N/A,N/A,N/A
Z-0104-2008,44901,"Catheter, Percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550",Boston Scientific mach 1 Guide Catheter,2,"October 27, 2007", 2007,Boston Scientific,Missing holes: Catheters are missing the catheter's side holes.,PRODUCTION CONTROLS: Process Control,"A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.",N/A,7,7,"Worldwide: NY, PA, and Japan",Terminated,"February 24, 2008",120,13,Not_Computer,N/A,N/A,N/A
Z-0102-2008,44812,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581",Biomet Orthopedics Apical Hole Plug,2,"October 27, 2007", 2007,"Biomet, Inc.",Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.,PRODUCTION CONTROLS: Process Control,The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts.,N/A,5,5,Nationwide,Terminated,"June 26, 2009",608,5,Not_Computer,N/A,N/A,N/A
Z-0118-2008,44736,"Cover, Biopsy Forceps",FFF,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40UPN Number: M00513332REF: 1333-40",Boston Scientific,2,"October 31, 2007", 2007,Boston Scientific Corporation,Device lacked manufacturing finishing process resulting in endoscope damage.,PRODUCTION CONTROLS: Process Control,Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.,N/A,734,734 boxes,"Worldwide, including USA, Sweden, and South Africa.",Terminated,"July 10, 2008",253,1519,Not_Computer,N/A,N/A,N/A
Z-0110-2008,38264,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.",Brilliance CT Systems,2,"October 31, 2007", 2007,Philips Medical Systems (Cleveland) Inc,Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.,DESIGN: Software Design,"Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.",N/A,404,404,"Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.",Open,N/A,N/A,1037,Not_Computer,N/A,N/A,N/A
Z-0063-2008,44724,Oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(K),"Medtronic Export XT Aspiration Catheter, 6F (US)Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)",Medtronic Export XT ,2,"October 31, 2007", 2007,"Medtronic, Inc.",Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.,DESIGN: Labeling Design,"Medtronic has notifed sales representatives to visit Cath lab site with the letter dated August 29, 2007 and educate the user, provide the Safety Alert Letter and document delivery of the letter with the confirmation form.",Contact the recalling firm for information,13940,"13,940 units","Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.",Terminated,"September 08, 2008",313,13940,Not_Computer,N/A,N/A,N/A
Z-0065-2008,44881,"Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)",LOM,N/A,N/A,Microbiology,PMA,"Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.",MONOLISA,3,"October 31, 2007", 2007,Bio-Rad Laboratories,Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.,PRODUCTION CONTROLS: Error in Labeling,"On 9/5/07 a letter titled ""IMPORTANT PRODUCT INFORMATION"" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled ""URGENT PRODUCT CORRECTION"" and supplied a corrected package insert to replace the original insert sent.",N/A,46,46,"Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.",Terminated,"November 15, 2007",15,46,Not_Computer,N/A,N/A,N/A
Z-0076-2008,44825,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.",Biomet Orthopedics DCM AGC Molded Tibial Component,2,"October 31, 2007", 2007,"Biomet, Inc.",Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.,DESIGN: Component Design/Selection,The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.,N/A,4,4,"Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.",Terminated,"July 24, 2008",267,5,Not_Computer,N/A,N/A,N/A
Z-0078-2008,44915,"Separator, Automated, Blood Cell And Plasma, Therapeutic",LKN,N/A,N/A,Gastroenterology/Urology,510(K),"Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.",Spectra Optia ,2,"October 31, 2007", 2007,"Gambro BCT, Inc.","Under specific conditions, apheresis machine could return up to 60mL of air to the patient.",DESIGN: Software Design,All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.,N/A,15,15 units,"US, Canada, Australia, Europe.",Terminated,"January 25, 2008",86,15,Not_Computer,N/A,N/A,N/A
Z-0105-2008,44929,"Lithotriptor, Biliary Mechanical",LQC,Mechanical lithotriptor.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.",Olympus Single Use Mechanical Lithotriptor,3,"October 31, 2007", 2007,Olympus America Inc.,Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath,PRODUCTION CONTROLS: Process Control,The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.,N/A,91,91 units,Nationwide,Terminated,"February 15, 2008",107,482,Not_Computer,N/A,N/A,N/A
Z-0109-2008,44939,"Catheter, Continuous Flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific-Renegade Hi-Flo Microcatheter Kit,UPN Material Number: MOO1183030,Catalog Number: 18-303",Boston ScientificRenegade HiFlo Microcatheter Kit,3,"October 31, 2007", 2007,Boston Scientific Corporation,Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.,PRODUCTION CONTROLS: Packaging Process Control,"Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the useof the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form.",N/A,153,153,Nationwide,Terminated,"December 20, 2007",50,153,Not_Computer,N/A,N/A,N/A
Z-0080-2008,38775,"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm;Hydroxylapatite coated;Titanium Plasma Spray;Howmedica Osteonics Corp.,ReUnion,2,"November 01, 2007", 2007,Stryker Howmedica Osteonics Corp.,The plasma spray may delaminate from the proximal portion of the humeral stem.,PRODUCTION CONTROLS: Process Control,"Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.",N/A,232,232 units,One hospital in Akron OH and 12 Stryker branches/agencies,Terminated,"March 07, 2008",127,232,Not_Computer,N/A,N/A,N/A
Z-0001-2008,38473,Full-Montage Standard Electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(K),"Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.",Ceegraph/Sleepscan Netlink with Video,2,"November 03, 2007", 2007,Bio-Logic Systems Corp,Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.,DESIGN: Device Design,"Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it to break. As a precaution to ensure customer safety, the accounts were instructed to place the enclosed red sticker on the pole, below the tightening knob. An Instruction sheet is enclosed . The warning label reads: ""Caution: Do not use as a handle to move cart. Always lower camera when transporting. Avoid sudden stops or collisions."" The accounts were requested to complete and return an enclosed reply sheet acknowledging the receipt of the letter and the placement of the warning labels on the poles. Any questions were directed to Customer Support at 1-800-332-3114.",N/A,311,311 units,"Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia",Terminated,"August 12, 2009",648,311,Not_Computer,N/A,N/A,N/A
Z-0064-2008,39416,"Enzyme Immunoassay, Digoxin",KXT,Digoxin test system.,Toxicology,Toxicology,510(K),"Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.",AxSYM Digoxin III Reagent Pack ,2,"November 03, 2007", 2007,"Abbott Diagnostic International, Ltd.","Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.",DESIGN: Labeling Design,"Abbott Diagnostics International Limited, Ltd., mailed a Product Correction Letter to customers on 7/20/02 advising an additional option(s) has been identified to resolve Error Codes: - Perform one of the two options to resolve these error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay. - Dilute the sample one to one (1 part sample plus 1 part Calibrator A) and repeat analysis. - The final concentration is equal to the reported concentration of the sample multiplied by the dilution factor - The minimum final concentration that may be reported out is 0.6 ng/mL, which corresponds to the sensitivity of the AxSYM Digoxin III assay (0.3 ng/mL) multiplied by the dilution factor (2). OR- Centrifuge the sample at 8,000 to 10,000 RCF for 10 minutes and repeat analysis.",N/A,3104,"3,104","Worldwide Distribution -- USA including States of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NY, NC, OH, OK, OR, PA, SD, SC, TN, TX, UT, VA, VT, WA, WI, WY, HI, Puerto Rico, and countries of Canada, Venezuela, Uruguay, Germany, Hong Kong, South Korea, Australia, and New Zealand",Open,N/A,N/A,3104,Other,N/A,N/A,Other
Z-0133-2008,39354,"Stains, Hematology",KQC,Dye and chemical solution stains.,Hematology,Pathology,510(K) Exempt,"HarlecoMay and Grunwald's Stain;0.17% w/v;Methanol Solution UN1230;EMD Chemicals Inc.An Affilifate of Merck KGaADamstadt, Germany;480 South Democrat Road;Gibbstown, NJ 08027;1 liter and 4 liter poly bottles",May and Grunwald's Stain,3,"November 03, 2007", 2007,EMD Chemicals Inc,Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.,TRAINING: Employee Error,EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.,Contact the recalling firm for information,26,"26 units (1 liter), 1 unit (4 liter)","Product was released to 2 distributors; one in the US, one in Canada",Terminated,"December 26, 2007",53,26,Not_Computer,N/A,N/A,N/A
Z-0081-2008,39422,Electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(K),"Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices.",Medtronic Paceart,3,"November 06, 2007", 2007,Medtronic Inc. Cardiac Rhythm Managment,"An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting",DESIGN: Software Design,A Medtronic letter was sent to consignees on 8/27/07. The letter described the issue and the product involved. It also notified customers that Medtronic is developing a software update that will correct the issue. An Acknowledgement form was attached to be filled by consignees as confirmation and understanding of the information received.,N/A,721,721,Nationwide.,Terminated,"November 03, 2008",363,721,Software,Display/Image,Software update,Software Update
Z-0129-2008,45476,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(K),"Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;",Welch Allyn AED10,1,"November 06, 2007", 2007,"Welch Allyn Protocol, Inc",Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where the serial number is located - upper left hand corner of the back panel of the device. In addition the letter includes a response form, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with a replacement and new five (5) year warranty.",N/A,1176,"1,794 distributed - 1176 in US and 618 internationally",Worldwide.,Open,N/A,N/A,1794,Hardware,Treatment/Delivery/Therapy,Replace device,Remove or Replace
Z-0113-2008,39400,"System, Imaging, Pulsed Echo, Ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(K),"GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.",GE VOLUSON E8 ULTRASOUND SYSTEM,2,"November 07, 2007", 2007,Ge Healthcare,"When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.",DESIGN: Software Design,"GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.",N/A,521,521 Units,Nationwide.,Terminated,"October 21, 2008",349,521,Software,Display/Image,Software update,Software Update
Z-0085-2008,44788,"Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Foundation¶_ Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.",Foundation Hip System Bipolar Modular,2,"November 07, 2007", 2007,"Encore Medical, Lp",Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.",N/A,479,479 units.,"Worldwide, including USA, Greece, Japan, and Saudi Arabia.",Terminated,"January 09, 2008",63,5174,Not_Computer,N/A,N/A,N/A
Z-0114-2008,39409,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.",Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil,2,"November 07, 2007", 2007,"Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK",Packaging weakness may compromise sterility and instructions for use are inadequate.,DESIGN: Packaging Design/Selection,"Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.",N/A,22632,"22,632","Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.",Terminated,"July 14, 2009",615,22632,Not_Computer,N/A,N/A,N/A
Z-0100-2008,44792,Tube Tracheostomy And Tube Cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(K),"Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, SterileRef: 536090",Smiths Portex,2,"November 07, 2007", 2007,"Smiths Medical ASD, Inc.","Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.",PRODUCTION CONTROLS: Process Control,"Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.",N/A,40,40 units,Nationwide.,Open,N/A,N/A,40,Not_Computer,N/A,N/A,N/A
Z-0121-2008,44950,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.,Brilliance CT Big Bore,2,"November 07, 2007", 2007,Philips Medical Systems (Cleveland) Inc,The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.,DESIGN: Software Design,"Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers.",N/A,206,206 systems,"Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Israel, and Lithuania",Open,N/A,N/A,206,Software,Output/Calculation,Remove,Remove or Replace
Z-0144-2008,44957,"Insufflator, Hysteroscopic",HIG,Hysteroscopic insufflator.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT",Storz ,2,"November 07, 2007", 2007,Karl Storz Endoscopy America Inc,Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.,DESIGN: Device Design,"All affected customers were notified via a Customer Letter issued on September 10, 2007 via FedEx overnight mail. The letter describes the problem with the device and the health hazard risk, and provides instructions for users to return the old stand and make arrangements for replacement stands.",N/A,287,287,Nationwide,Open,N/A,N/A,287,Not_Computer,N/A,N/A,N/A
Z-0147-2008,44961,"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.",ARCHITECT cSystem,2,"November 07, 2007", 2007,"Abbott Laboratories, Inc","Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.,N/A,89,89 units.,"Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.",Terminated,"October 04, 2010",1062,2159,Computer,N/A,N/A,N/A
Z-0170-2008,45491,"System, Nuclear Magnetic Resonance Imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(K),"Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China",Signa MFO/I Nuclear Magnetic Resonance Imaging System,2,"November 07, 2007", 2007,GE Healthcare,Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.,DESIGN: Labeling Design,Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006.,N/A,163,163,"Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MO, MS, MT, NJ, NY, OH, OK, PA, SD, VA, and WA, and countries of United Arab Emirats, Argentina, Belgium, Brazil China, Ivery Cost, Germany, Spain, France, United Kingdom, Hungary, Italy, Japan, Korea, Mexico, Oman, Panama, Puerto Rico, Russia, and Turkey",Terminated,"December 11, 2007",34,163,Not_Computer,N/A,N/A,N/A
Z-0075-2008,44813,"Table, Radiologic",KXJ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145,Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain",Suinsa FlexiDT Table ,2,"November 08, 2007", 2007,GE Healthcare,Design Problems Including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potenti,DESIGN: Device Design,"Recalling firm initiated correction by visit on August 2007. Corrections include replacement of one or more of the following: charger board, pin lodging, rear bumper. Also, replace the interface board and remove resistor mounted on chassis, remove brake pedal and assembly of cosmetic brake or apply caution labels.",N/A,96,96,"Class II Recall - Worldwide Distribution --- USA including States of -- AL, CA, FL, GA, IA, IL, IN, LA, ND, NY, OH, PA, TX, and WI, and Countries of -- BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GUAYANA, HONG KONG, HUNGARY, IRELAND, ISRAEL, ITALY, KUWAIT, LATVIA, LEBANON, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.",Terminated,"March 02, 2008",115,96,Hardware,Device Operation,Replace component,Remove or Replace
Z-0213-2008,38376,"System, Simulation, Radiation Therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(K),"Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems",Varian Ximatron CSeries Digital Imaging,2,"November 08, 2007", 2007,Varian Medical Systems Inc,"Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.",DESIGN: Software Design,"The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.",Contact the recalling firm for information,14,14 units,"Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---",Terminated,"February 04, 2008",88,14,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0218-2008,44826,"Set, Administration, Intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(K),"Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.","Texium Closed Male Luer (CML),",2,"November 08, 2007", 2007,Cardinal Health 303 Inc DBA Alaris Products,Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue),CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Recall notification was made via a Safety Alert Notification Letter dated August 30, 2007. Recall will be conducted through consignees (distributors) in the affected countries, as well as, direct customers for the Texium closed male luer. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management, and Director of Pharmacy at each facility. Distributors were sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their sub-account customers. The domestic letters (direct customers and distributors) were mailed on August 30, 2007 to all of the affected accounts. The international notifications will be coordinated out of the offices located in the affected countries. The appropriate international regulatory authorities will be notified of this issue, which will work with the country managers at each location.",N/A,376,"76, 300 units","Worldwide: USA including states of Arkansas, California, Colorado, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New England, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin. and countries of Australia, Canada, Japan and Switzerland",Open,N/A,N/A,76300,Not_Computer,N/A,N/A,N/A
Z-0159-2008,38516,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401316,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520",MEVATRON M2 6300,2,"November 09, 2007", 2007,"Siemens Medical Solutions USA, Inc","Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during ""Service Mode.""",DESIGN: Labeling Design,"Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment.Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during ""Service Mode."".",N/A,6,6 units,"Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia",Open,N/A,N/A,2120,Computer,N/A,N/A,N/A
Z-0119-2008,44880,"Electrode, Ion Specific, Sodium",JGS,Sodium test system.,Clinical Chemistry,Clinical Chemistry,510(K),"OPTI¶_ LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076",OPTI LION EPlus,2,"November 09, 2007", 2007,Opti Medical Systems Inc,"Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.",DESIGN: Device Design,"An Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested.",N/A,289,289 boxes of 25 cassettes,"Worldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela.",Terminated,"December 13, 2007",34,289,Not_Computer,N/A,N/A,N/A
Z-0256-2008,45332,"Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",LIP,Treponema pallidumtreponemal test reagents.,Microbiology,Microbiology,510(K),"BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD",BioPlex 2200 Syphilis IgG Kit ,3,"November 09, 2007", 2007,Bio-Rad Labroatories Inc.,Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive),CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.",N/A,36,36,Nationwide,Terminated,"April 16, 2008",159,36,Not_Computer,N/A,N/A,N/A
Z-0181-2008,37661,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),"GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862",InstaTrak 3500 Plus ,2,"November 10, 2007", 2007,"GE OEC Medical Systems, Inc","Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.",N/A,61,61 units,"Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kong, Italy, Japan, Mexico, and Spain.",Open,N/A,N/A,61,Software,Physical Safety Hazards,Software update,Software Update
Z-0059-2008,39392,"System, X-Ray, Fluoroscopic, Image-Intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)",BV Pulsera,2,"November 10, 2007", 2007,Philips Medical Systems North America Co. Phillips,System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.,DESIGN: Software Design,"On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem.",Contact the recalling firm for information,596,596 units,Nationwide,Terminated,"September 27, 2010",1052,633,Other,Device Operation,Software update,Software Update
Z-0219-2008,37214,"Stretcher, Wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Stryker Medical, Portage, MI 49002","Stryker stretcher, Model 660.",2,"November 10, 2007", 2007,Stryker Medical Div. of Stryker Corporation,"The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.",N/A,81367,"81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.","Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.",Terminated,"October 27, 2010",1082,81367,Not_Computer,N/A,N/A,N/A
Z-0182-2008,44944,"Cleaner, Ultrasonic, Medical Instrument",FLG,Ultrasonic cleaner for medical instruments.,General Hospital,General Hospital,510(K) Exempt,"Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005",Clarisonic Skin Care System,2,"November 16, 2007", 2007,"Pacific Bioscience Lab, Inc.","Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.",DESIGN: Device Design,"On August 30, 2007, the firm issued a press statement via PR Newswire and The Associated Press. They also posted a Recall Notice on their website (www.Clarisonic.com) requesting consumers to return their affected products for an exchange. All retailers and professional resellers were notified by telephone, E mail and/or letter and asked to return unsold inventory, as well as, post the provided point of sales notices and send provided post cards to known customers requesting exchange of recalled product. All users can contact the firm via the website or by phone at 1-866-378-7360 (6 am-6pm, M-F, Pacific Time) to arrange for the device exchange.",N/A,97500,"97,500","Worldwide Distribution - including USA and countries of Japan and Canada. Units were distributed to retailers and professional skin care clinics throughout the USA. In addition, units were distributed to one distributor in Japan and to 4 clinics in Canada.",Open,N/A,N/A,97500,Not_Computer,N/A,N/A,N/A
Z-0217-2008,44962,N/A,N/A,N/A,N/A,N/A,N/A,"Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403",Matrix MAX 3,2,"November 16, 2007", 2007,Skf USA Inc,Sudden failure of the actuator during lifting operation,DESIGN: Labeling Design,"On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later.",N/A,1298,"1,298 units (Z-0215-0217-2008)",Worldwide Distribution-USA and Canada,Open,N/A,N/A,1298,Not_Computer,N/A,N/A,N/A
Z-0214-2008,45106,N/A,N/A,N/A,N/A,N/A,510(K),"Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, GermanyDistributed in the United States by Howmedica Osteonics Corp.; 325 Corporate Drive, Mahwah, NJ 07430",Stryker T2 ,2,"November 16, 2007", 2007,Stryker Howmedica Osteonics Corp.,"Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.",PRODUCTION CONTROLS: Packaging Process Control,"Urgent Product Recall letters were sent on September 27, 2007, to all Stryker Branches/Agencies and hospitals who received the product requesting them to remove and quarantine the product for Stryker pick-up.",N/A,50,50,Nationwide,Terminated,"May 08, 2008",174,50,Not_Computer,N/A,N/A,N/A
Z-0176-2008,38464,"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures",SmartSeal Wedge Femoral Pressuriser,2,"November 17, 2007", 2007,"Depuy Orthopaedics, Inc.","Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.",PRODUCTION CONTROLS: Packaging Process Control,"Sales Force Managers were notified of this recall by an Urgent Information Recall Notice Letter, via email, on 7/13/07 and 7/23/07, to visit their Consignees. Letters for the Hospitals (Dear Materials Manager) and Dear Doctors Letters were provided as background by the Sales Force Managers during their visits. If any product remained in inventory, it should be quarantined immediately, and returned to DePuy. Hospitals should be notified immediately not to use the affected device. Replacement stocks will have a check mark on the bottom right front of package to indicate it has passed inspection.",N/A,3530,"3,530","Nationwide Distribution -- including States of Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, New Mexico, North Carolina, Pennsylvania, South Dakota, Texas, Utah and Washington.",Terminated,"June 23, 2009",584,3530,Not_Computer,N/A,N/A,N/A
Z-0254-2008,44811,"System, Imaging, Pulsed Doppler, Ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(K),"NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA.",NEMIO XG ,3,"November 17, 2007", 2007,Toshiba American Med Sys Inc,"Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.",DESIGN: Device Design,"Urgent Medical Device Notification letters were sent to customers on August 29, 2007. Customers were notified of the several issues related to the Nemio SSA-550A and Nemio SSA-580A recall and asked to share this information with all users of the device. Customers were informed that Toshiba is preparing software and corrected manuals for distribution to address these issues. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department.",N/A,128,128 units,Nationwide,Open,N/A,N/A,1406,Computer,N/A,N/A,N/A
Z-0174-2008,37879,"Vehicle, Motorized 3-Wheeled",INI,Motorized three-wheeled vehicle.,Physical Medicine,Physical Medicine,510(K),"Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F. Electronic Mobility Corporation, 599 Mantua Blvd, One Mobility Plaza, Sewell, NJ 08080",Rascal Scooter/Powerchair Motorized Vehicles,2,"November 21, 2007", 2007,Electric Mobility Corp,"Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consumers were sent an Urgent Medical Device Recall Notification on October 12, 2007, requesting that they immediately respond to the Medical Device Recall by calling EMC at 1-800-814-4365, or by returning an enclosed Recall Response Form, or by responding on-line at www.EMCIT.NET/801B. The Notification address three important safety issues on 1) Seat Lift Actuator Mast Screws and Washers; 2) Seat Lift Actuator or Seat Post Mounting Bolts and; 3) Incorrect Seat-On Lift Bracket Installation. Corrections to the devices will be made by the nearest Service Representatives, by scheduled in-home repairs, or return of the rear section of the scooter with EMC providing shipping material and freight payment.",Contact the recalling firm for information,12625,"12,625",Nationwide,Open,N/A,N/A,12625,Not_Computer,N/A,N/A,N/A
Z-0175-2008,37880,"Vehicle, Motorized 3-Wheeled",INI,Motorized three-wheeled vehicle.,Physical Medicine,Physical Medicine,510(K),"Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Electric Mobility Corporation (EMC), Sewell, New Jersey 08080",Rascal Scooter,2,"November 21, 2007", 2007,Electric Mobility Corp,"Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped w",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consumers were sent an Urgent Medical Device Recall Notification on October 12, 2007, requesting that they immediately respond to the Medical Device Recall by calling EMC at 1-800-814-4365, or by returning an enclosed Recall Response Form, or by responding on-line at www.EMCIT.NET/801B. The Notification address three important safety issues on 1) Seat Lift Actuator Mast Screws and Washers; 2) Seat Lift Actuator or Seat Post Mounting Bolts and; 3) Incorrect Seat-On Lift Bracket Installation. Corrections to the devices will be made by the nearest Service Representatives, by scheduled in-home repairs, or return of the rear section of the scooter with EMC providing shipping material and freight payment.",Contact the recalling firm for information,1756,"1,756",Nationwide: to consumers via direct purchase from Electric Mobility Corporation.,Open,N/A,N/A,1756,Not_Computer,N/A,N/A,N/A
Z-0180-2008,38276,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"Philips, Voxel Q workstations, untilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Philips Medical Systems, Cleveland, OH 44143","VoxelQ Workstation, Imaging Workstation",2,"November 21, 2007", 2007,Philips Medical Systems (Cleveland) Inc,"Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utlizing AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 when computing absolute patient marking coordinates with data containing reconstruction offsets from the Mx800, the Mx8001DT, and the Brilliance 6, 10, 16, 16P, and Big Bore CT systems. Whe",DESIGN: Software Design,"On November 1, 2007, after telcon with FDA, the firm revised its recall strategy to notify consignees via a November 9, 2007, Urgent Device Notification letter which indicates that warning labels will be affixed to the units that alerts the user of the reconstruction offset defect by Philips employees.",N/A,520,520 Devices,"Worldwide Distribution- USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and WY and Canada",Open,N/A,N/A,520,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-0245-2008,44894,"Visual, Pregnancy Hcg, Prescription Use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA",Clearview hCG Combo ,2,"November 21, 2007", 2007,Applied Biotech Inc,"Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.",DESIGN: Process Design,"A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product.",N/A,3238,"3,238 Kits (97,140 tests)",Worldwide: USA and Canada,Open,N/A,N/A,3638,Not_Computer,N/A,N/A,N/A
Z-0212-2008,45486,Ventricular (Assisst) Bypass,DSQ,N/A,N/A,Cardiovascular,PMA,"Thoratec Implantable Ventricular Assist Device (IVAD pump)(Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588",Thoratec Implantable Ventricular Assist Device (IVAD),1,"November 21, 2007", 2007,Thoratec Corp,Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).,DESIGN: Device Design,"An initial communication was sent to all affected IVAD customers on October 19, 2007, in the form of an ""Urgent: Medical Device Correction"" notice informing them of the problem. The correction notice requests that its customers/physicians take the following actions:1) Contact all ongoing patients with IVADs placed in the paracorporeal position toevaluate the percutaneous line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles. 2) Remind implanting surgeons and support staff of proper percutaneous line management and provide the patient with a copy of the recall information provided. Complete and sign an Acknowledgement form and fax it to Thoratec Regulatory Affairs. This is a User Level Recall. The firm also issued a November 7, 2007, Press Statement- Urgent Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device.",N/A,766,766,"Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Canada, France, Netherlands, Singapore, Switzerland, and The United Kingdom",Terminated,"May 26, 2009",552,766,Not_Computer,N/A,N/A,N/A
Z-0260-2008,38445,"Catheter, Percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA",Boston Scientific Guider Softip XF Guiding Catheter,3,"November 24, 2007", 2007,Boston Scientific Target,Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter),PRODUCTION CONTROLS: Labeling Mix-Ups,Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.,Contact the recalling firm for information,49,49 units,"Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.",Terminated,"December 05, 2007",11,96,Not_Computer,N/A,N/A,N/A
Z-0255-2008,45327,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582",Biomet Interlok 67 mm Fixed Cruciate Tibial Plate,2,"November 24, 2007", 2007,"Biomet, Inc.",Mislabeled as to size: the package actaully contained a 71 mm tray.,PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.,N/A,7,7,"Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.",Terminated,"June 04, 2008",193,7,Not_Computer,N/A,N/A,N/A
Z-0257-2008,45429,"Calculator/Data Processing Module, For Clinical Use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064",ACCELERATOR APS System,2,"November 24, 2007", 2007,"Abbott Laboratories, Inc","Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie",DESIGN: Software Design,Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.,N/A,1,1 unit.,Nationwide: including state of UT.,Terminated,"March 10, 2008",107,1,Software,Device Operation,Software update,Software Update
Z-0262-2008,45464,"Computer, Diagnostic, Pre-Programmed, Single-Function",DXG,"Single-function, preprogrammed diagnostic computer.",Cardiovascular,Cardiovascular,510(K),"Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614",Edwards Vigilance II Monitor,2,"November 24, 2007", 2007,"Edwards Lifesciences, Llc","MAP offset errors: If users are ""slaving"" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR,",DESIGN: Software Design,"An Urgent Customer notification letter dated May 17, 2007 was mailed to all Vigilance II customers advising that If they are ""slaving"" mean arterial pressure (MAP) from their bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), to be aware that at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25 mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, these may also not be accurate. A table is provided showing those bedside monitors with the problem: GE Solar, Phillips (HP) M1006A, M1006B, as well as, those bedside monitors verified to not have the problem: SpaceLabs Model 90402 and Nihon Kohden Model BSM 8000. The letter also serves to remind the customer of the Warning in the Vigilance II Directions for Use which is also provided in the letter that instructs user to verify slaved MAP values with those displayed on bedside monitor. A temporary work around for this offset problem is to manually enter the MAP based on the readings from the bedside monitor. All Vigilance II calculations from the MAP have been re-verified to be correct when the MAP is accurate. The problem is in the transfer of the MAP between the bedside monitor and the Vigilance II. Customers are also advised that if they have the GE Solar or the Phillips (HP) models listed in the letter or any monitor not listed as verified to be compatible with the Vigilance II (Space labs and Nihon Kohden models listed above) Edwards recommends verification of MAP accuracy prior to treating based on parameters from a Vigilance II in a ""slave"" configuration. If there is a difference, they should enter the MAP into the Vigilance II manually for a static calculation of SVR. Edwards will be supplying a software update to correct this problem.",N/A,2680,"2,680 units in North America distribution",Worldwide: USA and Canada,Terminated,"October 09, 2009",685,2680,Software,Output/Calculation,Software update,Software Update
Z-0263-2008,45489,"Syringe, Piston",FMF,Piston syringe.,General Hospital,General Hospital,510(K),"Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015",Baxter Duploject Easy Prep,2,"November 24, 2007", 2007,Baxter Bioscience,Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.,PRODUCTION CONTROLS: Packaging Process Control,"An Urgent Product Recall Letter dated October 24, 2007, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (Director of Materials Management, and Director of Risk Management). The recall letter requests sub recalls to the retail level and product quarantine and return. The recall notification letters were sent via commercial carrier (UPS Next Day Service).",N/A,4782,"4,782 units (6 units/case)","Worldwide-USA, Canada and European Union (France and UK)",Terminated,"March 13, 2009",475,4782,Not_Computer,N/A,N/A,N/A
Z-0264-2008,45539,"Filter, Intravascular, Cardiovascular",DTK,Cardiovascular intravascular filter.,Cardiovascular,Cardiovascular,510(K),"Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Manufacturer: B. Braun Medical 204, avenue du Marechal Juin BP 331 92107 Boulogne Cedex , France. (The VenaTech LP vena cava filter is pre-loaded in a syringe (cartridge) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either via the femoral or jugular approach.)",B. Braun (BIS) VenaTech LP Vena Cava Filter System,2,"November 24, 2007", 2007,B. Braun Interventional Systems,Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.,PRODUCTION CONTROLS: Packaging Process Control,B. Braun sent an Urgent Medical Device Removal letter (10/10/07) by express mail to each of the hospital accounts that received the recalled lot of VenaTech LP. B. Braun sales represenatatives will also contact each account directly to inquire if any inventory of the suspect lot remains and to provide guidance for return and replacement of any existing inventory.,N/A,60,60 units,"Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.",Terminated,"March 02, 2008",99,60,Not_Computer,N/A,N/A,N/A
Z-0053-2008,44793,"Implantable Pulse Generator, Pacemaker (Non-Crt)",LWP,N/A,N/A,Cardiovascular,PMA,"Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 and M179)*. Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. (* models are not available in the USA)",Guidant RENEWAL 3 and 4 RF CRTD,2,"November 24, 2007", 2007,Boston Scientific CRM Corp,"Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product",DESIGN: Device Design,"A Product Update titled ""ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators"", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge time behavior, projected rate of mid-life display of replacement indicators and Patient Management Considerations. ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Update, ""Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled.""*****Recalled units only cover devices implanted prior to July 2005****.",N/A,83,"83 within USA, 580 Foreign-Recalled units only cover devices implanted prior to July 2005",Worldwide,Terminated,"November 23, 2007",-1,83,Not_Computer,N/A,N/A,N/A
Z-0291-2008,45526,"Driver, Prosthesis",HWR,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855",Pioneer Quantum Spinal Rod System,2,"November 27, 2007", 2007,Pioneer Surgical Technology,"The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm.,N/A,38,38,"Nationwide: including states of California, Florida, Michigan and North Carolina.",Terminated,"March 31, 2008",125,38,Not_Computer,N/A,N/A,N/A
Z-0294-2008,45492,N/A,N/A,N/A,N/A,N/A,510(K),"Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460(software version 3.0)",Medtronic 0arm Imaging System,2,"November 27, 2007", 2007,"Medtronic Navigation, Inc","Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.",N/A,7,7 units,"Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany",Terminated,"November 27, 2007",0,7,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0290-2008,45462,"Driver, Prosthesis",HWR,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002",Odyssey Femoral Holder/Driver,2,"November 27, 2007", 2007,Wright Medical Technology Inc,Breakage: breaking of the connecting foot that is on the distal surface of the instrument,DESIGN: Device Design,"The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter.",N/A,66,66 units,Worldwide-USA and Australia,Terminated,"July 22, 2009",603,66,Not_Computer,N/A,N/A,N/A
Z-0293-2008,45567,Solid State X-Ray Imager (Flat Panel/Digital Imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(K),"Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780",Digital Radiography System with Flat Panel Detector,2,"November 27, 2007", 2007,Toshiba American Med Sys Inc,"System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.",DESIGN: Software Design,"Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.",N/A,23,23,"Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV",Open,N/A,N/A,23,Software,Device Operation,Software update,Software Update
Z-0296-2008,45529,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.",Xoran MiniCAT for ENT.,2,"November 27, 2007", 2007,"Xoran Technologies, Inc.","The hard drive may crash, resulting in loss of data from patient CT scans.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.,N/A,5,5,"Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.",Terminated,"March 13, 2008",107,5,Other,Device Operation,Replace,Remove or Replace
Z-0171-2008,37912,"Stimulator, Autonomic Nerve, Implanted For Epilepsy",LYJ,N/A,N/A,Neurology,PMA,"Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.",VNS System Leads,2,"November 28, 2007", 2007,"Cyberonics, Inc",Dissolution/Fractures to the leads of the VNS Therapy System,PRODUCTION CONTROLS: Process Control,"Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.",N/A,21419,"21,419 units.","Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.",Terminated,"October 05, 2009",677,56189,Not_Computer,N/A,N/A,N/A
Z-0179-2008,45436,"Catheter, Biliary, Diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K),"Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614",Edwards LifeStent FlexStar selfexpanding bilary stent system,2,"November 28, 2007", 2007,"Edwards Lifesciences, Llc",Failure to deploy.,PRODUCTION CONTROLS: Process Control,"This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.",N/A,12,12 units,"Nationwide including states of OK, GA, CA WI, MO, and LA",Open,N/A,N/A,12,Not_Computer,N/A,N/A,N/A
Z-0177-2008,44926,Oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(K),Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical,Oridion Capnostream20 ,2,"November 28, 2007", 2007,Oridion Capnography Inc,"Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.",DESIGN: Process Design,"Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.",N/A,21,21,"Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,",Terminated,"September 08, 2008",285,27,Not_Computer,N/A,N/A,N/A
Z-0265-2008,45514,"System, Image Processing, Radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(K),"GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188",GE Healthcare Advantage Workstations,2,"November 28, 2007", 2007,GE Healthcare,Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should NOT BE USED.,DESIGN: Software Design,"An Urgent Safety Notice to customers dated 9/10/07, was issued by the recalling firm informing them of the device defect, safety issues, warnings on future uses and promised new software updates to be installed by GE representatives, free of charge, beginning Nov. 2007.",Contact the recalling firm for information,2518,"2,518","Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, CU, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Guam, and countries of Canada, Mexico. Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Australia, China, Honk Kong, Indonesia, Japan, Korea, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Albania, Austria, Azerbaijan, Bosnia, Belgium, Belarus, Switzerland, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Guadeloupe, Greece, Hungary , Ireland, Israel, Italy, Kuwait, Lebanon, Morocco, Netherlands, Norway, French Polynesia, Poland, Portugal, Russian Federation, Saudi Arabia, Sweden, Slovenia, Tunisia, Turkey, and South Africa.",Open,N/A,N/A,2518,Software,Output/Calculation,Software update,Software Update
Z-0275-2008,45326,"Prosthesis, Hip, Femoral, Resurfacing",KXA,Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.,Orthopedic,Orthopedic,510(K),"Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.",Zimmer Durom ,2,"November 29, 2007", 2007,Zimmer Inc.,Mislabeled as to size; 54mm package contains 46 mm device and vice versa.,PRODUCTION CONTROLS: Packaging Process Control,"Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.",N/A,1,1,Nationwide,Terminated,"June 04, 2008",188,6,Not_Computer,N/A,N/A,N/A
Z-0270-2008,45154,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534",ECAT ART,2,"November 29, 2007", 2007,Siemens Medical Solutions USA Inc,"Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.",DESIGN: Software Design,"Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.",N/A,43,43 units,"Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.",Terminated,"September 11, 2009",652,446,Computer,N/A,N/A,N/A
Z-0268-2008,45515,Forceps,HTD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Pilling¶_ Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA",Pilling CenterAction Forceps ,2,"November 29, 2007", 2007,Telefelx Medical,"The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by an Urgent Medical Device Recall letter on/about 11/1/2007. They were instructed to immediately cease use and distribution of the affected product and to return them to Teleflex Medical, Durham, NC. In addition, each were instructed to forward the letter if they had further distribution into institutional settings or to homecare patients and retrieve relevant product form those locations. An Acknowledgement & Stock Status Form was enclosed to be completed and faxed back to Teleflex Medical.",N/A,113,113,"Worldwide: USA including states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, NV, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, France New Zealand and Singapore.",Terminated,"August 31, 2009",641,235,Not_Computer,N/A,N/A,N/A
Z-0380-2008,38345,"Accelerator, Linear, Medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520",Mevatron M2/PRIMUS Plus,2,"December 01, 2007", 2007,"Siemens Medical Solutions USA, Inc",Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.,DESIGN: Device Design,"The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.",N/A,64,64 units,"Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.",Open,N/A,N/A,258,Not_Computer,N/A,N/A,N/A
Z-0321-2008,38466,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103",Terumo Advanced Perfusion System 1,2,"December 01, 2007", 2007,Terumo Cardiovascular Systems Corp,"Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.",PRODUCTION CONTROLS: Process Control,"Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards.",N/A,16,16,"Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong and United Arab Emirates.",Terminated,"February 23, 2008",84,92,Hardware,Device Operation,Replace board,Remove or Replace
Z-0323-2008,38467,"Console, Heart-Lung Machine, Cardiopulmonary Bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(K),"Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103",Terumo APS 1,2,"December 01, 2007", 2007,Terumo Cardiovascular Systems Corp,"Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.",N/A,120,120,Nationwide.,Terminated,"July 07, 2009",584,120,Hardware,Device Operation,Replace board,Remove or Replace
Z-0261-2008,45402,"Lift, Patient, Non-Ac-Powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden","ARJO, Carendo MultiPurpose Hygiene Chair",2,"December 01, 2007", 2007,"Arjo, Inc.",Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.,DESIGN: Device Design,"Arjo sent Customer Field Correction Notification letters dated 10/15/07 to the end user accounts who received the affected chairs, advising them of the potential for the pinching of male patient genitals between moving parts of the care raiser function of the Carendo Hygiene Chair. They were instructed to review the enclosed revised Operating and Product Care Instructions manual, highlighting the warnings on pages 18 and 20; ensure all users receive refresher training in the chair's proper use and have access to the revised manual; and complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter. Any questions were directed to the Arjo Quality Department at 800-323-1245, ext. 6140 or 6165.",N/A,1342,"1,342 hygiene chairs",Nationwide,Terminated,"July 27, 2009",604,1342,Not_Computer,N/A,N/A,N/A
Z-0278-2008,45420,"Implant, Endosseous, Orthodontic",OAT,Endosseous dental implant.,Dental,Dental,510(K),"Straumann Palatal Implant , 4.8 L 4.2 mm,Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008",Straumann Palatal Implant ,2,"December 04, 2007", 2007,Straumann USA LLC,Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.,DESIGN: Device Design,"Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.",N/A,32,32 units,"Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.",Terminated,"April 16, 2010",864,90,Not_Computer,N/A,N/A,N/A
Z-0122-2008,38310,"Wire, Guide, Catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538",Transend EX ,3,"December 05, 2007", 2007,Boston Scientific Target,Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.,PRODUCTION CONTROLS: Process Control,"Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.",Contact the recalling firm for information,40,40,Nationwide.,Terminated,"December 21, 2007",16,40,Not_Computer,N/A,N/A,N/A
Z-0123-2008,44814,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581",Biomet Orthopedics Vanguard PS Open Box Femoral,2,"December 05, 2007", 2007,"Biomet, Inc.","Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.",PRODUCTION CONTROLS: Packaging Process Control,"Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.",N/A,16,16,Nationwide.,Terminated,"June 04, 2008",182,16,Not_Computer,N/A,N/A,N/A
Z-0385-2008,44893,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing",NJL,N/A,N/A,Orthopedic,510(K),"Depuy P.F.C. ¶_ E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430.",Depuy P.F.C. E Knee System,2,"December 06, 2007", 2007,"Depuy Orthopaedics, Inc.","An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.",PRODUCTION CONTROLS: Packaging Process Control,Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.,N/A,10,10,Nationwide.,Terminated,"April 30, 2008",146,1160,Not_Computer,N/A,N/A,N/A
Z-0279-2008,45432,"Catheter, Intravascular, Diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(K),"Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland",Boston Scientific Imager II Angiographic Catheter,3,"December 06, 2007", 2007,Boston Scientific Corporation,Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.,PRODUCTION CONTROLS: Packaging Process Control,Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.,N/A,14,14 boxes each containing 5 Units,"USA only including states of NJ, CA,TX,AZ",Terminated,"December 19, 2007",13,14,Not_Computer,N/A,N/A,N/A
Z-0328-2008,38471,"Introducer, Catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760", ACCUSTICK II,2,"December 07, 2007", 2007,Boston Scientific Corp,"Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.",N/A,"Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.",N/A,249,249 (199 U.S.A. plus 50 international),Worldwide: USA and The Netherlands.,Open,N/A,N/A,249,Not_Computer,N/A,N/A,N/A
Z-0330-2008,44959,"System, X-Ray, Angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(K),"Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021",Allura Xper FD20/10,2,"December 07, 2007", 2007,Philips Medical Systems North America Co. Phillips,Inaccurate anatomical measurements when using the optional SmartMask feature,DESIGN: Device Design,"The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.",N/A,53,53 units,Nationwide,Open,N/A,N/A,521,Computer,N/A,N/A,N/A
Z-0331-2008,44963,N/A,N/A,N/A,N/A,N/A,510(K),"Axya Bone Anchor , 3.0 mm Titanium with Nylon SutureCatalog Number: CAT1226, Axya Medical, Inc., Beverly, MA 01915",Axya,2,"December 08, 2007", 2007,Axya Medical,Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging,DESIGN: Packaging Design/Selection,"Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.",N/A,1008,"1,008 units",Nationwide,Open,N/A,N/A,17956,Not_Computer,N/A,N/A,N/A
Z-0358-2008,45427,"Apparatus, Autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(K),"Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)",Haemonetics cardioPAT System,2,"December 08, 2007", 2007,Haemonetics Corporation,Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest,MISBRANDING: Labeling False and Misleading,"Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.",Contact the recalling firm for information,106,106 units,"Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA",Open,N/A,N/A,106,Not_Computer,N/A,N/A,N/A
Z-0361-2008,45480,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121",VKS PE,2,"December 08, 2007", 2007,Plus Orthopedics USA,"Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.",TRAINING: Employee Error,Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.,N/A,10,10,"Nationwide: USA including states of ID, NY, VA & WI",Terminated,"December 13, 2007",5,10,Not_Computer,N/A,N/A,N/A
Z-0360-2008,45475,"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(K),"Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121",Gliding Nail,2,"December 08, 2007", 2007,Plus Orthopedics USA,The device was produced without the required distal locking hole,PRODUCTION CONTROLS: Reprocessing Controls,"The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.",N/A,3,3,Nationwide: AZ and ID,Terminated,"December 13, 2007",5,3,Not_Computer,N/A,N/A,N/A
Z-0359-2008,45465,"Injector And Syringe, Angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(K),"ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)",ACIST MultiUse Syringe KitModel A2000,2,"December 08, 2007", 2007,Acist Medical Systems,"Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.",DESIGN: Process Design,"The Urgent Medical Device Recall letter was sent by certified mail to all U.S. base customers on 10/3,4/07. Customers were advised to stop distribution of the product and immediately cease use of the product. Recalled product is to be returned using the FedEx Airbill that was enclosed with the recall letter. Customers were to complete the enclosed ""Device Recall Response"" form even if they did not have any impacted kits in inventory.",N/A,177050,"177,050 Kits","Nationwide Distribution - including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.",Terminated,"October 06, 2008",303,177050,Not_Computer,N/A,N/A,N/A
Z-0357-2008,45445,"Bed, Ac-Powered Adjustable Hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002",Stryker inTouch Zoom Critical Care ,2,"December 08, 2007", 2007,Stryker Medical Div. of Stryker Corporation,"Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re",PRODUCTION CONTROLS: Process Control,"Consignees were notified via an Urgent Medical Device Correction letter dated 11/2/07, and instructed to remove the beds from service if they display any unintended motions and informed that one of the firm's field service representatives will visit the facility to make corrections to all beds under recall.",N/A,329,329 units total for both models.,Worldwide-USA and Canada,Terminated,"October 27, 2010",1054,329,Not_Computer,N/A,N/A,N/A
Z-0362-2008,45484,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics",VKS Tibial Trial ,2,"December 08, 2007", 2007,Plus Orthopedics USA,"The VKS ""Tibial Trial"" was found to have an incorrect fixation pin hole diameter.",PRODUCTION CONTROLS: Process Control,The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used.,N/A,19,19,"Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA",Terminated,"December 13, 2007",5,19,Not_Computer,N/A,N/A,N/A
Z-0375-2008,44972,"Electrode, Ion Specific, Sodium",JGS,Sodium test system.,Clinical Chemistry,Clinical Chemistry,510(K),"Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.",iSTAT G Cartridge,2,"December 11, 2007", 2007,Abbott Point of Care Inc.,"Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.",N/A,N/A,N/A,Worldwide Distribution- including USA and country of Canada.,Terminated,"July 18, 2008",220,N/A,Not_Computer,N/A,N/A,N/A
Z-0441-2008,45456,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented",LWJ,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034",Excia Cemented Hip Stems ,2,"December 11, 2007", 2007,Aesculap Implant Systems,Sterility (package integrity) Compromised: Device package damaged during shipment,DESIGN: Packaging Design/Selection,The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.,N/A,167,167 units,"Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.",Terminated,"February 07, 2008",58,167,Not_Computer,N/A,N/A,N/A
Z-0363-2008,45523,"Orthosis, Spinal Pedicle Fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(K),"Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.",Ascent POCTS (Posterior Occipital Cervical Thoracic System) ,2,"December 11, 2007", 2007,"Blackstone Medical, Inc.","Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock.",Contact the recalling firm for information,319,"319 screws ( 212 domestic, 107 international)","Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.",Terminated,"June 06, 2008",178,319,Not_Computer,N/A,N/A,N/A
Z-0292-2008,45817,"Injector And Syringe, Angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,N/A,"Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051",Medrad Avanta MultiPatient Disposable Hand Controller,2,"December 11, 2007", 2007,Medrad Inc,Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised,PRODUCTION CONTROLS: Packaging Process Control,"The recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.",N/A,1002,"25, 977 units","Worldwide-USA and countries of Germany, Israel, Finalnd, Italy, Netherland, Austria, France, Japan, Denmark, Ireland, South Africia, Australia, Saudi Arabia, Singapore, Canada, New Zealand, Spain, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.",Terminated,"April 22, 2008",133,25997,Not_Computer,N/A,N/A,N/A
Z-0449-2008,45540,"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon MIS Femoral Adjustment Block;Catalog Number: 6541-5-601;Stryker Orthopaedics, Mahwah, New Jersey",Triathlon MIS Femoral Adjustment Block,2,"December 11, 2007", 2007,Stryker Howmedica Osteonics Corp.,Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.,DESIGN: Device Design,"Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.",N/A,2868,"2,868 units total for Recalls Z-0448-0450-2008","Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.",Terminated,"January 18, 2008",38,2868,Not_Computer,N/A,N/A,N/A
Z-0054-2008,45525,Condom,HIS,Condom.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(K),"Lubricated Latex Condom. Labeled in part: ""COMING TOGETHER IN DC"", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA",Global Protection Corp,2,"December 11, 2007", 2007,Global Protection Corp.,Condoms fail the water leak test and package integrity,PRODUCTION CONTROLS: Environmental Control,Global Protection Corp. recalled product by email on 9/11/07.,N/A,12700,"127,00 condoms",The District of Columbia Health Department,Terminated,"March 18, 2008",98,12700,Not_Computer,N/A,N/A,N/A
Z-0451-2008,45843,"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(K),"Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810",Philips Medical Systems IntelliVue Information Center,2,"December 11, 2007", 2007,Philips Medical Systems,"Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor ""off "" and then ""on"" in order to reset the system-Customer Care Contact telephone 1-800-722-9377).",N/A,60,60 units,"Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.",Open,N/A,N/A,60,Software,Alarm/Message,Software update,Software Update
Z-0452-2008,45867,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.",Electrosurgery Accessory Electrodes,2,"December 11, 2007", 2007,ConMed Electrosurgery,Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal,DESIGN: Process Design,"Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.",N/A,11319,"11,319 cases (476,160 units)","Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.",Terminated,"March 31, 2010",841,11319,Not_Computer,N/A,N/A,N/A
Z-0454-2008,45887,"Needle, Ophthalmic Suturing",HNM,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452",BD Visitec Nucleus Hydrodissector,2,"December 11, 2007", 2007,Becton Dickinson and Company,No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow,PRODUCTION CONTROLS: Process Control,The recalling firm notified consignees of the recall through a Voluntary Medical Device Recall letter and phone call on 11/20/2007. Instructions for product return were provided and a telephone number for questions was given (Customer Service 1-866-906-8080 Option 2).,N/A,43000,"43,000","Nationwide-USA including the states of CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MO, NC, NJ, NY, OH, PA, SC, TN, VA, and WA",Open,N/A,N/A,83450,Not_Computer,N/A,N/A,N/A
Z-0364-2008,38346,"System,Planning,Radiation Therapy Treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(K),"Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.",CyberKnife Robotic Radiosurgery System,2,"December 12, 2007", 2007,Accuray Inc,"Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.",DESIGN: Software Design,"The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com.",N/A,25,25 units,"Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.",Terminated,"December 26, 2007",14,25,Software,Display/Image,Software update,Software Update
Z-0459-2008,38897,"Analyzer, Chemistry, Micro, For Clinical Use",JJF,Micro chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732",Roche LightCycler,2,"December 12, 2007", 2007,Roche Diagnostics Corp.,False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by Urgent Medical Device Recall letter dated 8/30/07, to discontinue use of the 100uL capillaries, plus all of those received at installation, and to disposed of them per local guidelines.",N/A,119,119 boxes of 96 capillaries each,Nationwide,Terminated,"September 08, 2008",271,119,Not_Computer,N/A,N/A,N/A
Z-0074-2008,44787,"Appliance, Fixation, Spinal Interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(K),"Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131",TSRH SiLo 5.5 Spinal System,2,"December 13, 2007", 2007,Medtronic Sofamor Danek USA Inc,Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.,DESIGN: Device Design,"Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.",N/A,20,20 units,"Worldwide Distribution - USA, The Netherlands, Australia, and Canada.",Terminated,"August 21, 2009",617,20,Not_Computer,N/A,N/A,N/A
Z-0241-2008,38307,"System, Radiation Therapy, Charged-Particle, Medical",LHN,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA",Allegro 6800 Imaging table.,2,"December 13, 2007", 2007,Mizuho Orthopedic Systems Inc,"Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.",DESIGN: Software Design,The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.,N/A,117,117 units,"Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.",Terminated,"December 18, 2008",371,343,Not_Computer,N/A,N/A,N/A
Z-0458-2008,45483,"Glucose Oxidase, Glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)",Advance Microdraw Blood Glucose Monitoring System,3,"December 13, 2007", 2007,ARKRAY USA INC.,"Mis-labeled/coded strips : Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the ""867"" test strips, so the meter will function properly and give accurat",PRODUCTION CONTROLS: Process Control,"Distributors were sent a letter on 10/18/07 asking that product be quarantined. On 10/26/07, an Urgent Voluntary Medical Device Recall letter was sent asking that they return affected product and contact their customers to the retail level.",N/A,2005,"2,005 Kits","Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.",Terminated,"March 02, 2008",80,2005,Not_Computer,N/A,N/A,N/A
Z-0463-2008,45334,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(K),"Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair",Hipstar V40 Femoral Stem ,2,"December 14, 2007", 2007,Stryker Howmedica Osteonics Corp.,"Mis-labeled: The warning label ""Do not use with heads more than +10mm offset"" does not appear on 127 degree stem boxes.",PRODUCTION CONTROLS: Packaging Process Control,"Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.",N/A,59,59,"Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA",Terminated,"October 27, 2008",318,910,Not_Computer,N/A,N/A,N/A
Z-0475-2008,45982,"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.",Hipstar TMZF ,2,"December 14, 2007", 2007,Stryker Howmedica Osteonics Corp.,"Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.",PRODUCTION CONTROLS: Packaging Process Control,"Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.",N/A,192,192 protocols,"Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.",Terminated,"September 05, 2008",266,192,Not_Computer,N/A,N/A,N/A
Z-0132-2008,38381,"Electrosurgical, Cutting & Coagulation & Accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K),"VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138",VNUS ClosureFAST ,2,"December 15, 2007", 2007,VNUS Medical Technologies Inc,Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.,DESIGN: Packaging Design/Selection,The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.,N/A,92,92 units,"Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.",Terminated,"December 17, 2007",2,92,Not_Computer,N/A,N/A,N/A
Z-0317-2008,38468,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK",Zimmer ,2,"December 15, 2007", 2007,Zimmer Inc.,Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound,PRODUCTION CONTROLS: Process Control,Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.,N/A,62,62 (total for Z-0316-0317-2008),"Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.",Terminated,"March 17, 2008",93,62,Not_Computer,N/A,N/A,N/A
Z-0138-2008,44953,"Prosthesis, Intervertebral Disc",MJO,N/A,N/A,Orthopedic,PMA,"Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA","Prestige Cervical Disc System, Implant Trial",2,"December 19, 2007", 2007,Medtronic Sofamor Danek USA Inc,Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.,DESIGN: Device Design,"The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.",N/A,196,196 units,Nationwide,Terminated,"November 03, 2008",320,196,Not_Computer,N/A,N/A,N/A
Z-0136-2008,44883,"Plate, Fixation, Bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH",DRLock Bone Fixation Plate systems,2,"December 19, 2007", 2007,OrthoHelix Surgical Designs Inc,Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.,N/A,"On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix for replacement.",N/A,267,267 plates/52 DRL System Trays,"Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.",Open,N/A,N/A,267,Not_Computer,N/A,N/A,N/A
Z-0185-2008,44800,"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(K),"Encore¶_ Reverse¶_ Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758.",Encore Reverse Shoulder Prosthesis (RSP) Socket Insert,2,"December 19, 2007", 2007,"Encore Medical, Lp",Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.,PRODUCTION CONTROLS: Packaging Process Control,"Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling firm.",N/A,25,25 units.,"Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.",Terminated,"March 10, 2008",82,49,Not_Computer,N/A,N/A,N/A
Z-0145-2008,44958,"Dna-Probe, Reagents, Streptococcal",MDK,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K),"Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121","Accuprobe Group B Streptococcus Culture Identification Test,",2,"December 19, 2007", 2007,Gen-Probe Inc,Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches,PRODUCTION CONTROLS: Packaging Process Control,"Gen-Probe notified customers by phone on May 2nd and 3rd, 2007; a recall notice letter was faxed to each customer on May 3rd, 2007 and mailed on May 4th, 2007 via certified mail. The letter describes the packaging error and the remote health hazard risk, and provides instructions for users to return all kits of this lot number.",N/A,106,106 kits,"Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT",Terminated,"May 03, 2010",866,106,Not_Computer,N/A,N/A,N/A
Z-0137-2008,44928,"Wheelchair, Mechanical",IOR,Mechanical wheelchair.,Physical Medicine,Physical Medicine,510(K),"Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065",Freedom Designs TriPod w/Anti tipper Manual Wheelchair,2,"December 19, 2007", 2007,Freedom Designs Inc,Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.,PRODUCTION CONTROLS: Process Control,"Urgent Field Correction Notification letters were sent to customers on May 15, 2007 via US Postal return receipt requested. Consignees were notified via delivery of a field correction package consisting of:(1) A letter to the dealer (2) FAQ sheet clarifying their responsibility (3) A corrective/preventive action tracking sheet specific for the consignees affected units(4) Replacements of anti-tipper assembly for each unit shipped with an instruction sheet.A Notice was also posted on the Freedom Designs website.Correction will be made to the consumer level.",N/A,41,41 units,"Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA",Terminated,"July 14, 2008",208,41,Not_Computer,N/A,N/A,N/A
Z-0304-2008,44913,"System, Tomography, Computed, Emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(K),"c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark",c.cam Gamma Camera,2,"December 19, 2007", 2007,"Siemens Medical Solutions USA, Inc.","Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.",DESIGN: Software Design,"Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens office at: 1-800-888-7436 (USA).",N/A,486,486 units,"Worldwide: USA including Puerto Rico and Brazil, Canada, France, Germany, Great Britain, Israel, The Netherlands, and Portugal.",Terminated,"January 09, 2009",387,486,Hardware,Physical Safety Hazards,Repair,Repair
Z-0287-2008,45499,"Laser, Ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(K),"Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )",Ellex Integre Duo,2,"December 20, 2007", 2007,Ellex USA,Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.,DESIGN: Device Design,"Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.",N/A,1,1,"Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.",Terminated,"October 17, 2008",302,11,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-0204-2008,44967,"Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar",NVR,N/A,N/A,Orthopedic,510(K),"Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA","Medtronic Sofamor Danek, Satellite System Sphere PEEK",2,"December 22, 2007", 2007,Medtronic Sofamor Danek USA Inc,"Labeling, including indications for use, lack 510 (K) approval",DESIGN: Labeling Design,"On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.",N/A,179,179 units,Nationwide,Terminated,"August 18, 2009",605,6071,Not_Computer,N/A,N/A,N/A
Z-0533-2008,44734,"Attachment, Breathing, Positive End Expiratory Pressure",BYE,Positive end expiratory pressure breathing attachment.,Anesthesiology,Anesthesiology,510(k),"Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark",Ambu PEEP valve,2,"December 22, 2007", 2007,Ambu Incorporated,Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.,DESIGN: Process Design,"Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by ""Urgent Device Recall"" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.",N/A,197,197 total,Nationwide.,Terminated,"June 16, 2008",177,197,Not_Computer,N/A,N/A,N/A
Z-0312-2008,44916,"Counter, Differential Cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(K),"COULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer)",COULTER LH750 Analyzer,2,"December 22, 2007", 2007,Beckman Coulter Inc,"Patient Mis-identification can occur:1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier.2)- When manually entering a Patient ID, if a blank space is entered between th",DESIGN: Software Design,"Product Corrective Action (PCA) letters were mailedon April 18,2007, to all GENS, LH500, LH750 andLH780 accounts. They are informed that a potentialmisidentification can occur in 2 scenarios.1. When a positive identifier (Sample ID orCassetteIPosition) is manually edited to apositive identifier that is already in the ToDo list.The workstation will accept the entry and noerror message will be generated, creating 2samples with the identical positive identifier.2. When manually entering a Patient ID, if a blankspace is entered between the characters in thePatient ID field, the system will only accept thecharacters before the space.----Short term fix-----The letter explains the issues and provides thecustomer work around. (Letters were sent by USmail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.",N/A,130,"2,214 units in US; 130 units in Canada",World wide: USA and Canada,Open,N/A,N/A,4198,Software,Output/Calculation,Software update,Software Update
Z-0319-2008,44892,Orthopedic Manual Surgical Instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN",Biomet Optigun ,2,"December 22, 2007", 2007,"Biomet, Inc.","Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.",N/A,6590,"6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008","Worldwide: USA, Canada and Japan.",Terminated,"June 30, 2009",556,6590,Not_Computer,N/A,N/A,N/A
Z-0523-2008,45814,Automated External Defibrillators (Non-Wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.",lifecel ,2,"December 22, 2007", 2007,"BatteryZone, Inc.",Marketed without 510 (K) approval,DESIGN: Component Design/Selection,"The original recall communication (important recall information) was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone. A second recall communication, Urgent Device Recall, was issued by Battery Zone dated 10/25, and was sent out to all customers (even those who had returned product) on 11/5/07. Both communications were sent by first class mail.",N/A,24,24 units,Nationwide; (primarily police/fire departments),Open,N/A,N/A,142,Not_Computer,N/A,N/A,N/A
Z-0153-2008,45435,"Gown, Surgical",FYA,Surgical apparel.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico",Tape Fog Shield Surgical Mask Green Fiberglass Free,2,"December 28, 2007", 2007,"Precept Medical Products, Inc.",Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff,PRODUCTION CONTROLS: Process Control,"The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.",N/A,11546350,"11,546,350 (both products-Z-0153/0154-2008)","Worldwide; USA, Australia and Canada",Terminated,"September 11, 2009",623,11546350,Not_Computer,N/A,N/A,N/A
Z-0148-2008,45398,"System, Imaging, Pulsed Echo, Ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(K),"Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827",Eye Cubed Ultrasound System ,2,"December 28, 2007", 2007,Ellex Inc.,Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.,DESIGN: Software Design,"A Global Customer Service Bulletin (GCSB)-Urgent Notification of Software Correction was issued on 25 September 2007, which provided short term workaround directions pending a free software undate promised in the near future.",N/A,59,59,"Worldwide; including Canada and Mexico. U.S.A. distribution included states of AL, AZ, CA, CT, FL, GA, IL, MA, ME, MI, MN, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, and TX.",Terminated,"September 08, 2008",255,59,Software,Output/Calculation,Software update,Software Update
Z-0149-2008,45404,"Port & Catheter, Implanted, Subcutaneous, Intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(K),"Vortex¶_ VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816",Vortex VX,2,"December 28, 2007", 2007,"Rita Medical Systems, Inc.",Incorrect Size Catheter: The product may contain an incorrect size catheter.,TRAINING: Employee Error,"Notification of the AngioDynamics, Inc. sales force and the domestic and international distributors began on 10/3/2007. Starting on 10/09/2007, Urgent Medical Device Recall letters were sent to all customers requesting that device useage cease and immediate return begin as well as the completion of a fax back form (number of devices used, number to be returned).",N/A,150,150 kits,"Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.",Terminated,"July 14, 2008",199,150,Not_Computer,N/A,N/A,N/A
Z-0211-2008,45426,Nebulizer (Direct Patient Interface),CAF,Nebulizer.,Anesthesiology,Anesthesiology,510(K),"HUDSON RCI¶_, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.",HUDSON RCI,2,"December 28, 2007", 2007,Teleflex Creek Dr,"Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient)",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm.",N/A,215656,"215,656 units","Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom.",Open,N/A,N/A,215656,Not_Computer,N/A,N/A,N/A
Z-0366-2008,44790,"System, X-Ray, Tomography, Computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(K),"Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)",Cardiac Viewer,2,"December 29, 2007", 2007,Philips Medical Systems (Cleveland) Inc,"Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.",DESIGN: Software Design,"Consignees were notified of this recall by an Urgent Device Notification letter sent on 9/10/07. The letter instructed the users to not save any zoomed images to a batch file. Make all measurements of zoomed images in the CT viewer, which provides correct measurements. Do not perform measurements on any zoomed batched images that have been stored on a PACS System. Phillips in investigating the problem and will provide updates free of charge when completed.",N/A,2544,"2,544","Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV, and WY, and country of Canada.",Open,N/A,N/A,2544,Software,Output/Calculation,Update,Other
Z-0456-2008,45442,"Kit, Quality Control For Culture Media",JTR,Quality control kit for culture media.,Microbiology,Microbiology,510(K),"MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303.(Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)",Proteus vulgaris,2,"December 29, 2007", 2007,Microbiologics Inc,Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.,TRAINING: Employee Error,"Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.",N/A,20,20,"Worldwide Distribution - USA including states of OR, PA, NY, RI, GA, SC, IL, PR, CA, AZ, and NJ, and countries of Japan, France, Colombia, and Brazil.",Terminated,"June 26, 2008",180,20,Not_Computer,N/A,N/A,N/A
Z-0377-2008,45805,"Calibrator, Multi-Analyte Mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(K),"Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190. Roche Diagnostics Corporation, Indianapolis, IN 46250",Roche Ammonia/Ethanol/CO2 Calibrator ,2,"December 29, 2007", 2007,Roche Diagnostics Corp.,High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.,DESIGN: Process Design,"Consignees were notified of this recall by an Urgent Medical Device Recall letter sent on 11/14/07. The letter instructed the users to immediately discontinue use of Ammonia/ Ethanol/CO2 Control N and Ammonia/Ethanol/CO2 Control A (with listed lots) for quality control assessment of the bicarbonate assay. They were informed that controls may still be used to assess ammonia and ethanol, but alternative controls must be used for assessment of the bicarbonate assay. Consignees are instructed to destroy products at their facility. Consignees were notified of the availability of replacement product via letter dated .",N/A,1904,"1,904",Nationwide Distibution,Terminated,"September 22, 2009",633,4011,Not_Computer,N/A,N/A,N/A
Z-0126-2008,45328,full-montage standard electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(k),"Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711",NicoletOne,3,"January 03, 2008", 2008,Nicolet Biomedical Div of Viasys Healthcare,Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.,DESIGN: Component Design/Selection,Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.,N/A,33,33,"Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.",Open,N/A,N/A,33,Other,Device Operation,Replace,Remove or Replace
Z-0246-2008,45153,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534",Biograph 16,2,"January 04, 2008", 2008,Siemens Medical Solutions USA Inc,Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols),DESIGN: Software Design,"A certified letter-Urgent Device Correction- dated June 15, 2007 was sent to all affected consignees on July 23, 2007 informing them of the problem (PET iterative reconstruction algorithm) and requesting as a short term fix that they discontinue the practice of operating using protocols other than the default Biograph. Software upgrades as the long term fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.",N/A,162,162 units,"Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.",Terminated,"September 11, 2009",616,415,Computer,N/A,N/A,N/A
Z-0301-2008,45446,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )",CELLDYN ,2,"January 04, 2008", 2008,Abbott Laboratories,Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott.,N/A,302,302 units,"Worldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Australia, Brazil, Chile, Germany, and Hong Kong.",Terminated,"November 17, 2009",683,302,Not_Computer,N/A,N/A,N/A
Z-0460-2008,45504,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)",Alaris Pump Module (formerly Medley Pump Module),1,"January 04, 2008", 2008,Cardinal Health 303 Inc DBA Alaris Products,"Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly",PRODUCTION CONTROLS: Process Control,"The field notification (Urgent Medical Device Recall Letter) will consist of a mailing conducted through consignees (distributors in the affected countries as well as direct customers for the Alaris Pump module (a.k.a. Medley Pump module). The domestic letters are expected to be mailed on November 5, 2007 to all of the affected accounts by return receipt mailing. A Customer Response Card will be mailed with each letter along with a Service Bulletin detailing the protocol to conduct the Occluder Pressure Test. Four (4) letters will be mailed to each account to the following titles/job functions: Director of Nursing, Director of Biomed, Director of Materials Management, and Director of Risk Management. Distributors will be sent multiple copies of the Recall Notification, Customer Response Cards, and Service Bulletin, along with a cover letter outlining their responsibilities to complete the Recall notification plan and notify their customers as requested. The letters will be the first source of communication regarding this issue. The Recall Center will be contacting customers shortly to make arrangements for inspection of the devices at the users site. The international mailings are being coordinated out of the offices located in the affected countries. The letter will be translated to the appropriate language and mailed to all of the affected customers. The appropriate international regulatory authorities will be notified of this issue, and will work with the country managers.---------A web site for all information on this recall is listed as: www.cardinalhealth.com/alaris/indexmodulealert.asp******************January 23, 2008 the firm notified the Los Angeles Districe that they will be sending a recall notification update to 267 customers and distributors who are affected by this 806 Notification Amendment. Cardinal Health intends to notify these consignees by mail on January 30, 2008. This update will affect a total of 267 customers, 5,681 units and 798 .",N/A,207257,"207,257 units","Worldwide: USA including the following forty-six (46) states, along with Washington, D.C. Puerto Rico and Guam: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming and countries of Canada & Saudi Arabia (Note: Devices were shipped to the Cardinal Health Distribution Center in the Netherlands. These devices were then shipped to Saudi Arabia.)",Open,N/A,N/A,207257,Not_Computer,N/A,N/A,N/A
Z-0457-2008,45799,"system, blood culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),"bioMerieux, BacT/ALERT¶_ FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704",BacT/ALERT FA Culture Bottles,2,"January 04, 2008", 2008,"bioMerieux, Inc.",Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT¶_ FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788),PRODUCTION CONTROLS: Process Control,bioMerieux notified all Consignees with a Urgent Product Recall Notice letter on 11/05/2007. They were instructed to examine their inventory to determine if they have any remaining inventory of the 3 affected lots. If they have any of these bottles they were instructed to stop using them and destroy all remaining inventory. A Customer Acknowledgement Form was attached to be completed and returned to bioMerieux via fax or mail. There were also instructions attached for the use of Generic Bottle Barcodes and Creating a Unique Bottle ID.,N/A,7025,"7,025","Worldwide Distribution-USA including countries of Australia, Austria, Bangladesh, Brazil, Bulgaria, Byelorussia, Chile, China, Colombia, Croatia, Denmark, Dijbouti, Estonia, Federation of Russia, Finland, France, Germany, Greece, Guadeloupe, India, Israel, Italy, Korea, Kuwait, Martinique, Mexico, Netherlands, New Caledonia, Norway, Panama, Poland, Portugal, Reunion, Saudi Arabia, Serbia Montenegro, Slovenia, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam.",Terminated,"December 08, 2009",704,7025,Not_Computer,N/A,N/A,N/A
Z-0566-2008,45904,"needle, acupuncture, single use",MQX,Acupuncture needle.,General Hospital,General Hospital,510(k),"HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea",Haeng Lim Seo Won ,2,"January 04, 2008", 2008,Marknew Products,Marketed without 510(k),PREMARKET APPROVAL: No Marketing Application,"Marknew Products, LLC, sent an Important Recall Notice to their customers on November 27, 2007, advising them that all Haeng Lim Seo Won Acupuncture Needles that they have received, have not been cleared for distribution in the USA. All customers have been requested to return product back to Marknew Products for credit. A response form was included. If customers have questions concerning this product, they are asked to call 562-908-5000.",N/A,800,320-380 boxes/100 packages (10 needles/package),Nationwide Distribution,Open,N/A,N/A,380,Not_Computer,N/A,N/A,N/A
Z-0320-2008,45852,"transilluminator, ac-powered",HJM,Transilluminator.,Ophthalmic,Ophthalmic,510(k),"Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.",Transilluminator Model BFO150,2,"January 09, 2008", 2008,Chiu Technical Corp,Device was marketed without a 510(k).,DESIGN: Process Design,"On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.",N/A,170,"Domestic: 170 units, Foreign: 21 units","Worldwide: USA, Canada and India",Open,N/A,N/A,170,Not_Computer,N/A,N/A,N/A
Z-0300-2008,45437,"stainer, tissue, automated",KEY,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ",Ventana Medical System's Symphony Staining System,3,"January 09, 2008", 2008,Ventana Medical Systems Inc,"Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.",PRODUCTION CONTROLS: Process Control,"On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test:- The HiPot test is a safety verification for the electrical path within the instrument.- The HiPot test was performed incorrectly during the manufacturing process.- The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument- The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition.- If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes.- Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete.The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.",N/A,45,45 units,"Worldwide: USA, Japan and France",Terminated,"July 08, 2008",181,45,Not_Computer,N/A,N/A,N/A
Z-0299-2008,45397,"kit, test,alpha-fetoprotein for testicular cancer",LOJ,Tumor-associated antigen immunological test system.,Immunology,Immunology,N/A,"ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA",ARCHITECT i System Assay CDROM WW (excluding USA accounts),2,"January 09, 2008", 2008,Abbott Laboratories,The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL,DESIGN: Software Design,"Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.",N/A,2490,"2,490","International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts.",Terminated,"November 05, 2008",301,2490,Not_Computer,N/A,N/A,N/A
Z-0310-2008,45461,"prosthesis, hip, cement restrictor",JDK,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.",VariLift Bone Plug,2,"January 09, 2008", 2008,"Encore Medical, Lp",Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....),CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.,N/A,61,61 units.,"Nationwide: including direct accounts in CO, KS and TX.",Terminated,"March 10, 2008",61,175,Not_Computer,N/A,N/A,N/A
Z-0297-2008,45511,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039",ACUSON Antares Ultrasound sytem and premium edition,2,"January 09, 2008", 2008,"Siemens Medical Solutions USA, Inc.",Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.,DESIGN: Software Design,"The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.",N/A,418,418 units (Z-0297-0298-2008),"Worldwide: Product was distributed to medical facilities Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.",Open,N/A,N/A,418,Software,Display/Image,Software update,Software Update
Z-0305-2008,45811,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780",Aplio XG ,2,"January 09, 2008", 2008,Toshiba American Med Sys Inc,"Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.",DESIGN: Software Design,"Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included ""Avoid using the Freeze Key when performing dynamic image acquisitions"".",Contact the recalling firm for information,69,69,"Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV",Open,N/A,N/A,69,Software,Device Operation,Software update,Software Update
Z-0447-2008,45460,"device, fixation, tracheal tube",CBH,Tracheal tube fixation device.,Anesthesiology,Anesthesiology,510(K) Exempt,"Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762",Dale 242 Blue,2,"January 11, 2008", 2008,"Dale Medical Products, Inc.","Revised Labeling : Instructions For use: ""Do not trim fastener hook tabs. "" Trimming can cause tabs to disengage at the trach plate",DESIGN: Device Design,"Dale Medical notified Distributors by letter dated 9/27/07, identified as an Urgent Medical Device Correction Letter. The letter requested distributors to notify all their customers by letter. The Correction Letter reminded users to take notice of new labeling "" Do not trim fasterner hook tabs"".",N/A,65000,"65,000","Worldwide-USA and countries of Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, The Netherlands, Norway, The UK, Spain, Switzerland, Australia, Hong Kong,India, Japan, Korea, Malaysia, New Zealand, The Philippines,Singapore, Taiwan, ROC, Brazil, Bermuda, Chile, Costa Rica,Ecuador, Mexico, Panama, Venezuela, Thailand, Saudi Arabia, and The United Arab Emirates.",Open,N/A,N/A,665000,Not_Computer,N/A,N/A,N/A
Z-0302-2008,45474,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)",Extron Electronics Digital Video Interface (DVI) Cable,3,"January 12, 2008", 2008,Stryker Communications,Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Firm notified consignees of recall via letter (Urgent Device Recall) on 09/21/07. Consignees were notified that a customer service representative would visit each facility to replace out-of-spec cables with properly shielded cables at no charge.,N/A,2255,"2,255 cables.","Worldwide: USA and Australia, Belgium, Canada, France, Germany, Great Britain, Hong Kong, Japan, Korea, Mexico, Netherlands, New Zealand, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, and The U.A.E.",Terminated,"June 16, 2008",156,3908,Not_Computer,N/A,N/A,N/A
Z-0376-2008,45494,"nucleic acid amplification assay system, group b streptococcus, direct specimen test",NJR,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089",Xpert GBS,3,"January 12, 2008", 2008,Cepheid,"Labeling Error: Some cartridges may be mislabeled as ""Xpert EV"" instead of ""Xpert GBS"". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.",N/A,105,105,Worldwide Distribution,Terminated,"April 04, 2008",83,105,Not_Computer,N/A,N/A,N/A
Z-0488-2008,45870,"knife, ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"Premier Edge, Bulk Microsurgical Knife, 3.0mm Slit Knife, Item Code B-PE3830, Oasis, Glendora, CA",Bulk Microsurgical Knife 3.0mm Slit Knife,2,"January 12, 2008", 2008,Oasis Medical Inc,"Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL",DESIGN: Packaging Design/Selection,"A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASISMedical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.",N/A,28319,"28,319 individual knives (Z-0485-0516-2008)","Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia",Terminated,"September 25, 2009",622,28319,Not_Computer,N/A,N/A,N/A
Z-0326-2008,38368,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon","Actiwatch 64 AM,",2,"January 17, 2008", 2008,"Mini-Mitter Company, Inc.","Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.",DESIGN: Software Design,"A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.",N/A,20,20,Worldwide,Terminated,"October 20, 2010",1007,1073,Not_Computer,N/A,N/A,N/A
Z-0150-2008,45405,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ",Panorama,2,"January 17, 2008", 2008,Datascope Corporation,"Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced.",DESIGN: Software Design,"Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade.",N/A,338,338 sites,Nationwide,Terminated,"November 04, 2008",292,338,Software,Display/Image,Software update,Software Update
Z-0295-2008,44941,"timer, general laboratory",JBS,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA",Nova Biomedical,3,"January 17, 2008", 2008,Nova Biomedical Corporation,Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples,DESIGN: Device Design,"Nova issued a Customer Advisory Notice notification by phoneon 9/17/07 to contact customers using a script . If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or NormalizedIonized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.",Contact the recalling firm for information,2999,"2,999 units","Worldwide, USA, Canada, Argentina, Bangladesh, Bolivia, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,Germany,Greece, Hungary, India, Indonesia, Ireland,Italy, Japan, Korea, Mexico, Peru, Poland, Scotland, South Africa, Spain, Sri Lanka. Switzerland, Syria ,Taiwan, Turkey and The United Kingdom",Open,N/A,N/A,2999,Not_Computer,N/A,N/A,N/A
Z-0128-2008,45431,"abutment, implant, dental, endosseous",NHA,Endosseous dental implant abutment.,Dental,Dental,510(k),"Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410",Certain PreFormance ,3,"January 17, 2008", 2008,Biomet 3i,"Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.",PRODUCTION CONTROLS: Process Control,"Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.",N/A,114,114,"Worldwide Distribution - USA, Italy, France, Spain and UK.",Terminated,"July 10, 2008",175,114,Not_Computer,N/A,N/A,N/A
Z-0484-2008,45822,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico",SERFAS Energy Suction Probe,2,"January 17, 2008", 2008,Stryker Endoscopy,Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a recall.",N/A,6037,"6,037 units","Worldwide Distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and WV; INTERNATIONAL: Affiliated Stryker Distribution Companies: Sweden (for Scandinavia area), Australia, Canada, France, Germany, Greece, South Africa, Iberia, Italy, Mexico, Portugal, Switzerland (2 separate sites), and The UK",Terminated,"January 16, 2008",-1,6037,Not_Computer,N/A,N/A,N/A
Z-0519-2008,45913,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems",Pro ,2,"January 17, 2008", 2008,General Electric Medical Systems Information Technology,Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.,DESIGN: Software Design,"A ""GE Urgent Medical Device Correction"" letter was sent to consignees on 10/16/2007. The letter described the problem and product involved. The letter also gave short term recommendations. A long term solution is being worked on by GE and will be announced when determined.",N/A,119,"3, 116","Worldwide-USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, and District of Columbia and countries of The United Kingdom, Turkey, Thailand, Tsiwan, Syria , Switzerland, Sweden, Spain, Slovenia, Singapore, Saudi Arabia, Russia, Poland, Qatar, Pakistan, Philippines, Palestinian Territory, New Zealand, Norway, Netherlands, Nigerie, Malaysia, Lebanon, Jordan, Italy, Israel , Ireland, India, Honk Kong, Greece, Germany, France, Finland, Egypt, Denmark, Czech Republic, Cyprus, Costa Rica, Colombia,China, Chile, Canada, Delgium, Bahamas, Austria, and Australia.",Open,N/A,N/A,3116,Software,Alarm/Message,Notification,Safety Notice/Insructions
Z-0733-2008,45906,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502, Sechrist Industries, Inc., Anaheim, CA",Sechrist ,2,"January 18, 2008", 2008,Sechrist Industries Inc,Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical),DESIGN: Device Design,"Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction.The Notification letter instructed their customers to:1. Locate the gurneys with the serial numbers listed in this advisory.2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location.3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely.4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional.5. Contract Sechrist for the replacement parts package.6. Complete the retrofit of the Gurney.7. Verify correct function of the brake assembly following retrofit.8. Complete and send the Correction Verification Form contained in the package to Sechrist.",Contact the recalling firm for information,559,559 Units Total (483 in US) for all models,"Worldwide-USA, Brazil, Bulgaria, Canada, Dubai, U.A.E., Estonia, India, Indonesia, Japan, Malaysia, Saudi Arabia, Sweden, Taiwan, Thailand, and Vietnam.",Open,N/A,N/A,559,Not_Computer,N/A,N/A,N/A
Z-0664-2008,45413,"catheter, assisted reproduction",MQF,Assisted reproduction catheters.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062",Tucker Embryo Catheter,2,"January 19, 2008", 2008,"Fertility Technology Resources, Inc.",Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.,DESIGN: Process Design,All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.,N/A,N/A,not reported,"Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.",Terminated,"February 06, 2008",18,N/A,Not_Computer,N/A,N/A,N/A
Z-0120-2008,44937,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"AmniSure ROM Test, Fetal Membrane Rupture Test forIn-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138",AmniSure,2,"January 19, 2008", 2008,AmniSure International LLC,"Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a ""hook effect""",DESIGN: Software Design,"AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.",N/A,319976,"319,976 units","Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador",Terminated,"February 06, 2008",18,319976,Not_Computer,N/A,N/A,N/A
Z-0529-2008,45482,"conserver, oxygen",NFB,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(k),"Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144",Oxy Serve II Oxygen Conserving Regulator,2,"January 23, 2008", 2008,Superior Products Inc,Leakage: Device was leaking oxygen,DESIGN: Component Design/Selection,"A Voluntary Medical Device Recall notification was delivered by certified mail on or about 10/19/2007, to all consignee's; ""bill to"" and ""sent to."" Consignee's are asked to contact their customers (if any), notify them of the recall, and return all implicated products to Superior Products.",N/A,125,125,"Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey",Open,N/A,N/A,125,Not_Computer,N/A,N/A,N/A
Z-0365-2008,39353,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.",WaveScan WaveFront System,2,"January 23, 2008", 2008,Visx Inc,"Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the ""off",DESIGN: Software Design,"AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).",N/A,196,196 systems are affected in the U.S. and 133 outside of the U.S.,"Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.",Terminated,"April 17, 2008",85,196,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0183-2008,45441,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116",InstaTrak 3500 Plus ,2,"January 23, 2008", 2008,"GE OEC Medical Systems, Inc","Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.",DESIGN: Device Design,"Consignees were sent an Urgent Recall Notice via mail dated 10/11/07, notifying the customer to examine the plastic end of the transmitter arm and to not use the transmitter arm, if any cracks or damage are observed. Also to stop using Steam Sterilization method and to utilize the other Sterilization methods indicated in the Operators Manual. The root cause is still under investigation GEHC Surgery will provide, at no charge, a solution to this issue when it becomes available.",N/A,169,169 units,"Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, MA, MD, MI, MS, NC, NY, OK, OR, PA, SC, TX, UT, VA, WI, and WV, and countries of Canada, China, France, Hong Kong, Japan, Mexico, Spain, and Switzerland.",Open,N/A,N/A,169,Not_Computer,N/A,N/A,N/A
Z-0481-2008,45528,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317",Proven Knee Tibial Augmentation and Screw,3,"January 23, 2008", 2008,Stelkast Co,The screws may fracture,DESIGN: Device Design,"The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.",N/A,41,41 units,"Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.",Terminated,"January 23, 2008",0,207,Not_Computer,N/A,N/A,N/A
Z-0588-2008,45919,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015",Baxter Single Day INFUSOR System,2,"January 23, 2008", 2008,Baxter Healthcare Corp.,Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.,PRODUCTION CONTROLS: Process Control,"Baxter on 11/30/07 sent an Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential leaks during filling or use of the infusor. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any clinical/technical questions were directed to the Baxter Healthcare Product Information Center at 1-800-933-0303.",N/A,86192,"86,192 units","Worldwide: USA, Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia and New Zealand.",Terminated,"April 29, 2010",827,86192,Not_Computer,N/A,N/A,N/A
Z-0589-2008,45965,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4"" x 12""; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ",BD Vacutainer ,2,"January 23, 2008", 2008,Becton Dickinson & Company,Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174.",N/A,105600,"105,200 USA; 400 Canada",Worldwide-USA and Canada,Terminated,"September 08, 2008",229,876100,Not_Computer,N/A,N/A,N/A
Z-0591-2008,46149,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",NWX,N/A,N/A,Cardiovascular,N/A,"AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.",AngioSculpt PTCA Scoring Balloon Catheter ,3,"January 23, 2008", 2008,AngioScore Inc.,"Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton",PRODUCTION CONTROLS: Process Control,"The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.",N/A,40,40 units,"Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.",Terminated,"March 25, 2008",62,40,Not_Computer,N/A,N/A,N/A
Z-0115-2008,45855,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Biomet Orthopedics, Inc., Warsaw, IN. 46581",Biomet Magnum Straight Insert Handle,2,"January 23, 2008", 2008,"Biomet, Inc.",Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction.,PRODUCTION CONTROLS: Process Control,Consignees were notified by Urgent Medical Device Correction Notice (letter) dated 9/4/07 to discontinue use of the instruments and to return them for evaluation.,N/A,22,22,"Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.",Terminated,"September 22, 2009",608,22,Not_Computer,N/A,N/A,N/A
Z-0530-2008,37989,"detector, bubble, cardiopulmonary bypass",KRL,Cardiopulmonary bypass bubble detector.,Cardiovascular,Cardiovascular,510(k),"Terumo Ultrasonic air sensor, 3/8"" by 3/32"" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103",Terumo Perfusion Systems Ultrasonic Air Sensor,2,"January 24, 2008", 2008,Terumo Cardiovascular Systems Corp,"False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.",PRODUCTION CONTROLS: Process Control,Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available.,N/A,2419,"2,419","Worldwide: USA, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Equador, Germany, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.",Terminated,"July 07, 2009",530,2826,Not_Computer,N/A,N/A,N/A
Z-0258-2008,38312,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA",Intuitive Surgical EndoWrist ,2,"January 24, 2008", 2008,"Intuitive Surgical, Inc.","Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)",DESIGN: Labeling Design,"On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.",Contact the recalling firm for information,1136,"1,136 units","Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)",Terminated,"August 01, 2008",190,1136,Not_Computer,N/A,N/A,N/A
Z-0127-2008,45395,"test, hepatitis b (b core, be antigen, be antibody, b core igm)",LOM,N/A,N/A,Microbiology,N/A,"Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064",AxSYM AUSAB Reagent Pack,2,"January 24, 2008", 2008,Abbott Laboratories,"Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Abbott sent a Product Recall letter, dated 10/01/07, to all AxSYM AUSAB customers that received the affected lots of product, informing them of the manufacturing error that resulted in both false reactive and false nonreactive specimens. The letter provided the assay bias for both lots. The accounts were requested to examine their inventory for the affected lots; destroy any packs found; record the number of packs destroyed on the Customer Reply Form; and fax the completed form back to Abbott at 1-800-777-0051 prior to 10/12/07. They were also requested to evaluate patient results generated with these lots in alignment with the information provided in the letter to determine if additional action is necessary. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the lots; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT.",N/A,1722,"1,722 packs","Nationwide Distribution, including Puerto Rico.",Terminated,"May 09, 2008",106,1722,Not_Computer,N/A,N/A,N/A
Z-0540-2008,45496,"slide stainer, automated",KPA,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ",Discovery,2,"January 24, 2008", 2008,Ventana Medical Systems Inc,Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.,DESIGN: Device Design,"The firm has mailed three customer letters, a) the first letter dated 9/30/2005 describes the upgraded Voila CD that contains safety information; b) a second letter, dated 6/27/2006, identified as a ""Customer Alert"" was mailed describing an upgrade to the software system version 9.3/10.3 and the CD that includes safety improvements, c) the third letter dated 9/29/2006 and identified as a Safety Alert advises that as part of their effort to continuously improve laboratory safety, they are updating the labeling and instructions for use regarding installation and cleaning for the carboy as the Ventana staining platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. Enclosed are pictogram labels that indicate ""slip hazard"" and ""refer to instructions for use."" The customer is instructed to apply these two labels to the carboys above the spigot as a reminder to laboratory personnel to keep the spigot in the full ""off"" position when not in use and to refer to the instructions for use for maintenance. In addition, the letter advises that there is an electrical shock warning for the power strip that is part of their system to indicate that it should be mounted off of the floor. This power strip is intended to connect the computer components of the staining system and should not be placed on the floor where fluid might contact it. Also included is a warning label for shock hazard to apply to their power strip.",N/A,2871,"USA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008)","Worldwide; USA, Australia, China, Canada, Germany, Great Britain, France, Italy, Hungary, Singapore, Korea, Taiwan, Spain, Poland, Greece, Austria, Sweden, Japan, Israel, Denmark, Turkey, Finland, Saudi Arabia, The Netherlands, Norway, Slovenia, Ireland, and Belgium",Open,N/A,N/A,2871,Computer,N/A,N/A,N/A
Z-0543-2008,45510,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138",VNUS 7F ClosureFAST Catheter,2,"January 24, 2008", 2008,VNUS Medical Technologies Inc,Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.,DESIGN: Labeling Design,"The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.",N/A,6221,"6,221 units",Worldwide,Terminated,"May 22, 2008",119,22937,Not_Computer,N/A,N/A,N/A
Z-0592-2008,46154,"monitor, bed patient",KMI,Bed-patient monitor.,General Hospital,General Hospital,510(K) Exempt,"Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort St. Mall, Suite 620,Honolulu, HI",Hoana LifeBed ,2,"January 24, 2008", 2008,Hoana Medical,"Bed Exit Failure: Failure to recognize ""Bed Exit"" when the feature is active due to a software anomaly.",DESIGN: Software Design,"On 11/7/07, all consignees were notified via an untitled letter and on-site visit by the firm's sales representative, informing them of the affected product and providing instructions on the recall. The recalling firm will arrange for installation of a software fix at each consignee.",N/A,216,216 units,"Nationwide including states of HI, CA, TX and MA",Terminated,"February 01, 2008",8,216,Software,Device Operation,Software update,Software Update
Z-0569-2008,45951,"crown, preformed",ELZ,Preformed crown.,Dental,Dental,510(K) Exempt,"3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.",Unitek Stainless Steel Permanent Molar Crowns,3,"January 24, 2008", 2008,3M Company / Medical Division,Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.,PRODUCTION CONTROLS: Labeling Mix-Ups,"3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07.The letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.",N/A,975,975,"Worldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.",Terminated,"October 17, 2008",267,975,Not_Computer,N/A,N/A,N/A
Z-0675-2008,46250,"dressing, wound and burn, interactive",MGR,N/A,N/A,General & Plastic Surgery,N/A,"Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021",Apligraf,2,"January 24, 2008", 2008,"Organogenesis, Inc.",Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, ""Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc."" Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.",N/A,177,177 units,Nationwide Distribution.,Open,N/A,N/A,177,Not_Computer,N/A,N/A,N/A
Z-0435-2008,45478,"appliance, fixation, nail/blade/plate combination, multiple component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581",Depuy TK2 ,2,"January 24, 2008", 2008,"Depuy Orthopaedics, Inc.",Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.,PRODUCTION CONTROLS: Process Control,"Consignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified.",N/A,4,4,"Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.",Terminated,"April 21, 2008",88,13,Not_Computer,N/A,N/A,N/A
Z-0546-2008,45809,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854",ProTimePROTIMEPRO,2,"January 25, 2008", 2008,International Technidyne Corporation,An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.,DESIGN: Device Design,"ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.",N/A,3482,"3,482 units","Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia.",Terminated,"August 12, 2008",200,5910,Not_Computer,N/A,N/A,N/A
Z-0549-2008,45871,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),"ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149",ACAT 1 Series,2,"January 25, 2008", 2008,Arrow International Inc,Leak may occur in the helium drive system for the IABP,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative.",N/A,47,47 units,"Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey.",Terminated,"January 11, 2010",717,272,Not_Computer,N/A,N/A,N/A
Z-0551-2008,45873,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL",ACCELERATOR Device Manager (ADM),2,"January 25, 2008", 2008,"Abbott Laboratories, Inc","Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the",DESIGN: Software Design,"Firm notified consignees via Product Correction, Immediate Action Required letter(s) on 10/25/07. Consignees were notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.",N/A,19,19 units.,"Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.",Terminated,"April 01, 2008",67,19,Software,Output/Calculation,Software update,Software Update
Z-0552-2008,45888,"barrier, control panel, x-ray, movable",IWX,Personnel protective shield.,Radiology,Radiology,510(K) Exempt,"AADCO Rayshield Frame Mounted Overhead X-Ray Barrier;Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060",AADCO Rayshield ,2,"January 25, 2008", 2008,Aadco Medical Inc.,Screws may become loose from the mounted shield compromising stability,DESIGN: Device Design,"AADCO Medical Inc., issued a Product Safety Notification/recall letter to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists and Cardiologists dated 11/1/07. AADCO will perform on site inspections with device tightening or replacement of parts as needed; at no cost the the users.",N/A,324,324 units,"Worldwide; USA, Canada, Mexico, Brazil, Venezula, Chile, Bermuda, Spain, and Panama",Open,N/A,N/A,324,Not_Computer,N/A,N/A,N/A
Z-0553-2008,45891,"stainer, tissue, automated",KEY,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc","Symphony Staining System, KPA",3,"January 25, 2008", 2008,Ventana Medical Systems Inc,Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.,DESIGN: Component Design/Selection,The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting.,N/A,55,55,"Worldwide-USA, France and Japan",Terminated,"April 14, 2008",80,55,Not_Computer,N/A,N/A,N/A
Z-0477-2008,45485,"reservoir, blood, cardiopulmonary bypass",DTN,Cardiopulmonary bypass blood reservoir.,Cardiovascular,Cardiovascular,510(k),"Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804",Medtronic ,3,"January 26, 2008", 2008,Medtronic Perfusion Systems,Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic .",N/A,413,413,"Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.",Terminated,"October 23, 2008",271,447,Not_Computer,N/A,N/A,N/A
Z-0522-2008,45819,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.",lifecel ,2,"January 26, 2008", 2008,Exocomm Tech Grp,Marketed without a 510K,PREMARKET APPROVAL: No Marketing Application,"The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries.",N/A,266,266 units,"Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee",Open,N/A,N/A,312,Not_Computer,N/A,N/A,N/A
Z-0527-2008,45856,"system, dialysate delivery, semi-automatic, peritoneal",KPF,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085",RenalSoft ,2,"January 26, 2008", 2008,Baxter Healthcare Renal Div,"Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with ""No Heparin"" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).",DESIGN: Software Design,"Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4.A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.",N/A,25,25 units,"Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom",Terminated,"February 03, 2010",739,34,Software,Display/Image,Software update,Software Update
Z-0478-2008,45513,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile)",Hallmark,2,"January 26, 2008", 2008,"Blackstone Medical, Inc.",Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification,DESIGN: Device Design,"On May 8, 2006, a communication to the field was sent via phone, e-mail and fax. Instruction was made to retrieve and return all product in the field.",N/A,1991,"1,991 semi-constrained primary and rescue screws.",Nationwide,Terminated,"November 06, 2008",285,1991,Not_Computer,N/A,N/A,N/A
Z-0554-2008,45519,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304",Varian RPM System version 1.7.3,2,"January 29, 2008", 2008,Varian Medical Systems Inc,"Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered",DESIGN: Software Design,"Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.",N/A,59,59 units,"Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada",Terminated,"September 30, 2009",610,59,Software,Device Operation,Software update,Software Update
Z-0565-2008,45869,"dissector, surgical, general & plastic surgery",GDI,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242",Endopath 5mm Curved Dissector,2,"January 29, 2008", 2008,Ethicon Endo-Surgery Inc,Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.,PRODUCTION CONTROLS: Process Control,"Endopath sent consignees an Urgent Device Recall notification letter on or about 11/15/07, informing them that the possibility exists that damage to the packaging of this product may have compromised the sterility of the product. The firms were told to examine their inventory, and remove all affected product. All consignees were instructed to complete the Business Reply Form; even if they did not have any product. Recalled products are to be returned to Ethicon for a credit.",N/A,2844,"2,844","Worldwide, USA including states of AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NV, NY, OH, PA, RI, TN, TX, AND WA, and countries of Austria, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Portugal, Puerto Rico, Republic of Panama, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, and Venezuela.",Terminated,"December 09, 2009",680,2844,Not_Computer,N/A,N/A,N/A
Z-0568-2008,45958,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,PMA,"Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX.",Cyberonics VNS Therapy System ,3,"January 29, 2008", 2008,"Cyberonics, Inc","Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.",DESIGN: Software Design,"Cyberonics sent an initial notification (Important Safety Alert) to physicians via Certified Mail on 10/01/07. Letter notified physicians that the Dell X5 handheld computer screen will freeze following an interrogation. Once frozen the handheld device becomes non-responsive to user inputs. The firm informed the user that in the event that the computer becomes non-responsive, the user has two options, 1) Reinitialized the flash memory and, 2) Perform a software reset of the handheld computer. A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response card, acknowledging receipt of the notification. Additional information will be posted at www.VNStherapy.com.",No consumer action necessary,199,"4,201 (US) 199 (International)","Worldwide Distribution- USA and the countries of; Austria, Belgium, Denmark, France, Germany, Ile de la Reunion, Ireland, Israel, Italy, Japan, Marocco, Mexico, Netherlands, Ireland, Norway, Poland, Portugal, S. Korea, Slovenia, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.",Terminated,"October 05, 2009",615,4400,Software,Display/Image,Software update,Software Update
Z-0708-2008,46142,"applier, aneurysm clip",HCI,Aneurysm clip applier.,Neurology,Neurology,510(k),"Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034",Casper Clip Appliers ,2,"January 29, 2008", 2008,Aesculap Inc,Breakage: the inner rod of the applier may corrode and break,DESIGN: Device Design,"The recalling firm issued an Import Recall Notice, on or about December 18, 2007, to all their customers to inform them of the problem and the need to return the devices .",N/A,60,60 clips,"Worldwide- USA hospitals in AZ, CA, CO, IL, KY, MI, MS, ND, NM, NY, OH, OK, PA, TX, VA, WA, and WI, to sales representatives in NC, OK, and MO and shipped to distributors in CA and Canada.",Terminated,"March 28, 2008",59,144,Not_Computer,N/A,N/A,N/A
Z-0124-2008,44824,electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(k),"Philips PageWriter Touch Cardiograph,Model: 860284, Philips Medical Systems, Andover, MA, 01810",Philips PageWriter Touch,2,"January 30, 2008", 2008,Philips Medical Systems,"Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.",N/A,266,266 units,"Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.",Open,N/A,N/A,266,Software,Display/Image,Software update,Software Update
Z-0828-2008,46182,"catheter,intravascular,therapeutic,short-term less than 30 days",FOZ,Intravascular catheter.,General Hospital,General Hospital,510(k),"Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501",Sierra PreFilled ,1,"January 30, 2008", 2008,AM2 PAT INC,Lack of assurance of sterility by manufacturer,DESIGN: Process Design,"AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.",N/A,N/A,N/A,Nationwide,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0658-2008,38315,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,",da Vinci S Surgical System 8 mm Long instrument cannula,2,"January 31, 2008", 2008,"Intuitive Surgical, Inc.","Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.",N/A,206,206 units,"Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.",Open,N/A,N/A,896,Not_Computer,N/A,N/A,N/A
Z-0462-2008,44934,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143",GEMINI GXL PET/CT system,2,"January 31, 2008", 2008,Philips Medical Systems (Cleveland) Inc,Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.,DESIGN: Software Design,"Philips Medical notified domestic customers via Product Safety Notification dated May 30, 2007. The product safety notification includes a Technical Bulletin notifying customers of the issue and how to avoid it. This information will be used until the software correction becomes available. The software correction will be released in October 2008. Once software is available, the firm will begin correcting the field.",N/A,126,126,"Worldwide Distribution - USA, Australia, Belgium, Canada, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Netherlands, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Taiwan, Turkey, and Venezuela.",Open,N/A,N/A,187,Software,Display/Image,Software update,Software Update
Z-0660-2008,44965,"analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)",CBR,Nitrous oxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027",Ultraview Multigas Analyzer,2,"January 31, 2008", 2008,"Spacelabs Healthcare, Incorporated",Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.,DESIGN: Software Design,"The firm sent out their Urgent Medical Device correction/recall letters on 10/5/2007, and an updated versions on 11/30/07 and 12/7/2007, forwarding an attached set of work around directions for use and associated tables for calculations. This short term fix will be updated to a permanent fix when a new software revision is released and installed at no cost to each user as noted in the recall notification. Telephone contact was provided at 1-800-522-7025.",N/A,722,722 devices,Worldwide,Open,N/A,N/A,722,Software,Output/Calculation,Software update,Software Update
Z-0691-2008,45845,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)",GE Innova,2,"January 31, 2008", 2008,GE Healthcare,"Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became ""frozen"" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older ""frozen"" image until the operator released the",DESIGN: Device Design,"Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.",Contact the recalling firm for information,320,320,"Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.",Open,N/A,N/A,869,Computer,N/A,N/A,N/A
Z-0281-2008,45495,"system, simulation, radiation therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(k),"Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520",Simview 3000 Simulator,2,"January 31, 2008", 2008,"Siemens Medical Solutions USA, Inc",Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.,DESIGN: Labeling Design,"Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.",N/A,287,"287 units total, all recalls Z-0281-285-2008","Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countries of Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, China, Israel/Palestine, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, UK, and Vietnam.",Open,N/A,N/A,287,Not_Computer,N/A,N/A,N/A
Z-0520-2008,45820,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)",Vital Images ViTAL Connect ,2,"January 31, 2008", 2008,"Vital Images, Inc.","Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not up",PRODUCTION CONTROLS: Process Control,Customers were notified via telephone (11/7 -11/8/2007) and issued an Urgent Medical Device recall notification letter on 11/8/07. The letter described the problem and product involved. The letter also informed customers they they will provide a free software patch within the next 6-8 weeks.,N/A,18,18,"Worldwide-USA including states of SC, MO, MI, WI, NY, FL, CO, CA, PA, and WA, and countries of England and The Netherlands",Open,N/A,N/A,18,Software,Display/Image,Software Patch,Software Update
Z-0885-2008,45857,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751",ArgoGuide Hydrophilic Wire,2,"January 31, 2008", 2008,"Argon Medical Devices, Inc",Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.,PRODUCTION CONTROLS: Reprocessing Controls,"Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.",N/A,30,30,"Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.",Terminated,"June 05, 2008",126,2951,Not_Computer,N/A,N/A,N/A
Z-0696-2008,45889,arterial blood sampling kit,CBT,Arterial blood sampling kit.,Anesthesiology,Anesthesiology,Enforcement Discretion,"Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016",AddOn Kids Kit,3,"January 31, 2008", 2008,Smiths Medical Asd Inc,"Misbranded; The product codes are labeled incorrectly with a green promotional label for ""New split septum sampling site. Only use needle-free access devices ......."", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device",PRODUCTION CONTROLS: Packaging Process Control,"Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot. Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.",N/A,250,250 units,"Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.",Terminated,"September 30, 2010",973,1690,Not_Computer,N/A,N/A,N/A
Z-0707-2008,46141,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581",Biomet CC Cruciate Tibial Tray,2,"January 31, 2008", 2008,"Biomet, Inc.",Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.,DESIGN: Software Design,Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.,N/A,8,8,"Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.",Terminated,"June 11, 2008",132,8,Not_Computer,N/A,N/A,N/A
Z-0945-2008,45903,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.",Impulse Angiographic Catheter,2,"January 31, 2008", 2008,Boston Scientific,"Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****.",N/A,211,211 total single units,"Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.",Terminated,"October 23, 2008",266,211,Not_Computer,N/A,N/A,N/A
Z-0567-2008,45957,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),"Datascope CS 100 Intra-Aortic Balloon Pump and DatascopeCS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430",CS 100 and CS300 IntraAortic Balloon Pump ,2,"January 31, 2008", 2008,Datascope Corp,"Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.",PRODUCTION CONTROLS: Process Control,"Datascope sent a Product Field Correction notification letters to Hospital Administrators, via certified mail, on November 19, 2007. The letter informed them of a defect in the circuit board. It described the possible malfunction and provided instructions should malfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A Service Representative will be contacting the hospital to arrange for the replacement of the defective board.",N/A,70,70 units US,Worldwide Distribution,Terminated,"May 20, 2008",110,70,Hardware,Device Operation,Replace board,Remove or Replace
Z-0669-2008,46160,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Intuitive brand da Vinci S, 5 mm Instrument CannulaModel/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, Sunnyvale, CA",Intuitive da Vinci S,2,"January 31, 2008", 2008,"Intuitive Surgical, Inc.",Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.",N/A,89,89 units,"Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong",Terminated,"August 27, 2008",209,89,Not_Computer,N/A,N/A,N/A
Z-0280-2008,45454,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor)",CIC Pro v4.1,2,"February 01, 2008", 2008,General Electric Medical Systems Information Technology,"Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.",DESIGN: Software Design,"GE Healthcare sent a certified letter titled ""Urgent Medical Device Correction"" to customers on 3/13/07. As a Short Term Solution, GE recommends that user reboot of system according to instructions and precautions in Service Manual at least once every three months. Also, take the necessary precautions to ensure that system is shut down properly. This will decrease the likelihood of a continuous reboot. If system continues to reboot, GE suggest that user contact Technical Support at 1-800-588-7044 (Press Option 2) and ask for Technical Support. As for a Long Term Solution, GE will provide a software update that will rectify the issue as soon as an upgrade is available.",N/A,6217,"6,217 Units (1,549 OUS, 4,668 within US)","Worldwide Distribution - USA (excluding DE, HI, ID, MT, ND, SD, VT), Peurto Rico, Washington DC and including the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungaria, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherland, New Zealand, Norway, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom",Open,N/A,N/A,6217,Software,Alarm/Message,Software update,Software Update
Z-0699-2008,45966,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan.",Assure 3 Blood Glucose Test Strips,2,"February 01, 2008", 2008,ARKRAY USA INC.,Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.,DESIGN: Device Design,"On Friday, November 14, 2007 the recalling firm notified their distributors via telephone and email to inform them of the device defect and replaced all devices still in inventory. The distributors were also instructed to inform all of their customers of the issue and offer replacement product. Additionally, replacement will be offered to any end user that calls customer service about the issue. To reach ARKRAY use 1-800-818-8877 extension 3121 for replacement product.",N/A,4920,"4,920","Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX",Terminated,"October 30, 2008",272,4920,Not_Computer,N/A,N/A,N/A
Z-0738-2008,46292,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)",Optiflux 180NR ,2,"February 01, 2008", 2008,Fresenius Medical Care North America,Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.",N/A,2791,"2,791 cases (33,492 dialyzers)","Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.",Terminated,"February 08, 2008",7,2791,Not_Computer,N/A,N/A,N/A
Z-0742-2008,36595,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,PMA,"Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)",Medtronic SynchroMed EL Programable Pump,1,"February 02, 2008", 2008,Medtronic Neuromodulation,Pump motor stall due to gear shaft wear,DESIGN: Device Design,"Beginning August 3, 2007, consignees were notified by letter. The letter ""Medtronic Urgent: Medical Device Correction Aug 2007"" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.",N/A,895,"23, 895 total for recalls Z-0739-0746-2008","Worldwide: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of HONG KONG, AUSTRALIA, CANADA, AUSTRIA, BELGIUM, CROATIA, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, IRAN, ICELAND, IRELAND, ITALY, THE NETHERLANDS, NORWAY, POTUGAL, SAN MARINO, SAUDI ARABIA, SPAIN, SWEDEN, SWITERLAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, IRAQ, BRAZIL, and MEXICO.",Open,N/A,N/A,23895,Not_Computer,N/A,N/A,N/A
Z-0564-2008,45862,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"POOLE Suction Instrument, Product Code: 0035040, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501",POOLE Suction Instrument 50/C,2,"February 02, 2008", 2008,Conmed Corporation,"Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.",PRODUCTION CONTROLS: Packaging Process Control,"URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.",N/A,679424,"679,424 instruments",Nationwide and Worldwide Distribution,Open,N/A,N/A,2350432,Not_Computer,N/A,N/A,N/A
Z-0727-2008,45940,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Model 49261). The device is intended for intermittent operation. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604.",Cardioblate Gemini Surgical Ablation Device ,2,"February 02, 2008", 2008,Medtronic Cardiac Surgery Technologies,"Mechanism failure: Medtronic has identified an issue with four lots of the Cardioblate Gemini-s Surgical Ablation Devices in which the polycarbonate distal coil retainer can fail during the course of a procedure, potentially resulting in an inability to apply the necessary jaw closure force.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,Certified letters were sent on 11/21/07 to Consignees. The letter identifies the issue with the device and requests that customers return the device back to the firm. Customers will be requested to complete a Field Correction Action certificate acknowledging the receipt of the information. For additional information you can contact a Medtronic Sales Representative at 763-391-9167.,N/A,28,28 units,"Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI",Open,N/A,N/A,28,Not_Computer,N/A,N/A,N/A
Z-0948-2008,39366,"needle, conduction, anesthetic (w/wo introducer)",BSP,Anesthesia conduction needle.,Anesthesiology,Anesthesiology,510(k),"Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089",Functional Anaesthetic Discography (F.A.D.) Catheter System ,2,"February 05, 2008", 2008,Kyphon Inc,Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.,DESIGN: Labeling Design,A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.,N/A,6013102,"By Lot Number : J 6013102 = 147, Lot: J6033012 = 23","Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.",Terminated,"June 10, 2008",126,213,Not_Computer,N/A,N/A,N/A
Z-0693-2008,45847,"stimulator, electrical, implanted, for parkinsonian tremor",MHY,N/A,N/A,Neurology,PMA,"Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)",Kinetra Implantable Neurostimulator,2,"February 05, 2008", 2008,Medtronic Neuromodulation,Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.,DESIGN: Process Design,"A letter ""Medtronic Urgent: Device Recall"" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.",N/A,1427,"1,427","Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom",Open,N/A,N/A,3079,Not_Computer,N/A,N/A,N/A
Z-0697-2008,45936,"devices, breath trapping, alcohol",DJZ,Breath-alcohol test system.,Toxicology,Toxicology,Enforcement Discretion,"Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)",Maximo Concepts ,2,"February 05, 2008", 2008,"Sakar International, Inc.",Marketed without a 510(k),PREMARKET APPROVAL: No Marketing Application,"Recall notification letters , Urgent Device Recall, were sent by first class mail on 11/30/2007 requesting return of product and notification of accounts sold product.",N/A,72581,"72,581","Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.",Terminated,"June 30, 2010",876,72581,Not_Computer,N/A,N/A,N/A
Z-0698-2008,45949,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.",QuickCross Support Catheters,2,"February 05, 2008", 2008,Spectranetics Corporation,"Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.",PRODUCTION CONTROLS: Packaging Process Control,Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.,N/A,64,64,"Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.",Terminated,"February 08, 2008",3,64,Not_Computer,N/A,N/A,N/A
Z-0710-2008,46276,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.",Horizon Cardiology Hemo Monitoring System,2,"February 05, 2008", 2008,McKesson Provider Technologies,Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.",N/A,13,13,"Nationwide to hospital and medical centers in LA. CA, PA and IL,",Terminated,"May 28, 2008",113,13,Battery,Output/Calculation,Correction,Repair
Z-0518-2008,45986,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA",Magnetom Espree Sytem with Swiveling OR Table,2,"February 05, 2008", 2008,"Siemens Medical Solutions USA, Inc",Table may experience a deadlock situation,DESIGN: Device Design,"The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.",N/A,4,4 units,The products were shipped to medical facilities in TX and NY.,Terminated,"February 05, 2008",0,4,Computer,N/A,N/A,N/A
Z-0705-2008,45987,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.",Biomet RINGLOC Instrumentation Impactor Plate,2,"February 05, 2008", 2008,"Biomet, Inc.",The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.,PRODUCTION CONTROLS: Process Control,"Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.",N/A,141,141 total for all recalls Z-0700-0705-2008,"Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.",Terminated,"March 11, 2008",35,141,Not_Computer,N/A,N/A,N/A
Z-0135-2008,44879,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)",Cook Amplatz wire guide,2,"February 06, 2008", 2008,"Cook, Inc.","The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.",PRODUCTION CONTROLS: Process Control,Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.,N/A,33,33,"Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.",Terminated,"April 21, 2008",75,33,Not_Computer,N/A,N/A,N/A
Z-0525-2008,45918,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835",FlowCount Fluorospheres,2,"February 06, 2008", 2008,Beckman Coulter Inc,"Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert.",DESIGN: Process Design,"A Product Corrective Action (PCA) letter was mailed on May 21, 2007, to all accounts that have ordered Flow-Count Fluorospheres, Part Number 7547053, Lot # 754801F. The letter advised that Beckman Coulter has confirmed absolute count recovery failures with assayed control cell products. Additionally, internal testing has indicated secondary fluorescent populations slightly above their indicated 20% of the total population as stated in the Evidence of Deterioration section of the Package Insert. The letter requests that users immediately discard any bottles of the product and call for a replacement. If no evidence of deterioration has been observed, the firm states that there should not be any negative impact to the results obtained. A response form is included and should be returned to the firm within 10 days. Questions regarding this recall can be addressed by contacting Beckman Coulter Customer Service at 1-800-526-7694.",N/A,97,97 units in the US; 37 units Internationally,"Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality control.***",Open,N/A,N/A,97,Not_Computer,N/A,N/A,N/A
Z-0747-2008,46378,"catheters, transluminal coronary angioplasty, percutaneous",LOX,Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.,Cardiovascular,Cardiovascular,N/A,"CORDIS ""Dura Star"" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014",Dura Star,1,"February 06, 2008", 2008,Cordis Corporation,Slow Deflation or No Deflation,PRODUCTION CONTROLS: Process Control,"Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.",N/A,133300,"133,300 units total for recalls Z-0747-0824-2008",Worldwide.,Terminated,"October 20, 2009",622,133352,Not_Computer,N/A,N/A,N/A
Z-0826-2008,45532,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI",Xoran MiniCAT for ENT.,3,"February 07, 2008", 2008,"Xoran Technologies, Inc.",Misbranding; These devices do not bear the manufacturer's name or address.,DESIGN: Labeling Design,"Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.",N/A,71,71,Nationwide.,Terminated,"October 22, 2010",988,71,Not_Computer,N/A,N/A,N/A
Z-0934-2008,45407,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems International, Inc., Rockville, MD 20855",Inotech brand Heparin Adsorbant,2,"February 07, 2008", 2008,"Inotech Biosystems Intl., Inc",Erroneous Coagulation Tests,DESIGN: Labeling Design,"The recalling firm notified consignees by phone on 08/20/07 and provided instructions for increasing the speed of centrifugation from 1,500 x g to 2,500 x g and decanting the supernatant aliquot carefully so as to not draw in resin fibers that may be stuck on the test tube walls during sample preparation for testing in the coagulation studies. The firm updated their recall notification on 10/01/07 as an Urgent Recall/Correction to alert healthcare practitioners to not use ""lupus sensitive reagents"" with the heparin absorbant product and that Platelet Factor 3 and any other negatively charged molecule in the plasma may interact with the resin causing false high readings due to the partial removal of the clotting initiating factors.",No consumer action necessary,37370,"37,370 tubes",Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada.,Open,N/A,N/A,37370,Not_Computer,N/A,N/A,N/A
Z-0849-2008,45912,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Nexframe¶_ Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041,DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST,DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL,DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042,DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota",Nexframe Stereotactic ,2,"February 07, 2008", 2008,"Medtronic Image Guided Neurologics, Inc.","Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.",DESIGN: Packaging Design/Selection,"On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).",N/A,385,385,"Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.",Open,N/A,N/A,385,Not_Computer,N/A,N/A,N/A
Z-0125-2008,44854,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Medtronic Sofamor Danek COLORADO 2"" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.","COLORADO 2"" SPINAL SYSTEM ",2,"February 07, 2008", 2008,"Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK","Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.",PRODUCTION CONTROLS: Process Control,"Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.",N/A,2569,"2,569","Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.",Terminated,"July 14, 2009",523,2569,Not_Computer,N/A,N/A,N/A
Z-0844-2008,45846,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA",STERRAD Sterilizers ,2,"February 07, 2008", 2008,Advanced Sterilization Products,Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.",Contact the recalling firm for information,9686,"9,686 units","Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux,Uruguay,Venezuela,Argentina,Chile,Colombia,Ecuador,Belgium, Puerto Rico, Hong Kong,Indonesia,Mexico,Philippines,Australia,Austria,China,Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand,Turkey, Middle East, Peru,Canada,The Czech Republic,Portugal,S Africa,Spain,Sweden,Hungary,Poland,Brazil,Russia,Egypt,India &Slovenia; and Canada",Open,N/A,N/A,9686,Not_Computer,N/A,N/A,N/A
Z-0967-2008,45902,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy Product Number 6260-9-532Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland.Made in Ireland.",LFIT COCR V40 Femoral Head; xxLong (16mm) Neck Length 32mm Diameter ,2,"February 07, 2008", 2008,Stryker Howmedica Osteonics Corp.,Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.,DESIGN: Component Design/Selection,"Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.",N/A,5599,"5,599 total units",Nationwide Distribution,Terminated,"August 30, 2010",935,5599,Not_Computer,N/A,N/A,N/A
Z-0718-2008,38335,"device, microtiter diluting/dispensing",JTC,Microtiter diluting and dispensing device.,Microbiology,Microbiology,510(K) Exempt,"Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)",ML STAR Sample Carriers,2,"February 08, 2008", 2008,Hamilton Co,Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error notice.,PRODUCTION CONTROLS: Error in Labeling,"The firm sent an Urgent: Product Recall letter to consignees on June 25, 2007. The firm also issued an alert via their User news distribution. They instructed consignees to examine their stock and return any affected carriers. A fax back form was supplied with the notification. The firm will be providing replacements.",N/A,179,179 units distributed.,"Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.",Terminated,"April 15, 2008",67,179,Not_Computer,N/A,N/A,N/A
Z-0676-2008,45329,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035",Precedence SPECT/CT System ,2,"February 08, 2008", 2008,Phillips Nuclear Medicine,Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.,DESIGN: Software Design,"A Customer Advisory Notification was mailed to affected consignees on September 28, 2007. The firm informed consignees that incorrect measurement can occur when the Cardiac Viewer or Pulmonary Viewer is used to zoom and save derived images in batch files. The firm provided instructions for operators to prevent incorrect measurements. Phillips is currently investigating methods to correct this issue and will provide updates, free of charge, when they become available. If you have questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnostic Imaging, option 5:NM).",N/A,19,19,"Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.",Terminated,"February 04, 2009",362,19,Software,Output/Calculation,Software update,Software Update
Z-0847-2008,45851,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA",STERRAD 200 Sterilizer,2,"February 08, 2008", 2008,Advanced Sterilization Products,"User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.",DESIGN: Labeling Design,"Urgent Product Correction letters were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken to clarify instructions contained within the STERRAD System User Guides to reinforce appropriate use and to address two separate issues which have arisen from user reports: (1) User reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization. (2) User reports about light-colored residues observed on instruments, trays and pouches after sterilization. The Product Correction Letters instructed customers to refer to the revised excerpt of the User Guide (attached to the letter) for information about instrument preparation prior to sterilization, particularly with regard to the washing, rinsing and thorough drying of instruments prior to sterilization in the STERRAD Sterilization System. If customers have any questions they were instructed to call ASP Customer Care Center to answer additional questions at (888) 783-7723.",N/A,9686,"9,686 units total for recalls Z-0845-0848-2008","Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, The Philippines, Switzerland, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, The Czech Republic, Middle East, Portugal, S Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India & Slovenia",Open,N/A,N/A,9686,Not_Computer,N/A,N/A,N/A
Z-0688-2008,45910,"catalytic methods, amylase",JFJ,Amylase test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250",Roche LIPC Lipase colorimetric reagent,2,"February 08, 2008", 2008,Roche Diagnostics Corp.,False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.,DESIGN: Process Design,Consignees were sent and Urgent Medical Device Correction notice dated 12/03/07. The notice provided instructions for conducting an additional wash cycle whenever both the LDL-Cholesterol assays and Lipases assay are used on the COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers. Contact Roche Technical Support at 1-800-428-2336 for questions regarding these instructions.,N/A,9817,"9,817 kits.",Nationwide Distribution,Terminated,"June 11, 2008",124,9817,Not_Computer,N/A,N/A,N/A
Z-0950-2008,45595,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,PMA,"Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)",Medtronic SynchroMed EL ,2,"February 09, 2008", 2008,Medtronic Neuromodulation,Pump Motor Stall; pumps can stall due to gear shaft wear.,DESIGN: Device Design,"Begining August 3, 2007, consignees were notified by letter. The letter ""Medtronic Urgent: Medical Device Correction Aug 2007"" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.",N/A,81023,"81,023 total for recalls Z-0950-0957-2008","Worldwide-USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of HONG KONG, JAPAN, AUSTRALIA, CANADA, BELGIUM, CROATIA, AUSTRIA, CYPRUS, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN, ICELAND, IRELAND, ITALY, JORDAN, KWAIT, LEBANON, MALTA, The NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAN MARINO, SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, The UNITED KINGDOM, CHILE, VENEZUELA, BRAZIL, and MEXICO.",Open,N/A,N/A,81023,Not_Computer,N/A,N/A,N/A
Z-0881-2008,46322,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040.",PERFEKTUM,3,"February 12, 2008", 2008,Popper & Sons Inc,"Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.",PRODUCTION CONTROLS: Process Control,"The recalling firm, Popper & Sons, began contacting its customers by telephone on/about 1/02/08, informing them of the issue. This was followed up with formal recall letters, Urgent Recall, and response forms starting on 1/09/08 via Certified Mail, Return Receipt Requested to the US accounts, and Registered Mail to the two Canadian accounts. The firm has directed the customers to discontinue using or distributing the lot and return any remaining quantity of this lot of syringes. If the lot has been further distributed, the distributors were instructed to immediately contact their accounts, advise them of the recall situation and have them return their outstanding recall stock as indicated above.",N/A,272,Domestic - 259 units; Canada - 13 units,"Worldwide-USA including the states of NY, NJ, PA, MI, IL, OH, FL, MO, TX, and CA, and country of Canada",Terminated,"May 12, 2008",90,272,Not_Computer,N/A,N/A,N/A
Z-0873-2008,46267,dialysate concentrate for hemodialysis (liquid or powder),KPO,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"RenalPure¶_ Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.",RenalPure ,2,"February 13, 2008", 2008,"Rockwell Medical Technologies, Inc",Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.,PRODUCTION CONTROLS: Process Control,"Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.",N/A,6,6 cases (4 one gallon containers/case).,"Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.",Terminated,"March 31, 2008",47,49,Not_Computer,N/A,N/A,N/A
Z-1040-2008,37183,"drill, surgical, ent (electric or pneumatic) including handpiece",ERL,"Ear, nose, and throat electric or pneumatic surgical drill.",Ear Nose & Throat,Ear Nose & Throat,510(k),"Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.",MicroMax Motor Systems,2,"February 13, 2008", 2008,"The Anspach Effort, Inc.","Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.",MISBRANDING: Labeling False and Misleading,"Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.",N/A,7399,"7,399 total units",Worldwide Distribution,Open,N/A,N/A,7399,Not_Computer,N/A,N/A,N/A
Z-0880-2008,46304,"retractor, self-retaining, for neurosurgery",GZT,Self-retaining retractor for neurosurgery.,Neurology,Neurology,510(k),"Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.",Comfort THandle ,2,"February 13, 2008", 2008,Abbott Spine,Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.,DESIGN: Device Design,All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.,N/A,230,230 handles.,"Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.",Terminated,"October 04, 2010",964,230,Not_Computer,N/A,N/A,N/A
Z-0879-2008,46288,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112",CADD Medication Cassette Reservoirs ,2,"February 13, 2008", 2008,"Smiths Medical MD, Inc.",Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps,PRODUCTION CONTROLS: Process Control,"Consignees were mailed the recall letters on December 21,2007. The recalled letter ""Smiths Mecical Urgent Product Recall Notification"" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical.",N/A,4644,"4,644","Worldwide Distribution --- USA including states of AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and countries of AN, AR, AU, BR, CA, CL, CN, CZ, DK, EE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IT, JO, JP, KW, LB, MY, NL, NO, PA, PL, PT, SA, SE, SG, TAIWAN, TH, VI, ZA, CH, AT, and BE.",Open,N/A,N/A,1188870,Not_Computer,N/A,N/A,N/A
Z-0112-2008,39371,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter.",Multiple brand names including: Precision Xtra ,2,"February 14, 2008", 2008,"Abbott Diabetes Care, Inc.","Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.",DESIGN: Component Design/Selection,"Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter. Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be created and communications tracked according to local requirements. Abbott issued a Press Release August 31, 2007 also.",N/A,1765202,"882,601 total meters distributed, 316,439 in the U.S. and 566,162 outside of the U.S. including Mexico and Canada","Worldwide Distribution - USA, Canada, Mexico, Australia, Malaysia, Philippines, Germany, New Zealand, China, India, Singapore, Hong Kong, Taiwan, Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Puerto Rico, Uruguay, Venezuela, and Japan.",Open,N/A,N/A,882601,Not_Computer,N/A,N/A,N/A
Z-0619-2008,45469,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products contain human tissue (allograft bone) and are intended for transplantation)",Allogenix;,3,"February 14, 2008", 2008,Interpore Cross International Inc,"Unapproved Testing: Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank (""LifeLink""), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.",N/A,34,34,Nationwide,Terminated,"September 25, 2008",224,1290,Not_Computer,N/A,N/A,N/A
Z-0677-2008,46157,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520",Mevatron KD2,2,"February 14, 2008", 2008,"Siemens Medical Solutions USA, Inc","Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.",DESIGN: Device Design,"The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.",N/A,55,55 units,Worldwide Distribution,Open,N/A,N/A,642,Not_Computer,N/A,N/A,N/A
Z-0545-2008,45520,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system;Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC -- Stereotactic motion disable Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA",Varian ,2,"February 14, 2008", 2008,Varian Medical Systems Inc,"The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.",DESIGN: Labeling Design,"On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.",N/A,418,418 (total for Recalls Z-0544-0545-2008),"Worldwide- Canada, Mexico, and the USA",Open,N/A,N/A,418,Not_Computer,N/A,N/A,N/A
Z-0825-2008,45502,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"OsteoStim Cervical Allograft (Lordotic Cervical Spacer)H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054",OsteoStim Cervical Allograft,3,"February 14, 2008", 2008,"EBI, L.P.",Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.",N/A,19,19 units,"Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS",Terminated,"April 15, 2008",61,19,Not_Computer,N/A,N/A,N/A
Z-0720-2008,45527,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA",VARiS PRT Exchange,2,"February 15, 2008", 2008,Varian Medical Systems Inc,"Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.",DESIGN: Device Design,"An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.",N/A,N/A,N/A,Worldwide Distribution,Open,N/A,N/A,N/A,Software,Device Operation,Software update,Software Update
Z-0721-2008,45530,"kit, quality control for culture media",JTR,Quality control kit for culture media.,Microbiology,Microbiology,510(K) Exempt,"PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070",LyfoCults,3,"February 15, 2008", 2008,"PML, Inc. dba Pml Microbiologicals Inc.",Incorrect micro-organism-- Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.",N/A,30,30 packs (each pack contains 5 vials of Haemophilus parainfluenzae),Nationwide Distribution,Open,N/A,N/A,31,Not_Computer,N/A,N/A,N/A
Z-1107-2004,45411,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039",ACUSON Aspen Diagnostic Ultrasound System,2,"February 15, 2008", 2008,"Siemens Medical Solutions USA, Inc.","Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco",N/A,"Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.",N/A,280,280 units,"Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Switzerland, Thailand, and Turkey.",Open,N/A,N/A,280,Software,Output/Calculation,Correction,Repair
Z-0724-2008,45815,"electrode, ion based, enzymatic, creatinine",CGL,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2P/N 9600, Nova Biomedical, Waltham, MA 02454",Kit Meter EZCHEM,2,"February 16, 2008", 2008,Nova Biomedical Corporation,Incorrect Results - Creatinine results were lower than the laboratory reference method.,DESIGN: Device Design,"Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.",N/A,133,133 units,"Nationwide Distribution, including the state of NY",Terminated,"December 09, 2008",297,719,Not_Computer,N/A,N/A,N/A
Z-0728-2008,45953,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Invictus-- Bionime Rightest Blood Glucose Monitoring SystemMODEL: GM300; Invictus Scientific, Inc., San Diego, CA",Bionime Rightest Blood Glucose Monitoring System,3,"February 16, 2008", 2008,Invictus Scientific Inc,"Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause confusion as to when the last test was taken.",DESIGN: Software Design,"An Urgent: Device Recall Notification letter were sent to customers (direct accounts) beginning on November 20, 2007, via US Postal Service, with a return receipt requested. The distributors were instructed to inform consumers/users to fix the time format to the 24 hrs mode and to contact the distributors or the firm for replacement, if they prefer to use the time format in the 12 hrs mode. They were also instructed that if they have further distributed any of the recalled products, to please immediately contact those accounts and advise them of the recall situation, and have them return their outstanding recalled stocks. If customers have any questions, they were instructed to contact at 858-481-8485.",N/A,21070,"21,070",Nationwide Distribution,Open,N/A,N/A,21070,Hardware,Display/Image,Change time format/Replace,Remove or Replace
Z-0850-2008,45991,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA",Primus Linear Accelerator System,2,"February 19, 2008", 2008,"Siemens Medical Solutions USA, Inc",Door Hinge failures; loose or falling off (Stationary Structure Doors),DESIGN: Component Design/Selection,Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.,N/A,1284,"1,284 total for recalls Z-0850-0852-2008","Worldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Kansas, Mississippi, Rhode Island,Washington, South Carolina, Maryland, New Hampshire, Maine, Arkansas, Idaho, Missouri, Louisiana, Oklahoma, North Dakota, Minnesota, Massachusetts, and The District of Columbia and countries of Canada and Mexico.",Open,N/A,N/A,1284,Not_Computer,N/A,N/A,N/A
Z-0853-2008,46198,first aid kit with drug,LRR,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include:Labeled with First Aid Only, Inc. Vancouver, WA:Recreational Sports First Aid, Item SM-134;Welder's First Aid Kit, Item 253-U;Vehicle First Aid Kit, Item 220-0;On-The-Road Auto First Aid, Item FAO-310;Auto First Aid Essentials, Item FAO-340;Auto First Aid Essentials, Item FDA-532;Auto First Aid Essentials, Item FDA-552;Vehicle First Aid Kit, Item 221-U;Outdoor First Aid Kit, Item FAO-410;Outdoor First Aid Kit, Item FAO-410Outdoor First Aid Kit, Item FAO-420;Outdoor First Aid Kit, Item FAO-430;Outdoor First Aid Kit, Item FAO-440;First Aid & Survival Kit, Item FA-462;First Aid Kit, FAO-422-06;First Aid Kit, 403-PC;First Aid Response Kit, FA-504;All Purpose First Aid Kit, Item FAO-112;All Purpose First Aid Kit, Item FAO-122;All Purpose First Aid Kit, Item FAO-142;All Purpose First Aid Kit, Item FAO-432;All Purpose First Aid Kit, Item FAO-444;All Purpose First Aid Kit, Item FAO-452;First Aid Essentials, Item FAO-130;First Aid Essentials, Item FAO-132;First Aid Essentials, Item FAO-134;First Aid Essentials, Item FAO-422;First Aid Essentials, Item FAO-428;First Aid Essentials, Item FAO-432;First Aid Essentials, Item FAO-442;Refillable First Aid Kit, FAO-490C;Refillable First Aid Kit, FAO-490C; Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only):Item FAO-130-BS;Item FAO-132-BS;Item FAO-134-BS; Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544:Lake & Trail Outdoor First Aid Kit, Item MJR-420;Lake & Trail Outdoor First Aid Kit, Item MJR440; First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544:meijer First Aid Kit, Item MJR-130;meijer First Aid Kit, Item MJR-442; First Aid Kits labeled FIRST AID Exchange:General Purpose Home First Aid Kit, Item 2800;Auto First Aid Kit, Item 2825 First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO:All purpose First Aid Kit, Item FAO-132-MS First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions:First Aid Kit, Item 90030 First Aid Kit labeled NORTHERN Safety Co., Inc.:First Aid Kit, Item FAO-442-NS First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060:Grafco First Aid Kit, Item 1799-9133 and First Aid Kit labeled -Provided by MOTURIS LTD-Custom Kit, Item 9099",Distributed under various trade names,3,"February 19, 2008", 2008,First Aid Only Inc,"Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm issued an Urgent Device Recall letter dated 10/10/07 to consignees receiving any of the products. The letter instructs consignees to return any recalled product to the firm. If any recalled prdoucts were further distributed, the consignee was requested to notify those consignees and have product returned.",N/A,72904,"72,904 kits","Worldwide: USA and to one distributor in Dubai, United Arab Emirates.",Open,N/A,N/A,137211,Not_Computer,N/A,N/A,N/A
Z-0079-2008,38311,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.",daVinci S Surgical System IS2000,2,"February 21, 2008", 2008,"Intuitive Surgical, Inc.","System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe ""soft-lock"" state.",DESIGN: Software Design,"Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.",N/A,159,159,"Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.",Terminated,"September 05, 2008",197,159,Software,Device Operation,Software update,Software Update
Z-0151-2008,45518,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA",da Vinci S Surgical System,2,"February 22, 2008", 2008,"Intuitive Surgical, Inc.","Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that m",TRAINING: Employee Error,"A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections.",Contact the recalling firm for information,63,63 total units,"Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom.",Open,N/A,N/A,63,Not_Computer,N/A,N/A,N/A
Z-0583-2008,45807,"table, obstetric (and accessories)",KNC,Obstetric table and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Hill-Rom Affinity Three Birthing Bed, Model P3700A.",HillRom Affinity Birthing Bed,2,"February 22, 2008", 2008,"Hill-Rom, Inc.","Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.",DESIGN: Device Design,"Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.",N/A,32379,"32,379 for all model numbers","Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, The Netherlands, New Calidonia, New Zealand, Nigeria, Northern Mariana Islands, Norway, Oman, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguey, Venezuela, and Virgin Islands .",Terminated,"September 22, 2009",578,32379,Not_Computer,N/A,N/A,N/A
Z-0729-2008,46155,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Centurion Healthcare Products Laceration Tray, sterile; The primary kit is labeled as containing 1 needle, 21G x 1-1/2"", among other components, however some kits may contain a 21Gx1"" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size. (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 48844",Centurion Healthcare Products Arthrogram Tray,3,"February 23, 2008", 2008,Tri-State Hospital Supply Corporation,Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.",N/A,40,40 kits.,"Nationwide Distribution, including states of Massachusetts and Washington.",Terminated,"March 13, 2008",19,436,Not_Computer,N/A,N/A,N/A
Z-0732-2008,46318,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355",Syngo Imagaing,2,"February 23, 2008", 2008,"Siemens Medical Solutions USA, Inc",Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high),DESIGN: Software Design,"The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.",N/A,10,10 units,"Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.",Terminated,"September 17, 2008",207,10,Software,Output/Calculation,Software update,Software Update
Z-0731-2008,46266,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK COMPANY (now known as Carestream Heath Inc.) Rochester, NY 14608, or CARESTREAM HEALTH, INC., Rochester, NY 14608.",Kodak DirectView DR 3000 System,2,"February 23, 2008", 2008,"Carestream Health, Inc.",Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.,DESIGN: Software Design,"On 12/21/07, Service Bulletins (dated December 2007) were sent to consignees informing them of design modification, and providing modification instructions. The firm followed up with telephone calls to the direct user sites to schedule appointments to visit each site, in order to make the necessary modifications. The firm will be installing Safety Adaptation Board and software into all the affected DR3000 systems.",N/A,19,Domestic - 19 units,"Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA.",Terminated,"April 10, 2008",47,19,Software,Physical Safety Hazards,Software update,Software Update
Z-0131-2008,38377,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134",GreenLight HPS Surgical Laser System,2,"February 26, 2008", 2008,AMS Innovative Center - San Jose,Control knob break: The knob used to finely control the direction of the laser energy may break.,DESIGN: Process Design,"American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.",N/A,611,611 units,Worldwide Distribution - USA and Singapore.,Terminated,"March 23, 2010",756,611,Not_Computer,N/A,N/A,N/A
Z-0134-2008,44799,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - AdministratorREF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA",Sentry Pro Medication Safety Software,2,"February 26, 2008", 2008,"Smiths Medical MD, Inc.","Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.",DESIGN: Software Design,"A Smiths Medical MD employee visited the consignees between August 14 and 31, 2007, to verbally notify them of the recall, collect the recall CD-ROM containing the affected software and replace with the updated software.",N/A,3,3 CD-ROMs,"UT, MD, CO",Terminated,"October 31, 2008",248,3,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0674-2008,45878,"appliance, fixation, nail/blade/plate combination, multiple component, metal composite",LXT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.",External Bone Fixation System,2,"February 26, 2008", 2008,"Orthofix, Inc","Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.",PRODUCTION CONTROLS: Process Control,Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.,N/A,69,69 units.,"Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.",Terminated,"March 20, 2008",23,69,Not_Computer,N/A,N/A,N/A
Z-0920-2008,45947,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Modular Replacement System Curved Cemented Stem;MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430",Modular Hip and Knee Replacement System,2,"February 26, 2008", 2008,Stryker Howmedica Osteonics Corp.,Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.,DESIGN: Process Design,"On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.",N/A,803,"803 total, all sizes",Nationwide Distribution,Terminated,"September 22, 2008",209,803,Not_Computer,N/A,N/A,N/A
Z-0930-2008,46146,"enzyme immunoassay, gentamicin",LCD,Gentamicin test system.,Toxicology,Toxicology,510(k),"Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064",AxSym Gentamicin Reagent,2,"February 26, 2008", 2008,"Abbott Diagnostic International, Ltd.","Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: - Printed Error Code ""SPAN LESS THAN MIN SPAN"" - Controls out of range. When a control is out of range, patient results should not be reported.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers ""Customer Letter (Product Recall) ""Customer Reply Form AxSYM Customers ""Customer Letter (Product Correction) ""Customer Reply Form The Customers were instructed the following: TDx/TDxFLx Gentamacin Reagents "" Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00. "" Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits. "" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication. AxSYM Gentamicin Reagents "" Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007. "" Run each level of control with each AxSYM Gentamicin sample or batch of samples. "" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.",N/A,3787,3787 kits,"Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.",Open,N/A,N/A,5186,Not_Computer,N/A,N/A,N/A
Z-0578-2008,46158,"table, surgical with orthopedic accessories, manual",JEB,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.",TENET Wrist Stabilization Kit,2,"February 26, 2008", 2008,Tenet Medical Engineering Inc,Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.,PRODUCTION CONTROLS: Packaging Process Control,TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.,N/A,360,360 units.,Nationwide Distribution.,Terminated,"May 01, 2009",430,820,Not_Computer,N/A,N/A,N/A
Z-1135-2008,46210,"scale, patient",FRW,Patient scale.,General Hospital,General Hospital,510(K) Exempt,"BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts:a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5:Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift;Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift;Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift;b) Manufactured for Sunrise Medical, Longmont, CO 80503:Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale;Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC;Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale",BHM Medical Scales,2,"February 26, 2008", 2008,"Arjo, Inc.",Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.,DESIGN: Device Design,"Arjo sent Urgent Device Field Correction Notification letters dated 12/19/07 to the end user accounts who received the affected scales, advising them of the potential for the hanger bar assembly to detach. The accounts were given the option immediately stopping use of the lifts with the affected scales or removing the scales from the lift so the lift can continue to be used. Instructions for removal of the scales were provided with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating whether they will complete the correction upon receipt of the correction parts or if they require the assistance of an Arjo Service Technician.",N/A,772,772 scales,"Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin.",Terminated,"November 18, 2009",631,798,Not_Computer,N/A,N/A,N/A
Z-0961-2008,45853,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342",Precision Implantable Pulse Generators,2,"February 27, 2008", 2008,Advanced Bionics Corp,"Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of ""10h0"" or ""00h0"" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t",DESIGN: Component Design/Selection,"Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices.The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry.If any of patients encounter error code ""10h0"" or ""00h0"" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.",Contact the recalling firm for information,12000,"Over 12,000 units","Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.",Open,N/A,N/A,12000,Computer,N/A,N/A,N/A
Z-0576-2008,45984,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.",Roche COBAS 6000 ,2,"March 04, 2008", 2008,Roche Diagnostics Corp.,Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.,DESIGN: Software Design,"Roche Diagnostics contacted the consignee by phone on 12/4/07 and by follow-up letter dated 12/4/07. The user was instructed to discontinue use of two CRP assays on this analyzer. The letter described a workaround and that a new revision of software, due out first quarter 2008, will fix this.",N/A,1,1,USA Distribution in the state of Nebraska.,Terminated,"August 04, 2008",153,1,Software,Output/Calculation,Software update,Software Update
Z-0570-2008,45447,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.",MultiSET,2,"March 04, 2008", 2008,BD Biosciences,"Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.",DESIGN: Software Design,Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.,N/A,1136,1136 units,"Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.",Terminated,"April 15, 2008",42,1136,Software,Output/Calculation,Software update,Software Update
Z-0574-2008,45881,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.",Stryker Disposable StrykeProbe 32cm Spatula Tip,2,"March 05, 2008", 2008,Stryker Endoscopy,Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.,DESIGN: Device Design,"Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.",N/A,8,8 boxes of 6 units (48 total),Nationwide Distribution.,Terminated,"March 26, 2008",21,8,Not_Computer,N/A,N/A,N/A
Z-0856-2008,46206,"lavage, jet",FQH,Jet lavage.,General Hospital,General Hospital,510(K) Exempt,"Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio",Pulsavac,2,"March 06, 2008", 2008,Zimmer Orthopaedic Surgical Products,Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.,PRODUCTION CONTROLS: Process Control,"Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.",Contact the recalling firm for information,4921,"4,921 Kits","Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia",Open,N/A,N/A,84644,Not_Computer,N/A,N/A,N/A
Z-1182-2008,46877,endoscope and/or accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA",System 83 Plus WasherDisinfector,2,"March 07, 2008", 2008,"Custom Ultrasonics, Inc.","Inadvertent selection of the ""wash"" cycle",DESIGN: Labeling Design,The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire.,N/A,3190,"3,190 units",Worldwide; USA medical facilities and physicians and Canada,Terminated,"September 03, 2009",545,3190,Not_Computer,N/A,N/A,N/A
Z-0946-2008,45861,"system, peritoneal, automatic delivery",FKX,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A",HomeChoice Automated Peritoneal Dialysis Systems,2,"March 07, 2008", 2008,Baxter Healthcare Renal Div,"Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.",DESIGN: Device Design,"Urgent Product Recall letters dated 11/20/07 were sent via first class mail to all of the affected customers, informing them of the potential for overfill if the system is powered down or a power failure occurs during a fill cycle. A Baxter representative will contact the customer to schedule the software update which corects this anomaly. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.Baxter sent a follow-up letter dated 3/17/08 to the consignees, accompanied by a copy of the 11/20/07 letter. The letter reiterated the information in the 11/20/07 letter, emphasizing the serious consequences of an overfill for neonates and young pediatric patients, and providing information describing the symptoms of excess fluid in the abdomen and steps to be taken if the user suspects overfill of a neonate or young pediatric patient. Baxter requested that Baxter be contacted if an overfill should occur so Baxter can perform a complete investigation into the event. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.",N/A,71261,"71,261 units","Worldwide; USA, Australia, New Zealand, China, Hong Kong, the Philippines, Thailand, Asia, Canada, Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Malta, Morocco, The Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Latin America and Japan.",Terminated,"October 26, 2009",598,103490,Software,Device Operation,Software update,Software Update
Z-1196-2008,46784,"pack, hot or cold, disposable",IMD,Hot or cold disposable pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1"" x 8.4"" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219",Icy Hot Heat Therapy ,2,"March 08, 2008", 2008,Chattem Inc,Skin irritation and burns with product usage,DESIGN: Device Design,"The firm initiated its recall on 02/08/2008 by issuing a press release warning the public of the hazard and directing them to stop its use and either return or discard the products. The firm initiated the recall at the retail level on 02/12/2008 by notifying its employee sales force by email, containing a Urgent Medical Device Recall Letter, with instructions to immediately email a copy of the recall letter to each Chattem consignee (wholesalers and direct retail accounts) with sub recall requests.",N/A,666636,"666,636 units (total for Recalls Z-1196-1197-2008)","Worldwide - USA, Canada, and Honduras",Terminated,"October 05, 2009",576,712656,Not_Computer,N/A,N/A,N/A
Z-0186-2008,44911,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA",Allez Spine Laguna Pedicle Screw System,2,"March 11, 2008", 2008,"Allez Spine, LLC","Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.",DESIGN: Device Design,"On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.",Contact the recalling firm for information,317,317,"Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT",Open,N/A,N/A,1578,Not_Computer,N/A,N/A,N/A
Z-1192-2008,46726,"mixer, cement, for clinical use",JDZ,Cement mixer for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.",Stryker VertePort ,2,"March 11, 2008", 2008,Stryker Instruments Div. of Stryker Corporation,Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy),CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.",N/A,953,953 boxes Recalls Z-1192-1195-2008,Nationwide.,Terminated,"December 30, 2008",294,953,Not_Computer,N/A,N/A,N/A
Z-0572-2008,45859,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653",Exactech Biolox ,3,"March 12, 2008", 2008,"Exactech, Inc.","Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm",PRODUCTION CONTROLS: Process Control,"Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.",N/A,10,10,"Distributed to NY, OH and TN.",Terminated,"July 23, 2008",133,10,Not_Computer,N/A,N/A,N/A
Z-1200-2008,45901,"kit, wound dressing",MCY,Elastic bandage.,General Hospital,General & Plastic Surgery,Enforcement Discretion,"Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LJ1, Exu-Dry Large Burn Jacket, Smith & Nephew, Inc.,Largo, Florida",ExuDry Wound Dressing,2,"March 12, 2008", 2008,"Smith And Nephew, Inc. Wound Management Division",Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.,DESIGN: Packaging Design/Selection,"Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH.",N/A,370,370 dressings,"Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.",Terminated,"December 15, 2008",278,47554,Not_Computer,N/A,N/A,N/A
Z-0455-2008,38465,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113",CELLDYN 1800 System ,2,"March 13, 2008", 2008,Abbott Laboratories,Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.,DESIGN: Software Design,"A Product Correction letter was sent to all customers with a reply form on October 27, 2006. Product information letters are being packed with the instrument's accessory kit and with calibrators and quality control products used with the CELL-DYN 1800 System. Correction letters with reply forms have been resent to nonresponding customers.",N/A,4224,"4,224 Systems","Worldwide Distribution, USA and countries of Argentina, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guatemala, Honduras, Hong Kong, China, Japan, Mexico, Paraguay, Puerto Rico, Singapore, South Korea and Venezuela.",Open,N/A,N/A,4224,Not_Computer,N/A,N/A,N/A
Z-0932-2008,46207,"glucose dehydrogenase, glucose",LFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico).",Bayer Contour TS blood glucose test strips,2,"March 13, 2008", 2008,Bayer Healthcare LLC,Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.,PRODUCTION CONTROLS: Process Control,The firm issued a Press Release on 12/21/07. A Test Strip Recall letter was also sent to the firm's consignees and health care providers instructing them that use of the product should cease and that health care providers contact the firm for replacements. Additional information can be found at www.bayerdiabeties.com or by contacting the Bayer at 1-800-348-8100.,N/A,97000,"97,000 bottles of test strips","Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.",Terminated,"July 07, 2009",481,97000,Not_Computer,N/A,N/A,N/A
Z-0933-2008,46293,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.",Wireless footswitch.,2,"March 13, 2008", 2008,"Sound Surgical Technologies, LLC","Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.",DESIGN: Device Design,Consignees were sent an Advisory Notice on 12/28/2007. The notification describes the defect. Sound Surgical will be contacting facilities to arrange a service call to install new cables between the footswitch receiver and the VASER system. Facilities may contact the Technical Service Center at 1-888-677-8765.,Contact the recalling firm for information,127,127 switches,"Worldwide Distribution including USA states of AL, CA, CT, FL, GA, IN, KY, LA, MI, NJ, NY, OH, OK, PA, TX, and VA. Foreign Distribution to Colombia, Costa Rica and Switzerland.",Terminated,"April 01, 2008",19,127,Not_Computer,N/A,N/A,N/A
Z-0717-2008,46349,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah",OEC 7700 Mobile Fluoroscopy System,2,"March 15, 2008", 2008,"GE OEC Medical Systems, Inc",Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.,DESIGN: Device Design,"On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.",N/A,309,"309 systems (Domestic), 101 (Foreign)","Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.",Open,N/A,N/A,466,Not_Computer,N/A,N/A,N/A
Z-0571-2008,45798,"microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity",NQN,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(k),"Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755",Ventana Image Analysis System (VIAS),2,"March 18, 2008", 2008,Ventana Medical Systems Inc,"Incomplete upgrade: The software upgrade from February 1, 2007 may not have beencompleted. This software upgrade adds the algorithm (Slidetype) for thePATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Beginning in 6/07, Ventana Medical Systems, Inc., made phonecalls to labs asking to confirm software version, date of upgrade if available and confirmation of whether site uses 4B5 and Imaging together. A phone script was provided. Customers with systems not ugraded were to upgrade before further use of system. A notification letter dated 8/17/2007 was later sent to VIAS customers advising that the software upgrade from February 1 , 2007 may not have beencompleted on their system. This software upgrade adds the algorithm (Slidetype) for thePATWAY anti-HER-2/neu (4B5) antibody to their VIAS system . This Slidetype is cleared for marketingand is required prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5).The letter also advises that their VIAS and NEXES systems are conneded to the internet which enables this upgrade to beperformed remotely with the support of the Ventana Medical Systems Customer Support Center(CSC). customers are instructed to call the CSC to carry out the upgrade or to schedule aTechnical Applications Specialist (TAS) to assist with the upgrade in their lab. Arrangements for the upgrade are to be made prior to imaging slides stained with PATHWAYanti-HER-2/neu (4B5).",N/A,77,77 devices,Nationwide and Canada,Open,N/A,N/A,77,Software,N/A,Software update,Software Update
Z-1053-2008,46742,"incubator, neonatal",FMZ,Neonatal incubator.,General Hospital,General Hospital,510(k),"Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969",GTIC Globe Trotter IC,2,"March 18, 2008", 2008,"Draeger Medical, Inc.",Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.,DESIGN: Component Design/Selection,"The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com.",N/A,4,4 units,"Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.",Terminated,"May 08, 2008",51,24,Not_Computer,N/A,N/A,N/A
Z-0593-2008,44704,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810",CALAXO,2,"March 19, 2008", 2008,"Smith & Nephew, Inc. Endoscopy Division","Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Smith & Nephew issued an Urgent Product Recall letter via Federal Express to User Facilities, Sales Reps and Distributors on 8/21/07. A second letter was issued on 8/23/07 to correct two errors in model numbers listed in the original letter. Letter issued by FedEx and/or email to OUS contacts.",N/A,2569,2569 units,"Worldwide Distribution - USA, Austria. Belgium, Germany, Denmark, Spain, Finland, France, England, Italy, Portugal, Netherlands, Norway, New Zealand, Sweden, Turkey, Switzerland,China, Hong Kong, Malaysia, Taiwan, Singapore, Thailand, Australia, Canada, Mexico, Colombia, South Africa, Dubai, Venezuela, and Chile.",Open,N/A,N/A,66263,Not_Computer,N/A,N/A,N/A
Z-0620-2008,45479,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.",Zimmer Trilogy Acetabular Shell,2,"March 19, 2008", 2008,Zimmer Inc.,Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.,PRODUCTION CONTROLS: Process Control,"Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.",N/A,31,31,"Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.",Terminated,"May 21, 2008",63,31,Not_Computer,N/A,N/A,N/A
Z-1108-2008,46362,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822",UniCel Dxl Access Immunoassay Systems Reaction Vessels ,2,"March 19, 2008", 2008,Beckman Coulter Inc,Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.,PRODUCTION CONTROLS: Process Control,"A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Accesslmmunoassay System Reaction Vessels lot 1201291 and1201431. The customers were informed that a smallpercentage of the reaction vessels (Lot #s: 1201291and1201431 ) have been found to be defective and there is apotential for an increase in signal leading to an erroneousresult. The customers were instructed to discontinue use anddiscard these lots. A response form was included.",Contact the recalling firm for information,264,264 units in the US; 9 units in Canada,Nationwide & Canada,Open,N/A,N/A,264,Not_Computer,N/A,N/A,N/A
Z-1109-2008,46387,"nad reduction/nadh oxidation, cpk or isoenzymes",CGS,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030",Clinical Chemistry Creatine Kinase,2,"March 19, 2008", 2008,Abbott Laboratories Inc.,"Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On October 12, 2007, A Product Recall letter was provided to all Clinical Chemistry Creatine Kinase Reagent customers that have received lot number 52044HW00 . Customer reply form were included in all US customers letter. The letter instructed customers to discontinue use of the kits and destroy them following their laboratory procedure, and document the number of kits discarded. Abbott will provide reimbursement for destroyed kits.",N/A,498,334 Distributed Worldwide; 164 Domestically,"Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.",Open,N/A,N/A,498,Not_Computer,N/A,N/A,N/A
Z-1054-2008,46743,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.",CIVCO LatexFree Needle Guide,3,"March 19, 2008", 2008,Civco Medical Instruments Inc,Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).,TRAINING: Employee Error,"On 1/16/08, the recalling firm contacted their customers and notified them of the problem. Pictures of the problems were provided for identification. The firm requested that all products be returned.",N/A,207697,Lot M102250 - 5 boxes; Lot M105440 - 2 boxes,Nationwide Distribution- including states of TX and GA,Terminated,"April 03, 2008",15,7,Not_Computer,N/A,N/A,N/A
Z-0130-2008,38336,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.",GreenLight HPS Surgical Laser System,2,"March 20, 2008", 2008,AMS Innovative Center - San Jose,Component missing: Some products were issued without thermal protection switches.,DESIGN: Process Design,"AMS issued Important: Medical Device Correction letters, dated April 17, 2007, to its US and international consignees by mail, instructing them to return an acknowledgement form. The letter informs customers that some HPS systems may lack a motor overload switch, that the firm believes that there is no immediate safety issue, and installation of the MOL switch will be conducted during normal preventive maintenance. AMS expects to complete installation of the switches by end of August 2007.",N/A,169,169 units,"Worldwide Distribution - USA, Italy, France, Germany, Spain, UK, Denmark, Sweden, Australia, India, Japan, Greece, Switzerland, Saudi Arabia, Thailand, Turkey, Singapore, Taiwan/Hong Kong (China), and Austria.",Terminated,"March 23, 2010",733,169,Not_Computer,N/A,N/A,N/A
Z-0621-2008,45854,"prosthesis, hip, hemi-, femoral, metal",KWL,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430",UHR,2,"March 20, 2008", 2008,Stryker Howmedica Osteonics Corp.,Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.,PRODUCTION CONTROLS: Process Control,"Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.",N/A,360,360 total,"Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.",Terminated,"January 27, 2010",678,360,Not_Computer,N/A,N/A,N/A
Z-1142-2008,46685,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.",Medtronic SynchroMed EL ,1,"March 22, 2008", 2008,Medtronic Neuromodulation,"Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d",DESIGN: Device Design,"An Urgent Medial Device Correction letter was sent January 16, 2008, to Health Care Professionals. The letter describes the incidences, symptoms and recommendations for patient management. Excerpts from the approved Medtronic Professional Labeling are also included with the letter. The firm has requested unreported inflammatory mass in a patient with a Medtroinc device to the firm and to the FDA MedWatch Program by phone at 1-800-FDA-1088. Additional assistance may be obtained by contacting Medtronic Neuromodulation Technical Services at 1-800-707-0933.",N/A,205584,"~102,792 worldwide. 90,330 within US and 12,462 OUS","Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.",Open,N/A,N/A,102792,Not_Computer,N/A,N/A,N/A
Z-1367-2008,45950,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401",Phoenix Hemodialysis Delivery System,2,"March 25, 2008", 2008,"Gambro Renal Products, Inc.",Kinked tubing on hemodialysis device may cause hemolysis.,DESIGN: Component Design/Selection,"On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.",Discard product or return to place of purchase for a full refund or exchange,41000000,"41,000,000","Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.",Open,N/A,N/A,41000000,Not_Computer,N/A,N/A,N/A
Z-1042-2008,46245,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355",Magnetom Harmony,2,"March 25, 2008", 2008,"Siemens Medical Solutions USA, Inc","Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.",DESIGN: Software Design,"The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.",N/A,12,12 units,Nationwide Distribution,Open,N/A,N/A,210,Not_Computer,N/A,N/A,N/A
Z-1297-2008,46746,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany",Stryker T7 Locking Screw,2,"March 25, 2008", 2008,Stryker Howmedica Osteonics Corp.,Screws do not have locking threads,PRODUCTION CONTROLS: Process Control,"Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals.",N/A,100,100 units,"Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA.",Terminated,"June 04, 2008",71,100,Not_Computer,N/A,N/A,N/A
Z-1299-2008,46780,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine",AlloCraft DBM ,3,"March 26, 2008", 2008,LifeCell Corporation,Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody),COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.",Return product to place of purchase for a full refund,110,110 kits,"All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.",Terminated,"May 14, 2008",49,156,Not_Computer,N/A,N/A,N/A
Z-1350-2008,46214,osmometer for clinical use,JJM,Osmometer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.",Osmocoll,3,"March 27, 2008", 2008,"Wescor, Inc",Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.",N/A,950,950 vials,"Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.",Terminated,"March 27, 2008",0,1025,Not_Computer,N/A,N/A,N/A
Z-1352-2008,46307,"antigen, c. difficile",MCB,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121",Triage Micro ClostrIdium difficile (C.difficile) Panel,2,"March 27, 2008", 2008,Biosite Inc,False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.,DESIGN: Process Design,"Consignees located in the United States received an Urgent Medical Device Recall Letter notification by United Parcel Service on 12/4/2007 and 12/14/2007. Consignees outside of the United States were notified by Federal Express on 12/4/2007 and 12/14/2007. The Customer Recall Letter with attached fax-back Verification form informed customers of the recall and instructed customers to dicontinue use, discard appropriately all affected kits and complete and FAX the enclosed Verification form. Contact information was also provided form the recalling firm. (USA-(800) 640-0640 ).",Contact the recalling firm for information,4549,"4,549 kits","Worldwide- USA, Argentina, Australia, Belgium, Canada, Switzerland, Colombia, The Czech Republic, Germany, France, Greece, Guatemala, Hong Kong, Croatia, India, Italy, Mexico, Portugal, Sweden, Turkey & The United Kingdom",Open,N/A,N/A,4549,Not_Computer,N/A,N/A,N/A
Z-1356-2008,46783,"nitrophenylphosphate, alkaline phosphatase or isoenzymes",CJE,Alkaline phosphatase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.",Liquid Alkaline Phosphatase Reagent ,2,"March 27, 2008", 2008,"Pointe Scientific, Inc.",May be contaminated with microorganisms.,PRODUCTION CONTROLS: Process Control,"Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.",N/A,32.8,32.8 L,"Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.",Terminated,"June 12, 2009",442,302,Not_Computer,N/A,N/A,N/A
Z-1361-2008,46706,template,HWT,Template for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.",Biomet Vanguard Width Checker ,2,"March 28, 2008", 2008,"Biomet, Inc.",The instrument's sizing line is in the wrong place.,PRODUCTION CONTROLS: Process Control,"Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.",N/A,35,35 (31 to U.S. and 4 international).,"Worldwide: USA, Canada, China and Finland.",Terminated,"June 26, 2009",455,36,Not_Computer,N/A,N/A,N/A
Z-1313-2008,46869,cardiovascular procedure kit,OEZ,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,Enforcement Discretion,"Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible sucker, Catalog No. 804113)","Terumo ""Custom"" Cardiovascular Procedure Kit",2,"March 28, 2008", 2008,Terumo Cardiovascular Systems Corp,Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.",N/A,252,252,"Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.",Terminated,"July 07, 2009",466,1121,Not_Computer,N/A,N/A,N/A
Z-1365-2008,47341,"abutment, implant, dental, endosseous",NHA,Endosseous dental implant abutment.,Dental,Dental,510(k),"BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.",Certain MicroMiniplant Straight Healing Abutment,3,"March 28, 2008", 2008,"Biomet 3i, Inc.",Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.,DESIGN: Device Design,USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.,N/A,270,270,Worldwide,Terminated,"July 07, 2008",101,270,Not_Computer,N/A,N/A,N/A
Z-1050-2008,46351,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052",LIFEPAK 20,2,"March 29, 2008", 2008,"Physio Control, Inc.",Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.,N/A,103,"103 total devices - 84 domestic, 19 international","Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.",Open,N/A,N/A,103,Hardware,Device Operation,Replace device,Remove or Replace
Z-1366-2008,47342,"abutment, implant, dental, endosseous",NHA,Endosseous dental implant abutment.,Dental,Dental,510(k),"BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL",Emergence Profile (EP) Healing Abutment,3,"March 29, 2008", 2008,"Biomet 3i, Inc.",Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform),PRODUCTION CONTROLS: Process Control,"Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.",N/A,254,254,Worldwide,Terminated,"July 10, 2008",103,254,Not_Computer,N/A,N/A,N/A
Z-1349-2008,46889,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI",Agfa IMPAX CardioVascular Suite Results Management ,2,"March 31, 2008", 2008,AGFA Corp.,"Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.",DESIGN: Software Design,"All five (5) sites utilizing this product were notified about the issue directly via telephone. An ""Urgent Safety Notice"" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.",N/A,5,5 units,"Nationwide to five hospitals in DC, NY, OH, TN, and VA.",Terminated,"July 27, 2010",848,5,Software,Output/Calculation,Change configurations,Other
Z-1383-2008,46882,cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system,ODW,Drug metabolizing enzyme genotyping system.,Toxicology,Toxicology,510(k),"Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062",Verigene Warfarin Metabolism Nucleic Acid Test Cartridge,2,"March 31, 2008", 2008,"Nanosphere, Inc.","Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).",PRODUCTION CONTROLS: Process Control,"Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.",N/A,624,624 units,"Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.",Terminated,"May 17, 2010",777,624,Not_Computer,N/A,N/A,N/A
Z-0617-2008,45444,"table, obstetrical, ac-powered (and accessories)",HDD,Obstetric table and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006",HillRom Affinity 4 Birthing Bed; Model P3700B.,2,"April 02, 2008", 2008,"Hill-Rom, Inc.",Brake failure: The brakes may not hold or lock properly.,DESIGN: Component Design/Selection,Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.,N/A,1796,"1,796","Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syria, Turkey, United Arab Emirates and United Kingdom.",Terminated,"October 15, 2010",926,1796,Not_Computer,N/A,N/A,N/A
Z-1107-2008,46350,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138",ACL Workstation slider,2,"April 02, 2008", 2008,Stryker Endoscopy,"Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.",DESIGN: Component Design/Selection,"On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.",N/A,142,142 sliders were distributed.,"Worldwide Distribution - including USA states of South Carolina, Oregon, Michigan, Nebraska, Maryland, California, New Mexico, Ohio, Texas, West Virginia, Massachusetts, and Florida and countries of Canada, Mexico, Hong Kong, Argentina, Brazil, France, Germany, Greece, Spain, India, Italy, Columbia, Switzerland, Poland, Sweden, Australia, and Netherlands.",Terminated,"December 29, 2008",271,142,Not_Computer,N/A,N/A,N/A
Z-1398-2008,46940,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA",Oncor Impression Medical Linear Accelerator,2,"April 02, 2008", 2008,"Siemens Medical Solutions USA, Inc",Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.,DESIGN: Software Design,"This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.",Contact the recalling firm for information,31,31 units,"Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela",Open,N/A,N/A,1646,Computer,N/A,N/A,N/A
Z-0715-2008,45907,"lavage, jet",FQH,Jet lavage.,General Hospital,General Hospital,510(K) Exempt,"Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411",Elefant Suction Irrigation Device,2,"April 03, 2008", 2008,Coloplast Corp,Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.,DESIGN: Process Design,"Coloplast sent customers an ""Urgent: Recall Notification"" letter on 11/12/07. The letter described that the sterilization of the products was not performed according to ISO 11135 standard. The notification requested the customers to return the product immediately and to send a fax or contact the company via email in regard to inventory at hand. A phone script for distributors also included an advice to discontinue dispensing the product and to fax or email in regard to inventory at hand.",N/A,4,4,"Nationwide, including Puerto Rico.",Terminated,"November 04, 2008",215,717,Not_Computer,N/A,N/A,N/A
Z-1387-2008,46912,"heparin, vascular access flush",NZW,Intravascular catheter.,General Hospital,General Hospital,510(k),"Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015",HEP LOCK,2,"April 04, 2008", 2008,Baxter Healthcare Corp.,"Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals.",N/A,76175,"76,175 vials","Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients",Open,N/A,N/A,4603297,Not_Computer,N/A,N/A,N/A
Z-0711-2008,38631,"bur, surgical, general & plastic surgery",GFF,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773",Ultrapower Bur,2,"April 08, 2008", 2008,Linvatec Corp.,Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.,PRODUCTION CONTROLS: Packaging Process Control,"Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.",N/A,1181,1181 units,Worldwide Distribution.,Terminated,"October 01, 2009",541,1181,Not_Computer,N/A,N/A,N/A
Z-0689-2008,46353,"system, endovascular graft, aortic aneurysm treatment",MIH,N/A,N/A,Cardiovascular,N/A,"Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including:AEXC202040, IEXC121255,ILXC1212115,ILXC151585,AEXC222240, IEXC131355,ILXC1212135,ILXC1616115,AEXC242440, IEXC141455,ILXC121285,ILXC1616135,AEXC262640, IEXC151555,ILXC1313115,ILXC161685, AEXC282840, IEXC161655,ILXC1313135,ILXC1620115,BFXC2012135, IEXC162085,ILXC131385,ILXC1620135,BFXC2012165, IEXC181855,ILXC1414115,ILXC1818115,BFXC2213135, IEXC182285,ILXC1414135,ILXC1818135,BFXC2213165, IEXC182485,ILXC141485, ILXC181885, BFXC2414135, IEXC202055,ILXC1515115,ILXC1822115,BFXC2414165, ILXC1515135,ILXC1822135,BFXC2615135, ILXC1824115,BFXC2615165, ILXC1824135,BFXC2816135, ILXC2020115,BFXC2816165, ILXC2020135, ILXC202085; Product is manufactured and distributed by Medtronic, Inc., Santa Rosa, CA 95403",Medtronic,2,"April 08, 2008", 2008,Medtronic CardioVascular,Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.,DESIGN: Packaging Design/Selection,"Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.",N/A,7000,"7,000",Nationwide Distribution.,Terminated,"July 28, 2008",111,7000,Not_Computer,N/A,N/A,N/A
Z-0712-2008,45503,"stimulator, cranial electrotherapy",JXK,Cranial electrotherapy stimulator.,Neurology,Neurology,510(k),"CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024",CES Ultra,2,"April 08, 2008", 2008,Neuro-Fitness LLC,No FDA clearance for the .35Hz/.45Hz frequency option on device.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237.",N/A,3000,"3,000 units",Worldwide Distribution,Open,N/A,N/A,3000,Not_Computer,N/A,N/A,N/A
Z-1317-2008,46398,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.",OneTouch Data Management Software v1.0,3,"April 08, 2008", 2008,Lifescan Inc,Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.,DESIGN: Software Design,"The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.",N/A,260,260 units,"Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.",Terminated,"July 18, 2008",101,260,Software,Device Operation,Uninstall drivers,Other
Z-0585-2008,46251,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.",Laser Surgical Fiber,2,"April 09, 2008", 2008,"Lumenis, Inc.","Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.",PRODUCTION CONTROLS: Error in Labeling,"The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355.",N/A,59,59 units.,MA,Terminated,"April 09, 2008",0,59,Not_Computer,N/A,N/A,N/A
Z-1448-2008,46792,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32"" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.",Zimmer Hemovac Wound Drainage Device Infection Control Kits,2,"April 09, 2008", 2008,Zimmer Inc.,"Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.",PRODUCTION CONTROLS: Process Control,Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.,N/A,34354,"34,354 for Recalls Z-1448/1458-2008","Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.",Terminated,"November 12, 2009",582,34354,Not_Computer,N/A,N/A,N/A
Z-0526-2008,45880,N/A,N/A,N/A,N/A,N/A,N/A,"BD FACS Sample Prep Assistant II, Part Number: 337170;Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131",BD FACS Sample Prep Assistant II,2,"April 10, 2008", 2008,BD Biosciences,Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.,DESIGN: Software Design,"On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.",N/A,N/A,N/A,"Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago.Australia, Belgium, Hong Kong, Trinidad and Tobago.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0586-2008,46317,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Myelotec¶_ Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.",Myelotec Steerable Video Guided Catheter,2,"April 10, 2008", 2008,"Myelotec, Inc.",Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.,PRODUCTION CONTROLS: Error in Labeling,"Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec.",N/A,1252,"1,252 shipping containers","Worldwide Distribution --- USA including states of AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, and OR, and countries of Aurba, Korea, Japan, Switzerland, South Africa, UK.",Terminated,"December 03, 2008",237,1252,Not_Computer,N/A,N/A,N/A
Z-0916-2008,46380,"adhesive, bracket and tooth conditioner, resin",DYH,Bracket adhesive resin and tooth conditioner.,Dental,Dental,510(k),"Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740",Grengloo (Unidose Tips),2,"April 10, 2008", 2008,Ormco Corporation,Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.,DESIGN: Process Design,"Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741.",N/A,4,4 kits (Total US and Internationally),"Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa.",Open,N/A,N/A,4,Not_Computer,N/A,N/A,N/A
Z-0843-2008,45812,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA",Oximeter,2,"April 11, 2008", 2008,"Nonin Medical, Inc",Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.,TRAINING: Employee Error,"An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196.",N/A,240,240,"Worldwide Distribution ---- USA including states of ME, SC, SD, CA, MO, NY, MI, FL, IL, PA, NC, CT, and TX, and countries of Canada, Greece, Russia, Italy, Sweden, Australia, & Japan.",Open,N/A,N/A,240,Not_Computer,N/A,N/A,N/A
Z-0892-2008,46151,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035"" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404",PeelAway Introducer Set,2,"April 16, 2008", 2008,"Cook, Inc.",Packaging Problem: The peel-away sheath does not peel uniformly or completely.,DESIGN: Packaging Design/Selection,"Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.",N/A,1881,"1,881 of total products","Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.",Terminated,"April 15, 2008",-1,1881,Not_Computer,N/A,N/A,N/A
Z-0914-2008,46347,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417.",BD 5 ml Syringe Luer Lok Tip,2,"April 16, 2008", 2008,Becton Dickinson & Company,"Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility.",DESIGN: Packaging Design/Selection,"BD notified distributors by an Urgent Product Recall Letter sent via UPS on January 7, 2008. In addition, the firm sent an Urgent Product Recall Letter on January 11, 2008 to customers identified by the distributors. The letter instructed the users to remove the product from its inventory and to return affected products to the firm using an enclosed customer packing list. For additional information, contact 1-888-237-2762.",N/A,1754100,"1,754,100","Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.",Terminated,"May 19, 2008",33,4680660,Not_Computer,N/A,N/A,N/A
Z-0668-2008,46275,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker GMRS Proximal Femoral Surgical Protocol;Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedics, Mahwah, NJ 07430",GMRS Proximal Femoral Surgical Protocol,2,"April 22, 2008", 2008,Stryker Howmedica Osteonics Corp.,"The GMRS Proximal Femoral Surgical Protocol states "" The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads."" This statement is incorrect and conflicts with the Alumina Head label and packaging insert.",DESIGN: Labeling Design,"Stryker sent Urgent Product Recall notification letters and Product Accountability forms via FedEx on 12/21/2007, return receipt requested. An Urgent Product Recall letter dated 1/7/2008, was sent to surgeons who are GMRS users, advising that the GMRS Proximal femoral components are not compatible with Alumina ceramic heads.",N/A,5869,5869,"Worldwide Distribution - USA, Canada, Mexico, China, Australia, Hong Kong, Singapore, Sweden, Germany, Brussels, the Netherlands, Italy, Poland, Dubai, United Kingdom, Spain, and South Africa.",Terminated,"October 15, 2008",176,5869,Not_Computer,N/A,N/A,N/A
Z-0575-2008,45892,"diagnostic software, k-nearest neighbor algorithm, autoimmune disease",NVI,Amphetamine test system.,Toxicology,Immunology,510(k),"BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547",BioPlex 2200 ,2,"April 22, 2008", 2008,Bio-Rad Laboratories Inc,"Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.",DESIGN: Software Design,"Bio-Rad sent a Voluntary Field Correction notice dated November 1, 2007. Consignees were notified by phone call on Nov. 13, 2007, followed up by facsimile (domestic). Sub-recall to be by e-mail message for consignees outside the US. Distribution of the product ceased on Nov. 2, 2007. Bio-Rad will provide Calibrator Set CDs with only one lot of calibrator assignment values until a new version of software is available.",N/A,85,85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.,"Worldwide Distribution - USA, Canada, France, and Germany.",Terminated,"July 23, 2008",92,101,Software,Output/Calculation,Software update,Software Update
Z-0990-2008,46341,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long ""R"" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-90.",TPS Bur,2,"April 22, 2008", 2008,Stryker Instruments Div. of Stryker Corporation,Lack of assurance of sterility.,DESIGN: Packaging Design/Selection,"Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.",N/A,10588,"10,588 of all products","Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.",Terminated,"December 01, 2009",588,10588,Not_Computer,N/A,N/A,N/A
Z-0661-2008,45410,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA",ACUSON Sequoia Diagnostic Ultrasound System,2,"April 24, 2008", 2008,"Siemens Medical Solutions USA, Inc.","Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia"" system is operating at a software revision below 8.0. 2) The Sequoia"" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective"" advanced display options listed above, an image or clip is t",DESIGN: Software Design,Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.,N/A,280,280,"Worldwide Distribution including the countries of: Australia, Austria, Belgium, Brazil, Brunei, China, Denmark, Finland, France, Germany, Great Britain (UK), Greece, Hungary, India, Iran, Ireland, Italy, Latvia, Netherlands, New Zealand, Romania, Russian Federation, Singapore, Spain, Switzerland, Thailand. U.S customers were not affected.",Open,N/A,N/A,280,Software,Output/Calculation,Software update,Software Update
Z-1055-2008,45545,"ventilator, non-continuous (respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(k),"BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.","BIPAP AUTO, CORE PACKAGE",2,"April 24, 2008", 2008,"Respironics, Inc.",Foreign material: Glass fragments may present in the plastic bag material used to ship components.,PRODUCTION CONTROLS: Environmental Control,The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.,N/A,20950,20950 units,The products were shipped nationwide to medical facilities.,Terminated,"September 01, 2009",495,20950,Not_Computer,N/A,N/A,N/A
Z-1165-2008,46368,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.",Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer,2,"April 24, 2008", 2008,Abbott Laboratories,"Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.",PRODUCTION CONTROLS: Process Control,"On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.",N/A,2746,"2,746 syringes were distributed.","Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.",Open,N/A,N/A,2746,Not_Computer,N/A,N/A,N/A
Z-1102-2008,46150,"radioimmunoassay, vancomycin",LEH,Vancomycin test system.,Toxicology,Toxicology,510(k),"Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.",Seradyn QMS Vancomycin ,2,"April 29, 2008", 2008,"Seradyn, Inc.",False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.,DESIGN: Device Design,"Consignees were notified of the problem via Urgent Medical Device Correction letter dated 12/20/07. The letter provided information on the issues concerning the recall. The firm will revise the package insert to address the potential occurrence of false negative bias. If inconsistencies with Vancomycin level exist, confirm with an alternative test method. For further information please contact 1-800-428-4072.",N/A,3682,"1,819 kits plus bulk material for 1,863 kits.","Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.",Terminated,"December 30, 2008",245,3682,Not_Computer,N/A,N/A,N/A
Z-1038-2008,46360,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355",Leonardo Workstation,2,"April 29, 2008", 2008,"Siemens Medical Solutions USA, Inc",Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.,DESIGN: Software Design,Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.,N/A,47,47 Units,Nationwide Distribution.,Terminated,"September 30, 2008",154,47,Software,Display/Image,Software update,Software Update
Z-0958-2008,45945,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834","Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1",3,"April 30, 2008", 2008,Beckman Coulter Inc,"Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.",DESIGN: Software Design,"Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.",N/A,516,516 units in the US; 73 units in Canada,Worldwide Distribution- USA and country of Canada.,Open,N/A,N/A,516,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0973-2008,46200,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.",Coherence Impression Therapist,2,"April 30, 2008", 2008,"Siemens Medical Solutions USA, Inc","Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im",DESIGN: Software Design,"On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.",N/A,16,16 units,Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.,Terminated,"December 24, 2008",238,94,Not_Computer,N/A,N/A,N/A
Z-0905-2008,46330,"dilator, catheter, ureteral",EZN,Ureteral dilator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760",Pathway Balloon Expandable Ureteral Access Sheath 11/14/28,2,"April 30, 2008", 2008,Boston Scientific Corporation,Sheath Removal Difficulty: Users experience difficulty in removing the sheath.,DESIGN: Device Design,"Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.",N/A,89,89,Nationwide Distribution,Terminated,"October 22, 2008",175,1998,Not_Computer,N/A,N/A,N/A
Z-1037-2008,46358,"attachment, precision, all",EGG,Precision attachment.,Dental,Dental,510(K) Exempt,"Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810",Straumann NC Closure Screw,3,"April 30, 2008", 2008,"Straumann Usa, Llc","Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.",N/A,26,26 units,"Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.",Terminated,"November 06, 2009",555,26,Not_Computer,N/A,N/A,N/A
Z-1106-2008,46340,"mixer, cement, for clinical use",JDZ,Cement mixer for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.",Stryker ACM bowl without cartridge,2,"May 01, 2008", 2008,Stryker Instruments Div. of Stryker Corporation,"Sterility may be compromised, as the packaging may have channels in the packaging seal.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.,Contact the recalling firm for information,25,25 boxes of 6 each,"Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.",Terminated,"July 31, 2008",91,25,Not_Computer,N/A,N/A,N/A
Z-1104-2008,46306,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010",GE Centricity PACS RA1000 Workstation,2,"May 01, 2008", 2008,GE Healthcare Integrated IT Solutions,"Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [",DESIGN: Software Design,"GE Healthcare IITS sent Product Safety Notification letters dated 12/28/07 to all customers who have the GE Centricity PACS RA1000 Workstation software versions 2.1.X, or 3.0.X, informing them of the potential patient safety issue involving the exam notes window, which may be used to provide various patient information including lab results. To mitigate this problem, the users were instructed not to use the following four special characters (greater than sign",N/A,557,557 units,"Worldwide Distribution - USA, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, New Zealand, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.",Terminated,"May 17, 2010",746,557,Software,Output/Calculation,Software update,Software Update
Z-1118-2008,45911,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.",Pregnancy test,2,"May 06, 2008", 2008,Innovacon Inc,"Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.",DESIGN: Labeling Design,"Inverness Medical sent an Urgent Medical Device Alert letter, dated October 1, 2007, to all Innovacon customers for the product via US Postal Service return receipt requested. The field correction notice removed the extended read time of 10 minutes. Customers were instructed to note that although the package insert currently allows interpretation up to 10 minutes, do not read at times greater than 3 minutes for urine and 5 minutes for serum.",N/A,1825480,"1,825,480 units",Nationwide,Open,N/A,N/A,1825480,Not_Computer,N/A,N/A,N/A
Z-1128-2008,46693,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-002.ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within USA).",Intrastent Balloon Expandable Biliary Stent,2,"May 06, 2008", 2008,"Ev3, Inc",Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"ev3 notified all consignees via ""Medical Device Recall"" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the ""Device Recall Field Action Reconciliation Form."".",N/A,70,70,"Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Terminated,"November 04, 2008",182,942,Not_Computer,N/A,N/A,N/A
Z-1119-2008,46346,hepatitis a test (antibody and igm antibody),LOL,Hepatitis A virus (HAV) serological assays.,Microbiology,Microbiology,N/A,"ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.",Siemens Medical Solutions Diagnostics,2,"May 06, 2008", 2008,Siemens Medical Solutions Diagnostics,Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.,N/A,49533,"49,533","Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,49533,Not_Computer,N/A,N/A,N/A
Z-1036-2008,46348,"set, tubing, blood, with and without anti-regurgitation valve",FJK,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109",Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike,3,"May 07, 2008", 2008,"B. Braun Medical, Inc.",Faulty tubing does not prime machine as intended.,N/A,B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.,N/A,956,956 units,Nationwide Distribution.,Terminated,"October 28, 2008",174,2500,Not_Computer,N/A,N/A,N/A
Z-0517-2008,46044,"electrode, ph, stomach",FFT,Stomach pH electrode.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432",Medtronic Bravo pH Capsule with Delivery System,2,"May 07, 2008", 2008,Medtronic Neuromodulation,Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Consignees were notified by an Urgent Device Recall in December 2007. The letter emphasizes to users the current Instructions for Use regarding detachment of the capsule from the deliver system. It advises that users may continue to use the Bravo capsules and delivery systems. It instructs users to discard all copies of the ¶_2005 Bravo pH Monitoring System Interactive Training CD and to use the enclosed ¶_2007 Bravo pH Monitoring System Interactive Training. A ""Bravo Delivery System Disassembly Procedure"" was also provided with the letter. The letter requests consignees to complete and return the reply form included with the notification. For additional information, contact 1-800-707-0933.",N/A,169365,"169,365 individual Bravo capsule and delivery systems have been sold worldwide","Worldwide Distribution -- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan , Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Portugal, Russian Federation, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.",Open,N/A,N/A,169365,Not_Computer,N/A,N/A,N/A
Z-1305-2008,46785,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311","Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in/ 55cm",3,"May 07, 2008", 2008,Boston Scientific Corporation,Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.",N/A,4,4,"Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU, SOUTH KOREA, NZ, TR, TW and ZA.",Terminated,"November 03, 2008",180,94,Not_Computer,N/A,N/A,N/A
Z-1240-2008,46832,"system, test, vitamin d",MRG,Vitamin D test system.,Clinical Chemistry,Clinical Chemistry,510(k),"LIAISON¶_ 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082",LIAISON 25OH Vitamin D Kit,3,"May 07, 2008", 2008,Diasorin Inc.,Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.",N/A,2267,"2,267 kits","Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.",Terminated,"October 31, 2008",177,2267,Not_Computer,N/A,N/A,N/A
Z-1179-2008,46802,"collector, ostomy",EXB,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558","Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mm",3,"May 07, 2008", 2008,ConvaTec,"Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.",N/A,3986,3986 market units,Nationwide Distribution.,Terminated,"October 21, 2008",167,3986,Not_Computer,N/A,N/A,N/A
Z-1141-2008,46414,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.",iSite PACS,2,"May 08, 2008", 2008,"Philips Healthcare Informatics, Inc.","Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.",DESIGN: Software Design,"Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.",N/A,197,197 units,"Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.",Terminated,"October 07, 2009",517,197,Software,Display/Image,Software update,Software Update
Z-1543-2008,47378,"heparin, vascular access flush",NZW,Intravascular catheter.,General Hospital,General Hospital,510(k),"Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe",Heparin I.V. Flush Syringe 100 units/mL,2,"May 09, 2008", 2008,Medefil Incorporated,The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Medefil telephoned the direct accounts on 3/20/08, e-mailed them a copy of the 3/20/08 recall letter on 3/21/08, and sent the accounts a hard copy of the recall letter on 3/24/08. The accounts were informed of Medefil's recall of 19 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0773, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant in the recalled lot of API. The accounts were instructed to stop use of the 19 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact all customers to whom they further distributed the product, telling them to stop use of the product and return the product to Medefil through their supplier. The accounts were requested to complete and return to Medefil via fax the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.",N/A,3151080,"3,151,080 syringes","Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.",Terminated,"April 15, 2010",706,3713040,Not_Computer,N/A,N/A,N/A
Z-1602-2008,47436,"heparin, vascular access flush",NZW,Intravascular catheter.,General Hospital,General Hospital,510(k),"Tyco Healthcare Monoject Prefill 100UlmL HeparinLock Flush Syringe 5mL, withBLUNTIP plastic cannulaREF # 8881591125, Tyco Healthcare, Mansfield, MA 02048",Monoject Prefill 100UlmL Heparin,2,"May 09, 2008", 2008,Covidien LP,"Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement.All customers are required to respond to the notice regardless of remaining inventory..",N/A,21600,"21,600 units",Nationwide Distribution,Open,N/A,N/A,11054984,Not_Computer,N/A,N/A,N/A
Z-0987-2008,46294,"ventilator, non-continuous (respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(k),"AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Cardinal Health, McGaw Park, IL 60085",AirLife Infant nCPAP System Driver,2,"May 14, 2008", 2008,Cardinal Health,Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxillary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min.,DESIGN: Device Design,"Cardinal Health sent an Urgent Medical Device Correction Notice dated 1/4/08 with a list of catalog number and affected serial numbers of the nCPAP Driver, and informed them that the nCPAP Driver may exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min. Customers were instructed to discontinue use of the PTO/Auxiliary port and were provided with a sticker reading ""WARNINIG! DO NOT USE PTO/AUXILIARY PORT"" that must be affixed to each unit in their possession. Sticker placement instructions and photo showing proper placement were provided with the letter. The accounts were informed that future upgrades to this device will eliminate the PTO/Auxiliary port and are expected to be completed in the field by June1, 2008. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their possession. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.",N/A,314,314 units,Nationwide Distribution,Terminated,"January 09, 2009",240,314,Not_Computer,N/A,N/A,N/A
Z-0982-2008,46215,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)",AVEA Ventilator,2,"May 14, 2008", 2008,"Viasys Respiratory Care, Inc.dba Bird Products",Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.",N/A,2,2,"Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.",Terminated,"May 13, 2008",-1,41,Not_Computer,N/A,N/A,N/A
Z-1105-2008,46331,impactor,HWA,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430",Triathlon Baseplate Impactor Extractor,2,"May 14, 2008", 2008,Stryker Howmedica Osteonics Corp.,Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.,DESIGN: Device Design,"Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110.",N/A,293,293 total units,Worldwide Distribution,Terminated,"May 30, 2008",16,293,Not_Computer,N/A,N/A,N/A
Z-1103-2008,46296,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064",White Blood Cell (WBC) ReagentPart A used with the CELLDYN 4000 and CELLDYN Sapphire Systems,2,"May 14, 2008", 2008,Abbott Laboratories,Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.",N/A,113503,"Product was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2","Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and WV, and countries of: Argentina, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Singapore, South Korea and Venezuela.",Terminated,"July 02, 2008",49,3499,Not_Computer,N/A,N/A,N/A
Z-1462-2008,46740,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064",AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0,3,"May 14, 2008", 2008,Abbott Laboratories,"Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.",N/A,1270,"1,270 disks","Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.",Terminated,"December 01, 2009",566,1270,Not_Computer,N/A,N/A,N/A
Z-1624-2008,46801,"device, general purpose, microbiology, diagnostic",LIB,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215",Remel RapID Inoculation Fluid 1ML,3,"May 14, 2008", 2008,Remel Inc,Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.,OTHER/UNDETERMINED: Pending,"Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.",N/A,501,500/1-ml packs,"Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.",Terminated,"July 16, 2008",63,1056,Not_Computer,N/A,N/A,N/A
Z-1461-2008,47401,"forceps, ophthalmic",HNR,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.","Alcon/Grieshaber Morris ILM Forceps, Direct Action",3,"May 14, 2008", 2008,"Alcon Research, Ltd",Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.,DESIGN: Device Design,"Consignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.",N/A,24,24 units,Nationwide Distribution including states of AL and CA.,Terminated,"July 18, 2008",65,24,Not_Computer,N/A,N/A,N/A
Z-1138-2008,46373,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043",syngo US Workplace,2,"May 20, 2008", 2008,"Siemens Medical Solutions USA, Inc.",Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.,DESIGN: Software Design,"Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.",N/A,17,17 units,"Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.",Open,N/A,N/A,17,Software,Output/Calculation,Software update,Software Update
Z-1616-2008,47205,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.",9051 Electrode Adapter,3,"May 21, 2008", 2008,Cardiac Science Corporation,"Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were notified by an Urgent Medical Device Recall letter sent on 01/23/2008. The letter instructs users to check each cable of the affected lot to ensure that it properly connects to the electrode. Users were also instructed to return any defective product to the recalling firm for a replacement. For additional information, contact 1-888-466-8686 x2041.",N/A,58812,Lot W029275 - 24; Lot W029475 - 38,"Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.",Open,N/A,N/A,62,I/O,Device Operation,Check/Replace,Remove or Replace
Z-1614-2008,46905,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.","Fiducial Markers, Sterile (0.9 x 3 mm) Soft tissue gold markers",3,"May 21, 2008", 2008,Med Tec Inc dba CIVCO Medical Solutions,"Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.",N/A,36,33/3-marker pouches,"Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.",Terminated,"July 02, 2008",42,72,Not_Computer,N/A,N/A,N/A
Z-1608-2008,46863,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.",MTAPSD2.4 TypeS Thermoplastic Mask,3,"May 21, 2008", 2008,Civco Medical Instruments Inc,Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.,PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688.,N/A,160,160,"Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.",Terminated,"July 02, 2008",42,160,Not_Computer,N/A,N/A,N/A
Z-1132-2008,46741,"ophthalmoscope, ac-powered",HLI,Ophthalmoscope.,Ophthalmic,Ophthalmic,510(k),"Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008",Keeler All Pupil II Indirect Ophthalmoscope,2,"May 22, 2008", 2008,Keeler Instruments Inc,Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.,DESIGN: Process Design,Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.,N/A,25,25 units,The products were shipped to a distributor in NJ.,Terminated,"August 12, 2008",82,25,Not_Computer,N/A,N/A,N/A
Z-1110-2008,45909,"nadh oxidation/nad reduction, alt/sgpt",CKA,Alanine amino transferase (ALT/SGPT) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188",Liquid ALT ,2,"May 22, 2008", 2008,"Pointe Scientific, Inc.",Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.,PRODUCTION CONTROLS: Process Control,"Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.",Contact the recalling firm for information,955,955 for all products.,"Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.",Terminated,"September 15, 2008",116,955,Not_Computer,N/A,N/A,N/A
Z-1094-2008,45960,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc.",Synchron LX20 Clinical Chemistry System,2,"May 24, 2008", 2008,Beckman Coulter Inc,"Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 orDxC instruments have been related to an intermittent failure of the stirrermotor.-Stirrer motors can stall without any flags or motion errors.-If a stall occurs during a GLUm test near the time of sample inject,results may be affected.-Affected GLUm results may be high or low.",DESIGN: Software Design (Manufacturing Process),"GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.",N/A,344,344 in the US; 26 in Canada,Worldwide Distribution - USA including Canada.,Open,N/A,N/A,2447,Not_Computer,N/A,N/A,N/A
Z-1166-2008,46389,"electrode, ion-specific, chloride",CGZ,Chloride test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064",ICT Calibrator,3,"May 24, 2008", 2008,"Abbott Laboratories, Inc","Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected.The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be bel",DESIGN: Device Design,"An Immediate Action Product Recall dated 9/26/07, was provided to all AEROSET and ARCHITECT cSYSTEM customers that have received Lot Number 0505017. The effectiveness check will be completed through a customer reply form for 100% of US customers. Outside of the U.S. each individual country will determine the methods of effectiveness check.Necessary Actions:If the ICT calibration generates an acceptable slope for (K+), and the calibration is verified by generating QC results within the acceptable range, then the customers may continue to use the lot until a new one is available.If the ICT calibration generates an acceptable slope for (K+) with results below QC range, and (Na+) and (Cl-) are not affected, then they should discontinue use of the Calibrator vials that generate the unacceptable calibration and destroy them following their laboratory procedures.If (Na+) and/or (Cl-) calibration slopes or QC results are not acceptable, additional troubleshooting is required.Questions may be addressed to Abbott Customer Support at 1-877-4ABBOTT.",N/A,1796,"1,377 Distributed Worldwide; 419 Domestically","Worldwide Distribution --- including USA, Puerto Rico and countries of Mexico, Ecuador, Brazil, Canada, Hong Kong, New Zealand, Venezuela, Chile, , Germany, Thailand, Trinidad/Tobago, Columbia, Argentina, El Salvador, Singapore, Australia, and the Bahama.",Open,N/A,N/A,1796,Not_Computer,N/A,N/A,N/A
Z-1644-2008,47526,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029.",EVMS (Enterprise Visual Medical System Software),3,"May 28, 2008", 2008,Emageon,"Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.",DESIGN: Device Design,"Consignees were notified by Urgent Device Correction letters that were sent on 1/9/08 and 1/18/08. The letters instructed users not to use the standard uptake value in EVMS for diagnostic interpretation when viewing PET studies unless they received service bulletin 445, 446 or 7.0.1. Users were also instructed to replace pages in the user's guide with the pages provided and to affix the enclosed warning sticker on all workstations. Users will be contacted by the recalling firm to schedule a software patch.",N/A,99,99,"Nationwide Distribution including states of: MI, WI, CA, MN, AZ, CO, MN, MD, DC, MO, TX, IL, GA, FL, WI, SC, PA, NY, KS, TN, AL and OK.",Terminated,"June 11, 2009",379,99,Software,Output/Calculation,Software/manual update,Software Update
Z-1546-2008,47386,"full field digital,system,x-ray,mammographic",MUE,Full-field digital mammography system.,Radiology,Radiology,N/A,"Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810",The Selenia Full Field Digital Mammography System ,3,"May 28, 2008", 2008,"Lorad, A Hologic, Inc.",Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.,DESIGN: Software Design,"Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.",N/A,73,73 units,Worldwide Distribution including USA and countries of Canada and the Republic of Korea.,Terminated,"February 03, 2009",251,73,Software,Display/Image,Software update,Software Update
Z-1137-2008,45959,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021",Philips MutliDiagnost Eleva FD,2,"May 28, 2008", 2008,Philips Medical Systems North America Co. Phillips,Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional,DESIGN: Software Design,"On 11/29/07 Philips Medical Systems sent a letter dated 11/28/07 to customers stating that if users perform certain image file housekeeping operations, fluoroscopy cannot be performed and new exposures cannot be acquired until those operations are complete. It also instructs that the unavailability of fluoroscopy and exposure can be avoided by not pressing the ""Delete All Images"" button until any pending Autopush operation is complete. FCO 70800067 will be issued to service representatives to install new software.",N/A,9,"9 units were distributed to hospitals in the US, 6 were installed, 3 were not installed or in use.","USA Distribution - CO, MN, NC, NJ and TX.",Terminated,"September 17, 2010",842,9,Software,Display/Image,Software update,Software Update
Z-0580-2008,44725,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591",ADVIA Centaur TnIUltra Assay,2,"June 05, 2008", 2008,Siemens Medical Solutions Diagnostics,Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.",N/A,58818,"Domestic: 31,497 kits; Foreign: 27,321 kits","Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela",Open,N/A,N/A,58818,Not_Computer,N/A,N/A,N/A
Z-1139-2008,46393,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051",AMO VISX STAR Excimer Laser System,2,"June 05, 2008", 2008,"VISX INCORPORATED, A SUBSIDIARY OF AMO INC","Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading (""fully swung out"" unlocked) position under an IntraLase FS laser.",DESIGN: Component Design/Selection,"On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656.",N/A,1853,"1,853 units","Worldwide Distribution - USA, including the states of: AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVand countries of: ArgentinaAustraliaAustriaBahrainBelgiumBoliviaBrazilBulgariaCanadaChileChinaColombiaCosta RicaCyprusCzech RepublicDjiboutiDominican Rep.EcuadorEgyptFinlandFranceGermanyGreat BritainGreeceHong KongIndiaIndonesiaIrelandIsraelItalyJapanJordanKasachstanKuwaitLebanonMalaysiaMartiniqueMexicoMongoliaNetherlandsNew ZealandNorwayOmanPakistanParaguayPhilippinesPolandPortugalRussian Fed.Saudi ArabiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTrinidad,TobagoTurkeyUnit.Arab Emir.VenezuelaVietnam",Terminated,"May 05, 2010",699,1853,Not_Computer,N/A,N/A,N/A
Z-1140-2008,46394,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887",BK Medical,2,"June 10, 2008", 2008,"B & K Medical Systems, Inc.",Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.,PRODUCTION CONTROLS: Process Control,"B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.",N/A,7,7,"USA Distribution: MA, MI, PA, TX, and OR.",Terminated,"June 23, 2008",13,7,Not_Computer,N/A,N/A,N/A
Z-0842-2008,46859,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.",Proteus,2,"June 10, 2008", 2008,GE Healthcare,"The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.",PRODUCTION CONTROLS: Process Control,"GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008.",N/A,400,400 Units,"Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.",Open,N/A,N/A,400,Not_Computer,N/A,N/A,N/A
Z-1712-2008,47335,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"U9 Socket Integrated Circuit (""U9 IC"") on the display board of the following Alaris System modules built on or before October 4, 2005:(1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module)(2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130",(1) Alaris Syringe module Model 8110 & Syringe Module 8120,2,"June 10, 2008", 2008,Cardinal Health 303 Inc DBA Alaris Products,"A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module (""Syringe module"") and Alaris PCA module (""PCA module"") for modules manufactured on or before October 4, 2005. The user will be required to re",DESIGN: Device Design,"An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all include Required Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.",N/A,8286,"8,286 units","Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WY, Guam and country of Canada.****CDRH Comments: ""Note for District Office to follow-up"" The firm has not provided a grand total of devices affected by these problems. It is possible that devices suffering from U19 & U9 problems may also experience IUI problems. This recall has 3 problems with 6 modules. One problem affects only 2 modules, one problem affects 6 modules. For simplicity and expediency, CDRH agrees to keep the file as is, rather than separate into 6 products and have complicated explanations of the problems.77,515 devices affected by IUI problem.85,286 devices affected by U19 problem.8,286 devices affected by U9 problem. ****",Open,N/A,N/A,171087,Hardware,Device Operation,Notification,Safety Notice/Insructions
Z-1178-2008,46795,"scissors, general, surgical",LRW,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5"", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalog #SSI-0003",Sterile OR Scissors,2,"June 11, 2008", 2008,Cardinal Health,The product has the potential of being non-sterile.,PRODUCTION CONTROLS: Process Control,"Cardinal Health notified the accounts who ordered the affected scissors via letter dated 2/12/08, informing them that the scissors that were labeled sterile were subject to a sterility test failure. Upon review of the letter, the accounts were requested to inspect their inventory and immediately segregate any affected product and to telephone Cardinal Customer Sales Operations Group at 1-800-766-0706 for return instructions and to obtain credit/replacement. Any questions were directed to Cardinal's Quality Systems, Professional Services at 800-292-9332.",N/A,16,16 cases,USA Distribution: Kansas and Missouri,Terminated,"October 16, 2008",127,16,Not_Computer,N/A,N/A,N/A
Z-1158-2008,45875,"epstein-barr virus, other",LSE,Epstein-Barr virus serological reagents.,Microbiology,Microbiology,510(k),"BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.",BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte,2,"June 11, 2008", 2008,Bio-Rad Laboratories,False negative results due to reagent packs exhibiting low signal.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.",N/A,996,996 kits,"Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.",Open,N/A,N/A,11616,Not_Computer,N/A,N/A,N/A
Z-1176-2008,46745,"sucker, cardiotomy return, cardiopulmonary bypass",DTS,Cardiopulmonary bypass cardiotomy return sucker.,Cardiovascular,Cardiovascular,510(k),"CalMed Pericardial Sump, with 1/4""/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626",Pericardial Sump ,2,"June 11, 2008", 2008,California Medical Laboratories Inc,"Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.",PRODUCTION CONTROLS: Process Control,"CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall forCorrection: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same.The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes ofissuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.",N/A,31124,"31,124 units of all models","Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.",Open,N/A,N/A,31124,Not_Computer,N/A,N/A,N/A
Z-1155-2008,44884,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201",GE LOGIQ 3 Expert ,2,"June 12, 2008", 2008,GE Healthcare Clinical Systems,"Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"GE sent consignees a ""GE Urgent Medical Device Correction"" letter dated 8/14/07. The letter informed the customers about the problem, offer a short-term workaround and informed them that a representative will schedule a visit to upgrade the software.",N/A,62,62,"Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic.",Open,N/A,N/A,62,Software,Display/Image,Software update,Software Update
Z-1168-2008,46691,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Trident Hemispherical Solid BK Acetabular Shells;42mm to 74mm, Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430",Trident,2,"June 12, 2008", 2008,Stryker Howmedica Osteonics Corp.,Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.,DESIGN: Process Design,"Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt.The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.",N/A,129312,"129,312 total shells, all Trident hemispherical types",Nationwide distribution.,Open,N/A,N/A,149694,Not_Computer,N/A,N/A,N/A
Z-1180-2008,46716,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086",da Vinci S Surgical System,2,"June 12, 2008", 2008,"Intuitive Surgical, Inc.","Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.",DESIGN: Software Design,"Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.",N/A,9,9 units,"USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA",Terminated,"August 15, 2008",64,9,Not_Computer,N/A,N/A,N/A
Z-1161-2008,46204,"system,network and communication,physiological monitors",MSX,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.",S/5 iCentral,2,"June 24, 2008", 2008,GE Healthcare,Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.,DESIGN: Device Design,"Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the ""connection to monitor loss"" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled ""How to ensure a 'Connection to monitor lost' alarm on iCentral."" For additional information, contact 1-800-558-7044.",N/A,2146,2146,"Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Guans, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen.",Open,N/A,N/A,2146,Software,Alarm/Message,Instructions,Safety Notice/Insructions
Z-0189-1,2263,N/A,N/A,N/A,N/A,N/A,N/A,"Immunosimplicity brand anti-SSA Test kit, Catalog 720-250, Each Kit contains reagents for 96 tests including Antigen Wells, Calibrator vial, Negative Controls, Positve Contrals, Sample Diluent and Was Concentrate, Conjugate, Substrate, Stop Solution. Catalog # 720-250",N/A,3,"June 25, 2008", 2008,DIAMEDIX CORP.,Unexpected equivocal/weak positive results,N/A,"The firm notifed both clients on 3/21/03 during their service telephone/e-mail communications to correct the problem, and they were given a correction work around. A software patch was installed at both clients on 6/25/2003. .",N/A,113,113,"Product was distributed to 18 domestic (user accounts, e.g. labs) in TN, GA, NY, MS, OH, PA, AL, CA, VA, KY, CA, MO, HI, AND TO 5 international accounts as follows: Delta Biologicals, Cipollia and Zanetti, Fiumicino Airport, Roma, Italy; Movaco, S.A.,Iberconco S.A., Loading terminal office NR-9, Barcelona Airport, Spain; Rochem Biocare Columbia S, Deposito Snider y Cia, S.A., Sant Fe de Bogota, Colombia;",Open,N/A,N/A,113,Computer,N/A,N/A,N/A
Z-1160-2008,45955,"radioimmunoassay, immunoreactive insulin",CFP,Immunoreactive insulin test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318.",Access Ultrasensitive Insulin Assay Kit,2,"June 25, 2008", 2008,Beckman Coulter Inc,False negative results when used to test serum samples (as compared to plasma samples).,PRODUCTION CONTROLS: Process Control,"On September 19, 2007, Beckman Coulter mailed to its consignees an Urgent Product Corrective Action Letter informing them that the affected lots of the product were giving false negative results when used to test serum samples (as compared to plasma samples). The letter instructed consignees to discontinue using the affected lots of the product, and to re-test using an EDTA plasma sample if there was any discordance between the results of the serum sample (if it was obtained using an affected lot of the product) as compared with the clinical presentaion of the patient and the results of other diagnostic tests. The letter also instructed consignees to return, within 10 days, the Response Sheet .",N/A,332,"8,205 units in the US; 332 in Canada",Worldwide: including USA and Canada.,Open,N/A,N/A,8537,Not_Computer,N/A,N/A,N/A
Z-1163-2008,46280,"bag, reservoir",BTC,Reservoir bag.,Anesthesiology,Anesthesiology,510(K) Exempt,"3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number DYNJ09422, Anesthesia Kit-LF; 2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand; 3) Item Number 00-GS2675K, Pacemaker Kit; 4) Item Number ACC010004A, Anesthesia Drawer 6; 5) Item Number ACC010015, Anesthesia Drawer 8; 6) Item Number ACC010015A, Anesthesia Drawer 8; 7) Item Number ACC010031, Anesthesia Case Cart Drawer 6; 8) Item Number ACC010036, Anesthesia Drawer 6; 9) Item Number ACC010056, Anesthesia Cart Drawer 6; 10) Item Number CDS760048M, D&C; CDS; 11) Item Number CDS760050L, Vag Hyster CDS; 12) Item Number CDS760054F, Laparoscopy CDS; 13) Item Number CDS780080J, Major Spinal CDS; 14) Item Number CDS780081G, Minor Spine CDS-LF; 15) Item Number CDS780127C, Lumbar CDS; 16) Item Number CDS780150A, Craniotomy CDS-LF; 17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF; 18) Item Number CDS840144B, Open Heart CDS; 19) Item Number CDS840270C, Carotid CDS; 20) Item Number CDS840325B, Major Vascular CDS; 21) Item Number CDS840336A, Heart-LF; 22) Item Number CDS840337A, Vascular Minor CDS-LF; 23) Item Number CDS840338A, Carotid Endarectomy CDS-LF; 24) Item Number CDS840384A, Open Heart CDS; 25) Item Number CDS840429, Arrowhead Open Heart CDS; 26) Item Number CDS840463A, Accessory Pack; 27) Item Number CDS840494, AV Fistula CDS; 28) Item Number CDS860094C, Laparoscopic Colon Resection; 29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF; 30) Item Number CDS860159, Major ABD Procedure CDS-Pack A; 31) Item Number CDS860159A, Major ABD Procedure CDS; 32) Item Number CDS860160A, Minor ABD Procedure CDS; 33) Item Number CDS860161, Lithotomy Major CDS; 34) Item Number CDS860161A, Lithotomy Major CDS; 35) Item Number CDS860200, Lap Appy Kit; 36) Item Number CDS860200A, Lap Appy Kit; 37) Item Number CDS860201, Lap Chole Kit; 38) Item Number CDS860201A, Lap Chole Kit; 39) Item Number CDS860202, Lap Nissen Kit; 40) Item Number CDS860202A, Lap Nissen Kit; 41) Item Number CDS920108C, Laparoscopy CDS; 42) Item Number CDS930145C, Lap Chole CDS; 43) Item Number CDS930178F, Lap Chole Somc CDS-LF; 44) Item Number CDS930183A, Lap Chole CDS-LF; 45) Item Number CDS930208B, Lap Chole CDS; 46) Item Number CDS940836B, Shoulder CDS; 47) Item Number CDS940836C, Shoulder CDS; 48) Item Number CDS940837B, Knee CDS; 49) Item Number CDS940844C, Shoulder Arthroscopy CDS; 50) Item Number CDS940859C, Arthroscopy CDS-LF; 51) Item Number CDS940896F, Arthroscopy CDS; 52) Item Number CDS940900F, Shoulder CDS; 53) Item Number CDS941067A, Knee Replacement Total-LF; 54) Item Number CDS941068B, Total Hip CDS-LF; 55) Item Number CDS941248, Extremity Ortho CDS; 56) Item Number CDS941248A, Extremity Ortho CDS; 57) Item Number CDS941325, Dr Zeegan Total Hip Encino; 58) Item Number CDS941326, Dr Zeegan Total Hip Encino; 59) Item Number CDS980153B, Basic CDS; 60) Item Number CDS980211C, O.R. Turnover Kit; 61) Item Number CDS980228K, Breast Biopsy CDS; 62) Item Number CDS980232L, Plastic CDS; 63) Item Number CDS980395, D&C;/Vaginal Minor CDS-LF; 64) Item Number CDS980510D, Neuro Associates Laminectomy; 65) Item Number CDS980701, Shoulder Arthroscopy Procedure; 66) Item Number CDS980702, Knee Arthroscopy Procedure; 67) Item Number CDS980703, Extremity Procedure; 68) Item Number CDS980704, Spine Procedure; 69) Item Number CDS980749, Minor CDS; 70) Item Number CDS980794, Lithotomy CDS; 71) Item Number CDS980796, Knee Arthroscopy CDS; 72) Item Number CDS980797, Gyn Abd CDS; 73) Item Number CDS980798, C-Section CDS; 74) Item Number CDS980799, Lap Chole CDS; 75) Item Number CDS980800, Hand CDS-Dr Casey; 76) Item Number CDS980801A, Lap Gastric CDS; 77) Item Number CDS980817, Total Hip CDS; 78) Item Number CDS980818, AV Fistula CDS; 79) Item Number CDS980819, Knee Arthroscopy CDS; 80) Item Number CDS980820, Shoulder Arthroscopy CDS; 81) Item Number CDS980821",3 Liter LatexFree Breathing Bag,2,"June 25, 2008", 2008,Medline Industries Inc,Separation from Bushing: The breathing bag may separate from the bushing during use.,DESIGN: Device Design,"Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label ""INSPECTED."" For additional information, contact 1-866-359-1704.",N/A,436750,"436,750 bags",Nationwide Distribution.,Terminated,"October 16, 2008",113,571500,Not_Computer,N/A,N/A,N/A
Z-1229-2008,46281,N/A,N/A,N/A,N/A,N/A,N/A,"INTELECT ADVANCED, Model No. 2772MC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.",INTELECT ADVANCED,2,"June 25, 2008", 2008,Chattanooga Corp Inc,Device malfunction: causing electric shock and burn.,DESIGN: Device Design,"Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.",N/A,2002,2002 units,Worldwide Distribution - including USA,Terminated,"February 19, 2010",604,22000,Computer,N/A,N/A,N/A
Z-1236-2008,45946,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA,Solar PureFix HA Soulder Humeral Stem,2,"June 26, 2008", 2008,Stryker Howmedica Osteonics Corp.,Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.,PRODUCTION CONTROLS: Process Control,"On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product.",N/A,915,915 units,Nationwide - USA,Terminated,"January 25, 2010",578,915,Not_Computer,N/A,N/A,N/A
Z-1188-2008,46397,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614",Reusable Ohmeda Compatible Finger Clip Sensor,2,"June 26, 2008", 2008,Kentec Medical Inc,"Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consignees were notified via telephone on 5/18/07 and an ""Important Voluntary Market Withdrawal Notice"" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an ""Acknowledgement of Market Withdrawal Notification"" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996.",N/A,41,41,"Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.",Open,N/A,N/A,41,Hardware,Device Operation,Return,Remove or Replace
Z-1241-2008,46381,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.",Agfa HeartLab Cardiovascular DICOMstore ,2,"June 27, 2008", 2008,AGFA Corp.,MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.,N/A,"On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an ""Urgent Medical Device Correction"" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.",N/A,43,43 units,"Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.",Terminated,"August 04, 2008",38,43,Software,Output/Calculation,Software update,Software Update
Z-1242-2008,46382,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891",Agfa Heartlab Cardiovascular Results Management Product,2,"June 27, 2008", 2008,AGFA Corp.,Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.,N/A,"On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.",Contact the recalling firm for information,6,6 units,"Nationwide Distribution -- USA including states of GA, NH, NY and TX",Terminated,"October 10, 2008",105,6,Other,Output/Calculation,Upgrade,Repair
Z-1606-2008,47518,"total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer",MTF,N/A,N/A,Immunology,N/A,"Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714",Dimension Total Prostate Specific Antigen Flex Reagent Cartridge,2,"June 28, 2008", 2008,Siemens Healthcare Diagnostics Inc.,False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.,DESIGN: Device Design,"The recalling firm issued a letter (Urgent Field Safety Notice) dated 3/25/08 to inform their customers to discontinue use of any remaining inventory, retest using an alternate lot for those samples from post-prostatectomy patients which recovered positive TPSA results less than 1.0 ng/nL. The firm has requested that you call the them for no-charge replacement product at 1-800-441-9250 and/or for technical assistance.",N/A,1631,1631 cartons,"The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE",Terminated,"October 15, 2008",109,1631,Not_Computer,N/A,N/A,N/A
Z-2196-2008,48655,"system, simulation, radiation therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(k),"Update Instructions ""TH003/08/S"" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems;Part Number: 5488460; Product is manufactured and distributed by Siemens Medical Solutions, Oncology Care System,4040 Nelson Ave, Concord CAThe product is indicated for use in Radiation therapy simulation.","Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems",2,"June 28, 2008", 2008,"Siemens Medical Solutions USA, Inc","The firm sent an Update Instruction, ""TH003/08/S"" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.",DESIGN: Software Design,"On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.",N/A,300,300 units,Worldwide and Nationwide,Open,N/A,N/A,300,Software,Physical Safety Hazards,Software update,Software Update
Z-1167-2008,46408,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.",Zoll E Series Defibrillator with 12 Lead ECG,2,"June 28, 2008", 2008,"ZOLL Medical Corporation, World Wide Headquarters","Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.",DESIGN: Software Design,"Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011.",N/A,5018,"5,018 units","Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA.",Open,N/A,N/A,5018,Software,Output/Calculation,Software update,Software Update
Z-1306-2008,46812,"system, digital image communications, radiological",LMD,Medical image communications device.,Radiology,Radiology,510(K) Exempt,"IMPAX¶_ 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.","IMPAX Network Gateway Server, License Key",2,"July 01, 2008", 2008,AGFA Corp.,"Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.",N/A,12,12 units,"Nationwide Distribution - USA, including states of CA, GA, IA and SD.",Terminated,"July 21, 2010",750,12,Other,N/A,N/A,Other
Z-1248-2008,46679,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Edwards Lifesciences LLC, Irvine, CA 92614.",Edwards LifeStent FlexStar Biliary Stent System,2,"July 02, 2008", 2008,"Edwards Lifesciences, Llc","Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.",Contact the recalling firm for information,678,"Lot #FR6G0122 - 3 UNITS, FR6G0123 - 2 UNITS, FR6H0193 - 4 UNITS, FR6H0201 - 6 UNITS",Nationwide Distribution,Open,N/A,N/A,4497,Not_Computer,N/A,N/A,N/A
Z-1307-2008,46813,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning. AGFA Corp., Greenville, South Carolina 29601","IMPAX 4.5, IMPAX 5.0 OT3000 Orthopedic Client, IMPAX 5.0 Orthopedic Client, IMPAX ES for Radio",2,"July 02, 2008", 2008,AGFA Corp.,Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.,DESIGN: Software Design,"On 2/15/07, AGFA notified their consignees of the situation by sending them ""Urgent Medical Device Correction"" letters, instructing them on how to work around the problem until the firm was able to install the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgraded software had been installed at all affected sites.",N/A,879,879 units,"Worldwide Distribution - USA including states of AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, KS, MA, MD, ME, MI, NC, NJ, NV, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA and WA, and country of Canada.",Terminated,"June 30, 2009",363,879,Software,Output/Calculation,Software update,Software Update
Z-1314-2008,47210,"collector, ostomy",EXB,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.",GentleTouch System Postoperative Kit,3,"July 02, 2008", 2008,ConvaTec,"Mislabeled: The carton label reads ""For postsurgical use following a urostomy procedure."" It should read ""For postsurgical use following a colostomy or ileostomy procedure.""",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified by an Urgent Product Recall letter sent on 3/7/08. The letter instructed users to return any unused affected product to the recalling firm for a credit. For additional information, contact 1-800-422-8811.",N/A,9299,"9,299 units",Worldwide Distribution including USA and country of Canada.,Terminated,"October 21, 2008",111,9299,Not_Computer,N/A,N/A,N/A
Z-0670-2008,45800,"flowmeter, blood, cardiovascular",DPW,Cardiovascular blood flowmeter.,Cardiovascular,Cardiovascular,510(k),"Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007",Parks Medical Ultrasonic Doppler Flow Detector,3,"July 03, 2008", 2008,Parks Medical Electronics Inc,Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.,PRODUCTION CONTROLS: Process Control,"811-B: On 9/28/07 Parks Medical Electronics notified their related U.S. distributor, Parks Medical Electronics Sales, Inc., Las Vegas, NV by email instructing them to stop further shipments. On 10/1/07 firm followed up with phone call instructing all units be returned for rework. On 11/8/07 firm sent replacement units accompanied with a Warranty Exchange Letter to their other U.S. customers notifying them of affected units. Letters were customized for each customer with a fill-in-the-blank of the model and serial numbers. Letters and replacement units were sent UPS 2nd Day Air and informed customer about the assembly error and instructions for returning the defective units. On 11/8/07 emails were sent to Brazilian and Australian distributors informing about assembly error and affected units. Rework instructions and a schematic were provided by email for each distributor to perform their own rework. On 11/28/97 Canadian customers were sent Warranty Exchange Letters and replacement units via UPS Ground.Firm is retrieving units from US and Canadian firms and will rework them. Firm is waiting to hear whether Brazilian or Austraian distributors need to sub-recall. Canadian distributors instructed to conduct subrecall if needed.All returned units will be reworked by disassembly of unit, removal of affected printed circuit board, washing board to remove acid flux, and testing.",N/A,122,"122 units distributed to: 9 hospitals, 5 distributors, 5 veterinary clinics/hospitals, 1 veterinarian college. U.S., Canada, and Australia","Worldwide Distribution - USA, Brazil, Australia, and Canada",Open,N/A,N/A,162,Hardware,N/A,Rework/Replace,Repair
Z-1779-2008,47833,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips ""HeartStart On Site Defibrillator"" and outside the U.S. by Philips with the brand name Philips ""HeartStart Defibrillator"". The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.",HeartStart defibrillator,2,"July 09, 2008", 2008,Philips Medical Systems,"Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.",DESIGN: Component Design/Selection,"Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. ""If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate."" 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. ""As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers."" 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).",N/A,3959,"3,959 units","Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.",Open,N/A,N/A,4596,Not_Computer,N/A,N/A,N/A
Z-2016-2008,46287,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 with UPS, Automated differential cell counter; Part Number: 626553; Beckman Coulter; Miami, FL 33196.",FC 500 with UPS,2,"July 11, 2008", 2008,Beckman Coulter Inc,"Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.",DESIGN: Software Design,Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.,N/A,445,445 units in the US; 56 units in Canada,Worldwide Distribution including USA and country of Canada.,Open,N/A,N/A,445,Software,Display/Image,Notification,Safety Notice/Insructions
Z-1315-2008,46806,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.",Fabius GS Anesthesia Machine,2,"July 16, 2008", 2008,"Draeger Medical, Inc.","Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.",Contact the recalling firm for information,196,196 UNITS,Nationwide Distribution.,Terminated,"September 09, 2008",55,196,Not_Computer,N/A,N/A,N/A
Z-1235-2008,46833,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.",InFast Ultra Transvaginal Bladder Neck Support System,2,"July 16, 2008", 2008,American Medical Systems,"Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.",PRODUCTION CONTROLS: Process Control,"All customers received phone calls on 1/28/08 explaining the error and associated risks and were followed up with detailed letters. The letter ""AMS Important Product Recall"" dated 1/28/08 described the product and problem. Customers were advised to return the enclosed ""Recall Acknowledgement Form"" to AMS along with any affected product that they have in inventory.",Contact the recalling firm for information,N/A,N/A,Nationwide Distribution.,Terminated,"October 13, 2010",819,N/A,Not_Computer,N/A,N/A,N/A
Z-1379-2008,46947,"attachment, breathing, positive end expiratory pressure",BYE,Positive end expiratory pressure breathing attachment.,Anesthesiology,Anesthesiology,510(k),"Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.",Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System,2,"July 16, 2008", 2008,"Smiths Medical ASD, Inc.",Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Consignees were notified on 2/26/08 via telephone to place the affected products on hold pending further instruction from the recalling firm. A follow-up letter was issued on 3/4/08 advising consignees to return any product in stock for a replacement or credit. Distributors were requested to provide their customer lists to the recalling firm in order to notify their customers of this recall.,N/A,650,650,"Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.",Open,N/A,N/A,846,Not_Computer,N/A,N/A,N/A
Z-1381-2008,47219,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.",Scorpio Total Knee Cruciate Retraining Femoral Component,3,"July 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.",PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.,N/A,7,7 units,"Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.",Terminated,"July 16, 2008",0,12,Not_Computer,N/A,N/A,N/A
Z-1233-2008,46800,"lift, patient, ac-powered",FNG,AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board",BHM Medical Infrared (IR) Hand Control System,2,"July 18, 2008", 2008,"Arjo, Inc.",The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.,DESIGN: Device Design,"Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating the number of units requiring correction.",N/A,25,25 units,Nationwide Distribution.,Terminated,"September 11, 2010",785,25,Not_Computer,N/A,N/A,N/A
Z-1917-2008,48084,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.,Lithium Heparin,2,"July 18, 2008", 2008,Celsus Laboratories Inc,Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Celsus notified their customers by e-mail on April 24, 2008, explaining that oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. Celsus recommended the device manufacturers quarantine material from the specified lots.",N/A,211818,"HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g","Worldwide Distribution. The Lithium Heparin was sold to companies in USA (Nebraska, New Jersey, Ohio), Puerto Rico, Austria, and Denmark.",Open,N/A,N/A,49880,Not_Computer,N/A,N/A,N/A
Z-1308-2008,46814,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.,8596SC Intrathecal Catheter Pump Segment Revision Kit,2,"July 22, 2008", 2008,Medtronic Neuromodulation,Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by an Urgent Medical Device Recall letter sent in January 2008. The letter informed users that the recalling firm would contact them regarding removing the affected products from their inventory. Users were requested to return a response form indicating the number of affected product. For additional information, contact 1-800-707-0933.",N/A,18,18,"Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.",Terminated,"October 08, 2010",808,18,Not_Computer,N/A,N/A,N/A
Z-1473-2008,47225,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.,Medline EndurO2 Oxygen Concentrator with Oxygen Monitor,2,"July 23, 2008", 2008,Medline Industries Inc,"Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.",DESIGN: Device Design,"Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.",No consumer action necessary,N/A,N/A,Nationwide Distribution,Terminated,"June 17, 2010",694,N/A,Hardware,Device Operation,Replace/Return,Remove or Replace
Z-1479-2008,46888,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.,Sequoia Spinal System Surgical Kits,2,"July 23, 2008", 2008,Abbott Spine,"Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)",DESIGN: Device Design,The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur.,N/A,38,38 surgical kits.,"Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.",Terminated,"July 28, 2008",5,38,Not_Computer,N/A,N/A,N/A
Z-1902-2008,47409,"pump, blood, cardiopulmonary bypass, non-roller type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),Levitronix CentriMag Back-Up ConsoleArticle Number: 201-30200; extracorporeal blood circulation system.,Levitronix CentriMag,1,"July 23, 2008", 2008,"Levitronix, Llc",Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit,DESIGN: Device Design,"Levitronix issued an Urgent - Voluntary Device Correction letter on 3/17/08 mailed to the US distributor and requested to contact their accounts. The letter revises the warning in the CentriMag Console Manual. Levitronix is issuing revised manuals.On March 13, 2008 the firm emailed and mailed (FedEx) to the one Canadian Hospital and Health Canada was informed of the Voluntary Advisory Notice via email on Wednesday, March 19, 2008.Rest of the World: Wednesday, March 12, 2008 throughMonday, March 17, 2008. The Notice was issued as aVoluntary Advisory Notice after review and follow up with theUK MHRA. On 7/24/08 the firm issued a revised Recall Letter to advise users not to use Valley Lab Force FX-C or SSE2L Electrosurgery device with the firm's CentriMag Blood Pumping System and include the significant risk to health. The firm revised their letter and Black Box Warning and reissued the letters to the hospital, surgeons, etc. on 7/24/08.On 2/5/09 the firm issued a ""Follow-Up to Urgent Device Correction of 3/17/08 "" to advise users of the software upgrade to be installed in the CentrigMag Primary software Version 3.0 and CentriMag Back Up console , software version 2.0. Site visits will be made by Levitronix between Feb 2009 and April 2009 , software upgrade installed and new Operating Manuals provided.",Contact the recalling firm for information,237,237 units,"Worldwide Distribution: USA, Canada, Switzerland, UK, Italy, France, Greece, Spain, Slovenia, Czech, Turkey, South Africa, Argentina, Chile, Panama, Singapore, Taiwan, Israel, and Saudi Arabia.",Terminated,"July 06, 2010",713,867,Not_Computer,N/A,N/A,N/A
Z-1372-2008,46212,"drape, surgical",KKX,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.",Vascular Drape,2,"July 23, 2008", 2008,"OEC Medical Systems, Inc",No Premarket Notification: Product does not have FDA 510(k) approval for use.,PREMARKET APPROVAL: No Marketing Application,"Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378.",N/A,158,158 units,"Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.",Terminated,"July 22, 2008",-1,158,Not_Computer,N/A,N/A,N/A
Z-1923-2008,48100,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532",Medtronic Carmedacoated,2,"July 24, 2008", 2008,Medtronic Perfusion Systems,"Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.",Contact the recalling firm for information,12,12 US,"Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.",Open,N/A,N/A,844,Not_Computer,N/A,N/A,N/A
Z-1566-2008,47203,"calibrator, primary",JIS,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),AxSYM Ultrasensitive hTSH II Master CalibratorsMicroparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.,AxSYM Ultrasensitive hTSH II Master Calibrators,2,"July 24, 2008", 2008,"Abbott Diagnostic International, Ltd.",High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.",Contact the recalling firm for information,882,882 total units,"Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.",Open,N/A,N/A,882,Not_Computer,N/A,N/A,N/A
Z-1571-2008,47253,"system, radiation therapy, charged-particle, medical",LHN,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.,Diagnostic Ultrasound Unit,3,"July 24, 2008", 2008,Hitachi Medical Systems America Inc,Miscalculation reading. A software error in the firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans.,DESIGN: Software Design,"A Device Correction Letter was issue by the firm on 02/25/2008. The letter asks the affected customers not to use the value of ICA/CCA on the Measurement Report for diagnosis, but instead to follow the Immediate countermeasure detailed in the 'Note in Use' document which accompanies the Device Correction letter. The customers are asked to follow the Immediate Countermeasure until they receive a Temporary Countermeasure to correct the ICA/CCA ratio calculation. The Temporary Countermeasure will include: 1) a Disk to import a new carotid measure package; 2) an Installation booklet detailing how to import the new carotid measurement package and optional customization tools; and 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software revision, service personnel will replace the software at each customer location.",N/A,20,20 units,"Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.",Open,N/A,N/A,20,Software,Output/Calculation,Software update,Software Update
Z-1376-2008,46708,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464.",Biomet Vanguard DCM CR Tibial Bearing,2,"July 25, 2008", 2008,"Biomet, Inc.","Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.",PRODUCTION CONTROLS: Packaging Process Control,"Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.",N/A,8,8,Worldwide: USA and Australia,Terminated,"December 22, 2009",515,12,Not_Computer,N/A,N/A,N/A
Z-1572-2008,47400,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Triathlon TS Femoral Trial;Size 1 LeftNon-SterileCatalog number 5512-T-101Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.",Triathlon TS Femoral Trial,2,"July 26, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.",PRODUCTION CONTROLS: Process Control,"Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.",N/A,1,1,"Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.",Terminated,"October 25, 2010",821,106,Not_Computer,N/A,N/A,N/A
Z-1373-2008,46751,"defibrillator, implantable, dual-chamber",MRM,N/A,N/A,Cardiovascular,N/A,"Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software.",Lumax Cardiac Resyncronization Therapy Defibrillator (CRTD),3,"July 29, 2008", 2008,Biotronik Inc,"Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S.",DESIGN: Software Design,Consignees were notified by a letter sent 1/10/07. The letter advised users to stop usage of the affected software. Users were instructed not to implant additional devices until the software program has been corrected. The recalling firm requested that all affected software be scrapped or returned to them. Users were requested update the software with a corrected version as soon as it becomes available.,N/A,53,53 of the 603.U discs distributed.,"Nationwide Distribution including states of AL, AZ, CA, CO, DE, FL, GA, IL, LA, MI, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TX and WA.",Open,N/A,N/A,53,Software,N/A,Software update,Software Update
Z-2005-2008,48101,"monitor, blood-gas, on-line, cardiopulmonary bypass",DRY,Cardiopulmonary bypass on-line blood gas monitor.,Cardiovascular,Cardiovascular,510(k),"Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5, 4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83R, 5R69R1, 5U35R, 9059R20, 9243R19, CB0A12R15, CB2T58R4, CB3L15R5, CB4D99R4, CB4E05R6, CB4J24R2, CB4J67R1, CB4K47R1, CB4K64R5, CB5B53R, CB5C01R2, CB5C82R9, CB5P29R4, CB5Q88R, CB5S97R2, DP38T, HY0W55R17, HY0Y86R17, HY1709R34, HY1C73R16, HY2F13R22, HY2F13R23, HY2J04R2, HY2K12R5, HY2K16R5, HY2K51R14, HY2K60R3, HY2Q31R1, HY2Q32R2, HY2T49R3, HY2U43R5, HY2U98R5, HY2W85R9, HY3B29R13, HY3C53R1, HY3E77R13, HY3H52R13, HY3L42R12, HY3L78R1, HY3M41R4, HY3M43R1, HY3M45R1, HY3Q11R14, HY3T77R2, HY3U59R4, HY4A96R3, HY4B44R, HY4B50R, HY4E05R8, HY4E66R5, HY4V82R2, HY4X31R7, HY4Y15R11, HY4Z59R7, HY4Z62R5, HY5C74R15, HY5D07R, HY5D70R1, HY5L38R1, HY5N41R2, HY5N42R3, HY5P52R, HY5Q00R, HY5S13R, HY5S33R2, JP1Z53R11, M310113Q, M310319A, M310523D, M310525C, M310531G, M310538A, M310543F, M310824V, M310852C, M310854A, M311028K, M311224A, M311818C, M320234E, M320410V, M320608K, M321014K, M321505L, M322318C, M330112G, M330344D, M330607H, M332108C, M332607G, M333405W, M333809B, M334007C, M334007C, M334008D, M334209A, M335615B, M336202V, M337412A, M337414A, M337415A, M337417A, M337418B, M338001P, M340305C, M340615E, M343105G, M380324D, M390206E, M390322C, M390508D, M390824C, M391817L, M391817M, M391908B, M392814A, M392815A, M395216B, M395217B, M395319B, M396010D, M397013G, M397912B, M398309C, M399510A, M399511A, M410811K, M430737A, M443307B, M443822B, M443823B, M447005R, M460524D, M460530B, M460531B, M460532B, M462007B, M470233C, M470237C, M470945S, M470945T, M490750B, M495512K, M580211B, M580416B, M580418E, M720407F, M720409F, M720714C, M720718D, M720720B, M930401B, M930402B, M960116A, M960119A, M973502E, M973901C, M999308D, P391401B, TL0A42R21, TL0W56R7, TL1E95R12, TL1J50R3, TL2C82R4, TL2H89R7, TL2J77R, TL2K45R6, TL2L66R5 TL2L67R, TL2M25R6, TL2P63R1, TL2P93R5, TL2P94R9, TL2R00R3, TL2R66R, TL2S03R4, TL2S21R1, TL2S24R3, TL2S80R24, TL2S80R30, TL2S80R30, TL2T46R7, TL2U42R13, TL2U59R, TL2W21R, TL2W22R5, TL2W90R11, TL2Z00R4, TL2Z34R, TL2Z35R, TL3A08R16, TL3B47R8, TL3C66R4, TL3C69R16, TL3E97R5, TL3E98R7, TL3E99R2, TL3F17R2, TL3F33R1, TL3G03R2, TL3G89R1, TL3H76R12, TL3H85R1, TL3H86R6, TL3K26R8, TL3L73R5, TL3M00R7, TL3M35R14, TL3M92R1, TL3N21R3, TL3N58R1, TL3P08R4, TL3P79R8, TL3R32R4, TL3R79R4, TL3R82R6, TL3R95R3, TL3S25R, TL3S39R3, TL3S63R, TL3T02R2, TL3T11R11, TL3V10R11, TL3V42R6, TL3X14R3, TL3X14R4, TL3X86R5, TL3Y45R1, TL3Y70R1, TL3Y77R, TL3Z02R4, TL3Z07R, TL3Z67R4, TL4A55R19, TL4A76R, TL4A98R1, TL4B15R2, TL4B16R5, TL4C84R, TL4D71R1, TL4E06R1, TL4E30R11, TL4F57R2, TL4F60R, TL4F71R1, TL4F88R6, TL4F97R7, TL4H65R, TL4H98R1, TL4J16R, TL4J32R10, TL4J96R7, TL4K33R3, TL4K78R, TL4K84R8, TL4K88R, TL4K93R, TL4K95R3, TL4L34R4, TL4M16R2, TL4M22R10, TL4M94R5, TL4N20R10, TL4N27R3, TL4N84R, TL4P48R2, TL4P64R4, TL4Q43R3, TL4Q43R4, TL4R10R2, TL4R21R, TL4S97R8, TL4T06R3, TL4U93R7, TL4V76R1, TL4V77R, TL4W07R4, TL4W22R, TL4W94R1, TL4X63R1, TL4X99R8, TL4Y20R2, TL4Z28R2, TL5054R11, TL5263R2, TL5398R19, TL5398R20, TL5A39R3, TL5B82R1, TL5B83R1, TL5C29R2, TL5C35R6, TL5C63R2, TL5C64R3, TL5C97R6, TL5D45R4, TL5D65R, TL5D66R3, TL5E04R, TL5E11R1, TL5F48R, TL5F62R5, TL5F64R4, TL5F96R, TL5G03R2, TL5G04R2, TL5G26R1, TL5G27R, TL5G27R1, TL5G41R2, TL5H55R1, TL5J24R6, TL5J74R2, TL5L27R1, TL5N42R2, TL5N43R3, TL5N53R1, TL5N59R, TL5N60R, TL5N62R4, TL5N79R, TL5N94R, TL5P14R, TL5P59R2, TL5P73R2, TL5P76R2, TL5Q40R1, TL5Q76R3, TL5Q85R2, TL5Q89R1, TL5R08R, TL5R15R2, TL5R18R1, TL5R52R, TL5R57R1, TL5R91R5, TL5S53R, TL5T73R, TL5U33R, TS1259R14, TS1259R15, TS1366R3, TS1366R4, TS1366R5, TS1404R1, TS1414R3, TS1420R",Medtronic Trillium AFFINITY NT,2,"July 30, 2008", 2008,Medtronic International Trade Inc,"Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulm",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic Cardiovascular Customers were sent the May 05, 2008 Urgent Medical Device Corrective Action letter to advise them that certain Trillium-coated cardiopulmonary bypass products were manufactured with heparin which may be contaminated with oversulfated chondroitin sulfate. The letter discussed the risk evaluation and gave recommendations to healthcare professionals for patient care. Affected devices can continue to be used in cardiopulmonary bypass procedures.",N/A,59500,59500,"Worldwide Distribution, including USA.",Terminated,"December 01, 2008",124,59500,Not_Computer,N/A,N/A,N/A
Z-2037-2008,48755,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.",Centricity Perinatal (formerly QS) System PFILS software,2,"July 30, 2008", 2008,GE Healthcare Integrated IT Solutions,"Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.",DESIGN: Software Design,"GE Healthcare notified their Centricity Perinatal customers via letter dated 7/20/07 of the problem with the PFILS application that could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. The letter provided the users with a workaround and provided them with a Frequently Asked Questions document which listed the availability of a software patch to fix the problem. A follow-up letter dated 6/27/08 was sent on 6/30-7/2/08 to those accounts who had not requested a PFILS Hotfix CD-ROM or had not had their software recently upgraded. The letter a copy of the 7/20/07 letter, the most recent FAQ, the PFILS Hotfix CD (PFIL67_66) and Installation Procedure for the PFILS Patch instructions for installation of the software patch. The accounts were advised that they can request an analysis of existing patient records to determine whether they have been affected by the PFILS issue, by submitting a non-critical Technical Support Request on the GE Centricity Perinatal Web site: http://www.gehealthcare.com/usen/security/cis/stupgrades.html, indicating ""PFILS ANALYSIS REQUEST"" in the Description of Issue field. Any questions were directed to Technical Support at 800-433-2009.",N/A,1031,"1,031 units","Worldwide: USA, Puerto Rico, Canada, and China.",Terminated,"September 06, 2010",768,1031,Software,Output/Calculation,Software update,Software Update
Z-1460-2008,46919,"system, simulation, radiation therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(k),Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.,Acuity with Conebeam Computed Tomography,2,"July 30, 2008", 2008,Varian Medical Systems Oncology Systems,"Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.",DESIGN: Software Design,"Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.",N/A,16,16 UNITS,"Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.",Terminated,"September 30, 2009",427,16,Software,Display/Image,Software update,Software Update
Z-1549-2008,47474,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.",Standard Drip Administration Set,3,"July 30, 2008", 2008,Smiths Medical Asd Inc,"Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.",PRODUCTION CONTROLS: Packaging Process Control,"On 3/24/2008, the firm issued separate URGENT: PRODUCT RECALL NOTIFICATIONs sent via certified mail to their distributor and medical customers. Both recall notifications inform the customers of this labeling error and ask that the customers: 1) check their inventories for the presence of the suspect product; 2) complete and return the attached 'Product Recall Notification Response Form'; and 3) make arrangements to return any unused affected product to the recalling firm in exchange for a credit or replacement product. In addition, the distributors are asked to either provide the recalling firm with a list of their sub-account customers so that Smith Medical can contact the enduser customers and notify them of the recall, or as an alternative measure, the distributor can notify their branches and customers directly, via their own certified letter.",N/A,350,350 units,"Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.",Terminated,"September 30, 2010",792,350,Not_Computer,N/A,N/A,N/A
Z-1557-2008,47456,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter.Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5",MedilifterIII Plus and Summit Total Lift ,2,"July 30, 2008", 2008,"Arjo, Inc.","Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at the time, the patient could fall and sustain injuries.",DESIGN: Device Design,"Arjo sent Urgent Device Recall Customer Notification letters dated 4/1/08 on the BHM Medical letterhead to the end user accounts who received the affected patient lifts with mast scales, advising them of the potential of fracture at the load cell assembly which might cause the scale to fall. Should a patient be in the lift at the time, the patient could fall, potentially sustaining injuries. The accounts were instructed to immediately stop using the patient lifts. A BHM representative will contact the accounts within 5 days to arrange for the correction of the lifts. The accounts will be given the option of returning the lifts for repair (with shipping costs covered by BHM), or purchasing a replacement lift at a significantly reduced price. Any questions or concerns were directed to the BHM Service Department at 1-819-868-0441 or service@bhm-medical.com.",Contact the recalling firm for information,37,37 lifts,"Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.",Terminated,"November 18, 2009",476,37,Not_Computer,N/A,N/A,N/A
Z-1555-2008,47334,"expander, surgical, skin graft",FZW,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7716-000-10. Single use device for use during skin grafting procedures.",Zimmer Dermacarriers Skin Graft Carrier ,2,"July 30, 2008", 2008,Zimmer Inc.,"Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products.",N/A,99345,99345 of all units,"Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.",Terminated,"December 17, 2009",505,99345,Not_Computer,N/A,N/A,N/A
Z-1569-2008,47236,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05.Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System.Abbott Laboratories, Abbott Park, IL 60064",Architect Free T4 MasterCheck ,3,"July 31, 2008", 2008,Abbott Laboratories,Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, discontinue use of the lots and destroy any remaining inventory. For lots 82140M, 82150M and 84120M, if they know the date the lot was received or the date it was thawed, they may continue to use lots if they have been stored at 2 to 8 degrees C unopened for less than 60 days. If the material has been stored at 2 to 8 degrees C for greater than 60 days or they do not know the number of days it has been thawed, they were instructed to discard the material. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. Customers outside of the U.S., were requested to contact their local customer support representative.",N/A,197,197 units,Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.,Terminated,"November 05, 2008",97,325,Not_Computer,N/A,N/A,N/A
Z-1556-2008,47347,"stent, iliac",NIO,N/A,N/A,Cardiovascular,N/A,"CORDIS S.M.A.R.T.¶_ Control"" Nitinol Stent SystemModel Number(s): C10040SL, Manufactured in Mexico.Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.","CORDIS S.M.A.R.T. Control"" Nitinol Stent System",2,"July 31, 2008", 2008,Cordis Corporation,"Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.",N/A,398,398 units,Worldwide Distribution --- including USA and countries of Japan and Canada.,Terminated,"October 01, 2009",427,398,Computer,N/A,N/A,N/A
Z-2138-2008,48974,"device,anastomotic,microvascular",MVR,N/A,N/A,Cardiovascular,510(k),"GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation SterilizedThis is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.",GEM 2753 Microvascular Anastomotic Coupler,2,"August 02, 2008", 2008,Synovis Micro Companies Alliance Inc,Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.,DESIGN: Device Design,"Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.",N/A,3812,"3,812 units","Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.",Terminated,"April 09, 2010",615,3812,Not_Computer,N/A,N/A,N/A
Z-0274-2008,47235,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),Precision 500D Classical R&F; System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.,"GE Healthcare, Precison 500D Classical R&F; System ",2,"August 02, 2008", 2008,GE Healthcare,"Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure.",DESIGN: Software Design,"Consignees were notified by two ""Product Safety Notification"" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.",Contact the recalling firm for information,101,101,"Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.",Terminated,"September 10, 2008",39,101,Software,Display/Image,Software update,Software Update
Z-1459-2008,46852,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.",HighDefinition 120 MultiLeaf Collimator,2,"August 02, 2008", 2008,Varian Medical Systems Oncology Systems,"Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.",DESIGN: Software Design,Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.,N/A,3,3 units subject to correction,"Nationwide Distribution including states of NC, FL and CA.",Terminated,"August 18, 2010",746,3,Software,Output/Calculation,Software update,Software Update
Z-1190-2008,46753,"sterilant, medical devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(k),"Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.",C1160 Universal Flexible Processing Tray,2,"August 05, 2008", 2008,Steris Corp,"Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.",DESIGN: Device Design,"Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.",Contact the recalling firm for information,28766,"28,766 units","Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.",Open,N/A,N/A,28766,Not_Computer,N/A,N/A,N/A
Z-1191-2008,46788,"device, monitoring, intracranial pressure",GWM,Intracranial pressure monitoring device.,Neurology,Neurology,510(k),"INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences",Integra NeuroSensor,2,"August 05, 2008", 2008,Integra Neuro Sciences,"Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg.",DESIGN: Process Design,"Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2"" x 1/2"" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included.In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.",Contact the recalling firm for information,43,43 units,"USA Distribution: CA, GA, NM, TX, NE, WA, and NY.",Terminated,"April 22, 2010",625,43,Not_Computer,N/A,N/A,N/A
Z-1636-2008,47428,ultrasonic diathermy for use in applying therapeutic deep heat,IMI,Ultrasonic diathermy.,Physical Medicine,Physical Medicine,510(k),"VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.",VECTRA GENISYS,2,"August 06, 2008", 2008,Chattanooga Corp Inc,Device may fail to administer therapy during use.,DESIGN: Component Design/Selection,"Chattanooga Group sent an Urgent Medical Device Recall letter dated 02/29/2008 to consignees to advise them of problem and the recall. The first group of letters was sent to the distributors via certified mail. The letter stated that the devices were failing and the recall was to the User level. The firm is recalling the devices for repair and calibration. The firm followed with a user notification, by US Mail not certified beginning on March 11, 2008.",N/A,207,207 devices,Nationwide Distribution.,Terminated,"February 19, 2010",562,1565,Not_Computer,N/A,N/A,N/A
Z-1181-2008,46846,"pump, infusion, pca",MEA,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled ""LifeCare PCA Barcode Label Utility Program."" This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials.","Hospira LifeCare PCA Label Utility, Version 1.0",2,"August 06, 2008", 2008,Hospira Inc.,"Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.",DESIGN: Software Design,"Hospira sent letters dated 1/3/08 to the immediate recipients of the product via FedEx overnight letter on the same date. The letters informed the accounts of the reports of independent changes in drug concentration while editing a saved formulation using the Hospira LifeCare PCA Label Utility Software CD that was provided to some customers in a Hospira MedNet Drug Library Creation Team Introductory Kit-LifeCare PCA kit. The accounts were requested to remove the utility from any PC in their facility on which it is currently installed, destroy the CD and sign and return the enclosed removal verification form verifying that they have removed the software from their system. The letter listed commercially available software packages that the account could validate and implement in their facility. Any questions concerning the utility software withdrawal were directed to Hospira at 1-800-241-4002, option 4, then option 1.",N/A,127,127 CDs,Nationwide Distribution and Canada,Terminated,"March 09, 2010",580,127,Computer,N/A,N/A,N/A
Z-1348-2008,46890,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments.Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA",Da Vinci S 8mm Instrument Cannula ,2,"August 06, 2008", 2008,"Intuitive Surgical, Inc.",(1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function.(2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.,PRODUCTION CONTROLS: Process Control,"On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.",N/A,39,39 units,Nationwide,Open,N/A,N/A,39,Not_Computer,N/A,N/A,N/A
Z-1538-2008,46916,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145Intended for use in securing soft tissue to bone in certain procedures in specific areas.","Wedge HS Suture Anchor II, 6.5 mm with Needles",2,"August 06, 2008", 2008,Stryker Endoscopy,Product package may crack and cause loss of sterility.,DESIGN: Packaging Design/Selection,"Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the ""Acknowledgment of recipt"" card needs to be signed and returned to Stryker Endoscopy.",N/A,53,53 units,"Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.",Open,N/A,N/A,927,Not_Computer,N/A,N/A,N/A
Z-1620-2008,47521,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product.Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.","FLAT DRAIN 10MM, CHARIKERJETER DRESSING KITS (LARGE AND SMALL) ",3,"August 06, 2008", 2008,"Smith And Nephew, Inc. Wound Management Division",Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.",N/A,4796,4796,Nationwide Distribution.,Terminated,"November 18, 2008",104,4796,Not_Computer,N/A,N/A,N/A
Z-1239-2008,46773,"spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide",JKS,Carbon monoxide test system.,Toxicology,Toxicology,Enforcement Discretion,"International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220",AVOXimeter 4000 ,2,"August 06, 2008", 2008,International Technidyne Corp.,Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.,DESIGN: Process Design,ITC sent Urgent - Medical Device Field Recall - ITC No. 08-001 letters dated 2/08/2008 to hospitals and/or medical facilities identified as having affected instruments. The letter instructed users not to use the instrument if the diagnostic mode is enabled. ITC will reset affected devices and return them to the customers.,"Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",61,"61 US, 2 International","Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.",Terminated,"July 24, 2009",352,234,Not_Computer,N/A,N/A,N/A
Z-1529-2008,46370,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.",Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager,2,"August 08, 2008", 2008,Beckman Coulter Inc,Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.,DESIGN: Software Design,"A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.",N/A,141,141 units,Worldwide Distribution --- including USA and country of Canada.,Open,N/A,N/A,141,Computer,N/A,N/A,N/A
Z-1530-2008,46372,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer SystemModel/Catalog number 642685Software is used to simplify acquisition of flow cytometry data.,BD FACSDiva,2,"August 08, 2008", 2008,BD Biosciences,Values might not update in statistics views after certain functions are performed in a worksheet.,DESIGN: Software Design,The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.,N/A,74,74 units,Nationwide Distribution.,Terminated,"September 24, 2008",47,74,Software,Output/Calculation,Software update,Software Update
Z-1561-2008,46750,"antisera, all groups, n. meningitidis",GTJ,Neisseriaspp. direct serological test reagents.,Microbiology,Microbiology,510(k),"BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial unitsFor use in slide agglutination tests for serotyping Neisseria Meningitidis.",BD DifcoTM Neisseria Meningitidis Antiserum Group Y,3,"August 08, 2008", 2008,BD Diagnostic Systems / Lee Laboratories,Exhibits cross reactivity with Neisseria meningitides Group W135,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.",N/A,200,200 units,Worldwide Distribution --- including USA and country of New Zealand.,Terminated,"March 24, 2009",228,1440,Not_Computer,N/A,N/A,N/A
Z-1568-2008,46950,"indicator, physical/chemical sterilization process",JOJ,Sterilization process indicator.,General Hospital,General Hospital,510(k),"3M Comply EO Chemical Indicators Strips, Catalog #1251The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized.3M Health Care3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000",3M Comply EO Chemical Indicators Strips,2,"August 08, 2008", 2008,3M Company / Medical Division,"A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Customers and Distributors were each sent a ""Voluntary Product Recall"" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the ""Product Return Form"". Replacements will be provided to those with affected products remaining in their stock.",N/A,4,"12,998 cases ( 4 boxes per case & 480 strips per box))","Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.",Open,N/A,N/A,12998,Not_Computer,N/A,N/A,N/A
Z-1369-2008,46906,"accessories, cleaning, for endoscope",FEB,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.",EvoTech Endoscope Cleaner & Reprocessor,2,"August 08, 2008", 2008,Advanced Sterilization Products,"Cleaning cycles are being cancelled. Specific issues are:a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging,b) Interface board malfunction resulting in a premature lid opening, andc) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).",DESIGN: Device Design,"Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.",Contact the recalling firm for information,2,2 units,Worldwide Distribution --- including USA and countries of Canada and Japan.,Open,N/A,N/A,66,Not_Computer,N/A,N/A,N/A
Z-1629-2008,47355,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"STERRAD 50 Sterilization System, Product Code 10050Used to sterilize heat and moisture sensitive reusable medical devices.",STERRAD 50 Sterilizer,2,"August 08, 2008", 2008,Advanced Sterilization Products,"Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, ""haze,"" or ""smoke.""",DESIGN: Device Design,"The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.",N/A,9950,"9,950","Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Peru, Canada, Czech Republic, Middle East, Portugal, S. Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.",Open,N/A,N/A,9950,Not_Computer,N/A,N/A,N/A
Z-0870-2008,47371,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001.Intended for qualitative and quantitative in vitro determinations using a wide variety of tests.Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250",Roche/Hitachi Modular P Module GMMI immunoassay analyzer,2,"August 13, 2008", 2008,Roche Diagnostics Corp.,Possible mismatch between patient and result.,DESIGN: Software Design,"Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.",N/A,11,11 of all models,"Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.",Terminated,"November 18, 2009",462,11,Computer,N/A,N/A,N/A
Z-1634-2008,47361,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054.Intended to provide a pathway through which therapeutic and diagnostic devices are introduced.","Abbott Vascular 6F Viking Guiding Catheter, Shape BPL",3,"August 13, 2008", 2008,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,Mislabeling: The part number on the product label packaging may not match the product.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.",N/A,7,7 units,Nationwide Distribution.,Open,N/A,N/A,17,Not_Computer,N/A,N/A,N/A
Z-1470-2008,46850,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.",Power circuit board assembly kits,2,"August 13, 2008", 2008,"Cardinal Health 203, Inc",The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.,DESIGN: Device Design,"An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An ""Update"" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.",Contact the recalling firm for information,175,175 (OUS only),"Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.",Open,N/A,N/A,20603,Not_Computer,N/A,N/A,N/A
Z-2141-2008,48697,"stent, carotid",NIM,N/A,N/A,Cardiovascular,N/A,"Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]",Boston Scientific NexStent Monorail,1,"August 13, 2008", 2008,Boston Scientific Corporation,"Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the sten",DESIGN: Component Design/Selection,"Boston Scientific sent an urgent Voluntary Medical Device Recall letter, dated 06/06/08, to affected customers. The letter described the issue, identified affected product, requested to cease using or distributing the product and provided direction on how to return the recalled devices to Boston Scientific, Quincy, MA. A Reply Verification Tracking Form was asked to be returned to Boston Scientific. Since the issue is with the delivery system, patients already implanted with the stent are not affected.",N/A,1946,"1946 units (1570 U.S., 376 OUS)","Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.",Open,N/A,N/A,1946,Not_Computer,N/A,N/A,N/A
Z-2152-2008,48435,"tube, collection, capillary blood",GIO,Capillary blood collection tube.,Hematology,Hematology,510(K) Exempt,"Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200¶_l, Heparinized: 6 IU Na & 9 IU Li/100 ¶_l,",Vitrex,2,"August 14, 2008", 2008,Opti Medical Systems Inc,This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Opti Medical sent a Recall Notice, dated May 8, 2008 to all consignees. Consignees were notified via email on/about May 5th thru 7th , 2008. They were instructed to discontinue use of the affected lot and to immediately return all remaining product to OPTI Medical for replacement.",Contact the recalling firm for information,31750,31750 tubes,"Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal",Terminated,"January 22, 2010",526,31750,Not_Computer,N/A,N/A,N/A
Z-1635-2008,47373,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791",Comed PICC Insertion Tray,2,"August 14, 2008", 2008,Integra Pain Management,Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.",N/A,500,500 kits,CO,Terminated,"November 05, 2008",83,500,Not_Computer,N/A,N/A,N/A
Z-1830-2008,48124,"catheter, ventricular, general & plastic surgery",GBS,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case",Atrium,2,"August 14, 2008", 2008,Atrium Medical Corporation,Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.,N/A,10,10 cases (10 individual/case),"Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.",Terminated,"August 20, 2009",371,1842,Not_Computer,N/A,N/A,N/A
Z-1442-2008,46920,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.","Varian Medical Systems OnBoard Imager, Versions 1.0.15 and 1.2.05",2,"August 15, 2008", 2008,Varian Medical Systems Oncology Systems,"If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.",DESIGN: Software Design,"The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.",N/A,291,291 units,"Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO, CT, ND, WA, and UT, and countries of Sweden, Switzerland, Germany, Denmark, Japan, UK, France, Italy, Norway, Taiwan, New Zealand, Canada, Poland, Australia, Colombia, China, Spain, Belgium, Russian Federation, India, Iceland.",Open,N/A,N/A,291,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1445-2008,47244,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.,Newdeal Qwix Fixation Screw,2,"August 15, 2008", 2008,Integra LifeSciences Corp.,Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.,PRODUCTION CONTROLS: Labeling Mix-Ups,Integra Reps were sent recall notification with a recall acknowledgement on 2/27/2008. The customers who were shipped affected product were also notified on that date.,Contact the recalling firm for information,42,42 units,"Nationwide Distribution --- including states of NC, IL, CA, NC and TX.",Terminated,"August 21, 2008",6,62,Not_Computer,N/A,N/A,N/A
Z-1619-2008,47495,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"BCI ¶_3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.",BCI 3180 Pulse Oximeter,2,"August 15, 2008", 2008,"Smiths Medical PM, Inc.","The Smith Medical PM, Inc. BCI ¶_¶_3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to",OTHER/UNDETERMINED: Pending,"Consignees were contacted by an URGENT: Product Safety Information Voluntary Recall Notification letter dated March 11, 2008 with attached Safety Action Bulletin 08-SAB01 dated February 27, 2008 and email between March 7 and March 13, 2008. The consignees will need to return the device to be evaluated in the Smiths Medical PM, Inc.",N/A,900,900,"Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL, AZ, OH, CA, MS, UT and Countries: Argentina, Bangladesh, Iran, Thailand, Mexico, India, Germany, Guatemala, Pakistan, Chile, Colombia, Brazil, Saudi Arabia, Morocco, Kuwait, Trinidad and Tobago, Ecuador, Paraguay, Uruguay, Canada, Poland, Portugal, Peru, Qatar, Cyprus, Greece, Italy, Spain, United Arab Emirates, Israel.",Open,N/A,N/A,900,Hardware,Device Operation,Return,Remove or Replace
Z-1622-2008,47753,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),"Deltec Cozmo¶_ Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous Insulin Infusion for the control of diabetes.","Deltec Cozmo Insulin Pump, Model 1700",2,"August 15, 2008", 2008,"Smiths Medical MD, Inc.","Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo ¶_Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were mailed an Urgent Medical Device Recall letter dated March 10, 2008. The Urgent letter addressed to ""Distributors, Clinicans, Patients and Other Customers"" contains Description of the Problem, Results of Investigation, and Advise on Action to be taken by the User. The patient users will be required to return a Recall Confrirmation Form. The USA distributors, USA prescribing physicians and the USA managed Care Accounts (Insurance Companies) will be mailed also a cover letter.",N/A,436,436,"Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME. RO, MN, MO, MS, ME, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Greece, Netherland, Sweden, France, Germany, Turkey, China, Great Britain, Israel, Italy, Kuwait, New Zealand, Australia.",Open,N/A,N/A,1502,Not_Computer,N/A,N/A,N/A
Z-1694-2008,47766,"injector, contrast medium, automatic",IZQ,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.,OptiVantage DH Injector Suspension System (JBow),2,"August 15, 2008", 2008,Mallinckrodt Inc,Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.,DESIGN: Component Design/Selection,"On April 18, 2008, Mallincrodt Inc. issued an Urgent Device Correction letter informing customers to check their inventory, and determine if they have any defective system units. If they observe any loose screws, sheared screws and/or elongated opening(s) around the screws, they are to immediately take the system out of service and contact the firm's service representative. Covidien's customers were all asked to inspect their inventories and to complete an 'Effectiveness Check Return Form' whether or not the product is defective. However, only those system units observed to have loose screws, sheared screws, and/or elongated openings around the screws, will be scheduled to receive correction by a Covidien Service Representative.",N/A,783,783 Units,"Product is distributed in the US throughout the following states: AL, AR, AZ, CA, CO ,CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV.",Open,N/A,N/A,783,Not_Computer,N/A,N/A,N/A
Z-1621-2008,47767,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"CADD-MS ¶_¶_3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care patients but can also used in health care facilities.",CADDMS 3 Ambulatory Infusion Pump,2,"August 15, 2008", 2008,"Smiths Medical MD, Inc.",Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS ¶_3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were mailed an Urgent Medical Device Recall letter dated March 7, 2008. (Urgent Field Safety Notice dated March 7, 2008 for International Consignees.) The Urgent letter was addressed to ""Risk & Safety Mangers, ""Distributors"", ""Clinicians"", ""Patients"" and ""other Customers"". The letter contains a Description of the Problem, Results of Investigation, and Advice on Action to be taken by the User which includes contacting Smiths Medical MD, Inc. Customer Service Department to make arrangements for a replacement pump. The letter also requests consignees to return the confirmation form.",N/A,646,646,"Class II Recall - Worldwide Distribution --- USA including states of PA, TX, KY, FL, MN, GA, HI, NM, MD, and countries of CZ, GB, IT.",Open,N/A,N/A,646,Not_Computer,N/A,N/A,N/A
Z-1526-2008,44927,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.",GE DatexOhmeda Engstrom Carestation,2,"August 16, 2008", 2008,"Datex - Ohmeda, Inc",Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstr¶_m Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a Medical Device Correction Notification letter on July 2, 2007. The firm's short term recommendation is that Neonatal Flow Sensors may continue to be used with added viligance around potential patient circuit disconnections and the associated alarms. Ther firm recommends that the MV exp high and Circuit leak alarms be set appropriately for each patient in order to detect a patient disconnect. The long term recommendation was to order the replacement part when available and dispose of the old part when the replacement is received.",N/A,394,394,"Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates.",Open,N/A,N/A,394,I/O,Output/Calculation,Replace component,Remove or Replace
Z-1528-2008,46323,"antisera, all types, shigella spp.",GNB,Shigellaspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017***Used for the identification of Shigella species by the slide agglutination test",Shigella Antiserum Poly Group B,2,"August 16, 2008", 2008,Becton Dickinson & Co.,In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm notified distributors by faxed letter flagged as ""Urgent Product Recall"" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an ""Urgent Product Recall"" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.",N/A,643,643 (recall total) vials,Worldwide Distribution,Terminated,"November 12, 2008",88,643,Not_Computer,N/A,N/A,N/A
Z-1515-2008,46941,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA.Used to facilitate the delivery of defined radiotherapy treatment plans.",MOSAIQ versions 1.3 and 1.4 SEQUENCER,2,"August 16, 2008", 2008,Impac Medical Systems Inc,"Software issue may result in change to intended treatment field, potentially resulting in mistreatment.",DESIGN: Software Design,"Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.",N/A,36,36 units,"Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.",Terminated,"June 24, 2009",312,36,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1444-2008,46942,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.,iSite PACS,2,"August 16, 2008", 2008,"Philips Healthcare Informatics, Inc.","When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.",DESIGN: Software Design,"The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.",N/A,2,2 units,"Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.",Terminated,"September 25, 2008",40,5,Computer,N/A,N/A,N/A
Z-1525-2008,38337,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609Flexible data acquistion and analysis package specifically designed for digital-based flow cytometers.",BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2,2,"August 16, 2008", 2008,BD Biosciences,"When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.",DESIGN: Software Design (Manufacturing Process),"The firm has issued a customer Important Product Information letter via mail on 04/20/2007 to inform them of the software issues. The letter states that to avoid this problem, make sure each tube or well has at least two fluorescence parameters before exporting FCS 3.0 data files. Manually exporting tubes or wells one at a time or restarting the software after the export of an FCS data file containing one or no fluorescence parameters will prevent the problem from occurring. Customers are requested to fill out and return the response form and to contact BD Customer Support Center if there are any additional questions. A software fix is being developed in version 6.0 and a free maintenance release with no product enhancments (version 5.0.3).",N/A,1074,1074 units,"Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and countries of Buenos Aires, BE, Brazil, Canada, Chile, China, Hong Kong, Japan, Singapore, Taiwan, Venezuela, Mexico, Trinidad and Tobago, and Columbia.",Terminated,"September 30, 2009",410,1074,Software,Output/Calculation,Software update,Software Update
Z-1750-2008,47764,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Omnifit EON Surgical Protocol;Literature Number: LSP48 4/04Stryker Howmedica Osteonics Corp., Mahwah, NJ",Omnifit EON Surgical Protocol,2,"August 17, 2008", 2008,Stryker Howmedica Osteonics Corp.,"The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.",DESIGN: Labeling Design,"Styrker Branches/Agencies were notified of the incorrect information printed in the protocal on May 17, 2007 via an Important Product Correction letter. The letter requested that all incorrect copies of the protocol be located and destroyed immediately. They requested that the Acknowledgement Form be completed and faxed, and that a Stryker Orthopaedics Customer Service rep be contacted in order to reorder the destroyed product.",N/A,2501,2501 units,"Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.",Terminated,"August 19, 2008",2,2501,Not_Computer,N/A,N/A,N/A
Z-1764-2008,47459,"enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific",LGC,Herpes simplex virus serological assays.,Microbiology,Microbiology,510(k),"HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900GIntended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.",HerpeSelect 1 and 2 Immunoblot IgG Kit,2,"August 17, 2008", 2008,Focus Diagnostics Inc,"A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.",DESIGN: Process Design,"Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.",N/A,190065,"Lot Code 063169 - 97 Kits, Lot Code 063354 - 16 Kits, Lot Code 063355 - 74 Kits","Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.",Terminated,"June 25, 2009",312,187,Not_Computer,N/A,N/A,N/A
Z-1370-2008,46771,"system/device, pharmacy compounding",NEP,Intravascular administration set.,General Hospital,General Hospital,510(K) Exempt,"Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.",Baxa ExactaMix 2400 Pharmacy compounding system.,2,"August 19, 2008", 2008,Baxa Corporation,Flush solution from TPN compounder may be added to patient's TPN bag.,DESIGN: Software Design,Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush.,Contact the recalling firm for information,1000,1000 units,"Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.",Open,N/A,N/A,1221,Not_Computer,N/A,N/A,N/A
Z-1322-2008,46870,N/A,N/A,N/A,N/A,N/A,N/A,"Implantable Cardioverter DefibrillatorEPIC HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-337",Epic HF Model V337,2,"August 19, 2008", 2008,St Jude Medical CRMD,"A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators(ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.",DESIGN: Software Design,"A January 16, 2008, letter entitled, ""Important Device Upgrade Information"" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.",N/A,N/A,N/A,"Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium,Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic,Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama,Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguayand Venezuela.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1772-2008,47781,"wheelchair, mechanical",IOR,Mechanical wheelchair.,Physical Medicine,Physical Medicine,510(k),"Bariatric Wheelchair, 28"" Wide and 20"" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA;Item #MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable.item #MDS809850 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.","Medline Excel Shuttle Wheelchair, 28"" Wide",2,"August 19, 2008", 2008,Medline Industries Inc,Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. The injuries can be severe from fracture to severing.,DESIGN: Component Design/Selection,"A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled ""How to Open a Wheelchair"" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning ""CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT."" The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.",N/A,201,201 wheelchairs,Class II Recall - Worldwide Distribution --- including USA and Canada.,Terminated,"May 11, 2010",630,1138,Not_Computer,N/A,N/A,N/A
Z-1378-2008,46938,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.,Radius Capsin,2,"August 19, 2008", 2008,Stryker Spine,The Radius Capsin has separation of the tip from the inserter.,DESIGN: Device Design,"Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256.",N/A,52,52,Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.,Terminated,"August 19, 2008",0,117,Not_Computer,N/A,N/A,N/A
Z-1183-2008,46316,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Power Supply Assembly SledPart Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.",Access Power Supply Assembly Sled,2,"August 20, 2008", 2008,Beckman Coulter Inc,"Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure ofthe electrical grounding. The source of the problem was traced to inadequate soldering.",PRODUCTION CONTROLS: Process Control,"Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers.The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure ofthe electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced aproactive initiative to inspect the power supply sled assemblieson all instruments referenced. A response form was included.",N/A,3055,3055 instruments in the US; 192 instruments in Canada,Nationwide Distribution and Canada,Open,N/A,N/A,3055,Not_Computer,N/A,N/A,N/A
Z-1184-2008,46336,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100With: UniCel Dxl 800 Modification (MOD ID 10027)and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.",UniCel Dxl 800 Access lmmunoassay System,2,"August 20, 2008", 2008,Beckman Coulter Inc,Incorrect results: There is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027)and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¶_C and 32¶_C operating range.,DESIGN: Device Design,"Beckman Coulter mailed a Product Corrective Action (PCA) letter the week ofOctober 8, 2007 to the customers who have the affected UniCel Dxl 800Access lmmunoassay systems advising that there is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027)and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¶_C and 32¶_C operating range. The letter further advises that Beckman Coulter will contact the customer to arrange a date to remove the modificatlons but until the modification is completed, the system should be operated in aroom temperature of 20¶_C to 30¶_C. This can be acomplished by monitoringand recording room tamperature in the area of the instrument. Customers are also asked to review historical quality control records to ensure assay performance is within their laboratory specification and that patient results should be reviewed in context of other diagnostics tests and the clinical presentations of the patient. A response form is included.",Contact the recalling firm for information,111,111 units in the US; 9 units in Canada,Nationwide and Canada,Open,N/A,N/A,111,Not_Computer,N/A,N/A,N/A
Z-1189-2008,46728,N/A,N/A,N/A,N/A,N/A,N/A,"Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.",AntiHBC EIA,2,"August 20, 2008", 2008,Bio-Rad Laboratories,Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.,PRODUCTION CONTROLS: Process Control,Bio-Rad called each customer and alerted them to the issue on 1/7-8/2008. A letter was faxed and sent via overnight carrier (DHL) to each customer site on 1/8/2008. Customers were told not to use the affected lot of the product and to discard it. The firm will provide another lot of the product to customers.,N/A,31,31 distributed,Nationwide Distribution.,Open,N/A,N/A,31,Not_Computer,N/A,N/A,N/A
Z-1478-2008,46781,"support, patient position",CCX,Patient position support.,Anesthesiology,Anesthesiology,510(K) Exempt,"Allen Medical C-Flex, Polar Head PositionerCatalog Number: A-70700-A1Product is a medical device used to maintain the position of an anesthetized patient during surgery.","Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1",2,"August 20, 2008", 2008,"Allen Medical Systems, Inc.","Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.",DESIGN: Device Design,Allen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded.,N/A,2,2,"MA, MS",Terminated,"August 26, 2008",6,2,Not_Computer,N/A,N/A,N/A
Z-1447-2008,46388,"system, imaging, gastrointestinal, wireless, capsule",NEZ,Ingestible telemetric gastrointestinal capsule imaging system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Given¶_ Diagnostic System with PillCam¶_ SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.",Given Diagnostic System with PillCam SB Capsule,2,"August 20, 2008", 2008,Given Imaging Inc,"The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.",TRAINING: Employee Error,Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging.,N/A,1392,1392 units,Worldwide Distribution --- US including Puerto Rico and country of Canada,Terminated,"November 15, 2010",817,1392,Not_Computer,N/A,N/A,N/A
Z-1695-2008,47824,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.",AMO WaveScan WaveFront System v3.65,2,"August 20, 2008", 2008,"VISX INCORPORATED, A SUBSIDIARY OF AMO INC","Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determined to be extremely remote. To ensure that this type of incident will not happen again, a software update was developed.",DESIGN: Software Design,"VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.",Contact the recalling firm for information,1310,1310 units,"Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.",Terminated,"June 08, 2010",657,1310,Software,Output/Calculation,Software update,Software Update
Z-1769-2008,47773,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.",Siemens,2,"August 20, 2008", 2008,"Siemens Medical Solutions USA, Inc","Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alerts all its affected customers of the image issue to prevent potential mistreatment.",DESIGN: Software Design,"Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the ""Filter Images on Loading"" and ""Saving of Filtered Images"" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.",Contact the recalling firm for information,N/A,N/A,"Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.",Open,N/A,N/A,N/A,Software,Display/Image,Software update,Software Update
Z-1773-2008,47785,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.",EndoWave Connector clip,2,"August 20, 2008", 2008,EKOS Corporation,Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.,OTHER/UNDETERMINED: Pending,Firm representatives will visit and distribute connector clips and instructions for use to consignees beginning 04/01/2008 at no cost to the consignee.,No consumer action necessary,218,218 units,Class II Recall - Nationwide,Open,N/A,N/A,218,Not_Computer,N/A,N/A,N/A
Z-1186-2008,46345,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet brand Modular Microplasty Cup Impactor, 3/8"" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.",Biomet Microplasty Cup Impactor,2,"August 20, 2008", 2008,"Biomet, Inc.",The weld at the lock location may fracture during impaction.,DESIGN: Device Design,"Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.",N/A,59,59,"Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.",Terminated,"September 22, 2009",398,1004,Not_Computer,N/A,N/A,N/A
Z-1539-2008,46960,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758.Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.",3DKNEE Tibial Insert Trial,2,"August 20, 2008", 2008,"Encore Medical, Lp","Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.",PRODUCTION CONTROLS: Error in Labeling,Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.,N/A,6,6 units.,Distribution --- country of Germany.,Terminated,"September 02, 2008",13,6,Not_Computer,N/A,N/A,N/A
Z-1513-2008,46297,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872",VITALITY DR ICD,2,"August 21, 2008", 2008,Boston Scientific CRM Corp,Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD,DESIGN: Device Design,"An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.",N/A,25001,"BSC CRM estimates that the number of devices implanted in a susceptible orientation is likely less than 1% of the total active implants 25,000 (w.w.)","Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.",Terminated,"December 30, 2008",131,250,Not_Computer,N/A,N/A,N/A
Z-2139-2008,47801,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CAFor in vitro diagnostic use in counting and characterizing blood cells.",CELLDYN Sapphire Hematology Analzyer,2,"August 21, 2008", 2008,Abbott Laboratories,"Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Recall initiated on April 11, 2008. A Product Correction letter and customer reply form were sent to all currently active CELL-DYN Sapphire Customers. The letter requests that users be certain that the transmission of test results receipt by the host interface is mapped according to the Numerical Result Label, when configuring their CELL-DYN Sapphire Hematology Analyzer for results transmission to a Clinical Laboratory Information System or Middleware. Affected product was distributed to a total of 4 distributors. However, notification was made to all 154 customers that received the CELL-DYNE Sapphire product. If the customer or the health care providers that they serve have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT.",N/A,15,15 copies of the specification were sent worldwide,Nationwide Distribution.,Terminated,"March 12, 2010",568,15,Not_Computer,N/A,N/A,N/A
Z-1471-2008,46903,"stainer, tissue, automated",KEY,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B",Xmatrx FISH Automated Staining System,2,"August 22, 2008", 2008,Biogenex Laboratories,Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.,DESIGN: Component Design/Selection,The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.,N/A,10,10 units distributed.,"Product was distributed to a single distributor, which further distributed the product.",Open,N/A,N/A,10,Not_Computer,N/A,N/A,N/A
Z-2148-2008,48184,"lipase-esterase, enzymatic, photometric, lipase",CHI,Lipase test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.",Genzyme,3,"August 22, 2008", 2008,Genzyme Corporation,Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Genzyme notified accounts by Fed'X on 4/14/08 via an Imprtant Field Correction letter, requesting users to discard kits and follow the ""User Update"" instructions previously provided to minimize calibration error. Customers are to complere and sign the Confirmation of Notification form and fax it back to the firm regardless if they have any affected product or not. Also, requires that the customer confirms that the REagent OD limits for First and Last H are set at 0.15 for Lipase on the Olympus AU400/400e, AU600, AU640/640e and AU2700/AU5400 Systems.",Contact the recalling firm for information,3443,"3,443",Nationwide Distribution,Terminated,"September 16, 2008",25,3443,Not_Computer,N/A,N/A,N/A
Z-2140-2008,48465,"cerclage, fixation",JDQ,Bone fixation cerclage.,Orthopedic,Orthopedic,510(k),"Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, ""2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 "".",Orthopedic implant,2,"August 22, 2008", 2008,Acumed LLC,"Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.",TRAINING: Employee Error,"On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed.",N/A,50,50 units,"Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.",Terminated,"February 03, 2010",530,50,Not_Computer,N/A,N/A,N/A
Z-1531-2008,46908,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),"Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10",Quickie Rhythm Power Wheelchair,2,"August 23, 2008", 2008,Sunrise Medical Inc,"Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.",DESIGN: Software Design,"Initial phone contact began on January 11, 2008. Medical device correction letters were also sent to affected dealers.",N/A,141,141 units total,"Product was distributed to 126 retailers nationwide throughout the USA, as well as Canada and Australia.",Terminated,"November 16, 2009",450,141,Not_Computer,N/A,N/A,N/A
Z-1540-2008,46961,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"CareVue Chart Release C ,Versions C.00.00 through C.00.06Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.",IntelliVue Clinical Information Portfolio (ICIP),2,"August 23, 2008", 2008,Philips Medical Systems,Medications prescribed for one patient were printed on the record of another patient.,DESIGN: Software Design,"Philips Medical issued letter notification, dated 29 Feb 2008 to customers titled; ""Urgent Medical Device Correction Notice"".Customers were asked to not solely rely on the Worklist to remind them when to administer orders or interventions until the software has been upgraded. Customers should review the reminders and verify orders and interventions on the Medication Administration Record and Administration record. The correction will be in the form of a software upgrade and will be performed remotely by Philips service personnel.",N/A,138,138 for products,"NationwideCanada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE",Open,N/A,N/A,138,Software,Output/Calculation,Software update,Software Update
Z-1542-2008,47252,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation.,Altaire MRI System,2,"August 23, 2008", 2008,Hitachi Medical Systems America Inc,"The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.",DESIGN: Component Design/Selection,"The firm issue a DEVICE CORRECTION letter to their customers on 2/11/2008. The letter informs the customers of the Emergency Rundown Switch Unit (ERDU) defect and provides a warning which lists instructions for the safe use of the ERDU Unit. The letter informs the customer(s) that their local Hitachi Field Service Engineer (FSE) will be scheduling a visit to test the ERDU in order to verify its state of operation. The letter also states that This test requires specific tools in order to verify the operation without actually quenching the magnet and that Hitachi will begin the test ING in March, 2008 and will continue the program until all installed ERDU units are verified.Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",235,235 units,"The recalled device units were distributed to customers located in the following states nationwide: CA, OH, IL, NJ, NY, FL, TX, NE, AR, MD, OR, MN, NV, MS, OK, IN, TN, MO, SC, VA, HI, LA, NC, NM, WY, WA, AL, PA, UT, WA, and KY",Terminated,"September 24, 2010",762,235,Not_Computer,N/A,N/A,N/A
Z-2156-2008,48472,"motor, drill, pneumatic",HBB,Pneumatic cranial drill motor.,Neurology,Neurology,510(k),"Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23Medtronic Powered Surgical Solutions, Forth Worth, TXIntended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.",Midas Rex Legend dissecting tool,2,"August 23, 2008", 2008,Medtronic Powered Surgical Solutions,"Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.",PRODUCTION CONTROLS: Process Control,"Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.",N/A,1306,"1,306 units",Nationwide Distribution.,Terminated,"August 22, 2009",364,1306,Not_Computer,N/A,N/A,N/A
Z-2157-2008,48596,template,HWT,Template for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm lengthCatalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-0145565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-0205565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Used in Revision TKA.","Stem Trial, Triathlon Revision Instruments",2,"August 23, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.",PRODUCTION CONTROLS: Process Control,"Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available.",N/A,5565,"Catalog Number 5565 T-009 to 025: 2629 US, 238 international: Catalog 5566 T-009 to 025: 2625 US, 239 international","Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.",Terminated,"January 26, 2010",521,11297,Not_Computer,N/A,N/A,N/A
Z-2234-2008,48685,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"StatSampler 200 uL, Li Heparin (micro blood collector)Ref: SS2H Packed in Catalog Numbers:SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit)Intended for collection and processing of capillary blood to prepare plasma/serum.",StatSampler,2,"August 23, 2008", 2008,"StatSpin, Inc., dba Iris Sample Processing",EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Iris Sample Processing notified customers by telephone followed by an Urgent: Product Recall letter dated 6/19/08. Users are requested to return inventory, to not use product from Lot Number 7296, and to repeat tests where the recalled tubes were used.The firm identified an additional lot : 8031 was effected and recalled the lot to two consignees.",N/A,171,171 vials,"Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.",Open,N/A,N/A,171,Not_Computer,N/A,N/A,N/A
Z-1234-2008,46383,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System",Nautica (GK) Mattress Stretcher,2,"August 24, 2008", 2008,"Arjo, Inc.",Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor.,DESIGN: Device Design,"BHM Medical initially notified the end users on 1/23/07 of the potential for the back and leg rest latch ratchets to become damaged, allowing the rests to pivot freely. Should a patient be in the stretcher at the time, the patient could fall, potentially sustaining cuts, bruises or even more severe injuries. The letters provided safety instructions to follow until a permanent fix is available, and requested the accounts to complete and return the enclosed response form acknowledging receipt of the letter and dissemination of the safety instructions to all employees operating the lifts with the affected GK stretchers.BHM sent Customer Field Correction Notification letters dated 1/23/08 to the accounts, along with the Technical Advisory Notice - TAN A dated 1/3/08, reiterating the safety instructions from the 1/23/07 letter and requesting the accounts to, if at all possible, remove the equipment from service until an authorized engineer can replace the ratchets in the backrest and leg rest latches.All consignees have been contacted.",N/A,7,7 units,"Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas.",Terminated,"August 25, 2008",1,7,Not_Computer,N/A,N/A,N/A
Z-1563-2008,46807,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F; System. It is a remote analog R&F; system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain.",Precision Rxi,2,"August 24, 2008", 2008,GE Healthcare,GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F; System. .,DESIGN: Device Design,"Two letters ""GE Product Safety Notification"" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information. The joystick can become stuck causing unintentional motion of the tube.Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location.If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge.If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.",N/A,66,66,(USA)AKCOILLAMAMIMSNCNJNYPASCTNUTVAWAWI(OUSA)BR CA MX AU C3 KR PH TW AE AT BE BF BG CM CY CZ DE ES FI FR GB GE GR GY HR HU IT LB LV MT NA NG PL PT RO RU SA SD SE SI SK SY TN TR UA YU ZA,Open,N/A,N/A,265,Not_Computer,N/A,N/A,N/A
Z-1567-2008,46921,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The FASTPAK battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity.Battery part number 9-10424-18. Sold with LIFEPAK defibrillators and also sold separately.",FASTPAK ,2,"August 24, 2008", 2008,"Physio Control, Inc.","Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.",PRODUCTION CONTROLS: Labeling Mix-Ups,"On February 27, 2008, the firm sent a ""URGENT MEDICAL DEVICE - ACCESSORY RECALL"" letter via certified return receipt to their consignees. The letter states the batteries are fully functional 1.0 amp/hour batteries mislabeled as 2.4 amp/hour batteries and that the batteries will provide half the monitoring time and half the number of defibrillation shock as of a 2.4 amp/hour LIFEPAK NiCd battery. Enclosed with the letter is a confirmation sheet for the consignee to indicate the number of recalled batteries they have and fax back to the firm. The firm will send out replacement batteries and the consignee is to then send back the mislabeled batteries.If there are any questions, contact the technical support group at 1-800-442-1142 - option 5 or visit www.physio-control-notices.come/fastpak.",N/A,811,811 batteries,"Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.",Open,N/A,N/A,811,Not_Computer,N/A,N/A,N/A
Z-1615-2008,46965,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.,TomoTherapy HiArt System,2,"August 24, 2008", 2008,TomoTherapy Incorporated,"In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number ""8"" may appear as the number ""0"" on the printed page.During the registration process, the H",DESIGN: Software Design,"Consignees were sent a letter ""TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice"" dated February 22,2008. The letter described the Issue, Product Affected, Cause, Recommended Customer Action and Resolution.If you have not received this letter or have questions, contact the firm as outlined below:North America: 1 866 368 4807Belgium: 0800 38783France: 0805 631 565Germany: 0800 000 7541Italy: 800 986 399Netherlands: 0800 0201364Spain: 800 300049Switzerland: 0800 001927United Kingdom: 0808 238 6035China/CNC (Northern): 10 800 712 1701China (Southern): 10 800 120 1701Hong Kong: 800 967912Japan: 0044 22 132374Singapore: 800 1204 683South Korea: 0079 81 4800 7204All other locations: +1 608 824 2900 or +32 2 400 44 44.",N/A,32,32,"Worldwide Distribution --- USA including states of CA ,CT, DC, FL, IL, LA, MD, MI, MO, NE, NJ, NY, SC, TN, VA, WI , and countries of Canada, Germany, Taiwan, and Turkey.",Terminated,"December 02, 2008",100,32,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-1558-2008,47463,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.",24mm Rotating CMount Coupler,2,"August 24, 2008", 2008,Stryker Endoscopy,The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned.",N/A,28,28 units,Product was delivered to one consignee in Iowa.,Terminated,"September 17, 2008",24,28,Not_Computer,N/A,N/A,N/A
Z-1640-2008,47441,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.",Logix TPN Software Solution,2,"August 24, 2008", 2008,Baxter Healthcare Corp.,"Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.",DESIGN: Software Design,"Baxter sent the 3/28/08 Urgent Device Correction letter to affected customers, to the attention of the Director of Pharmacy, via first class mail to advise them of the potential inaccuracy of the Delivery Report due to a software anomaly. The accounts were instructed to review each delivery report for accuracy. If the report contains zero actual volumes the user must manually reprint the report. The letter outlined the process for reprinting the Delivery Report. Any questions were directed to the Baxter Nutritional Professional Services at 1-800-422-2751. The accounts were requested complete the enclosed reply form acknowledging receipt and understanding of the letter and dissemination of the information to their staff. A software upgrade will be provided.If you have questions about this letter or you did not receive this letter contact Baxter Nutrition Professional Services at 1-800-422-2751.",N/A,5,5 units,"Arizona, Minnesota, Wisconsin, Puerto Rico and Canada",Terminated,"August 25, 2008",1,5,Software,Output/Calculation,Software update,Software Update
Z-1643-2008,47524,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.",syngo Imaging XS,2,"August 24, 2008", 2008,"Siemens Medical Solutions USA, Inc",The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.,DESIGN: Software Design,"The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update.If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.",N/A,236,236 units,"The product was shipped to medical facilities in AL, AZ, CA, CO, CT, FL, GA, IA, KS, KY, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, WI, and WV.",Terminated,"November 19, 2008",87,236,Software,Display/Image,Software update,Software Update
Z-1648-2008,47758,N/A,N/A,N/A,N/A,N/A,N/A,Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution OnlyProduct Number: 4301-05,Seprafilm,2,"August 24, 2008", 2008,Genzyme Corporation,Sterility may be compromised,TRAINING: Employee Error,"Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.",N/A,517,517 (10 packs),"NationwideKorea, Taiwan, Japan",Open,N/A,N/A,3149,Not_Computer,N/A,N/A,N/A
Z-1641-2008,47471,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"CADD-MS""3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication.Reorder Numbers 21-7401-51/49/00 & 21-7411-51","CADDMS""3 Ambulatory Infusion Pumps",2,"August 24, 2008", 2008,"Smiths Medical MD, Inc.","Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief ""chirp"" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their Pump, there is a potentia",DESIGN: Labeling Design,"A ""Smith Medical Urgent Medical Device Correction"" letter dated February 22, 2008 was distributed to consignees. The letter addressed to Risk/Safety Managers, Distributors, Clinicians, Patients and other Customers, instructs them to fully tighten the battery cap and to routinely monitor the pump for damage that may result in power down situations. Consignees are to return the ""Urgent Medical Device Correction"" form.If you have questions about the letter or did not received the letter contact Mike Herbert at 651-628-7049 or Jeff Esselman at 651-628-7920.",N/A,2303,2303,AZCAFLGAHIILKYMDMIMNNCNENJNMNYPATNTXUTCANADACHILECZECH REPUBLICGERMANYGREAT BRITAINITALYJAPANNETHERLANDSNORWAYSWEDEN,Open,N/A,N/A,2303,Not_Computer,N/A,N/A,N/A
Z-1703-2008,47522,"catheter, electrode recording, or probe, electrode recording",DRF,Electrode recording catheter or electrode recording probe.,Cardiovascular,Cardiovascular,510(k),"Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart.",LASSO 2515 Variable Circular Mapping Catheter,2,"August 25, 2008", 2008,Biosense Webster Inc,"This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep",DESIGN: Device Design,"A letter entitled, ""Urgent Safety Field Notice"" dated March 25, 2008, and certification form were sent to all customers and Johnson & Johnson affiliates who purchased the product in the past year as of March 25, 2008, due to the expiration date. For customers in the US, two letters and forms were sent out - one addressed to the EP/Cardiology Lab and a second to the Risk Management Office.If you have questions or have not received a letter contact Customer Service at 1-800-729-9010.",Contact the recalling firm for information,14295,"14,295 units for both products","Nationwide and Worldwide to:Argentina,Australia,Austria,Belgium,Brazil,Canada,Chile,China,Columbia,Czechia,Denmark,Egypt,Finland,France,Germany,Greece,Hong Kong,Hungary ,Iran,Ireland,Isra¶_¶_l,Italy,Japan,Lithuania,Luxembourg,Mexico,Middle East,Netherlands,Norway,Panama,Poland,Portugal,Russia,Serbia,Slovenia, South Africa,Spain,Sweden,Switzerland,Taiwan,Turkey,United Kingdom",Open,N/A,N/A,14295,Not_Computer,N/A,N/A,N/A
Z-1649-2008,47800,"system, measurement, blood-pressure, non-invasive",DXN,Noninvasive blood pressure measurement system.,Cardiovascular,Cardiovascular,510(k),"BCI Non Invasive Blood Pressure MonitorProduct/Catalog number 6004,","Smith Medical PM, Inc., BCI MiniTorr Plus NIBP Monitor with SpO2 BuiltIn Printer",2,"August 25, 2008", 2008,"Smiths Medical PM, Inc.","Due to a component that may be installed backwards, the device may turn off or may immediately reset.",TRAINING: Employee Error,"Consignees were contacted on 4/2/08 with a Safety Action Bulletin, 08-SAB02, and Technical Worksheet 08-TW01 dated April 1, 2008, which included information regarding the potential safety issue and the proper inspection method for the monitor(s).If you have not received the Safety Action Bulletin or the Technical Worksheet contact Smiths Medical PM, Inc. at Telephone: (262) 542-3100 or Toll Free: (USA): (800) 558-2345 or email info.pm@smiths-medical.com.",N/A,195,195,"USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR.OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom",Open,N/A,N/A,195,Not_Computer,Device Operation,Instructions,Safety Notice/Insructions
Z-1696-2008,47871,"cement, dental",EMA,Dental cement.,Dental,Dental,510(k),"Dental Cement-Bisco BISCEM¶_ Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.",Bisco BISCEM SelfAdhesive Luting Cement Translucent,2,"August 25, 2008", 2008,Bisco Inc,"During product stability testing, Bisco determined that after 15 months of storage, BISCEM¶_ Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time.",EXPIRATION DATING: Incorrect or No Expiration Date,"Bisco sent Urgent Medical Device recall letters dated 4/25/08 to the U.S. consignees via 1st class mail on 4/28/08. The letters informed the users that after 15 months of storage, BISCEM¶_ Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Future production lots will be labeled with a shelf life of 1 year with a requirement to refrigerate the product when not in use. The accounts were requested to destroy their remaining stocks of the product and record the number of used or partially used syringes destroyed, indicating the lot numbers of the units destroyed on the enclosed response form and fax it back to Bisco at 847-534-66101. Questions were directed to Bisco Dental Products Customer Service at 1-800-247-3368.",N/A,N/A,N/A,"Nationwide including Puerto Rico and internationally to Argentina, Australia, Bulgaria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vietnam",Terminated,"September 14, 2010",750,N/A,Not_Computer,N/A,N/A,N/A
Z-1702-2008,47908,"unit, phacofragmentation",HQC,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.",AMO WHITESTAR SIGNATURE Phacoemulsification System,2,"August 25, 2008", 2008,"Advanced Medical Optics, Inc.",AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.,DESIGN: Device Design,"On April 2, 2008, AMO began distribution of an Urgent Safety Notice to all customers in the United States via overnight carrier (Federal Express). The U.S safety notice was used as a template for all global AMO communications regarding the Urgent Safety Notice , many of which required translation into local language prior to distribution. Included in this correspondence is a listing of the serial numbers of the affected products.The Notice informed customers of the problem and gave the customers modifications to the Vitrectomy Cutter Priming Instructions. In addition, the notice informed the customers that an AMO Field Service Engineer will be scheduling a site visit to modify a pressure setting on the AMO Whitestar Signature system. Contact the AMO Phaco Technical support at 1-877-AMO-4LIFE for assistance. AMO will provide updates to the FDA, including all information regarding the recall effectiveness as part of the recall progress reports.",Contact the recalling firm for information,191,191 units,"Nationwide and to: AL, AR, CA, CO, FL, HI, IL, IN, MD, NC, ND, NJ, NY, OH, OR, PA, PR, SC, TX & WA and worldwide to: Azerbaijan, Belgium, Germany, Denmark, Egypt, Spain, France, Great Britain, Croatia, Hungary, Israel, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Netherlands, Norway, Poland, Portugal, Saudia Arabia, Sweden, Turkey, South Africa, Australia, India, New Zealand and Singapore",Terminated,"January 21, 2010",514,191,Not_Computer,N/A,N/A,N/A
Z-2159-2008,48601,"formalin, neutral buffered",IFP,General purpose reagent.,Pathology,Pathology,510(K) Exempt,"10% Buffered Formalin Phosphate; CertifiedFor laboratory and manufacturing use only, not for drug, food or household use.Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20Fisher Scientific, Fail Lawn, NJ 07410",10 Buffered Formalin Phosphate,2,"August 25, 2008", 2008,"ThermoFisher Scientific Co., LLC","Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.",N/A,1640,"1052 x 4 liters, 564 x 20 liters",Worldwide Distribution --- including USA and Canada.,Open,N/A,N/A,1616,Not_Computer,N/A,N/A,N/A
Z-2160-2008,48602,"camera, x-ray, fluorographic, cine or spot",IZJ,Cine or spot fluorographic x-ray camera.,Radiology,Radiology,510(k),General X-Ray System types with Digital Spot Imaging (DSI) software,General XRay System types with Digital Spot Imaging (DSI),2,"August 25, 2008", 2008,Philips Medical Systems North America Co. Phillips,"X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).",DESIGN: Software Design,"On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.",N/A,41,41 units,Nationwide Distribution.,Terminated,"September 28, 2010",764,41,Software,Output/Calculation,Update software,Software Update
Z-2161-2008,48604,"cutter, surgical",FZT,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ENDOPATH¶_ETS-Flex Endoscopic Linear Cutter, ATW35Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.",ENDOPATHETSFlex Endoscopic Linear Cutter,2,"August 25, 2008", 2008,Ethicon Endo-Surgery Inc,The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.,PRODUCTION CONTROLS: Process Control,"Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.",N/A,16053,"16,053 Pieces","Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.",Open,N/A,N/A,42434,Not_Computer,N/A,N/A,N/A
Z-2167-2008,48611,"shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)",HOY,Ophthalmic eye shield.,Ophthalmic,Ophthalmic,510(K) Exempt,"Radiation Protective Eyewear (only involving multifocals.FTC 28 Progress X-Ray Protective EyewearProtective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.",Radiation Protective Eyewear,3,"August 25, 2008", 2008,Phillips Safety Products,Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.,PRODUCTION CONTROLS: Process Control,"Customers were all notified by phone, followed by an Urgent Recall letter dated June 3, 2008. The letter asked that customers examine their stock immediately to determine if they had any of these radiation protective bifocals on hand, discontinue use or distribution of the lot, and set the products aside for further instructions. Also, if customers distributed these items, they needed to contact their accounts and advise them of the recall and have them return their outstanding recall stock to them. The firm will send replacement products in the weeks to follow.",N/A,845,845 pairs of eyewear,"Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.",Terminated,"December 24, 2008",121,845,Not_Computer,N/A,N/A,N/A
Z-1716-2008,47468,"unit, liquid-oxygen, portable",BYJ,Portable liquid oxygen unit.,Anesthesiology,Anesthesiology,510(k),"Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.",Caire Generation 4 electronic liquid level gauge,2,"August 26, 2008", 2008,"Caire, Inc.",Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.,DESIGN: Device Design,"A Technical Service Bulletin was sent to consignees on/about October 23, 2007 to notify customers of the potential issue. Technical support and information for ordering replacement Generation 4 liquid gauges were offered.For technical concerns or if you have not received the notification from the firm, contact U.S. Technical Service at 1-800-482-2473 or European Technical Service at +44 (0) 797 1260077.",N/A,3470,3470,"U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.",Terminated,"December 17, 2009",478,3470,Not_Computer,N/A,N/A,N/A
Z-1868-2008,48427,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758.Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.",Modular Femoral Neck,2,"August 26, 2008", 2008,"Encore Medical, Lp","Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.,N/A,20,20 units,"Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.",Terminated,"September 08, 2009",378,20,Not_Computer,N/A,N/A,N/A
Z-2154-2008,48467,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Corometrics¶_ MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002.Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.","Corometrics MODEL 250 Series Maternal/ Fetal Monitor,",2,"August 26, 2008", 2008,"Datex Ohmeda, Inc. dba GE Healthcare",Communication connector within monitor is defective and may cause potential loss of telemetry.,DESIGN: Component Design/Selection,"The recalling firm notified healthcare professionals by an Urgent Medical Device Correction letter dated 07/01/2008 to Healthcare Administrators, Risk Managers, Nurse Managers and Directors of Clinical Engineering. The letter advised of a defect in a communication board that may cause a potential loss of telemetry monitoring. The firm recommended that the device should not be used with the firm's 340 Series telemetry system pending replacement of the defective board by service engineers. The Healthcare Professionals are asked to contact the GE Healthcare Technical Support center at 1-800-558-7044.",N/A,133,133 units,Nationwide Distribution.,Open,N/A,N/A,133,I/O,Device Operation,Replace component,Remove or Replace
Z-2166-2008,48608,"catheters, transluminal coronary angioplasty, percutaneous",LOX,Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.,Cardiovascular,Cardiovascular,N/A,"Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, IrelandREF 38928-1225Use before 2007-01UPN H7493892812250Sterilized with ethylene oxide gasBoston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland Ballybrit Business Park, Galway, IrelandREF 38928-2035Use before 2007-01UPN H7493892820350Sterilized with ethylene oxide gasIndicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.","Maverick 2"" Monorail PTCA Catheter ",2,"August 26, 2008", 2008,Boston Scientific Corporation,"Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required""letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned.",Contact the recalling firm for information,67,67 Units,"International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.",Terminated,"September 10, 2008",15,67,Not_Computer,N/A,N/A,N/A
Z-2170-2008,48615,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Ev3 Primus GPS Biliary Stent System8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75Use before 2009-02Sterile EOEv3 4600 Nathan Lane North, Plymouth, MN 55442-2920Intended as a palliative treatment of malignant neoplasms in the biliary tree.","Protg GPS"" Biliary Stent System ",2,"August 26, 2008", 2008,"Ev3, Inc","A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.",TRAINING: Employee Error,The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.,Contact the recalling firm for information,1,1 Unit,Nationwide Distribution --- state of NJ,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-2165-2008,48607,"catheters, transluminal coronary angioplasty, percutaneous",LOX,Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.,Cardiovascular,Cardiovascular,N/A,"Boston Scientific Scimed Maverick 2 Monorail"" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530Lot 9565194Use before 2010-04Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.","Maverick 2 Monorail"" PTCA Catheter",2,"August 26, 2008", 2008,Boston Scientific Corporation,"The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.",N/A,24,24 Units,"International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.",Terminated,"September 10, 2008",15,24,Not_Computer,N/A,N/A,N/A
Z-2169-2008,48614,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Ev3 Protege GPS Biliary Stent Systems6 mm, 60 mm, 120cm, .35, 6Fr, OTWEv3 4600 Nathan Lane North, Plymouth, MN 55442-2920REF SERB65-06-60-120Lot 2675311Use before 2009-01-01Sterile EOIntended as a palliative treatment of malignant neoplasms in the biliary tree.","Protg GPS"" Biliary Stent System ",2,"August 26, 2008", 2008,"Ev3, Inc","A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.",TRAINING: Employee Error,The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.,Contact the recalling firm for information,1,1,Nationwide Distribution --- state of LA.,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-1774-2008,47795,N/A,N/A,N/A,N/A,N/A,N/A,"Hall Easy-Fit¶_ Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.",Hall EasyFit Prosthetic Heart Valve A,2,"August 27, 2008", 2008,Medtronic Heart Valve Division,Medtronic has identified an issue with 685 Hall Easy-Fit¶_ valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.,PRODUCTION CONTROLS: Process Control,"A Medtronic ""Urgent Communication"" letter dated March 24, 2008 was sent to consignees on 3/25/08. The letter describes the product and problem. The letter requests that they return the impacted devices and to return the reconciliation form ""Medtronic Recall Certificate (FCA0807)"" confirming whether they have the valves in inventory or if they have been implanted.",Contact the recalling firm for information,69,"69 (USA), 117 (EUROPE), 5 (CANADA), 179 (HONG KONG)","Class II Recall - Worldwide Distribution --- including USA states of TX, WY, CA, MI, WI, MO, IL, NY, TN, AR, LA, KY, WA, WV, and countries of Canada, Hong Kong, Australia, Albania, Belgium, Croatia, Germany, India, Italy, Netherlands, Poland, Romania, Russian Federation, South Africa, and Turkey.",Open,N/A,N/A,400,Not_Computer,N/A,N/A,N/A
Z-1776-2008,47807,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),"Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107",QLogic Controller Software,2,"August 27, 2008", 2008,Pride Mobility Products Corp,Software - Watch dog timer feature was disabled.,DESIGN: Software Design,The recalling firm issued an Urgent Device Correction letter on 4/11/08. This letter instructs the dealers to contact the end users so that the units can be upgraded to enable the watch dog feature.,N/A,4129,4129,Class II Recall - Worldwide Distribution --- including USA and Canada.,Terminated,"November 13, 2009",443,4129,Software,N/A,Software update,Software Update
Z-1777-2008,47819,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.",Century Bed,2,"August 27, 2008", 2008,"Hill-Rom, Inc.",A risk of entrapment will exist between the head and foot rails if installation instructions are followed.,OTHER/UNDETERMINED: Pending,Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist.,N/A,69,69,"Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.",Terminated,"September 22, 2009",391,69,Not_Computer,N/A,N/A,N/A
Z-1778-2008,47829,reamer,HTO,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Xcelerate Patella System Reamer Shaft Assembly;Non-Sterile;Howmedica Osteonics Corp.,325 Corporate Drive;Mahwah, NJ 07430Authorized representative in Europe:Stryker France ZAC Satolas Green PusignanCedex, France",Xcelerate Patella Reamer Shaft Assembly and Adapter,2,"August 27, 2008", 2008,Stryker Howmedica Osteonics Corp.,The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.,DESIGN: Process Design,"An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.",N/A,24,24 total,"Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.",Terminated,"September 24, 2008",28,24,Not_Computer,N/A,N/A,N/A
Z-2171-2008,48616,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic 8578 Sutureless Pump Connector Revision KitMedtronic Inc., Minneapolis, MN 55432A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.",8578: Suturless Pump Connector Revision Kit,2,"August 27, 2008", 2008,Medtronic Neuromodulation,The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.,DESIGN: Device Design,"Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.",N/A,232,232 total from all models,International Distribution --- country of Belgium.,Terminated,"September 10, 2008",14,232,Not_Computer,N/A,N/A,N/A
Z-1309-2008,46834,"light, ultraviolet, dermatological",FTC,Ultraviolet lamp for dermatologic disorders.,General & Plastic Surgery,General & Plastic Surgery,510(k),HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes.A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.,HOUVA III Phototherapy System with DermaSense Technology,3,"August 28, 2008", 2008,National Biological Corp,"Software allows operator to override ""low line voltage"" error warning and store light intensity value.",DESIGN: Software Design,"National Biological sent an ""Important safety reminders for your Houva DermaSense phototherapy device"" letters, dated 2/11/08 to users. It states that the user should collect a ""Profile"" of the light energy and record it on a daily/weekly flow chart. The chart should be in plain view so each operator can clearly determine the units output. If an error message appears in the display panel, treatment should not be continued unless the phototherapy booth operator was able to identify and correct the cause of the error. Make sure both breakers are in the ""ON"" position before starting up the unit each morning and before giving treatment.",N/A,48,48 Units,"Worldwide distribution --- USA including states of: CA, DE, FL, GA, ID, IL, IN, MA, MI, MN, NC, NH, NY, OH, OR, PA, TX, VA, WA and WI, and country of Canada.",Open,N/A,N/A,48,Software,N/A,Instructions,Safety Notice/Insructions
Z-1650-2008,47885,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model AB1102 - Standard basic model Ambulift with chair and leg rest.Model AB1552 - Standard basic model Ambulift with chair and leg rest and scales.",Arjo Ambulift,2,"August 28, 2008", 2008,"Arjo, Inc.","The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.",DESIGN: Device Design,"Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.",N/A,11,11 lifts,"Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA",Terminated,"February 03, 2010",524,14,Not_Computer,N/A,N/A,N/A
Z-2153-2008,48466,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, "" Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR "".",AcuLoc Distal Radius Plate,3,"August 28, 2008", 2008,Acumed LLC,Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.,PRODUCTION CONTROLS: Process Control,"The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed.",N/A,51,51 pieces,"Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.",Terminated,"February 03, 2010",524,51,Not_Computer,N/A,N/A,N/A
Z-2155-2008,48468,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, ""Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.",3.5mm X 32.5mm Cortical Screw ,2,"August 28, 2008", 2008,Acumed LLC,Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.",N/A,112,112 pieces,"Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.",Terminated,"February 03, 2010",524,112,Not_Computer,N/A,N/A,N/A
Z-2201-2008,49030,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),"Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002",MOST,1,"August 28, 2008", 2008,Pacific Consolidated Industries LLC,"The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. With one unit the operator was able to shut off the oxygen flow, however one rupture resulted in a fire. No injuries were reported.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"PCI sent a Recall Notification letter to the Spanish Air Force September 8, 2007. The Recall Notification letter was mailed to the US Defense Supply Center on July 24, 2008 after a recall agreement was signed on July 8, 2008 between Pacific Consolidated Industries and the Defense Supply Center. The recall notification to Spanish Air Force informed the consignee of the problem and asked the consignee to remove the affected units from service until a Technical Service Representative could be sent to Spain to inspect the affected units and perform the corrective action. The recall notification to Defense Supply Center instructed the consignee to keep the affected units in quarantine (units placed in quarantine by US Air Force August 3, 2007) until they have been refurbished under recall agreement that was signed on July 8, 2008.",N/A,1032,1032 units,Worldwide to US Air Force and also to Spain,Open,N/A,N/A,1032,Not_Computer,N/A,N/A,N/A
Z-1618-2008,47388,"catheter, electrode recording, or probe, electrode recording",DRF,Electrode recording catheter or electrode recording probe.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter",SteeroCathDx Diagnostic Catheter,2,"August 30, 2008", 2008,Boston Scientific Corp,"Package sterile barrier may be breached, compromising sterility.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form.If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com.",N/A,827,827 units total,"Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.",Open,N/A,N/A,827,Not_Computer,N/A,N/A,N/A
Z-1705-2008,47774,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.",OEC 9800,2,"September 01, 2008", 2008,"OEC Medical Systems, Inc",Use of existing four-pedal footswitch on a different machine may cause various operational errors.,DESIGN: Device Design,Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.,Contact the recalling firm for information,78,78 units,"Nationwide, including one VA facility in FL. No military or foreign distribution.",Open,N/A,N/A,103,Not_Computer,N/A,N/A,N/A
Z-1715-2008,47384,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.",Clnitest,2,"September 01, 2008", 2008,Siemens Medical Solutions Diagnostics,False negative hCG results due to decreased sensitivity,DESIGN: Component Design/Selection,"Siemens notified Distributors ( Distributor Bulletin Urgent Field Safety Notice) and end-users (Customer Bulletin Urgent Field Safety Notice) Clinitest hCG Cassette Recall by letter dated 4/3/08. Users are requested to, discontinue use, discard the product, and immediately contact Siemens technical support representative or distributor for replacement cassettes from a different lot.If you have any question or have not received the recall notification, contact your local Siemens Distributor Relations Representative or Siemens Technical Support at 877-229-3711 option 13 then 5.",Contact the recalling firm for information,8180,8180,Nationwide,Open,N/A,N/A,8180,Not_Computer,N/A,N/A,N/A
Z-1524-2008,47517,"heart-valve, allograft",MIE,N/A,N/A,Cardiovascular,Contact ODE,"CryoValve, Pulmonary Valve & Conduit",CryoValve,2,"September 01, 2008", 2008,"CryoLife, Inc.","Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.",N/A,1,1 tissue,"Hospitals in DE, TN",Terminated,"January 12, 2010",498,1,Not_Computer,N/A,N/A,N/A
Z-1642-2008,47487,"block, beam-shaping, radiation therapy",IXI,Radiation therapy beam-shaping block.,Radiology,Radiology,510(k),AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.,AD 7 Patient table,2,"September 01, 2008", 2008,Philips Medical Systems North America Co. Phillips,Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.,DESIGN: Device Design,"On 03/22/2004, firm sent letters via certified mail to notify customers of issue. Letter advises customers of potential risk for patients and users, and states to not use system for critical examinations or treatments if table movements suddenly stops or makes a freeing movement. The letter indicates a representative will contact customer for installation of a Hardware filter, free of charge, to prevent Electromagnetic interference (EMI) from affecting the force sensor. Please contact Philips at 1-800-722-9377 #5, #4, #1.",N/A,39,39 units,"Product is distributed to hospitals and medical centers nationwide to the following states: ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL.",Open,N/A,N/A,39,Not_Computer,N/A,N/A,N/A
Z-1646-2008,47535,"system,x-ray,extraoral source,digital",MUH,Extraoral source x-ray system.,Dental,Radiology,510(k),i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam,iCAT 1719 Cone Beam 3D Dental Imaging System,2,"September 01, 2008", 2008,Imaging Sciences Intl Inc,Incorrect scatter information in the manual.,PRODUCTION CONTROLS: Error in Labeling,"Firm issued Urgent Medical Device Recall letters dated 3/19/08 to their customers. The distributors were provided background information and specific instruction on the steps to perform to correct the problem.If you have questions or have not received this letter, contact Francine McCoonse at 215-997-5666 ext 1340.",Contact the recalling firm for information,1203,1203 units,"The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.",Terminated,"May 05, 2009",246,1203,Not_Computer,N/A,N/A,N/A
Z-1749-2008,47536,"colorimeter, photometer, spectrophotometer for clinical use",JJQ,"Colorimeter, photometer, or spectrophotometer for clinical use.",Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"UBiT¶_-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.",UBiTIR300 Infrared Spectrophotometer,2,"September 01, 2008", 2008,"Otsuka America Pharmaceutical, Inc.",Medical device power supply may overheat and cause smoke to be emitted from the device.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The initial distributor in the US notified consignees 03/14/08 and 03/26/08 by letter. Consignees were provided two different letters depending on the hours of use of the spectrophotometer. The notifications advised of the firm's preventive service and upgrade program for the instrument's power supply, in which consignees would receive a temporary replacement instrument while the service is completed. Consignees with spectrophotometers having",N/A,517,517 units,The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.,Open,N/A,N/A,517,Battery,Physical Safety Hazards,Replace/Instructions,Remove or Replace
Z-1592-2008,47424,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"InCompass¶_ Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5"" shaft) and 2151-5 (13"" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.",THandle Driver,2,"September 01, 2008", 2008,Abbott Spine,Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.,PRODUCTION CONTROLS: Error in Labeling,"Firm sent notification letters to sales agents via letter on 03/24/08. Enclosed with the notification letter, the firm provided updated product inserts for the InCompass¶_ and PathFinder¶_ Spinal Fixation System (Cat. #2199-0002-LB Rev. H and #1199-0002-LB Rev. H, respectively), as well as the ""Disassembly and Assembly Instructions for PathFinder¶_ & InCompass¶_ T-Handle Drivers"" (Cat #1199-0040-MKC Rev. A).Sales Agents instructed to distribute updated inserts and instructions to all locations that handle the drivers for cleaning and to destroy all copies of old inserts.If you have questions or have not received the recall notice from the firm, contact Kirstin Widding at 512-533-1852.",N/A,278,278 units.,"Nationwide Distribution --- including states of AR, AZ, CA, CT, CO, FL, IL, LA, MD, MI, MO, MN, MT, NC, NM, NJ, NY, OH, OK, OR, PA, SD, TX, VA and WI.",Terminated,"December 02, 2009",457,502,Not_Computer,N/A,N/A,N/A
Z-1475-2008,47352,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test systemProduct Number: 1760",Clinitest,2,"September 01, 2008", 2008,Siemens Medical Solutions Diagnostics,False positive hCG results,TRAINING: Employee Error,"Siemens issued a Service Bulletin to Siemens Healthcare Diagnostics Branches via email on 10/17/007, and a customer bulletin to outside the US . Users are requested to discontinue use and discard the product. A Completion Notification was requested to be completed and returned by the faculties.",Contact the recalling firm for information,3065,3065 kits,"NationwideCanada, France, Korea, Netherlands, UK",Open,N/A,N/A,3065,Not_Computer,N/A,N/A,N/A
Z-1717-2008,47527,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V); REF 600-01-114.",Zimmer Spine Cyclone anterior cervical plate system,2,"September 01, 2008", 2008,Zimmer Inc.,The screw locking cap may fracture when the surgeon rotates it into the locked position.,DESIGN: Device Design,Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.,N/A,N/A,N/A,"Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.",Terminated,"November 12, 2009",437,N/A,Not_Computer,N/A,N/A,N/A
Z-1591-2008,47423,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),"Deltec Cozmo¶_¶_ Insulin Pump, model 21-1800.This is similar to the currently distributed Deltec Cozmo¶_¶_ Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump.Reorder Numbers:21-1801-8121-1803-8121-1804-8121-1805-49/51/8121-1806-49/51/8121-1807-49/51/8121-1815-01/5021-1816-01/5021-1817-01/50",Insulin Infusion Pump,2,"September 01, 2008", 2008,"Smiths Medical MD, Inc.","Smith Medical has received reports of Deltec Cozmo¶_¶_ Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief ""chirp"" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood gl",DESIGN: Device Design,"Consignees and the USA demonstration pump physicians were mailed an ""Urgent Medical Device Correction"" letter on 2/22/08. The letter stated Details on Affected devices, Description of the problem, Advice on action to be taken by the user, Additional Information and New Warning. These consignees will be required to return the Correction Confirmation Form. The 17 countries with international mailing addresses were sent the Urgent Medical Device Correction letter (Urgent Field Safety Notice) via the Smiths Medical International Regulatory department based in Watford UK. The Smiths Medical Distributors and Affiliates will be required to mail the Safety Notice to their direct users. The USA distributors were mailed the Urgent Medical Device correction letter with a cover letter. These consignees will be required to add the letter to in-house inventory. The USA prescribing physician and the the USA Managed Care Accounts (Insurance Companies) were mailed the Urgent Medical Device Correction letter with a cover letter. These consignees will not be required to respond and no follow-up will be done by Smiths Medical.Contact Mike Herbert at 651-628-7049 if you have any questions or did not receive the recall information from the firm.",Contact the recalling firm for information Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of AU, CA, CL, CN, DE, EG, FR, GB, GR, IL, KW, MX, NL, NZ, ON, PL, SA, SE, TR, UK.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1767-2008,47529,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593",Sonoline Antares 5.0 ultrasound system,3,"September 02, 2008", 2008,"Siemens Medical Solutions USA, Inc.","Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.",DESIGN: Software Design,The firm initiated a field correction on 03/21/2008. Site visits to correct the problem and install the revised software version 200.0.063A are planned for all consignees. No other notification was made. The firm can be contacted at 650-694-5993.,N/A,51,51 active units total,"Product was distributed worldwide to 539 consignees, in the USA to MD, SC, AZ, FL, IL, WI, NJ, NC, CA, OH, VA TX, PA MO, NH, IA, NE, MN, NY, GA, MI, WA, HI, MA, SC, WV, VA, ND, IN, WY, UT, MS, TN, PR, SD, KY, OK, OR, and worldwide to Sweden, Saudi Arabia, Austria, New Zealand, Italy, Switzerland, Mexico, Germany, Australia, Canada, Great Britain, France, China, South Korea, Singapore, Denmark, Brazil, Poland, Norway, Faroe Islands, South Africa, Russian Federation, Romania, Trinidad and Tobago, Greece, India, Spain, Thailand, Ukraine, Nicaragua, Japan, India, Czech Republic, Egypt, Taiwan, Turkey, Malaysia, Qatar, Bosnia an dHerzogovina, Vietnam, Brunei Darussalam, Italy, Kuwait, Turkey, Portugal",Terminated,"September 30, 2009",393,51,Computer,N/A,N/A,N/A
Z-1824-2008,47834,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .,M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM Headset,2,"September 02, 2008", 2008,Resonance Technology Inc,Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.,DESIGN: Device Design,"The strategy was notifying customers by written communication. The letter advises Resonance Technology, Inc. is voluntarily recalling the MRI Headset, Model No. RTC-2K and RTC- 551-070 because of potential safety concerns. Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to skin. The letter also advises that Resonance Technology Inc. has designed and developed the significantly improved MRI Headset, Model No. RTC-661-060-09P-001 (upgrade) and began shipping this product in January 2007. Customers who received the Headset Model; RTC-2K and RTC- 551-070, are asked to upgrade to MRI Headset Model No. RTC-661-060-09P-001. Response is requested as to the number of headsets to be replaced. In addition, consignees are advised that if they further distributed this product, to identify their customers and notify them at once of this product recall. If you have questions, contact Olivia Shayesteh at 818-882-1997 or via email at Olivia@mrivideo.com.",N/A,29,29 units,"Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,",Open,N/A,N/A,49,Not_Computer,N/A,N/A,N/A
Z-1826-2008,48078,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010",GE Centricity PACS RA1000 Workstation,2,"September 02, 2008", 2008,GE Healthcare Integrated IT Solutions,"A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.",DESIGN: Software Design,"GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.",N/A,177,177 units,"Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and United Kingdom.",Terminated,"February 03, 2010",519,177,Software,Display/Image,Software update,Software Update
Z-1821-2008,48123,"device, acupressure",MVV,N/A,N/A,Neurology,510(k),"Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).",Psi Bands,2,"September 02, 2008", 2008,Psi Health Solutions,Product was marketed before its 510(k) application cleared.,PREMARKET APPROVAL: No Marketing Application,Recall imitated 04/26/07. Retailers were informed via phone and email and mail.The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions.,N/A,21000,21000 units,"Product was distributed to approximately 21,000 consumers and retailers throughout the US.",Terminated,"December 18, 2008",107,21000,Not_Computer,N/A,N/A,N/A
Z-1817-2008,48115,"cannula, manipulator/injector, uterine",LKF,N/A,N/A,Obstetrics/Gynecology,510(k),"ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.",Uterine manipulator,2,"September 02, 2008", 2008,"Clinical Innovations, LLC",Inadequate package seal could compromise sterility.,PRODUCTION CONTROLS: Process Control,Consignees were notified by letter on 05/12/2008 with instructions to conduct the recall to the end user. All remaining product is to be quarantined and returned to CI. A response form was included and a letter template to use in any sub-recall. Contact Richard Dixon at 801-268-8200 if you have questions.,N/A,260,260 units,"CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.",Terminated,"September 25, 2008",23,760,Not_Computer,N/A,N/A,N/A
Z-1825-2008,47840,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010",Centricity AW Suite 2.0 Software,2,"September 02, 2008", 2008,GE Healthcare Integrated IT Solutions,Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.,DESIGN: Software Design,"GE Healthcare IITS sent Urgent Safety Notice letters dated 5/9/08 to all customers who have the AW Suite Software Version 2.0, informing them of the incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta analysis protocol or customized protocols. The users were instructed not to use the aorta analysis protocol or the customized protocols for an aneurysm until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",207,207 units,"Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Malta, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland and Turkey.",Terminated,"September 24, 2010",752,207,Software,Output/Calculation,Software update,Software Update
Z-1820-2008,48116,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)",N/A,2,"September 02, 2008", 2008,"Allez Spine, LLC","This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the ""Instructions for Use"" for the impacted systems are incorrect.The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.",PRODUCTION CONTROLS: Error in Labeling,"Allez Spine issued a safety notice with attached fax-back attachment on April 14, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of the failure of the sterilization validation and requesting them to use the new recommended sterilization parameters. The notice included copies of the updated Instructions for Use for the Allez Spine Laguna Pedicle Screw System and the Allez Spine Del Mar Pedicle Screw System. The safety notice requested that the revised recommended instructions be used for all future cleaning, decontamination and sterilization. Copies of the revised instructions were also provided with the safety notice along with links to the company website where additional copies may be downloaded.Contact Mark De Baca at 415-357-9908 if you have any questions.",N/A,2,2 systems,"Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT",Terminated,"January 25, 2010",510,66,Not_Computer,N/A,N/A,N/A
Z-1752-2008,47245,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core",EndoWave,2,"September 02, 2008", 2008,EKOS Corporation,Potential for unit to burn patient.,DESIGN: Software Design,"In March 2008, the firm planned to visit each consignee to install the new software version 01.05.02 and hand deliver letters, dated 02/20/2008, notifying consignees of the reason for the action. The old software version is 01.04.02. The software was upgraded because the Ultrasound Core heats very quickly and if removed from the DDC while operating it may result in burns to the patient or user. The software will turn off the Ultrasound Core automatically if removed from the DDC during operation, and will prompt to restart therapy if ultrasound is turned off during treatment.On 04/17/2008, the firm issued a new letter with the date of April 2008 informing customers of the issue. In addition the letter indicates that the corrective action, release of the new software is delayed to incorporate further changes, and that customers will be notified when the software is available for their unit. Customers are advised that the device is safe to use when operating according to the Instructions for Use. EKOS contact number 1-888-356-7435.",No consumer action necessary,218,218 units,Products were distributed nationwide to hospitals.,Open,N/A,N/A,218,Software,Physical Safety Hazards,Software update,Software Update
Z-1698-2008,47888,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.,Galil Medical Warming Catheter,2,"September 03, 2008", 2008,Galil Medical,The warming catheter was manufactured with the inlet and outlet tubes switched.,PRODUCTION CONTROLS: Process Control,"The recalling firm telephoned their customers in April 2008 to inform them of the problem and the need to return the product. There customers were also asked to contact the firm if they had actually used any of the kits with the serial numbers listed, even if they experienced no problem. As a follow up to the telephone call, a letter was issued to the customers. For assistance, please call 770-565-6166.",N/A,541,541 catheters,"Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada",Terminated,"September 02, 2008",-1,541,Not_Computer,N/A,N/A,N/A
Z-1827-2008,48114,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP.,MM 4.0 and MIM 4.1,2,"September 03, 2008", 2008,MIMvista Corp,"In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"MIMvista Corp has issued this safety recall notification for MIM versions 4.0.2 through 4.1.2. An error has been discovered in the way SW and contour statistics are measured and reported under some specific circumstances. Users of these versions should immediately contact MIMvista support at (866) 421-2536 or visit httv://www.mimvista.com/recall/ to obtain complete instructions regarding this error. A new version that corrects this problem is available on the Downloads page, http://www,mimvista.com/download.",N/A,221,221,"The product was sold in the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI & WV. It was also sold in Europe, Asia and Canada.",Open,N/A,N/A,221,Software,Output/Calculation,Software update,Software Update
Z-1828-2008,47889,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.",CT9000 & CT9000 ADV,2,"September 03, 2008", 2008,Mallinckrodt Inc,The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.,DESIGN: Device Design,"Letter dated April 18, 2008. The firm has requested their customers check their inventory, and determine if they have any of the affected suspension systems. If they observe any loose screws or cracking around the J-Bow tube, immediately take the system out of service. A service representative will contact them to schedule any required system corrections.For assistance, contact Product Monitoring Department at 1-800-778-7898 or by email at productmonitoringhazelwood@covidien.com.",N/A,2546,2546 pieces,"Product was sold in 46 US states: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV & WY,",Open,N/A,N/A,2546,Not_Computer,N/A,N/A,N/A
Z-2192-2008,48650,N/A,N/A,N/A,N/A,N/A,N/A,"AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. The AMPLATZER Delivery System was designed to facilitate attachment, loading, delivery and deployment of the AMPLATZER Septal Occluder and comprised of a delivery sheath, dilator, loading device, plastic vise and delivery cable.",AMPLATZER Delivery System,2,"September 03, 2008", 2008,AGA Medical Corporation,AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devices to confirm the integrity of the ou,PRODUCTION CONTROLS: Packaging Process Control,"The firm Fed Ex'd and emailed a Field Inspection/Correction letter to customer 04/28/2008. The letter identified affected product, requested that customers check the outer package seal, and if it is incomplete the device should be returned for replacement. A form was also asked to be returned to AGA Medical. Contact AGA Medical at 1-763-513-9227 for assistance.",Contact the recalling firm for information,10,"10 (9 US, 1 OUS)","Within the US to include: AL, AZ, CA, CT, FL, IA, ID, MA, MD,MI, MO, NC, NH, NY, OH, PA, SD, TN, TX, WI. OUS to include: Brazil, Greece, Netherlands, Portugal, and Slovakia",Terminated,"October 13, 2010",770,141,Not_Computer,N/A,N/A,N/A
Z-2182-2008,48635,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,PMA,"Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-560440 ml Pumps Model 8637-40 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.",Medtronic SynchroMed II Programmable Pump,2,"September 03, 2008", 2008,Medtronic Neuromodulation,SynchroMed II pumps (non-implanted) may have been manufactured without propellant.,PRODUCTION CONTROLS: Process Control,"Consignees were contacted by ""Medtronic Urgent: Medical Device Recall"" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Product and Accounting for Lost Inventory Product. Contact Medtronic at 1-800-707-0933.",N/A,6047,6047,"AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, WY, Australia, Canada ,Austria, Belgium, Cyprus, Russian Federation, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Ireland, Italy, Kuwait, Luxembourg, Netherlands, Norway, Poland, Portugal, Reunion, San Marino, Slovenia, South Africa, Spain, Sweden Switzerland, Turkey, United Arab Emirates, United Kingdom, Vatican City, Saudi Arabia, Hong Kong, Latin America, Brazil, Puerto Rico, and Dominican Republic.",Open,N/A,N/A,13515,Not_Computer,N/A,N/A,N/A
Z-0369-2008,46680,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Precision 500D Classical Radiographic-FluoroscopicX-ray System. Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations.",GE Precision 500D Classical RadiographicFluoroscopic,2,"September 04, 2008", 2008,GE Healthcare,"It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lower dosage irradiation time which will result in indication of cumulative air kerma higher than that to which the patient was actually exposed.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A customer letter ""GE Healthcare Product Safety Notification"" dated 10/4/07 was distributed to customers informing them of the safety issue. A Field Modification Instructions (FMI 10806) was issued to the field for the Precision 500D product to install a sofware upgrade to correct the issue. This correction was released in October 2007.",Contact the recalling firm for information,106,106,"AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, ITALY, Kuwait, Great Britan, Spain and Canada.",Open,N/A,N/A,106,Software,Output/Calculation,Software update,Software Update
Z-1768-2008,47756,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506, 7339125, 7341410, 7341428, 7345411, 7345429, 7345437, 8139839, 8139847, 8147667, and 8147675","Coherence, Primeview, AG, Impression and Syngo",2,"September 04, 2008", 2008,"Siemens Medical Solutions USA, Inc","Images may potentially shift, causing an incorrect alignment of the patient, which may result in a dose to the wrong location. It was discovered through the complaint handling process that a potential image shift issue can occur after using the interactive shift tool and filtering tool due to incorrect consideration of the flat panel alignment.",DESIGN: Software Design,"A Customer Safety Advisory Notice was issued on September 19, 2007--All affected consignees were notified certified mail (includes update instruction TH029/07/S). Customers were request to maintain a copy of the safety advisory notice with the COHERENCE Therapist R2.1/Primeview 3i manuals. A copy of the firm's corrections & removal report will be forwarded to Quality Management of Siemens Regional units responsible for reporting to local country authorities and a copy of the report is also forwarded to the firm's distributor.",N/A,256,"143 units, 113 active","Class II Recall - Worldwide Distribution --- including USA, Algeria, Argentina, Australia, Canada, Colombia, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, New Zealand, P.R. China, Poland, Russian Fed., Saudi Arabia, South Africa, Spain, Turkey.",Open,N/A,N/A,256,Other,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1782-2008,47859,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.",EZloc 78mm TM Femoral Fixation Femoral Hook,2,"September 04, 2008", 2008,Biomet Sports Medicine,"This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package.As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm.Alternatively, as supplied, label indicates product size as EZLoc 9-1",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"An Urgent Medical Device Removal Notice was issued by BIOMET on May 2, 2008, to all customers in the United States via overnight carrier (UPS). The U.S. Removal Notice was used as a template for all global communications regarding this urgent removal notice. Included in this recall correspondence were three Recall Letters; one for direct customers, one for Physicians and one for distributors.The notice informed customers of the problem and the risks associated with the use of this product (note: The Physician letter included more detail instruction for physician with patients already implanted with the devices). The customers were instructed to take the following actions:(1) Immediately locate, discontinue use , and quarantine the implants referenced. (2) Return the product listed in table below to Biomet Sports Medicine at the address provided.(3) Include a copy of this letter with your returned products.(4) Use priority carrier for your shipment.(5) If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed Dear Biomet Customer notice. For questions related to this notice, an 800 number and contact person was referenced in the letter.The recalled product will be returned to the firm's warehouse and quarantined until final disposition is determined after notification to the local FDA office.",N/A,80,80,"Class II Recall - Worldwide Distribution --- including USA and countries of Argentina, Chile, Italy, Netherlands, Norway & Poland.",Open,N/A,N/A,80,Not_Computer,N/A,N/A,N/A
Z-1699-2008,47891,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.",Custom Kit,2,"September 04, 2008", 2008,"Merit Medical Systems, Inc.",Convenience kits may be non-sterile due to inadequate package sealing.,PRODUCTION CONTROLS: Process Control,Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.,N/A,10,10 kits,MO. Foreign distribution to Japan. No military or government distribution.,Terminated,"September 03, 2008",-1,129,Not_Computer,N/A,N/A,N/A
Z-1854-2008,48125,"snare, surgical",GAE,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.",Recovery Cone Removal System,2,"September 04, 2008", 2008,Bard Peripheral Vascular Inc,This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body.,DESIGN: Device Design,"On May 9, 2008, BARD began distribution of an Urgent Recall Notice with fax-back attachment to all customers in the United States via overnight carrier (FedEx). The Notice informed customers of the problem and the risks associated with the use of this product. The letter instructed their customers to check all inventory locations for the recalled product, remove and return affected product to BPV. The letter also asked their customers to share this information regarding the recall with physicians that perform procedures with the affected product at their facility.Once the product affected by the recall has been removed from their inventory, the customers were asked to contact the BPV Recall Coordinator at 1-800-321-4254 X 2727 to obtain a Return Authorization Number to facilitate replacement of the returned devices. A mailing label was enclosed to return the recalled product.",N/A,11679,"11,679",Nationwide,Terminated,"December 10, 2009",462,12678,Not_Computer,N/A,N/A,N/A
Z-1857-2008,48135,"hook, surgical, general & plastic surgery",GDG,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Weck, DermaHook"", Catalog #382805, 1/2"" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709",Weck DermaHook,2,"September 04, 2008", 2008,Telefelx Medical,The bands are breaking within the sealed packaging or in use prior to the expiration dates.,EXPIRATION DATING: Incorrect or No Expiration Date,"Consignees were notified by letter via UPS next day, on/about 05/12/2008. They were instructed to return all affected product or acknowledge that the product no longer exists. They were further instructed to forward the letter to if they have further distributed the affected lots into institutional settings or to homecare patients and retrieve relevant product from those locations.If you require additional information or clarification regarding this matter, please contact Jackie Warner at 1-800-334-9751, ext. 4973.",N/A,8492,8492 units,"U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands",Open,N/A,N/A,14255,Not_Computer,N/A,N/A,N/A
Z-1133-2008,48144,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493.The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/power unit.",GE Healthcare Definium 5000 Digital Radiographic Imaging System.,2,"September 04, 2008", 2008,GE Healthcare,GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.",N/A,14,14 devices (12US & 2 OUS),"MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.",Terminated,"September 10, 2008",6,14,Not_Computer,N/A,N/A,N/A
Z-2168-2008,48612,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment.Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)",Medela Vario 18 Vaccum Pump ,2,"September 04, 2008", 2008,Medtronic Neuromodulation,The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.,TRAINING: Employee Error,"Affected customers contacted by letter ""Medtronic Urgent: Medical device Recall April 2008"" that indicates that some Medela Vario 18 Vacuum Pumps were provided with an incorrect Suction Jar Lid that did not have the correct Conical Connection for the Vacuum Tube and the method to obtain a replacement part if needed. The letter requires customers to locate the Vacuum Pump serial number and compare it against the Serial Number on the Reply Form provided. Next customers are to review the Suction Jar Lid and check the part number. ""Reply form and Instruction for Receiving Replacement Lid "" included. Contact Medtronic 1-800-707-0933 for assistance.",N/A,1500,1500 pumps (20 affected),"USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.",Open,N/A,N/A,1500,Not_Computer,N/A,N/A,N/A
Z-2180-2008,48632,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Impax¶_ 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images.",IMPAX Clients 6.x ,3,"September 04, 2008", 2008,AGFA Corp.,"The IMPAX client failed to ""refresh"" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the ""active"" study.",DESIGN: Software Design,"An ""Urgent Safety Notice"" letter was sent to all the sites using potentially affected units on/about June 4, 2008. Dealers were notified via letter on June 9, 2008. The letter requests that all users be reminded that Agfa recommends the system is configured so that demographic information is not removed from the image viewing area. They will be provided with the appropriate Service Update, based on the current version of IMPAX Client 6.x in use at their site. They were advised to distribute the information within their facility to all those who need to be aware of it. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.",N/A,371,371 units,"U.S., Canada, Europe, Asia Pacific and Latin America.",Terminated,"October 09, 2009",400,371,Software,Display/Image,Software update,Software Update
Z-2194-2008,48652,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately.",Aria Radiation Oncology Version 8.1,2,"September 04, 2008", 2008,Varian Medical Systems Oncology Systems,Dose delivery may be altered after import from a third party planning system during radiation therapy.,DESIGN: Software Design,"Recall was initiated on May 21, 2008. A product notification letter (sent via certified mail) was distributed to all affected users, with description of the problem i.e., dose delivery may be altered after import from a third party planning system during radiation therapy . The letter was also distributed to Varian Sites, Marketing and Service Organizations. A software upgrade is currently being developed. For assistance, contact Varian Medical Systems, Oncology Systems at 1-650-424-5731.",N/A,241,241 units,"US and to Canada, Australia, Bahrain, Belorussia, Colombia, Finland, Germany, Greece, India, Italy, Japan, Kuwait, Lithuania, Mexico, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and the UK.",Open,N/A,N/A,241,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1789-2008,47870,"prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented",MRA,N/A,N/A,Orthopedic,PMA,"Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.",Polyethylene Liner,2,"September 05, 2008", 2008,"Encore Medical, Lp",Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.,OTHER/UNDETERMINED: Pending,"An Urgent: Medical Device Recall letter was issued by the firm on 04/11/08. Consignees were told that they did not have marketing approval for the Polyethylene Backup Liner (poly liner) for use with the Keramos Ceramic-on-Ceramic Acetabular System. Therefore, they are removing it from the market while pursuing marketing approval.",N/A,28,28 units.,"Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.",Terminated,"January 21, 2009",138,180,Not_Computer,N/A,N/A,N/A
Z-1784-2008,47869,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.",Bone Awl,2,"September 05, 2008", 2008,Abbott Spine,"Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca",DESIGN: Device Design,"Phone calls and emails were used to disseminate information about this recall. Firm notified consignees via telephone beginning on 04/17/08. Consignees were told that some problems were found through normal wear and tear as well as product mis-use and material weaknesses. The firm explained that they noticed from wear and tear from use as well as damage from use could cause the tip to become dull and flared causing breakage. The firm explained that they redesigned the awl and requested that consignees return outstanding inventory, which will be replaced with a new version of the awl.",N/A,180,180 units.,"Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MO, MT, NC, NJ, NV, NY, NM, OH, OK, PA, SD, TX and WI, and countries of Argentina, Australia, Belgium, Canada, China, Columbia, Cyprus, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey and UK/Ireland.",Terminated,"December 02, 2009",453,180,Not_Computer,N/A,N/A,N/A
Z-1791-2008,47873,"tubing, fluid delivery",FPK,Intravascular administration set.,General Hospital,General Hospital,510(k),"Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.",Surgical Tubing,2,"September 05, 2008", 2008,"Mentor Texas, Inc","During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.",OTHER/UNDETERMINED: Pending,"A Customer Letter was issued to all consignees by the firm on 4/21/2008. Consignees were informed that a recent testing of these products discovered a potential defect in the packaging configuration, which could result in a loss of package integrity. Consignees were asked to review inventory and dispose of product and contact firm for credit.",N/A,12557,"12,557 boxes.","Class II Recall - Worldwide Distribution ---- including USA, Puerto Rico and countries of Argentina, Austria, Bermuda, Brazil, Canada, China, Costa Rica, Cyprus, Denmark, England, Germany, Greece, Guatemala, India, Italy, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Panama, Paraguay, Portugal, Slovak Republic, Slovenia, Spain, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey and Venezuela.",Terminated,"July 29, 2010",692,67962,Not_Computer,N/A,N/A,N/A
Z-2008-2008,48137,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.",N/A,2,"September 05, 2008", 2008,GE Healthcare,GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.,DESIGN: Device Design,"Field Modification Instructions (FMI No: 40815) will be issued to the field for the DST-XL product to install an arm or gantry rotation motor's brake. The customers letters ""Product Safety Notification"" dated March 10, 2008, have been distributed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter informs the customers of the safety issue, affected product, safety instructions, product correction and contact information.If you have questions, please contact GE Healthcare within the US or Canada at 1-800-437-1171 or outside the US the telephone number at 1-262-896-2890.",N/A,127,127,"AL, AR, CA , CO, DE , FL, IA, IL, KS, MA, MI, MS, NC , NJ, NY, OH, OK, PA , SC, TN, TX , VA, VT, WA United Kingdom, Belgium, Switzerland, Russia Federal Sweden, France, Italy, Spain, Germany Federal, Norway, Portugal, Netherlands, Saudi Arabia, Iran, India, Canada, Argentina, Taiwan, China, Bangladesh, Austria.",Open,N/A,N/A,127,Not_Computer,N/A,N/A,N/A
Z-1603-2008,47469,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,Hill-Rom 100 Low Bed; Model No. P3930.,HillRom 100 Low Bed,2,"September 05, 2008", 2008,"Hill-Rom, Inc.",The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked.,DESIGN: Device Design,"Consignees were notified via letter dated April 8, 2008 to lower these beds to their lowest position, to remove the beds from use if they move more than 1/2 inch with the brakes locked and that the firm will repair these beds when fixes become available.If you have questions regarding this recall, contact Hill-Rom Technical Support at 800-445-3730.",Contact the recalling firm for information Contact the recalling firm for information,753,753 beds,Worldwide: USA and Canada.,Terminated,"October 13, 2010",768,753,Not_Computer,N/A,N/A,N/A
Z-2009-2008,48139,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),Physio-Control LIFEPAK¶_ 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.,LIFEPAK20 Defibrillator and Monitor,2,"September 08, 2008", 2008,"Physio Control, Inc.","A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the ""MANUAL"" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.",DESIGN: Device Design,"On 5/13/08, the firm sent out letters to their domestic customers via Certified Receipt. The letter advised customers of the recall and instructed them to do the following, ""Keep the defibrillator in service. If pressing the MANUAL button does not take the defibrillator out of AED mode, press one of the following keys to select manual mode: ""ENERGY SELECT"", ""CHARGE"", ""PACER"", OR ""LEAD""... Please call your local Physio-Control service representative to arrange a service visit to replace the keypads.""If you have questions, contact Technical Support at 1-800-442-1142, option 5.",N/A,1219,"1,219 units","Product distributed to 1 US embassy, 97 domestic medical facilities nationwide, and 5 foreign consignees including the following countries: Germany, Netherlands, Canada, Australia and Hong Kong.",Open,N/A,N/A,1321,Not_Computer,N/A,N/A,N/A
Z-1913-2008,48079,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-226, UPN M001262260. The product is used with a radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.",Boston Scientific LeVeen SuperSlim Needle Electrode,2,"September 11, 2008", 2008,Boston Scientific Corp,The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.,DESIGN: Device Design,"Consignees were notified by recall letter on 4/30/08, sent fexex priority mail, to cease use of the products and to return them to the firm. For assistance, contact Boston Scientific at 1-508-683-4186.",N/A,7460,"7,460","Nationwide, Argentina, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Iraq, Ireland, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Arab Emirates.",Terminated,"August 04, 2009",327,20966,Not_Computer,N/A,N/A,N/A
Z-1881-2008,48633,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement knee joint.",Biomet OSS Interlok IM Stem w/Screw,2,"September 11, 2008", 2008,"Biomet, Inc.","Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.",PRODUCTION CONTROLS: Labeling Mix-Ups,"On May 15, 2008 an Urgent Medical Device Removal Notice was issued to consignees and implanting physicians notifying them to return the product and of risks involved, respectively. Any adverse reactions which may be experienced with the use of this product should be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852, or the MedWatch website at www.fda.gov/medwatch. If you have any questions contact Mary Hardesty, Manager, Corrective Actions, Biomet Orthopedics, Inc. at 1-800-348-9500.",N/A,14,14 for all products.,"Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.",Terminated,"November 03, 2008",53,14,Not_Computer,N/A,N/A,N/A
Z-2179-2008,48631,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.","Zimmer 4.5 Compression platebroad, 10 hole",2,"September 11, 2008", 2008,Zimmer Inc.,An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance.,N/A,7,7,International Distribution --- including Thailand.,Terminated,"November 12, 2009",427,7,Not_Computer,N/A,N/A,N/A
Z-1869-2008,48428,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.",ONQ PainBuster,2,"September 11, 2008", 2008,I-Flow Corporation,"The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.",N/A,"Firm sent letters on 2/12/2008 to affected customers advising of the possibility of an ON-Q PainBuster PS6502 (100 ml x 2 ml/hr) packed inside the ON-Q PainBuster PS6504 outer box. The intent of the letter is as follows:a) Inform customers of the potential for the wrong product inside the box.b) Require customers to inspect lot 772166 to ensure product inside is correct.c) If the product inside the box is correct, then no further action is required.d) If the product inside the box is incorrect, then the customer is advised to contact I-Flow Customer Service in order to exchange their product. Customers are also advised to send the letter to end users if they sold lot 772166 to other customers. Fax back forms will be provided to document customer compliance with the proposed field correction.If you have questions about this recall contact I-Flow Customer Service at 949-206-2700 from 8:00 am - 5:00 pm U.S. Pacific time.",N/A,345,345 units shipped,"Internationally - United Kingdom, Germany, Spain, Denmark, Australia, and Italy",Terminated,"February 05, 2010",512,345,Not_Computer,N/A,N/A,N/A
Z-2197-2008,48658,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.",Convenience Kit,2,"September 11, 2008", 2008,"Merit Medical Systems, Inc.",Component of convenience kit may not be sterile.,DESIGN: Packaging Design/Selection,"The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.",N/A,36,36 kits,"PA. No military, government, or foreign distribution.",Terminated,"September 09, 2008",-2,36,Not_Computer,N/A,N/A,N/A
Z-2230-2008,48695,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System;Model Number(s): 10035724, used with System Models: 08245875, 08246951, 08255412, 08255413, 08267697, 08269627, 10038241, 10038242, 10040724, 10040725, 10041008;Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Division, Mountain View, CAThe 17L5 transducer is intended for breast and small body parts imaging.",Siemens Ultrasound Transducer 17L5HD ,2,"September 11, 2008", 2008,"Siemens Medical Solutions USA, Inc.","The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately diagnose, incorrect positioning/locating/insertion of the biopsy needle and/or an interruption during the biopsy procedure.",PRODUCTION CONTROLS: Process Control,"On 6/6/08, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the affected product be returned. Affected transducers will be replaced. For assistance, contact Siemens Medical Solutions at 1-650-694-5993.",Contact the recalling firm for information,388,388 units,"Worldwide Distribution: USA, AUSTRALIA, AUSTRIA, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NORWAY, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, TAIWAN, and THAILAND.",Open,N/A,N/A,388,I/O,Display/Image,Replace component,Remove or Replace
Z-2229-2008,48694,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Naviscan PET Systems, Inc (""Naviscan"") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.","Naviscan PET Systems Inc (""Naviscan"") PEM Flex Solo II PET Scanner.",2,"September 11, 2008", 2008,Naviscan PET Systems,This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.,DESIGN: Device Design,"An Urgent Medical Device Field Correction Notice was sent to all PEM Flex Solo II customers about this issue via Federal Express Priority Service on June 19, 2008. Customers were informed of the:(1) Issue: Potential for motorized compression to exceed 25 pounds of compression force if continued beyond the primary safety limit, This could lead, to patient discomfort or injury.(2) Advisory: Naviscan recommends that patient breast positioning be completed by ceasing motorized-compression when the primary safety limit of 15 pounds pre-compression force is reached. This is indicated by the automatic stopping of the paddle movement as controlled by the primary safety system. ""Fine-tuning"" positioning, should be completed by using the manual adjustment knobs.(3) Correction: A Naviscan Field Service Engineer will contact each customer to schedule a field correction visit. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159.",N/A,13,13,"Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA",Terminated,"March 13, 2009",183,13,Not_Computer,N/A,N/A,N/A
Z-2225-2008,48689,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE 1.5T and 3.0T Signa HDX MR SystemModel Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,",Signa HDX MR System,2,"September 11, 2008", 2008,GE Healthcare,Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet).",N/A,720,720 units (360 US / 360 OUS) estimate,"AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of ArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaCzech RepublicDenmarkFinlandFranceFrench PolynesiaGermanyGreeceHong KongIndiaIndonesiaIrelandIsraelItalyJapanKoreaKuwaitLebanonMalaysiaMexicoNetherlandsNew ZealandNorwayPeruPhilippinesRussiaSaudi ArabiaSingaporeSouth AfricaSpainSwedenSwitzerlandTaiwanTaiwanThailandTurkeyUnited Arab Emirates andUnited Kingdom.",Open,N/A,N/A,720,Software,Output/Calculation,Software update,Software Update
Z-2200-2008,48679,"transducer, pressure, intrauterine",HFN,Intrauterine pressure monitor and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.",Intran Plus,2,"September 11, 2008", 2008,"Utah Medical Products, Inc",Possibility of compromised package sterility prior to the expiration date.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,All consignees were notified by a faxed Recall Notice letter beginning on 6/16/2008. Customers were asked to return all unused product for immediate replacement with units that have a protective barrier within the tray packaging. The firm cautioned customers to visually inspect packaging before use. Follow-up phone calls will be made the following week.,N/A,300000,"300,000 units.","Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.",Open,N/A,N/A,300000,Not_Computer,N/A,N/A,N/A
Z-2133-2008,48454,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.",OnQ Cbloc ,2,"September 11, 2008", 2008,I-Flow Corporation,"Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.",OTHER/UNDETERMINED: Pending,"Firm faxed customer notification letters to customers on February 14, 2008 advising that two lots of CB005 (lot numbers 792457 and 7A2667) may contain an incorrect fill port label. All other product labeling is correct for the CB005 pumps. Customers are asked to inspect the CB005 inventory to determine if they have any of the affected lots. If so, customers are not to use the product and quarantine any remaining inventory. Customers are also asked to provide a copy of the notification to end users who may have received CB005, lot numbers 792457 and 7A2667. A response form is also provided.",Contact the recalling firm for information,792457,792457 (430 units) and 7A2667 (390 units),"Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.",Terminated,"October 07, 2009",391,792457,Not_Computer,N/A,N/A,N/A
Z-2227-2008,48603,"warmer, infant radiant",FMT,Infant radiant warmer.,General Hospital,General Hospital,510(k),"Panda¶_ iRes and Giraffe¶_ Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.",Panda iRes and Giraffe Infant Warmers,2,"September 11, 2008", 2008,"Datex Ohmeda, Inc. dba GE Healthcare",Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.,DESIGN: Software Design,"The recalling firm notified Hospital Administrators, NICU Nursing Manager/Labor & Delivery Nursing Managers and Heads of Biomedical Engineering departments at consignee locations by certified letter on 05/20/08. The notification was flagged as ""Urgent Medical Device Correction"" and advised consignees of safety issues and recommended actions when using the device. The notification advised that the safest way to mitigate the potential interference issue is to disable the Hands Free Alarm Silence. Users were informed that once a permanent correction action is identified, service representatives will implement the correction. For assistance, contact GE Healthcare at 1-800-345-2700.",N/A,639,639 devices,The medical devices were distributed to hospitals nationwide.,Open,N/A,N/A,639,I/O,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-1802-2008,47880,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.",Fluid Administration Set,2,"September 11, 2008", 2008,"Merit Medical Systems, Inc.",Convenience kits may contain non-filtered drip chambers,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.,N/A,102,102 kits,"Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.",Terminated,"April 06, 2009",207,865,Not_Computer,N/A,N/A,N/A
Z-2106-2008,48444,"catheter, steerable",DRA,Steerable catheter.,Cardiovascular,Cardiovascular,510(k),"Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.",Artisan Control Catheter,2,"September 11, 2008", 2008,Hansen Medical Inc,"The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.",DESIGN: Device Design,"On May 21, 2008 an Urgent: Voluntary Product Recall Notification was issued. All customers who received affected product were verbally contacted directly by the firm, and were sent a follow up letter, asking them to segregate the product. Replacements will be shipped to them. If you have questions please contact Doug Worth at 1-650-404-5940.",N/A,369,369 units,"Class II Recall - Worldwide Distribution ---- including USA and countries of UK, Italy, Germany, and Czech Republic.",Terminated,"May 27, 2009",258,369,Not_Computer,N/A,N/A,N/A
Z-2134-2008,48455,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Vacuette, Plastic Cannula HOLDEX¶_, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.",HOLDEX,2,"September 11, 2008", 2008,"Greiner Bio-One North America, Inc.",At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.,DESIGN: Device Design,Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.,N/A,1606005,"1,606,005 units",Class II Recall - Nationwide Distribution.,Terminated,"August 21, 2009",344,1606005,Not_Computer,N/A,N/A,N/A
Z-1859-2008,48146,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport.,Wheeled Ambulance Stretchers,2,"September 11, 2008", 2008,Ferno-Washington Inc,"A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm sent an 'Urgent Field Correction' notification letter to their customers, via certified mail on 5/16/2008. The letter instructs the customers to examine all inventory of Model 35A stretchers. The letter also recommends that any identified unit be removed from service until the unit has been inspected by the customer and a field correction completed, if applicable. Once the inspection of the unit(s) has been completed by the customer, they are to contact the firm immediately and inform them of the results of t their inspections. In the event that a casting fails inspection, the customer is instructed to contact Ferno's Technical Support Div. in order to arrange for a casting replacement. To report the results of their inspection(s) or to address any questions or concerns which the customer may have, contact Ferno Technical Support at 1-866-987-3776 or send an email to Quality.Products@ferno.com.",N/A,783,783 units,"The recalled product was distributed to customers in the following location nationwide: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WI, and WV.",Open,N/A,N/A,783,Not_Computer,N/A,N/A,N/A
Z-1858-2008,48140,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Physio-Control LIFEPAK¶_ 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation operations. When clinically indicated, the LIFEPAK 12 defibrillator/monitor allows the operator to deliver a brief, high-energy shock to the heart of the patient. Operators may pre-configure the device to reduce complexity during normal operation.",PhysioControl LIFEPAK 12 defibrillator/monitor,2,"September 11, 2008", 2008,"Physio Control, Inc.",The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.,PRODUCTION CONTROLS: Process Control,"Starting May 8, 2008, letters were hand-delivered by the firm's service representatives as they visited customer sites to perform on-site service for affected units. Customers who had not been visited by May 16th were mailed a Certified Receipt letter on May 16, 2008. The letter explained the recall and notified customers that Physio Control was conducting a Field correction to replace all affected Biphasic PCBA. The firm recommends customers continue to perform therapy cable or Standard Paddles Defibrillation Check (monthly or as needed); to have a backup device available until their device is updated; and if no backup device is available, a loaner would be provided by the firm upon request.Contact Technical Support at 1-800-442-1142, option 5 - 6:00 am to 4:00 pm (Pacific), Monday -Friday or visit www.Physio-Control-notices.com/LP12.",N/A,1710,"1,710 Units","Product distributed nationwide to 5 Department of Defense accounts, 1 VA account, 5 government accounts, 49 hospitals, 223 first responders, and 1 direct account. 8 foreign accounts include: NETHERLANDS, MEXICO, JAPAN, HONG KONG, GERMANY, CANADA and AUSTRALIA.",Open,N/A,N/A,1710,Not_Computer,N/A,N/A,N/A
Z-2135-2008,48457,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, ""Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR "". Product is used as an orthopedic implant.",Orthopedic implant,3,"September 11, 2008", 2008,Acumed LLC,Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.,PRODUCTION CONTROLS: Process Control,The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.,N/A,400,400 screws,Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.,Terminated,"February 03, 2010",510,400,Not_Computer,N/A,N/A,N/A
Z-1871-2008,48458,"chisel, osteotome, surgical",EMM,Dental hand instrument.,Dental,Dental,510(K) Exempt,"Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).",Stella Interdental Osteotome,2,"September 11, 2008", 2008,"Biomet Microfixation, Inc.",The working tips of the Stella Osteotomes are thicker than specification.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm notified its consignees on 4/16/08 by certified mail with return receipt. Sub-accounts were contacted by email. All returned product will be stored in quarantine until a final determination of disposition is made.,N/A,36,36,"Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.",Terminated,"September 11, 2009",365,36,Not_Computer,N/A,N/A,N/A
Z-2105-2008,48440,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific Flexima Biliary Stent System, 200 cm long, .035"" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210.System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.",Boston Scientific Flexima Biliary Stent System,3,"September 11, 2008", 2008,Boston Scientific Corp,"Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.",PRODUCTION CONTROLS: Packaging Process Control,An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form.,Contact the recalling firm for information,80,80,"Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.",Terminated,"September 11, 2008",0,80,Not_Computer,N/A,N/A,N/A
Z-2231-2008,48431,"electrode, ion-specific, chloride",CGZ,Chloride test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX.The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.",ARCHITECT c8000 Clinical Analyzer,2,"September 11, 2008", 2008,"Abbott Laboratories, Inc","Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.",N/A,"Firm notified all ARCHITECT c8000 customers with a correction letter and response form distributed on 5/23/2008. The letter provided actions the users could take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBOTT.",N/A,2378,"2,378 units worldwide (431 in the USA; plus 1,947 International)","Worldwide distribution, including: USA (including Puerto Rico), Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Grand Cayman, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,2378,Software,Output/Calculation,Software update,Software Update
Z-2107-2008,48445,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.",Infusion catheter and Occluding Guide Wire,2,"September 11, 2008", 2008,"Merit Medical Systems, Inc.","Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.",PRODUCTION CONTROLS: Packaging Process Control,"Merit's six sales reps for the six hospital consignees were notified by letter on 05/14/2008. They were instructed to contact the hospitals and have them immediately quarantine any affected product for return to Merit. If you have any questions please contact Jackie Preece, Customer Service at 1-201-253-1600.",N/A,15,15 units,"Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.",Terminated,"March 08, 2010",543,15,Not_Computer,N/A,N/A,N/A
Z-1814-2008,48096,"prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.",Total Knee Posteriorly Stabilized Femoral Component ,2,"September 11, 2008", 2008,Stryker Howmedica Osteonics Corp.,Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.,TRAINING: Employee Error,"Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.",N/A,8,8 units,Worldwide Distribution,Terminated,"May 13, 2010",609,8,Not_Computer,N/A,N/A,N/A
Z-1815-2008,48098,"stent, superficial femoral artery",NIP,N/A,N/A,Cardiovascular,N/A,"ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.",IntraCoil Peripheral Stent Vascular,3,"September 11, 2008", 2008,"Ev3, Inc",Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).,TRAINING: Employee Error,ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product.,N/A,3,3,Nationwide Distribution including states of CA and MO.,Open,N/A,N/A,3,Not_Computer,N/A,N/A,N/A
Z-1863-2008,48170,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.",Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument,2,"September 11, 2008", 2008,Zimmer Inc.,The instrument is prone to fracture during use.,PRODUCTION CONTROLS: Process Control,Direct and hospital consignees were notified via email or letter on 5/16/08 to cease use and return the instruments.Contact Kevin W. Escapule at 800-846-4637 if you have questions.,N/A,500,500,"Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.",Terminated,"November 12, 2009",427,500,Not_Computer,N/A,N/A,N/A
Z-1245-2008,46386,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX¶_ 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.",IMPAX 6.2.1,2,"September 11, 2008", 2008,AGFA Corp.,Text and Images may not be synchronized.,DESIGN: Software Design,"AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.",N/A,154,154 units,U.S. Nationwide and Canada,Open,N/A,N/A,154,Software,Display/Image,Software update,Software Update
Z-1813-2008,48090,"glucose dehydrogenase, glucose",LFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter,Abbott Freestyle Blood Glucose Monitoring System Test STrips,2,"September 11, 2008", 2008,"Abbott Diabetes Care, Inc.","Flaws in strip voltage continuity may result in frequency of an Error 3 (""Er3"") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.",OTHER/UNDETERMINED: Pending,"Recall initiated on April 24, 2008. An Urgent Medical Device Correction was issued to customers. Consignees were notified, along with registered users of the FreeStyle Freedom meters, via recall letters, visits or phone calls. Distributors will be notified, along with the creation of customer lists and tracking of communications to sub-recall. If you have any questions call Tina Mazurkiewicz at 1-800-777-6565.",N/A,2954900,2954900 strips,"Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark.",Open,N/A,N/A,2954900,Not_Computer,N/A,N/A,N/A
Z-1316-2008,46907,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.",Stryker Digital Capture System Ultra (SDC Ultra),2,"September 11, 2008", 2008,Stryker Endoscopy,Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.,DESIGN: Software Design,"Stryker Endoscopy mailed Urgent Device Correction notices, dated February 14, 2008, to all consignees, and sales representatives will be supplied with a fix to distribute to the user base.",N/A,814,814 units distributed,"Worldwide distribution: USA, Canada, Greece, and Germany.",Open,N/A,N/A,814,Software,Output/Calculation,Software update,Software Update
Z-1588-2008,47421,hemoglobin a2 quantitation,JPD,Hemoglobin A2assay.,Hematology,Hematology,510(k),"VARIANT ¶_-thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with ¶_-thalassemia ROM card lot PA 62600, PIN 2700104",VARIANT thalassemia Short Program,2,"September 11, 2008", 2008,Bio-Rad Laboratories Inc,Some product ROM cards have an incorrect program loaded and are unable to be updated.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm initiated its recall on March 18, 2008 by issuing a recall notice to customers and subsidiaries via e-mail. Not all VARIANT ¶_-Thalassemia Short ROM Cards are affected. Inventory should be examined and quarantine the product subject to this Recall. Contact your regional Bio-Rad office for ROM Card replacement or if you have questions.",Contact the recalling firm for information Contact the recalling firm for information,64,64 kits total,"Product was distributed to 17 consignees and 7 subsidiaries Worldwide. Distribution included to states of CA, TX, WI, VA, UT, PA, TN, OH, FL, MA, OR, AR, IL, MD, CO, and NY, and countries of UK, Australia, Canada, France, Singapore, New Zealand, Italy.",Terminated,"November 10, 2009",425,64,Other,N/A,Remove,Remove or Replace
Z-1893-2008,47204,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.",Femoral Venous Cannula,2,"September 11, 2008", 2008,"Edwards Lifesciences Research Medical, Inc.","Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.",PRODUCTION CONTROLS: Process Control,Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.,N/A,25,25 units,Nationwide Distribution.,Terminated,"September 16, 2008",5,35,Not_Computer,N/A,N/A,N/A
Z-1415-2008,46735,"posterior metal/polymer spinal system, fusion",NQP,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, for spinal fixation.",CD Horizon Agile dynamic stabilization device,2,"September 11, 2008", 2008,Medtronic Sofamor Danek USA Inc,Breaks: Shear failure of the cable component of the system.,DESIGN: Device Design,Medtronic Sofamor Danek initiated its recall on 12/12/2007 by letter to all Risk Managers who received the product at their hospital. Letter were also mailed to surgeons who have implanted the product. Sales Representatives were notified via a conference call and letter to follow-up with thier respective surgeons who have implanted the product to verify that their surgeon received the communication of the recall and that they are aware that patient monitoring is recommended.,N/A,334,334 units,"Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.",Terminated,"August 10, 2010",698,7774,Not_Computer,N/A,N/A,N/A
Z-1318-2008,46707,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610.",Biomet Echo Hip Instrumentation Exact Slotted Stem Inserter,2,"September 11, 2008", 2008,"Biomet, Inc.",The instrument will not mate with its stem.,PRODUCTION CONTROLS: Process Control,Biomet distributors were notified via recall letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments.,N/A,78,78,Nationwide.,Terminated,"June 30, 2009",292,78,Not_Computer,N/A,N/A,N/A
Z-1244-2008,46384,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images.",WEB1000,2,"September 11, 2008", 2008,AGFA Corp.,Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Agfa Healthcare contacted all consignees on 5/14/2007 and by registered mail on 06/07/2007. The registered Urgent Field Safety Notice letters requested the accounts take the following steps immediately: 1. Turn off automatic JAVA updates to avoid this update being applied in the background. 2. Do not manually update JAVA on their station-even for other applications. 3. If JAVA 1.6 has already been applied, do not use Service/Admin Tools. They were instructed to contact their IT department or Agfa support for assistance in backing out of this version to apply the required version for the Agfa software. A Mandatory Service Bulletin will inform and assist affected account in removing JAVA 1.6 if it has been applied and turning off the automatic updates via the JAVA Plug-in Control Panel.",N/A,946,946 units (total),U.S. Nationwide and Canada.,Open,N/A,N/A,946,Computer,N/A,N/A,N/A
Z-1319-2008,46759,antistreptolysin - titer/streptolysin o reagent,GTQ,Streptococcusspp. exoenzyme reagents.,Microbiology,Microbiology,510(K) Exempt,"DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.",DIFCO BACTO FA Streptococcus Group A,3,"September 11, 2008", 2008,BD Diagnostic Systems / Lee Laboratories,Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification.",N/A,26,26 units,Nationwide Distribution and Canada,Terminated,"March 24, 2009",194,26,Not_Computer,N/A,N/A,N/A
Z-0257-02,3359,N/A,N/A,N/A,N/A,N/A,N/A,"Melt-spun Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic renal failure; 12 units per case; A-Series Dialyzers made from Altra Nova Fibers, AF-Series Dialyzers made from Altra Flux Fiber and AX-Series Dialyzers made from Altrex Fiber A-11, A-15, A-18, A-22, AF-150, AF-180, AF-220, AX-1500, AX-2200",N/A,1,"September 11, 2008", 2008,Baxter Healthcare Corp.,"Hemodialyzers associated with deaths in Croatia, Spain et al",N/A,The U.S. accounts were telephoned on 10/18/01 and sent follow-up recall letters dated 10/18/01 via Airborne overnight mail. Global recall of the A-series dialyzers initiated on 10/17/01 via telephone calls and follow-up letters dated 10/18/01. Global recall expanded to include the AF-series dialyzers on 10/18/01 and the AX-series dialyzers on 10/19/01.,Contact the recalling firm for information,2435306,2435306 dialyzers worldwide,"The dialyzers were distributed in the United States, Algeria, Argentina, Austria, Belgium, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Egypt, England, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Netherlands, Oman, Palestine, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Tunisia, Turkey, Venezuela, Ukraine, United Arab Emirates and United Kingdom. The AX-series dialyzers were not distributed in the United States. The U.S. distribution includes the following direct sale government accounts:a) VA Medical Center, 4150 Clement St, San Francisco, CAb) VA Medical Center, 1481 W. 10th Street, Indianapolis, INc) VA Medical Center, 3350 La Jolla Villa Dr, San Diego, CAd) VA Medical Center, 1111 E End Blvd, Wilkes Barre, PA e) VA Medical Center, 1660 S. Columbia Way, Seattle, WAf) VA Medical Center, One Jefferson Barracks Dr, St Louis, MO",Open,N/A,N/A,2435306,Not_Computer,N/A,N/A,N/A
Z-2341-2008,49396,"dna probe, trichomonas vaginalis",MJK,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.",LIFEPAK CR Plus,1,"September 16, 2008", 2008,"Physio Control, Inc.","This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h",TRAINING: Employee Error,"On 8/28/08 the firm began contacting consignees by telephone and stating that the LIFEPAK CR Plus defibrillators were discomfiture as semi-automatic, and that a responder is unable to press the shock button to deliver therapy when instructed by the AED voice prompt because the shock button is covered and not visible. The consignee was instructed that the unit(s) would be replaced immediately. This phone contact was followed by a letter flagged ""'URGENT - MEDICAL DEVICE RECALL"" dated August 2008 that was f axed or e-mailed the same day. The letter repeated the information provided in the telephone contact and stated to ""Immediately perform one of the following actions: Remove the affected AEDs from service or Remove and discard the shock button cover (see enclosed illustration). Enclosed with the letter is an illustration providing instructions for removal of the auto shock button cover. Customer notification was completed by 9/2/08.",N/A,249,249 units,"Worldwide Distribution including USA, and countries of Canada, Germany, and Hong Kong.",Open,N/A,N/A,249,Software,Device Operation,Replace/Remove button,Remove or Replace
Z-0156-2009,49452,"clip, implantable",FZP,Implantable clip.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.",Weck ,2,"September 16, 2008", 2008,Telefelx Medical,A hole in the sterile unit blister pack was detected that would compromise sterility.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks from the second mailing. Consignees also may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Upon return to Teleflex Medical, product will be quarantined, assessed for recall effectiveness, and either reworked or destroyed. Contact Telefex Medical at 1-800-334-9751 ext. 8066 for assistance.",Contact the recalling firm for information,786036,786036 (total pieces),Nationwide,Open,N/A,N/A,786036,Not_Computer,N/A,N/A,N/A
Z-2195-2008,48654,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.","FastPlan, Verison 5.5 or 5.5.1",2,"September 16, 2008", 2008,Varian Medical Systems Oncology Systems,"Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.",MISBRANDING: Labeling False and Misleading,"Recall was initiated by the firm on 05/29/2008. A product notification letter /field safety letter was distributed to all affected users, with a description of the problem and user corrective action steps. In addition, the letter will also be distributed to Varian Sales, Marketing and Service Organizations. Letters were sent to consignees via certified mail with return receipt mailing to US consignees. For foreign consignees, letters will be translated as necessary and distributed with return proof of notification. Varian Medical can be contacted at 1-650-483-3153 for assistance.",N/A,182,182,"Product was distributed throughout the US and to Australia, Brazil, Chile, France, Germany, Hong Kong, India, Israel, Japan, China, Malaysia, Russian Federation, Singapore and Spain.",Open,N/A,N/A,182,Software,Display/Image,Software update,Software Update
Z-2178-2008,48630,"microtools, assisted reproduction (pipettes)",MQH,Assisted reproduction microtools.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.,Flexipet Manipulation Pipette 300 micron,2,"September 16, 2008", 2008,Cook Vascular Inc.,mislabeled - 300 micron flexipets were labeled as 80 microns,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,The sales representatives were notified via email on 12/14/07 of the problem. The recalling firm issued recall letters on 12/18/07 via overnight mail. The letter informed the customers of the problem and the need to return any product. The letter also instructed customers to notify any sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.,Return product to place of purchase for a full refund,35,35 vials,"The product was shipped to a medical facility in TN and sales reps in NJ and MD. The product was also shipped to distributors in Indonesia, Australia, and Ireland",Terminated,"September 16, 2008",0,35,Not_Computer,N/A,N/A,N/A
Z-1877-2008,48621,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that incorporates a simple nail-mounted, in-line method of compression across the arthrodesis site.",Newdeal Ankle Nail,2,"September 16, 2008", 2008,Integra LifeSciences Corp.,"Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy",PRODUCTION CONTROLS: Process Control,"On March 24, 2008, Recall Notification Letters and Recall Acknowledgement Forms were sent to all Integra Sales Specialists to confirm products currently in their inventory and to place inventory on hold with no further shipments to customers. If you have any questions contact Judy O'Grady at (609) 936-2311.",N/A,45,"45 units received in US, 22 were distributed.",Class II Recall - Nationwide Distribution.,Terminated,"September 16, 2008",0,45,Not_Computer,N/A,N/A,N/A
Z-2038-2008,46796,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Advantx-E is an angiographic X-Ray system.,AdvantxE,2,"September 16, 2008", 2008,GE Healthcare,"Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system",PRODUCTION CONTROLS: Process Control,"Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information.If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.",N/A,252,252,"USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OHOR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LAME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV.OUSA: HungaryAlgeriaArgentinaAustraliaAustriaBelarusBelgiumBosniaBrazilBulgariaCanadaChileChinaColumbiaCzech RepublicDenmarkEgyptFinlandFranceGeorgiaGermanyGreeceGuadeloupeGuatemalaHondurasHong KongIndiaIndonesiaIranIrelandIsraelItalyJapanJordanKazakhstanKoreaKuwaitKuwaitLatviaLebanonMalaysiaMaltaMexicoMoroccoNetherlandsNew ZealandNigeriaNorwayPakistanPanamaPolandPortugalPuerto RicoRomaniaRussian FederationSaudi ArabiaSingaporeSpainSwedenSwitzerlandSyriaTaiwanThailandTurkeyUnited KingdomUruguayVenezuelaYugoslavia",Open,N/A,N/A,1582,Not_Computer,N/A,N/A,N/A
Z-1876-2008,48610,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"Straumann Handpiece Driver for RN Solid Abutment 6¶_ L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.",Straumann Handpiece Driver ,3,"September 16, 2008", 2008,Straumann Manufacturing Inc.,Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.",N/A,129,129 units,Class III Recall - Nationwide Distribution.,Terminated,"November 06, 2009",416,129,Not_Computer,N/A,N/A,N/A
Z-2175-2008,48626,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella.",AxSYM Rubella IgG Reagent Pack,3,"September 16, 2008", 2008,Abbott Laboratories,An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.,DESIGN: Device Design,Consignees were sent a Product Correction-Immediate Action Required letter on 6/2/08. The letter informed users of calibration failures due to elevates Calibrator A or Master Calibrator 1 rates when attempting to calibrate the AxSYM Rubella IgG assay and that they must clarify the Rubella IgG Calibrator A or the Rubella IgG Master Calibrator 1 and the Rubella IgG Negative Control by centrifugation at,N/A,33485,"33,485 reagent kits","Worldwide Distribution including USA, territory of Puerto Rico, and countries of Australia, Bahamas, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Mexico, Peru, New Zealand, Panama, Singapore, South Korea, Thailand, Turks & Caicos and Uruguay.",Terminated,"November 05, 2008",50,33485,Not_Computer,N/A,N/A,N/A
Z-2210-2008,48683,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE 1.5T and 3.0T Signa¶_ HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2.Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.",GE 1.5T and 3.0T Signa HDx MR System ,2,"September 16, 2008", 2008,GE Healthcare,A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.,DESIGN: Software Design,"A ""GE Product Safety Notification"" Customer letter addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists dated September 14, 2007 was was sent to consignees. The letter described the safety issue, affected product, safety instructions, product correction and contact information. The letter instructed customers to scan only from the Superior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746), which enables users to scan in both Inferior to Superior and Superior to Inferior directions and have no mismap between the functional and anatomical images.",N/A,58,58,"Worldwide Distribution --- USA including states of AL, AZ, CA, CO , CT, FL, GA ,IA , IL, IN , KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, NE , NJ, NY , OH, OR, PA, PR,SD, TN, TX, UT, VA, WA, WI , and WV, the countries of Canada, Mexico, Brazil, New Zealand, Japan, Hong Kong, India, Korea, Australia, China, Italy, Lebanon, Netherlands, Norway, Russian Federation, South Africa, Turkey, Iran, Kuwait, Taiwan, Switzerland, Germany, France, Great Britain, Ireland, Denmark, Spain, Saudi Arabia, and Macau.",Open,N/A,N/A,269,Computer,N/A,N/A,N/A
Z-2297-2008,48714,"aid, transfer",IKX,Daily activity assist device.,Physical Medicine,Physical Medicine,510(K) Exempt,"Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.",Zimmer Patient Helper Reinforced Overhead Bar ,2,"September 16, 2008", 2008,Zimmer Inc.,"If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar.",DESIGN: Device Design,Consignees were notified via recall letter dated 7/7/08 to discontinue use of these devices until the firm visits and replaces the devices. Contact Zimmer at 1-800-321-5533 for assistance.,N/A,645,645 of all systems,Nationwide and Canada.,Terminated,"November 12, 2009",422,645,Not_Computer,N/A,N/A,N/A
Z-2203-2008,48666,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"740 Series Multiparameter Monitor Software Version 3.0Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NNCAS Medical Systems, Inc., Branford, Connecticut 06405Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.",740 Series Multiparameter Monitor ,2,"September 16, 2008", 2008,"CAS Medical Systems, Inc.",Software: Audible alarm may be silenced if changed from the factory setting,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"CASMED notified customers by a Product Correction Notification letter on 6/24/08 to advise of problem of the audible alarm and a software upgrade to correct the problem. The firm requests that the alarm volume not be adjusted from its factory set value to ensure that alarms sound correctly. Also, the letter states that if the volume needs to be adjusted, that customers needs to be sure that they only select two clicks above, or two clicks below the mid-point, and that there is a corresponding beep when you make your selection. Customers are asked to review the attached list of serial numbers that will need to be updated with new software and to then email the a contact at the firm once updates have been completed. All updates must be completed by August 31, 2008.",N/A,820,820 units,"Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.",Terminated,"August 05, 2010",688,820,Software,Alarm/Message,Software update,Software Update
Z-2204-2008,48680,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.",da Vinci S Surgical System IS2000,2,"September 16, 2008", 2008,"Intuitive Surgical, Inc.",Defective software chip may cause the system to fail and lock up.,DESIGN: Software Design,"Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the acknowledgement form.",N/A,112,112 systems,"Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom.",Terminated,"July 29, 2009",316,112,Software,Device Operation,Software update,Software Update
Z-2293-2008,48710,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Stryker Ortholock EX Pin for use with the Stryker Navigation System, 4 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-104-150. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.",Stryker Navigation System pin,2,"September 16, 2008", 2008,Stryker Instruments Div. of Stryker Corporation,Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.,MISBRANDING: Labeling False and Misleading,"Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.",N/A,28861,"28,861 boxes of all products.","Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea, Sweden, Switzerland and Taiwan.",Terminated,"December 01, 2009",441,28861,Not_Computer,N/A,N/A,N/A
Z-2295-2008,48713,"evacuator, vapor, cement monomer",JDY,Cement monomer vapor evacuator.,Orthopedic,Orthopedic,510(K) Exempt,"Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile, Zimmer, Warsaw, IN; Cat. No. 5069-52. The product is used for the injection of bone cement.",Miller bone cement injector,2,"September 16, 2008", 2008,Zimmer Inc.,The cartridge is brittle and at increased risk of breakage.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Each consignee is being notified by letter dated June 30, 2008, which will be sent via mail or email. Consignees are requested to return the product. Contact Zimmer at 1-574-372-4487 for assistance.",N/A,257,257 packages of 10 kits each.,"Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.",Terminated,"November 12, 2009",422,257,Not_Computer,N/A,N/A,N/A
Z-2219-2008,48688,"stent, ureteral",FAD,Ureteral stent.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.",SILHOUETTE XTRAFLO ,2,"September 16, 2008", 2008,Applied Medical Resources Corp,The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"On May 20, 2008, Applied Medical began distribution of an Recall Notice with fax-back attachment ( Recall Notification Confirmation Form ) to all customers in the United States via Applied's Direct Sales Force. The Notice informed customers of the problem that caused the initiation of the recall and requested they complete and fax-back the Recall Notification Confirmation Form . The letter also instructed their customers to remove and return affected product to Applied Medical immediately via FedEx. If the customers had an questions they were to contact Mr. Frans VandenBroek at (949) 7l3-8369 or by e-mail at fvandenbroek¶_¶_appliedmedical.com.",N/A,103,103,"Nationwide to: AL, AZ, CA, CO, DC, FL, GA, KY, IL, LA, MI, MN, NC, NJ, NY, PA, TN, TX, WA, WI and Worldwide to: Australia & South Africa",Terminated,"April 14, 2010",575,236,Not_Computer,N/A,N/A,N/A
Z-2226-2008,48691,"catheter, ureteral, gastro-urology",EYB,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Gyrus ACMI 10 Fr. Dual Lumen CatheterReference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The ""ACMI"" Dual Lumen Catheter is a radiopaque ureteral catheter.",Gyrus ACMI 10 Fr. Dual Lumen Catheter,2,"September 16, 2008", 2008,Gyrus ACMI Corporation,Particulate matter in the catheter,PRODUCTION CONTROLS: Process Control,"Gyrus initiated a recall by letter dated 6/ 25 /08. An updated letter issued July 9, 2008 which supersedes the previous letter. The July 9th letter updates the lot numbers affected in the recall. A reply form request was sent to consignees informing them of the problem and asking them to obtain a RMA and return the product. They are also requested to FAX back a reply form so that the response can be tracked. For assistance, please contact Gyrus ACMI at 1-888-524-7266.",Contact the recalling firm for information,6820,6820 units,"NationwideForeign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey",Open,N/A,N/A,6820,Not_Computer,N/A,N/A,N/A
Z-2081-2008,48219,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"VariSource¶_ CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000.",VariSource CT/MR Ring & Tandem Applicator Set,2,"September 16, 2008", 2008,"Varian Medical Systems, Inc.",Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.,DESIGN: Device Design,"The firm notified medical device users by letter on 03/12/08. The notification provided updated instructions for use for the CT/MR Ring and Tandem Combination Applicator Set. Users were advised to characterize all ring applicators to develop an offset correction for each dwell position in order to construct a plan to deliver the dwell positions accurately and reliably. The characterization can be done by creating a set of autoradiographs with intended dwell positions and define treatment plan shifts in order to deliver dwell positions in intended locations. Users were advised that a subsequent set of verification autoradiographs should be made using the derived plan shifts to verify the corrected source positioning. The notification also advised that an individual ring's behavior can change over its duration of use and that periodic commissioning is dictated to ensure reproducibility and compensate for changes in the device over time.Users were instructed to inform all employees and extend the notice to any consignees. Users were requested complete and return the enclosed response form.If you have questions about this recall, send an email to brachyhelp@varian,com.",N/A,120,120 units,The medical devices were distributed to radiation oncology facilities nationwide.,Open,N/A,N/A,120,Not_Computer,N/A,N/A,N/A
Z-2208-2008,48681,"stopcock, i.v. set",FMG,Intravascular administration set.,General Hospital,General Hospital,510(k),"ICU Medical, Inc. Cath Lab Kit W/3Port ""ON"" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.","Cath Lab Kit W/3Port ""ON"" Manifold",2,"September 16, 2008", 2008,"ICU Medical, Inc.","Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,Every customer both direct and distributors who have purchased the affected lots were mailed a Product Recall Letter with attached fax-back Product Inventory Summary attachment on 06/11/2008 via fax and followed by UPS overnight delivery. The Product Recall Letter informed the customers of the reason for the recall and instructed them to complete and return the attached Product Inventory Summary. Instructions were also given for returning product in their inventory to ICU.,N/A,100,100,Nationwide Distribution,Terminated,"April 13, 2010",574,490998,Not_Computer,N/A,N/A,N/A
Z-2183-2008,48637,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010",GE Centricity AW Suite Software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus,2,"September 16, 2008", 2008,GE Healthcare Integrated IT Solutions,"When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label.",DESIGN: Software Design,"GE Healthcare IITS sent Product Safety Notification letters dated 6/11/08 to all customers who have the AW Suite Software Versions 2.0 and 2.0.1, informing them that if they also have Card IQ Xpress Pro or Plus, the AW Suite Card IQ software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label. The users were instructed not to make any clinical decisions based on a Card IQ Save State when a custom label has been ordered, and not to include leading or trailing blank characters (space bar) in the new branch name when customizing a Card IQ vessel analysis protocol until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.",N/A,207,207 units,"Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Malta, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland and Turkey",Terminated,"September 06, 2010",720,207,Software,Output/Calculation,Software update,Software Update
Z-2199-2008,48677,"handle, instrument, dental",EJB,Dental hand instrument.,Dental,Dental,510(K) Exempt,"Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.","Navigator System Surgical kit (SGKIT), ",2,"September 16, 2008", 2008,"Biomet 3i, Inc.",The drill malfunctions while in use. The drill has been observed to become lodged in the handle.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recall was initiated in 5/9/2008. Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a fax letter. International customers were first contacted by E-mail then by fax letter.Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affect product to Biomet 3I. Replacement handles will be provided. Contact Biomet 3i, at 1-561-776-6906 or x6904 for assistance.",N/A,N/A,N/A,Worldwide.,Terminated,"January 15, 2009",121,N/A,Not_Computer,N/A,N/A,N/A
Z-1911-2008,47886,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters.",SureSigns VS3 Vital Signs Monitor,2,"September 16, 2008", 2008,Philips Medical Systems,"Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached,",DESIGN: Labeling Design,All affected customers will receive the FSN (Field Safety Notice )informing them about the labeling correction. Included with the FSN will be an addendum to the instructions for use. customers are asked to read the addendum and insert a copy into each of their copies of the VS3 instructions for use. Customers will also receive a Medical Device Correction Confirmation Card that they will be asked to fill out and fax back to their local Philips representative.Contact your local Philips support organization at 1-800-722-9377 in the United States or 1-800-323-2280 in Canada.,N/A,7529,"7,529 units","Worldwide Distribution to United States, Canada and Foreign countries",Open,N/A,N/A,7529,Not_Computer,N/A,N/A,N/A
Z-2054-2008,47899,template,HWT,Template for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.",OmniFit HFx Xray Templates,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.,PRODUCTION CONTROLS: Process Control,"Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005.For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.",N/A,865,865 units,Worldwide,Terminated,"September 24, 2008",8,1675,Not_Computer,N/A,N/A,N/A
Z-1910-2008,47856,"catheter,intravascular,therapeutic,long-term greater than 30 days",LJS,"Percutaneous, implanted, long-term intravascular catheter.",General Hospital,General Hospital,510(k),"USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system.","PROLINE CT POWER INJECTABLE CVC, MODELS CTLINES5",2,"September 16, 2008", 2008,"Medical Components, Inc dba MedComp",kit contains incorrect component,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.,N/A,250,250 units,The products were shipped to customers in PA and TX.,Terminated,"October 28, 2008",42,350,Not_Computer,N/A,N/A,N/A
Z-1692-2008,47523,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA",PuritanBennett 800 Series Ventilator Backup Power Source Model 802,2,"September 16, 2008", 2008,Covidien Limited,Wiring in battery back-up power supply may short and cause thermal damage to ventilator.,PRODUCTION CONTROLS: Process Control,All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service.,N/A,157,6 Ventilators and 151 factory replacement units,"Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.",Terminated,"October 29, 2008",43,157,Hardware,Device Operation,Remove power sources,Remove or Replace
Z-1904-2008,47822,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),"Physio-Control LIFEPAK¶_ 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.",LIFEPAK 12 defibrillator/monitor ,2,"September 16, 2008", 2008,"Physio Control, Inc.","The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to analys",DESIGN: Software Design,"On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: ""Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new software, confirm the Auto Analyze Setup Option is set to OFF or After First Shock"". Instructions for changing the auto analyze setup option for the LP 12 and LP20 were attached to the letter. There was no software issued in response to this action. Since LP20 customers may purchase a software program allowing them to update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting for the software update is Auto-Analyze ON.Contact Technical Support at 1-800-442-1142, option 5 - 6:00 a.m. to 4:00 p,m, (Pacific), Monday - Friday or visit www.Physio-Control-notices.com/sas if you have questions.",Contact the recalling firm for information,19805,"19,805 units","Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, AUSTRALIA, BARBADOS, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, DOMINICAN REPUBLIC, GERMANY, GUAM, GUATEMALA, GUYANA, HONG KONG, JAMAICA, JAPAN, MEXICO, NETHERLANDS ANTILLES, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PARAGUAY, PERU, PUERTO RICO, TRINIDAD, UNITED STATES, URUGUAY, and VIRGIN ISLANDS.",Open,N/A,N/A,41876,Software,Output/Calculation,Instructions to change settings/Purchase Software update,Software Update
Z-2087-2008,48429,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.",TRIGEN Hind Foot Fusion Nail,2,"September 16, 2008", 2008,Smith & Nephew Inc,One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew Sales Representatives were notified of problem and the recall via certified letter and e-mail on 4-22-08. All affected Smith & Nephew International Distributors were notified via email on 4-22-08 and 4-23-08. They were instructed to immediately notify their accounts concerning the recall.If you have questions, contact Customer Service at 800-238-7538.",N/A,114,114,"Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.",Terminated,"May 28, 2010",619,265,Not_Computer,N/A,N/A,N/A
Z-1867-2008,48218,"light, catheter, fiberoptic, glass, ureteral",FCS,Fiberoptic light ureteral catheter.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.",Ureteral Universal Kit,2,"September 16, 2008", 2008,Stryker Endoscopy,"Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery",N/A,"Sales representatives were notified via telephone, and recall product advisory notices will be sent to all consignees on 05/09/2009.Contact a Regulatory Affairs representative at 408-754-2161 or 408-754-2000 should you have any questions.",N/A,1195,1195 units,"Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland",Open,N/A,N/A,5695,Not_Computer,N/A,N/A,N/A
Z-2012-2008,48158,"hammer, surgical",FZY,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis.",Slotted Mallet,2,"September 16, 2008", 2008,"EBI, L.P.",Customer complaint received regarding the separation of the mallet handle during a medical procedure.,PRODUCTION CONTROLS: Process Control,"Recall letters were sent to Sales reps and distributors on May 7, 2007. Questions should be directed to William Hennig, QA Manager at 973-299-9300.",N/A,38,38 mallets,Product was distributed to 20 Biomet sales representatives and distributors nationwide.,Terminated,"October 22, 2008",36,38,Not_Computer,N/A,N/A,N/A
Z-1872-2008,48461,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.",Lactosorb Trauma Plating System,2,"September 16, 2008", 2008,"Biomet Microfixation, Inc.","The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).",PRODUCTION CONTROLS: Packaging Process Control,On 3/19/08 the firm issued an Urgent Medical Device Recall Notice to its consignees by certified letters with return receipt. All returned products will be held in quarantine until final disposition is determined. If you have any questions contact Rachel Osbeck at 1-800-874-7711 or (904) 741-4400 ext 448.,N/A,117,117,"Class II Recall - Worldwide Distribution --- USA including states of NC, MI, TX, GA, HI, OK, IN and CA, and countries of Denmark, Germany, Mexico, Italy, Brazil, Japan, Canada, South Africa, China and the Philippines.",Terminated,"September 11, 2009",360,117,Not_Computer,N/A,N/A,N/A
Z-1865-2008,48206,"appliance, fixation, nail/blade/plate combination, multiple component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area. These components are now made available in sterile packaging.",Omega Compression Screw System,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.",PRODUCTION CONTROLS: Process Control,"Stryker branches and agencies were notified by letter on January 25, 2005. Letters to branches were notified of the packaging error and asked that all inventory location be examined to identify product. Product was to be returned to Stryker. If the product was further distributed, letters were provided to be sent to hospital OR Supervisors. A reconciliation form was also included and asked to be completed and returned.For information on this recall contact Rita Intorella at 201-831-5825.",N/A,20,20 units,To Stryker branches and hospitals nationwide.,Terminated,"September 24, 2008",8,20,Not_Computer,N/A,N/A,N/A
Z-2091-2008,48437,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.",Boston Scientific LeVeen SuperSlim Needle Electrode,2,"September 16, 2008", 2008,Boston Scientific Corp,The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.,DESIGN: Device Design,"Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product.Contact Rob Miragliuolo at 508-683-4186 if you have questions.",N/A,15604,"15,604 of all products",Japan.,Terminated,"September 16, 2008",0,15604,Not_Computer,N/A,N/A,N/A
Z-2080-2008,48204,"component, traction, invasive",JEC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.,Hoffman II compact Sterile Wrist Kit ,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.,DESIGN: Device Design,"Letters were sent to Stryker branches and hospitals on August 17, 2005.If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.",N/A,105,105 units,"The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide",Terminated,"September 24, 2008",8,105,Not_Computer,N/A,N/A,N/A
Z-1374-2008,47489,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.",OmniDiagnost Eleva,2,"September 16, 2008", 2008,Philips Medical Systems North America Co. Phillips,"Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off.",DESIGN: Software Design,"On 3/22/08, the firm mailed letters to their customers via certified mail. The letter informed the customers of the recall, advising the customers to, ""Use the emergency stop button or release the initiated movement command to halt undesired table movement. If you perform digital and conventional acquisition, you can avoid the problem by closing the single examinations daily or by clearing the patient database regularly."" The letter further informed the customers that a Philips representative will be installing updated software at a future date.Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.",N/A,22,22 units,"Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.",Terminated,"September 17, 2010",731,22,Software,Physical Safety Hazards,Software update,Software Update
Z-2079-2008,48199,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Osteonics Scorpio Total Knee;Posteriorly Stabilized Femoral Component; #13with posts, low friction Ion treatment.Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.",Osteonics Scorpio Total Knee,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.",PRODUCTION CONTROLS: Process Control,"The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005.",N/A,1,1 unit,The one unit was distributed to an International Stryker branch.,Terminated,"September 24, 2008",8,1,Not_Computer,N/A,N/A,N/A
Z-1864-2008,48200,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur.",Triathlon Femoral Sizer,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively.",DESIGN: Device Design,"Letters were sent to all affected Stryker Branches/Agencies on May 27, 2005. Letters requested that each branch examine the inventory and hospitals locations to identify the instruments.Contact James Young at 201-831-5110, Brian Coughlin at 210-831-5665 or Rita Intorrella at 201-831-5825 if you have questions.",N/A,560,560 units,To Stryker branches/agencies worldwide.,Terminated,"September 24, 2008",8,560,Not_Computer,N/A,N/A,N/A
Z-2090-2008,48436,prostate-specific antigen (psa) for management of prostate cancers,LTJ,Tumor-associated antigen immunological test system.,Immunology,Immunology,N/A,"COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.",COATACOUNT PSA IRMA kit ,2,"September 16, 2008", 2008,Siemens Medical Solutions Diagnostics,"The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).",N/A,"A Customer Bulletin (Urgent Field Safety Notice) was prepared and sent by fax or mail to all affected Siemens Healthcare Diagnostics Branches on May 21, 2008 both in the United States and elsewhere for communication with the affected customers. This bulletin advises the customer of the problem and the discontinuation of the product. Customers were also instructed to forward this notification to anyone to whom you may have distributed this product and if they have additional questions, please contact your local technical service center @ 1-877-229-3711. A Confirmation (Fax-back) Form is included to ensure that all customers have been notified. The goal is to complete 100% effectiveness by July 31, 2008.If you have questions, contact Siemens Technical Solutions at 1-877-229-3711, option 11, option 6.",Contact the recalling firm for information,64,64 kits,"Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile,Egypt,Cyprus,Korea,Philippines,Taiwan,Uruguay",Open,N/A,N/A,64,Not_Computer,N/A,N/A,N/A
Z-1870-2008,48447,"table, operating-room, mechanical",FWX,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.",AMIS Universal Table for Leg Positioner,2,"September 16, 2008", 2008,Medacta Usa Inc,Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient.,DESIGN: Labeling Design,"The Notification was sent via FedEx overnight on 05/27/2008 to the Director of Risk Management, Director of Biomedical, and Director of Operating Room at each institution with a table.The Safety Notification included:(1) Revised Instructions for Use that include (a) Improved instructions for the attachment of the clamps, and(b) Instructions for the use of new safety straps to provide a fail-safe attachment means.(2) A hang tag for labeling the devices.(3) A reply card indicating that the label has been attached to the table.Customers have been instructed in the proper adjustment of the clamps for the universal table as well as in the use of the safety straps. Customers have also been provided with a hang tag that reinforces the use of the safety straps when attaching the universal table.An additional copy of the notification will be provided to the sales representatives responsible for these hospitals. Included in these packets are instructions for the sales representatives to visit each hospital and provide hands-on training to the operating room personnel regarding proper attachment of the universal table, use of the clamps, and use of the straps.If you have questions, contact Medacta USA at 1-800-901-7836.",N/A,20,20 Units,"Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland",Open,N/A,N/A,20,Not_Computer,N/A,N/A,N/A
Z-1886-2008,46216,"collimator, automatic, radiographic",IZW,Diagnostic x-ray beam-limiting device.,Radiology,Radiology,Enforcement Discretion,"Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.",Philips Gallileo Automatic Collimator,2,"September 16, 2008", 2008,Philips Medical Systems North America Co. Phillips,"The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.",DESIGN: Device Design,"On 2/7/08, the firm issued an URGENT-DEVICE CORRECTION letter via certified mail to their customers. The letter explains the issue and states that the firm will upgrade the collimator by installing a safety plate to prevent the collimator form dislodging from the stand should the screws become lose. The letter also states, ""To avoid the potential risk of the collimator falling from the stand, please test the collimator for being loose. Rock the collimator forwards and backwards by grabbing the sides and gently shaking the unit. Please contact Philips immediately if the collimator is loose and do not use the system until Philips can service the unit."" The service representatives will visit the sites and install a safety plate to prevent the collimator from falling should the securing screws become loose.Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.",N/A,709,709 devices,"Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.",Open,N/A,N/A,709,Not_Computer,N/A,N/A,N/A
Z-2059-2008,48173,"enzyme immunoassay, diphenylhydantoin",DIP,Diphenylhydantoin test system.,Toxicology,Toxicology,510(k),"ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.",Abbott Clinical Chemistry Phenytoin Assay,2,"September 16, 2008", 2008,Abbott Laboratories Inc.,"An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further investigation is required to determine the root cause of this issue. Until the cause has been determined and a corrective action defined, specific instructions ar",OTHER/UNDETERMINED: Pending,"On February 15, 2008 A Product Correction letter with instrument specific attachments was provided to all Clinical Chemistry Phenytoin customers that have received the affected lots. A customer reply form was included in all US customers letter. The letter instructed customers to follow the attached instrument specific actions as described in the attachments (Attachment A: ARCHITECT cSYSTEM, Attachment B: AEROSET). Customers were also instructed to forward a copy of the Product Correction letter to any other laboratories to which they may have forwarded the affected product.If you have questions, U.S. customers should call Customer Support at 1-800-4ABBOTT and customers outside of the U.S. should contact your local customer support.",N/A,5275,"3266 Worldwide, 2009 Domestically","Nationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore",Open,N/A,N/A,5275,Not_Computer,N/A,N/A,N/A
Z-2058-2008,48169,"device, neurovascular embolization",HCG,Neurovascular embolization device.,Neurology,Neurology,510(k),"Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.",Cook Hilal Embolization Microcoil,3,"September 16, 2008", 2008,"Cook, Inc.",The product length is declared incorrectly in mm when the unit of measurement should be cm.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Consignees were notified via recall letter dated 5/9/08 that the firm would replace product on hand. Distributors were requested to notify their customers of the recall.If you have questions, contact Customer Relations Department at 800-346-2686.",N/A,180,180,"Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.",Terminated,"October 21, 2008",35,1363,Not_Computer,N/A,N/A,N/A
Z-1862-2008,48164,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",Cyberknife Robotic Radiosurgery System,2,"September 16, 2008", 2008,Accuray Inc,"Couch may move unexpectedly, which may result in patient impacting the linear accelerator.",DESIGN: Software Design,All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted.Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com for additional information.,N/A,105,105 units,"Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.",Open,N/A,N/A,105,Not_Computer,N/A,N/A,N/A
Z-2015-2008,48163,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.,Biopsy Guide Starter ,2,"September 16, 2008", 2008,Philips Medical Systems,HD3 Biopsy Guide Kits do not contain adequatelabeling instructions for safe and effective use.,DESIGN: Labeling Design,"On 6/4/08, the firm sent letters to their customers via UPS. The letter informed the customers of the recall, and informed them of the following: ""Customers who previously purchased and received a model C7-3 Biopsy Guide Starter Kit between November 29, 2005 and April 3, 2008 will receive a new kit at no charge, to replace the incomplete C7-3 kit previously purchased. New C7-3 kits will be distributed to affected customers by June 30, 2008. Please discard immediately the old C7-3 Biopsy Guide Kit... Customers who previously purchased and received model C5-2 and/or model L9-5 will find the respective new user manual enclosed with this letter. Please discard any old user manuals for models C5-2 and L9-5. The old C5-2 and L9-5 user manual is identified by part number 1-041-7385-02 and 1-041-7587-02 respectively. The part number is located in the lower left hand margin of the single page document."" Included with the letter is a form to be faxed back to Philips indicating they have received the notice and forwarded it onto any sub accounts.If you have questions, contact your local field service representative or Beth Brouillette at 978-659-4884.",Contact the recalling firm for information,59,59 units,"Products are distributed to 5 medical facilities located in NY, WA, GA, VA and MI and to 51 foreign consignees located in AR, AT, CH, CN, CO, CY, DE, DK, ES, FR, GB, GR, HK, HR, HU, IN, IT, KR, LB, LV, MA, MD, MY, NI, NL, PL, SG, SV, TH, TR, TW, ZA.",Open,N/A,N/A,173,Not_Computer,N/A,N/A,N/A
Z-1918-2008,48097,N/A,N/A,N/A,N/A,N/A,N/A,"AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms during an endovascular approach.",AneuRx AAAdvantage and AneuRx Xcelerant Hydro,2,"September 16, 2008", 2008,Medtronic CardioVascular,"Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"2 consignees were notified by letter delivered in person via sales representative the week of April 28. Both were delivered. For assistance, contact Medtronic CardioVascular at 1-707-566-1548.",Contact the recalling firm for information,4,4 units,NC and VA.,Terminated,"September 11, 2008",-5,4,Not_Computer,N/A,N/A,N/A
Z-1907-2008,47828,"electrode, pacemaker, temporary",LDF,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart.",Arrow Balloon Temporary Pacing Catheter Kit,2,"September 16, 2008", 2008,Arrow International Inc,The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by letter on/about 04/11/ 2008. They were instructed to cease use and distribution, and quarantine all affected product. They were also instructed to complete an enclosed Acknowledgement & Stock Status Form and fax back to Arrow International. Consignees were further advised to communicate the recall notice to anyone who has received the affected product by providing a copy of the recall notice to their customer(s).Contact Arrow International, Customer Relations Department at 800-523-8446 if you have questions.",N/A,686,686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally),"U.S. South Africa, Venezuela",Terminated,"December 08, 2009",448,686,Not_Computer,N/A,N/A,N/A
Z-1912-2008,48070,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,",Medtronic Lead Kit for Spinal Cord Stimulation,2,"September 16, 2008", 2008,Medtronic Neuromodulation,"Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to ""Affected Field Personnel"" . The memo described the product /problem and the action required .Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.",N/A,3,3,"NC, FL",Open,N/A,N/A,3,Not_Computer,N/A,N/A,N/A
Z-2089-2008,48430,"stent, carotid",NIM,N/A,N/A,Cardiovascular,N/A,"NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.",NexStent Monorail Carotid Stent System,2,"September 16, 2008", 2008,"Boston Scientific Cupertino, Corporation",Tip may detach from stent delivery system.,PRODUCTION CONTROLS: Process Control,"The firm issued notification letters and information sheets to consignees describing the risks. The firm requested the products be returned to the firm.If you have questions, contact the firm at 408-517-2800.",N/A,1326,1326 units,188 consignees throughout Europe received the product.,Terminated,"September 25, 2008",9,1326,Not_Computer,N/A,N/A,N/A
Z-2053-2008,47775,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms.",EasyVision RAD,2,"September 16, 2008", 2008,Philips Medical Systems North America Co. Phillips,Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).,DESIGN: Device Design,"On 03/14/08 the firmed mailed certified letters to the customers of the device. The letter advises of the problem and stated that images exported from the Easy Vision RAD workstation should not be used for measurements. The letter also states that the firm will be performing upgrades of the devices.If you have questions, contact Sarah Baxter at 425-487-7665 or the Philips Call Center at 800-722-9377, #5, #2.",N/A,401,401 units,"Products were distributed nationwide to 159 hospitals, 3 VA's and 12 Department of Defense accounts.",Terminated,"September 28, 2010",742,401,Software,Output/Calculation,Upgrade,Repair
Z-1626-2008,46963,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.",Gamma3 Set Screwdriver,2,"September 16, 2008", 2008,Stryker Howmedica Osteonics Corp.,"Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"On February 22, 2008 Urgent Product Recall notification letters were sent to Stryker Branches/Agencies, Risk Management Departments at hospitals and surgeons via Federal Express. If you have any questions contact Rita Intorrella at (201) 831-5825 or the Hip Fracture Team at (201) 831-5291.",N/A,43,43 total (single and kits),Class II Recall - Nationwide Distribution.,Terminated,"October 25, 2010",769,43,Not_Computer,N/A,N/A,N/A
Z-1892-2008,46923,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.",EndoWave Infusion System,2,"September 16, 2008", 2008,EKOS Corporation,"Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.",PRODUCTION CONTROLS: Process Control,"On 02/20/08 firm notified customers by phone or email informing them of the issue and notifying them to segregate affected product and hold for return. Letters were sent via FedEx or email, or were hand delivered by firm representative to customers on 02/21/08 informing them of the issue and requesting return of affected product for replacement.Contact Jocelyn Kersten at 425-415-3132 if you have questions.",No consumer action necessary,10,10 units,"Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.",Open,N/A,N/A,10,Not_Computer,N/A,N/A,N/A
Z-1609-2008,47538,"clip, implantable",FZP,Implantable clip.,General & Plastic Surgery,General & Plastic Surgery,510(k),"VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.","VNUS Medical UCLIP Removal Tool, UREM1860",2,"September 16, 2008", 2008,Medtronic Cardiac Surgery Technologies,"Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.",PRODUCTION CONTROLS: Process Control,"A Medtronic ""Urgent Medical Device Field Notification"" letter was sent to one distributor and a separate consignee Medtronic letter ""Urgent Medical Device Field Notification"" was sent to end users on February 25, 2008. The letters explained the situation and requested that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall certificate acknowledging the receipt of the information.If you have questions, contact your VNUS Sales Representative or Lauralie Millikan at 763-391-9124.",N/A,80,80,"AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.",Terminated,"November 10, 2008",55,80,Not_Computer,N/A,N/A,N/A
Z-1660-2008,47336,"transmitters and receivers, physiological signal, radiofrequency",DRG,Radiofrequency physiological signal transmitter and receiver.,Cardiovascular,Cardiovascular,510(k),LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility.,LifeSync Disposable LeadWear,2,"September 16, 2008", 2008,Lifesync Corporation,"LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Firm issued a Device Recall Letter on 12/14/2007. Users were requested to remove the product from inventory and discontinue use of the Large Sized LeadWear with the 12 Lead Adaptors. The current stock of product in inventory will be held under a stop shipment, pending destruction of non-conforming product.",N/A,576,576 completed leadwire units,Class II Recall - Nationwide Distribution.,Terminated,"October 01, 2008",15,1344,I/O,Device Operation,Remove,Remove or Replace
Z-1656-2008,46918,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.Affected part numbers: 320371500021 through 320371500038, 320371500043, 320371500044, 320371500046, 320371500048, 320371500050, 320371500056, 320371500058, 320371500063, and 320371500067.",LIFEPAK 1000,2,"September 16, 2008", 2008,"Physio Control, Inc.",Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"On February 27, 2008 the firm sent a URGENT MEDICAL DEVICE NOTIFICATION letter to consignees advising of the issue. The letter states the firm is performing accelerated function testing and that a follow up notification will be sent if the firm's final test results indicate further action is necessary. The letter recommends consignees ""Continue to use your LIFEPAK 1000 defibrillator/monitor Set your device to Auto-Analyze Contact Physio-Control immediately if your display begins to dim or goes blank. What to do if the display goes blank while in use: 1.Continue to use the device to treat the patient. (voice prompts and tones function normally). 2. If the device is not set to Auto-Analyze use the lower right soft key to select Analyze from the display screen... 3. All other buttons are labeled outside the display screen."" If you have any question contact technical support at 1-800-442-1142 - option 5 or visit the web site at www.physio-control-notices.com/LP1000.",N/A,426,"1,647 total - 426 US, 1,221 international","Worldwide Distribution --- including USA and countries of Netherlands, Germany, Australia, Hong Kong, Barbados and Brazil.",Open,N/A,N/A,1647,Other,Display/Image,Instructions,Safety Notice/Insructions
Z-1657-2008,46962,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures.",Topaz XL Integrated Cable Wand,2,"September 16, 2008", 2008,ArthroCare Corporation,Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.,PRODUCTION CONTROLS: Packaging,"Urgent Product Recall letters (Dated January 31, 2008) were issued to end users of the device (medical professionals) and direct distributors. The letter instructs users to return any affected products.",N/A,2129,"2,129","Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and countries of Sweden, Australia, Germany, Italy, UK, Austria, Saudi Arabia, Belgium, Portugal, UAE, Kuwait, Singapore, Ireland, Spain, Finland, South Korea, Russia and Vietnam.",Open,N/A,N/A,2129,Not_Computer,N/A,N/A,N/A
Z-1895-2008,47539,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography.",Essenta DR,3,"September 16, 2008", 2008,Philips Medical Systems North America Co. Phillips,"Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.",DESIGN: Software Design,"On 4/08/08, the firm notified customers by letter, sent by certified mail. The letter explained the recall and advised customers of the following: ""If direct radiation reaches the detector, the collimation should be not too tight, such that the area of direct radiation is larger than 30 mm x 30 mm. (1.2 inch by 1.2 inch). The reason is that a minimum area is needed to detect and prevent memory artifact... All possibly affected products in the field will be upgraded with FCO 71200026 to resolve the issue.""Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.",N/A,10,10 units,"Nationwide Distribution -- including states of SC, MN, CA, GA, TX, NY, OR and UT.",Open,N/A,N/A,10,Software,Display/Image,Software update,Software Update
Z-1607-2008,47528,"calibrators, ethyl alcohol",DNN,Clinical toxicology calibrator.,Toxicology,Toxicology,510(k),"EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.",Harleco brand Ethanol Standard 1.0 mg/ml,3,"September 16, 2008", 2008,EMD Chemicals Inc,Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.,PRODUCTION CONTROLS: Process Control,"VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail.",N/A,99,99 cases (10 ampules per case),Nationwide Distribution.,Terminated,"September 22, 2008",6,99,Not_Computer,N/A,N/A,N/A
Z-1684-2008,47430,"antibodies, gliadin",MST,Radioallergosorbent (RAST) immunological test system.,Immunology,Immunology,510(k),Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease.,IsantiGliadin IgG Enzyme Immunoassay Test Kit,2,"September 16, 2008", 2008,Diamedix Corporation,"Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.",PRODUCTION CONTROLS: Environmental Control,A Customer Notification Letter was sent to each customer via Certified Mail for domestic customers and via Federal Express for international customer requesting them to contact Diamedix Technical Services to arrange for the return and replacement of any kits of the lot in question. If you have any questions please contact Glenn Gerstenfeld at 1-800-327-4565 or (305) 324-2300.,N/A,174,174 Test Kits,Class II Recall - Worldwide Distribution.,Terminated,"February 11, 2009",148,174,Not_Computer,N/A,N/A,N/A
Z-2052-2008,47422,"needle, phacoemulsification, reprocessed",NKX,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A, 6 needles per pouch, nonsterile.","Bausch & Lomb Millenium Phacoemulsification Needle, Frag 60 Degree",2,"September 16, 2008", 2008,Bausch & Lomb Inc,The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"The recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned.If you have questions, contact Customer Service at 1-800-338-2020.",Contact the recalling firm for information,4061,"Total of all sizes - 4,055/6-needle packages","Distribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Thailand, Turkey, and United Arab Emerites.",Terminated,"January 21, 2010",492,4055,Not_Computer,N/A,N/A,N/A
Z-1658-2008,47238,"prosthesis, shoulder, non-constrained, metal/polymer cemented",KWT,Shoulder joint metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.",Hybrid Glenoid Boss Cutter,2,"September 16, 2008", 2008,"Biomet, Inc.","The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien",DESIGN: Device Design,Consignees were notified by Urgent Medical Device Removal Notice dated 3/13/08 to discontinue use of the instruments and return to the firm. Operating room managers were sent a separate letter dated 3/13/08 and informed of the possible effects to patients from previous use of this instrument and it was suggested they monitor patients for these effects. If you have any questions contact Mary Hardesty at 1-800-348-9500 or (574) 372-3983.,N/A,189,189,Class II Recall - Nationwide Distribution.,Terminated,"October 15, 2008",29,189,Not_Computer,N/A,N/A,N/A
Z-2035-2008,46749,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P.,"Internal handles and electrodes for LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, AND LIFEPAK 20 Defibrillator/",2,"September 16, 2008", 2008,"Physio Control, Inc.","Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented.",DESIGN: Labeling Design,"Starting 2/5/08, Physio-Control sent letters to customers which notifies them not to use Flash Gravity Steam, 12/88 Ethylene Oxide, STERRAD 100 machine, or Gravity Steam to sterilize. The firm recommends the use of 100% EO, STERRAD 100S machine, or Prevacuum steam for sterilization. The letter also recommends that after sterilization, the handles and paddles should be examined carefully for damage. If damaged, the product should be removed from use. The firm will follow up with a revised Sterilization Guideline document and requests posting the letter in the sterilization department in the meantime. Contact technical support at 800-442-1142 if you have questions.On 7/23/08 the firm issued new sterilization guidelines that supersede all others.",Contact the recalling firm for information,47274,"47,274 worlwide for Defibrillator Handles and Paddles","Distributed to hospitals and medical centers. Nationwide, DOD, and international: ARGENTINA, BAHRAIN, BANGLADESH, BERMUDA, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, INDIA, IRAN, ISRAEL, JAPAN, KOREA, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS - US, YEMEN, ZIMBABWE",Open,N/A,N/A,47274,Not_Computer,N/A,N/A,N/A
Z-1655-2008,46858,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, during and after transport.",HillRom Stretcher; Model P8000F,3,"September 16, 2008", 2008,"Hill-Rom, Inc.","The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure.",DESIGN: Device Design,"Consignees will be visited to correct the problem and notified via a hand delivered Device Modification letter dated 4/3/08 at the time of the visit. If you have any questions please contact Jeffrey C. Shaul, Director, RA/QA Acute Care at (812) 931-2604.",N/A,564,564,"Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom.",Terminated,"December 29, 2009",469,564,Not_Computer,N/A,N/A,N/A
Z-2213-2008,45806,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043.Implant is part of a system used to replace the tibial portion of the knee joint.",OSS (Orthopedic Salvage System) NonModular Tibial Base Long,2,"September 17, 2008", 2008,"Biomet, Inc.","Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.",PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.,N/A,22,22,"Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.",Terminated,"March 13, 2009",177,22,Not_Computer,N/A,N/A,N/A
Z-2004-2008,46818,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.",Esprit Power Supply Field Replacement,2,"September 17, 2008", 2008,Respironics California Inc,"This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in someunits. These failures, which were discovered through routine product monitoring, have been reportedin countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported aburning smell coming from the ventilator.",DESIGN: Device Design,"On January 25, 2008, letters were sent to all existing Esprit distributors in",N/A,309,309 units,"Internationally to: Argentina, Turkey, Peru, Russia, Uruguay, Malaysia, Lebanon, India, Spain, Hong Kong, Brazil, UAE, Cambodia, Thailand, Chile, Philippines, South Korea, Vietnam, Bangladesh, Singapore, Italy, United kingdom, South Africa, Egypt, Pakistan, Jordan, Algeria, and Japan",Open,N/A,N/A,2019,Not_Computer,N/A,N/A,N/A
Z-1888-2008,46377,"extractor, vacuum, fetal",HDB,Fetal vacuum extractor.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"M-Style¶_ Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.",Cooper Surgical Mityvac,2,"September 17, 2008", 2008,"Cooper Surgical, Inc.","Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.",DESIGN: Device Design,"On 1/16/08 Cooper Surgical issued an Urgent Notice of Recall via Fed Ex for USA destinations and via e-mail and facsimile for international destinations, and firm confirmed receipt. The letter requests that accounts return recalled product. The recall was extended to three additional lots, and an Urgent Recall Notice dated 3/18/08 was issued. If you have any questions contact Thomas Williams at (203) 601-4741.",N/A,N/A,N/A,"Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1714-2008,47224,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Electrode Adaptor Cable Quick-Combo System, Model 9055The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.",Electrode Adaptor Caple QuickCombo System,2,"September 17, 2008", 2008,Cardiac Science Corporation,Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.,DESIGN: Labeling Design,"On 1/23/08 the firm issued a letter titled ""9055 Electrode Adaptor IFU Update"" to consignees sent via certified return receipt requested. Enclosed with the letter is an updated Instructions For Use, part number 70-00180-01, revision C. Consignees were advised to discard their old Instructions For Use. For assistance, contact Cardiac Science at 1-888-466-8686.",Contact the recalling firm for information,63,63,Distributed Nationwide US and Canada and Internationally to: Norway and Guam,Open,N/A,N/A,63,Not_Computer,N/A,N/A,N/A
Z-1890-2008,48073,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.",GE 1.5T and 3.0T Signa HDx MR System ,2,"September 17, 2008", 2008,GE Healthcare,GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.,DESIGN: Software Design,"Consignees were sent a ""GE Healthcare Product Safety Notification"" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.",N/A,122,122,"AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO.AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.",Open,N/A,N/A,269,Not_Computer,N/A,N/A,N/A
Z-1812-2008,48089,"prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing",NJL,N/A,N/A,Orthopedic,N/A,"Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing intended to to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.",Depuy LCS Knee Meniscal bearing insert,2,"September 17, 2008", 2008,"Depuy Orthopaedics, Inc.","Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of insert.",PRODUCTION CONTROLS: Process Control,On 5/6/08 an Urgent Information - Recall Notice and an User Facility Reconciliation Report was issued to all customers/consignees informing them to find and return any product on hand and the one implanting surgeon was also notified via letter. If you have any questions contact Steve Dowell at 1-800-366-8143.,N/A,10,10,Class II Recall - Nationwide Distribution --- including states of Pennsylvania and Virginia.,Terminated,"October 14, 2009",392,10,Not_Computer,N/A,N/A,N/A
Z-2056-2008,48099,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.,CyberKnife Robotic Radiosurgery System,2,"September 17, 2008", 2008,Accuray Inc,"Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.",DESIGN: Software Design,"On April 16, 2008, the firm issued notifications via fedex to affected sites. In addition, installation and upgrade procedures will be updated to incorporate a step which decommissions sample beam data.If you have questions, contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or send and email to customersupport@accuray.com.",N/A,109,109 units,"Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey, France, Italy, Spain, Greece and Germany.",Open,N/A,N/A,109,Software,Output/Calculation,Software update,Software Update
Z-1811-2008,48085,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.",Intuitive Surgical ,2,"September 17, 2008", 2008,"Intuitive Surgical, Inc.","The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.",DESIGN: Software Design,"On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.",N/A,11,11,"Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI.",Open,N/A,N/A,11,Software,Device Operation,Remove,Remove or Replace
Z-2006-2008,48122,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"iReview"" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by Boston Scientific Corporation, Fremont, CA The iReview"" Software is provided on CD and is a computer application designed for reviewing cases recorded with firm's iLab ""System, and for exporting stills or videos of those runs.",Boston Scientific iReview Software ,2,"September 17, 2008", 2008,Boston Scientific Corporation,"The firm initiated a recall of a specific iReview"" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Customer notifications sent on May 2, 2008 indicating the need for field correction and included a replacement version of the software kit. For customer assistance, contact Boston Scientific at 1-508-652-5594.",N/A,10,10 kits,"Product was distributed in FL, MI, CA, AZ and SC",Terminated,"June 01, 2009",257,10,Software,N/A,Software update,Software Update
Z-2217-2008,48687,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002Orthopaedic instrument used for the preparation of the implant site prior to device implantation.",Dynasty Trial Shell ,2,"September 17, 2008", 2008,Wright Medical Technology Inc,Trials are 2.5mm larger than marked.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a ""fax back"" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Risk Managers, and Orthopaedic Department Managers.",N/A,127,127 units,Worldwide Distribution --- including USA and Canada.,Terminated,"January 25, 2009",130,382,Not_Computer,N/A,N/A,N/A
Z-1810-2008,47897,"staple, fixation, bone",JDR,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36"" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.",Lupine BR Anchor w/Orthocord,2,"September 17, 2008", 2008,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.,TRAINING: Employee Error,"DePuy Mitek notified customers by letter dated April 29, 2008 titled Urgent: Voluntary Medical Device Recall Letter asking consignees to isolate and do not use product and to return any of the identified product to DePuy Mitek using enclosed prepaid Federal Express shipping labels and to include a photocopy of the completed Business Reply Form. The firm is asking customers to complete the Business Reply Form with a self addressed, stamped envelope indicating level of inventory of the affected product and to return for immediate delivery of replacement product. If you have any questions contact DePuy Mitek Customer Service directly at 1-800-382-4682.",N/A,105,105 units,"Class II Recall - Worldwide Distribution --- USA including states of CA, NY, MA, NV, OH, TX, TN, MD, and countries of France, UK, Canada, Spain.",Terminated,"October 02, 2008",15,105,Not_Computer,N/A,N/A,N/A
Z-2242-2008,48706,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cannon Catheter"" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USAThe product is used for long term hemodialysis vascular access.","Cannon Catheter"" II,",2,"September 17, 2008", 2008,Arrow International Inc,The tips may not have been adequately welded to the catheter body.,DESIGN: Device Design,"Consignees were notified by letter on/about 06/10/2008. They were instructed to: 1. Cease use and distribution and quarantine all affected product immediately. 2. Contact Arrows Customer Service Department for a Return Authorization Number, enter the number on an enclosed Recall Acknowledgement & Stock Status Form and 3. Immediately fax back the form to Arrow International. All affected product is to be returned to Arrow International. A letter containing the recall information was enclosed for physicians who have implanted catheters. Contact Arrow's Customer Service at 1-800-523-8446 for assistance.",N/A,79248,79248 units (total for all catheters listed),"U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine",Terminated,"December 03, 2009",442,79248,Not_Computer,N/A,N/A,N/A
Z-2287-2008,48709,"atp and creatine kinase (enzymatic), creatine",JLB,Creatine test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.",Piccolo MetLyte 7 Reagent Disc,2,"September 17, 2008", 2008,Abaxis Inc,The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples,PRODUCTION CONTROLS: Process Control,"The firm issued a notification letter to its consignees on April 21, 2008. The firm intends to follow up with phone calls and provide a software upgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.",N/A,237,237 kits,Product was distributed Worldwide.,Open,N/A,N/A,1130,Computer,N/A,N/A,N/A
Z-2077-2008,48185,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740",Allez Spine Laguna Pedicle Screw System,2,"September 17, 2008", 2008,"Allez Spine, LLC","This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.",DESIGN: Device Design,Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory.All customers and consignees were contacted by the firm.,N/A,62,62,"Nationwide to AZ, CA, CO & UT",Terminated,"January 19, 2010",489,625,Not_Computer,N/A,N/A,N/A
Z-2299-2008,48715,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.",Zimmer Metasul Head,3,"September 17, 2008", 2008,Zimmer Inc.,The wrong part may be in the package. Package may contain a 28 mm head.,PRODUCTION CONTROLS: Packaging Process Control,Zimmer notified consignees via recall letter dated 6/20/08 to return the product.,N/A,4,4,"Florida, Pennsylvania, Texas and Virginia.",Terminated,"January 05, 2009",110,4,Not_Computer,N/A,N/A,N/A
Z-2351-2008,48189,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure.",InterGro DBM Demineralized Bone Matrix ,2,"September 17, 2008", 2008,"Michigan Orthopaedic Products, Inc.",Exposure to temperature extremes -- Product was not stored under controlled conditions and may have been temperature abused. Exposure to temperature extremes could cause problems with device safety (e.g. risk of infection) or problems with device effectiveness (e.g. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).,TRAINING: Employee Error,"Three units were picked up from the consignee on or about 5/05/08. The implanting physician was verbally advised of the problem with the fourth unit. If you have any questions contact Michigan Orthopaedic Products, Inc. at (616) 249-8937.",N/A,4,4 packages,Class II Recall - Nationwide Distribution --- including the state of Michigan.,Terminated,"October 21, 2008",34,4,Not_Computer,N/A,N/A,N/A
Z-2189-2008,48197,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.",Surgical Table,2,"September 17, 2008", 2008,Stryker Communications Corp,"Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.",DESIGN: Device Design,"Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance.Contact Karen Smith-Mosley at 972-410-7310 if you have questions.",N/A,10,10 units.,"Nationwide distribution to the following states: CA, CO, TX and UT.",Terminated,"January 08, 2010",478,10,Not_Computer,N/A,N/A,N/A
Z-1875-2008,48464,"enzyme immunoassay, methadone",DJR,Methadone test system.,Toxicology,Toxicology,510(k),VisuaLine Tricyclic Antidepressants:Six Dip (COC-THC-OPI-MET-BZD-OXD);Six Dip (COC-THC-OPI-MET-PCP-OXD);Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD);Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA);Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD);Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD);Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD).Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.,VisuaLine Tricyclic Antidepressants,2,"September 17, 2008", 2008,"Sun Biomedical Laboratories, Inc.","Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.",OTHER/UNDETERMINED: Pending,"On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading ""Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.",Contact the recalling firm for information,781,781 kits,"Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.",Terminated,"June 10, 2009",266,1136,Not_Computer,N/A,N/A,N/A
Z-2101-2008,48439,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.",Coherence Therapist 2.0,2,"September 17, 2008", 2008,"Siemens Medical Solutions USA, Inc","Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.",DESIGN: Software Design,"An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.",N/A,N/A,N/A,Class II Recall - Product distribution information pending from firm.,Open,N/A,N/A,N/A,Computer,N/A,N/A,N/A
Z-2232-2008,48425,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19Product is indicated for manual pipetting.","Hamilton Soft Grip Pipettes, 1 ml fixed volume",2,"September 17, 2008", 2008,Hamilton Co,Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity,DESIGN: Device Design,"Recall initiated May 7 2008. Notification issued via certified overnight mail explains the problem and instructs customers to inventory the affected pipettes. The firm will contact its customers and supply replacement lower-body assemblies, repair instructions and return information so that affected parts can be returned to Hamilton. A fax-back form is supplied with each notification. Responses will be tracked. Contact Hamilton Co. at 1-775-558-3000 for assistance.",Contact the recalling firm for information,48,48 units,"Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.",Open,N/A,N/A,353,Not_Computer,N/A,N/A,N/A
Z-2209-2008,48682,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"VectorVision (VV) Sky Navigation Platform (19"" Computer Rack); the 19"" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, GermanyIntended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.",VVsky Navigation Platform,2,"September 17, 2008", 2008,Brainlab AG,"Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables.",DESIGN: Component Design/Selection,"BrainLAB sent Product Notification letters dated 11/12/07 to their VectorVision Sky end users, informing them of the possible overload of electrical cables in VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels). The users were requested to perform an inspection of the medical power supplies and cabling on a regular basis. If anything suspicious is noted, they were directed to shut down the entire system and contact BrainLAB immediately. BrainLAB contacted each account shortly after the sending of the letter to arrange for the installation of small fuses/circuit breakers according to the specific load limits per device, which will open the circuit in case of overload on faulty circuits, and to exchange the low voltage cables that directly connect the medical power supply from 1.5 mm2 to 2.5 mm2 thickness to withstand the full 20 amp current in case of a failure. Any questions were directed to BrainLAB's customer hotline at 1-800-597-5911.",No consumer action necessary,23,23 units,"Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin.",Terminated,"July 24, 2009",310,23,Hardware,N/A,Install fuses/circuit breakers,Other
Z-2236-2008,48698,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),EndoVive Safety PEG Kits 24 FUniversal Product Number (UPN): MOO56648 1The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.,Boston Scientific,3,"September 17, 2008", 2008,Boston Scientific Corporation,"Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG",PRODUCTION CONTROLS: Labeling Mix-Ups,"Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts tocheck their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply VerificationTracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.",N/A,16,16 Kits (total number of Kits),"NJ, SC, TN, VA, and WI",Terminated,"December 10, 2008",84,16,Not_Computer,N/A,N/A,N/A
Z-2191-2008,48642,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,N/A,Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter,Polysulfone Petite Vital Port,2,"September 17, 2008", 2008,Cook Vascular Inc.,mislabeled - wrong size catheter was packaged in the box,PRODUCTION CONTROLS: Packaging Process Control,The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.,Contact the recalling firm for information,20,20 units,The products were shipped to distributors in Japan and Brazil.,Terminated,"September 18, 2008",1,41,Not_Computer,N/A,N/A,N/A
Z-2310-2008,48736,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors of the eye.",AMO WaveScan WaveFront System Version 3.90/3.901,2,"September 17, 2008", 2008,"VISX INCORPORATED, A SUBSIDIARY OF AMO INC","Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.",DESIGN: Software Design,"A product advisory notice was mailed to all consignees on June 9, 2008, advising consignees to closely monitor the WaveScan results to ensure that mistreatment is not given to patients. The firm has ceased distributing the updated software. ***UPDATE 08/29/2008*** The firm revised its recall strategy on 08/28/2008 because the firm was informed that a 180 day PMA supplement rather than a real time review supplement would be required for the software upgrade approval. The firm will instead revert products to the previous software version, 3.67/3.671.If you have questions, contact 1-877-AMO-4LIFE, options 1, 2, and then 2.",N/A,160,160 kits,Product was distributed to 152 customers throughout the United States.,Open,N/A,N/A,160,Software,Output/Calculation,Software update,Software Update
Z-2308-2008,48730,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments.",Eclipse V. 6.5,2,"September 17, 2008", 2008,Varian Medical Systems Oncology Systems,Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.,DESIGN: Software Design,"Recall initiated June 11, 2008 when the firm issued an Urgent Device Correction recall letter. The letter was distributed to all affected users, with problem description and user corrective action steps.If you have questions, contact your local Varian Customer Support Representative.",N/A,907,907 units,"Product was distributed throughout the USA and to Argentina, Australia, Austria, Belgium, Byelorussia, Brazil, Canada, Chile, China, Colombia, CzechRepublic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India,Israel, Iran, Italy, Ireland, Japan, Kozak, Latvia, Lebanon, Libya, Macau, Macedonia,Malaysia, Mexico, Morocco, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal,Russian Fed., Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland,Syria, Taiwan, R.O.C., Thailand, The Netherlands, Turkey, Ukraine, United Kingdom, Venezuela,Vietnam.",Open,N/A,N/A,907,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-2186-2008,48641,"densitometer, bone",KGI,Bone densitometer.,Radiology,Radiology,510(k),"Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.",Hologic Delphi Bone Densitometers ,2,"September 17, 2008", 2008,"Hologic, Inc.",Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.,DESIGN: Device Design,"Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals.If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.",N/A,82,82 units,"NationwideForeign: CanadaAlgeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK",Terminated,"October 25, 2010",768,1168,Computer,N/A,N/A,N/A
Z-2348-2008,48990,"apparatus, vestibular analysis",LXV,N/A,N/A,Ear Nose & Throat,510(k),"Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.","Isotechnology, Isobalance System",2,"September 17, 2008", 2008,Acacia Engineered Products LLC,The firm distributed an unapproved medical device.,PREMARKET APPROVAL: No Marketing Application,"On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.",N/A,24,24,"Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.",Terminated,"February 17, 2010",518,24,Not_Computer,N/A,N/A,N/A
Z-2300-2008,48716,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.",Zimmer Unicompartmental Knee System headed screw,3,"September 17, 2008", 2008,Zimmer Inc.,"An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.",N/A,5,5,"Florida, China and India.",Terminated,"December 17, 2008",91,5,Not_Computer,N/A,N/A,N/A
Z-2350-2008,48999,"sterilizer, steam",FLE,Steam sterilizer.,General Hospital,General Hospital,510(k),"Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.",Steris Small Renaissance Eagle 3000. ,2,"September 17, 2008", 2008,Steris Corp,"The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle initiation if the door is not locked. However, in the event the door switches are not properly adjusted they may falsely indicate that the door is locked even t",TRAINING: Employee Error,"On March 5, 2008, Steris issued an Urgent Product Correction. Beginning March 6, 2008 customers were notified by telephone. The firm instructed their customers to immediately discontinue using the small Renaissance Eagle 3000 steam sterilizer(s) until inspected and corrected by a service technician. Steris Service technicians were dispatched to affected customers to inspect and correct the sterilizers as appropriate. If you have any questions contact Holly Wright Lee at (404) 392-7019 or 1-800-548-4873 ext. 27019.",N/A,148,148 units,"Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, and WY, and countries of Canada and Mexico.",Terminated,"September 28, 2010",741,148,Not_Computer,N/A,N/A,N/A
Z-2235-2008,48657,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"NeuViz Dual series computed Tomography Scanner System, X-Ray SystemThe CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.",NeuViz,2,"September 17, 2008", 2008,"Philips And Neusoft Medical Systems Co., Ltd.",Labeling of patient position on scanned image does not match actual patient orientation.,DESIGN: Software Design,"On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.",N/A,15,15 units,"Distribution in US: CO, FL, KY, NC, SC, TN, and TX.",Open,N/A,N/A,15,Software,Display/Image,Software update,Software Update
Z-1903-2008,47755,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.",ISOMED refill kit,2,"September 17, 2008", 2008,Medtronic Neuromodulation,"Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by Medtronic field personnel, either by personal visits or telephone, beginning 2/4/08. This included the 8 additional consignees located outside of the U.S. Medtronic advised customers not to use any unused packages in their inventory and that a field representative would assist them in returning the product for replacement and/or credit. Upon completion of each follow-up, the field representatives completed and returned a Reply Card documenting the notification.If you have questions or comments, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.",Contact the recalling firm for information,1982,1982 kits,"Worldwide -- including the U.S. (AK, AL, AR, AZ, CA, CT, DC,DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV) and Argentina, Australia, and Hong Kong.",Terminated,"October 13, 2010",756,1982,Not_Computer,N/A,N/A,N/A
Z-2307-2008,48727,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"NeuViz Dual series computed Tomography Scanner System, X-Ray System",NeuViz Dual series computed Tomography Scanner System,2,"September 17, 2008", 2008,"Philips And Neusoft Medical Systems Co., Ltd.","Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair.If you have questions contact Service Support Department at nms-service@neusoft.com.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",15,15 units in US,"The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.",Terminated,"September 24, 2010",737,15,Not_Computer,N/A,N/A,N/A
Z-1995-2008,47369,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery.",Margron DTC Hip Replacement System.,2,"September 18, 2008", 2008,"Portland Orthopaedics Pty, Ltd.",Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.,DESIGN: Device Design,"Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.",No consumer action necessary,2403,2403 of all products,Nationwide.,Terminated,"November 12, 2009",420,2403,Not_Computer,N/A,N/A,N/A
Z-2136-2008,48462,"camera, multi format, radiological",LMC,Medical image hardcopy device.,Radiology,Radiology,Enforcement Discretion,"Drystar AXYS, Hardcopy PrinterA free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.",Drystar AXYS,3,"September 18, 2008", 2008,AGFA Corp.,"The ""Film Calibration"" setting on the printers was set to the default ""OFF"" position instead of ""ON"".",OTHER/UNDETERMINED: Pending,"Consignees were notified by an Urgent Safety Notice letter on/about 05/16/2008. The letter provides the procedure the customer can follow to change the film calibration setting from ""OFF"" to ""ON"". The letter also provides information on how to get assistance from Agfa, if the customers prefer a service engineer perform the change. Consignees were instructed to send a copy of the letter or similar letter to their affected accounts. Agfa also offers to dispatch a service engineer to perform the parameter change.",N/A,33,33 units,"Worldwide Distribution --- USA including states of DE, FL, IL, KS, MA, MD, ME, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, and Puerto Rico and country of Canada.",Terminated,"October 10, 2008",22,33,Not_Computer,N/A,N/A,N/A
Z-2137-2008,48463,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads ""ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONSIs an EPID-based (electronic portal imaging device) version of localization software for determining the treatment machine position of radiotherapy targets.",ISOLOC Software,2,"September 18, 2008", 2008,Civco Medical Instruments Inc,"A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.",DESIGN: Software Design,"On 06/16/08 Civco Medical Solutions issued an Urgent-Medical Device Correction letter to all its customers by certified mail. This letter states the circumstances in which the device works incorrectly, a temporary work around and the information that the new software version 6.7 will address the issue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and returned acknowledging the receipt of the Device Correction Notification.",No consumer action necessary,235,"235: 163 version 6.6, 60 version 6.5 and 12 version 6.0","Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.",Open,N/A,N/A,163,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2375-2008,49018,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization.Part # 50-07-0100Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.,FormPutty Bone Void Filler 10cc ,3,"September 18, 2008", 2008,Theken Spine LLC,The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.,PRODUCTION CONTROLS: Labeling Mix-Ups,"In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.",N/A,33,33 syringes,"Nationwide Distribution --- including states of FL, OH, TX, and UT.",Open,N/A,N/A,33,Not_Computer,N/A,N/A,N/A
Z-2228-2008,48693,"prosthesis, toe, hemi-, phalangeal",KWD,Toe joint phalangeal (hemi-toe) polymer prosthesis.,Orthopedic,Orthopedic,510(k),"Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.",Toe implant prosthesis,2,"September 18, 2008", 2008,OrthoPro LLC,Labeling presented conflicting information as to whether device was sterile or not.,PRODUCTION CONTROLS: Labeling Mix-Ups,"All sales agents were verbally notified on 05/29/2008 and told to locate and return all available affected implants. For assistance, contact OrthoPro at 1-801-746-0208.",N/A,210,210 units,"AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.",Terminated,"September 24, 2008",6,210,Not_Computer,N/A,N/A,N/A
Z-2347-2008,48988,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).",KyphX Osteo Introducer System,2,"September 18, 2008", 2008,Kyphon Inc,"Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Recall initiated on June 23, 2008. A recall letter and reconciliation form was sent out via e-mail to sales representatives for hand delivery to US hospital consignees. The consignees were asked to review the letter and complete/return the reconciliation form to the firm. If you have any questions contact Kyphon, Inc. at 1-408-548-6740.",N/A,310,310 units,Class II Recall - Nationwide Distribution.,Terminated,"October 07, 2009",384,310,Not_Computer,N/A,N/A,N/A
Z-2379-2008,49021,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX.Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.",VERTIER Surgical Table,2,"September 18, 2008", 2008,Stryker Communications Corp,"Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.",DESIGN: Device Design,Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.,N/A,4,4 units.,"Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC.",Terminated,"January 07, 2010",476,90,Not_Computer,N/A,N/A,N/A
Z-2346-2008,48986,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.xThe system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.",Philips Healthcare Informatics iSite PACS ,2,"September 18, 2008", 2008,"Philips Healthcare Informatics, Inc.",Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.,DESIGN: Software Design,"A ""product notification"" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.",Contact the recalling firm for information,198,198 systems,"Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria",Terminated,"October 07, 2009",384,198,Software,Display/Image,Software update,Software Update
Z-1652-2008,48985,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Ultraview Digital Telemetry Transmitter, Model 90478The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.",Ultraview Digital Telemetry Transmitter,2,"September 18, 2008", 2008,"Spacelabs Healthcare, Incorporated",Telemetry Modules are failing to alarm for low heart rate and asystole.,DESIGN: Software Design,"On 07/18/08 Spacelabs Healthcare issued a ""URGENT-MEDICAL DEVICE CORRECTION"" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.",N/A,37590,"37,590",Nationwide and Internationally,Open,N/A,N/A,37590,Software,N/A,N/A,N/A
Z-2241-2008,48705,"stimulator, spinal-cord, implanted (pain relief)",GZB,Implanted spinal cord stimulator for pain relief.,Neurology,Neurology,510(k),"Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.",Medtronic SPECIFY,2,"September 18, 2008", 2008,Medtronic Neuromodulation,Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit.,DESIGN: Software Design (Manufacturing Process),"In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer.If you have questions or comments, contact your Medtronic representative.",Contact the recalling firm for information,3669,"3669 (however only 962 units are scope of recall, because they are sold or in consignment AND are not registered implants","US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY",Terminated,"October 08, 2010",750,3669,Not_Computer,N/A,N/A,N/A
Z-2344-2008,48980,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),PLV-100 Portable Lifecare Ventilator Life support ventilationThe device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Life support ventilation,PLV100 Portable Lifecare Ventilator ,2,"September 18, 2008", 2008,"Respironics, Inc.",Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance.,N/A,197,197,"Worldwide Distribution ---USA: NC, IL, NJ, MO, TX , OH, IA, and OK and countries of Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India.",Terminated,"April 23, 2009",217,197,Not_Computer,N/A,N/A,N/A
Z-2374-2008,49015,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 60 ml Syringe, Luer-Lok TipSterile;Cases : 160 (4 x 40)Shelf Carton: 40BD; Franklin Lakes, NJ 07417 USA. Made in USA.Syringes for use in aspiration and injection of medications.",BD 60 ml Syringe LuerLok Tip,2,"September 18, 2008", 2008,Becton Dickinson & Company,Becton Dickinson identified the presence of open seals during an internal inspection process.,DESIGN: Packaging Design/Selection,"Urgent: Product Recall letters were sent to Distributors and Syringe Customers on July 15, 2008 by UPS second day air. Customers are to immediately review their inventory, determine if they have any affected product, and remove the affected if they have any. Next customers should complete the enclosed Customer Packing List and BD will send a replacement product upon receipt of the returned product. Questions are to be directed to BD Customer Service at 1-888-237-2762, M-F, 8:00 AM to 5:00 PM EST.",N/A,1246,1246 lots,Nationwide Distribution.,Terminated,"April 16, 2009",210,1246,Not_Computer,N/A,N/A,N/A
Z-2369-2008,49005,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B)Revision: B.02.07Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.",Philips,3,"September 18, 2008", 2008,Philips Medical Systems,"Software: If Weight Limits edited, values will return to default values that were deleted",DESIGN: Software Design (Manufacturing Process),"Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.",N/A,49,49 units,Nationwide Distribution.,Open,N/A,N/A,49,Software,Output/Calculation,Software update,Software Update
Z-2177-2008,48629,"microtools, assisted reproduction (pipettes)",MQH,Assisted reproduction microtools.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.,Flexipet Manipulation pipette 300 micron,2,"September 18, 2008", 2008,Cook Vascular Inc.,mislabeled - 300 micron flexipets labeled as 130 micron and vice versa,TRAINING: Employee Error,The recalling firm issued an Urgent product Recall letter on 3/3/08. The letter informed the customers of the problem and that the pouch is correctly labeled. Customers were instructed to return product and notify any sub accounts. Please contact Cook Vascular at 1-724-845-8621 for assistance.,Contact the recalling firm for information,120,120 boxes,"The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.",Terminated,"September 18, 2008",0,220,Not_Computer,N/A,N/A,N/A
Z-1477-2008,49388,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.",GE Precision 500D,2,"September 18, 2008", 2008,GE Healthcare,Necessary certification labels are missing from the x-ray contol.,TRAINING: Employee Error,A field Engineer from GE will visit the customer site to apply label to the X-ray control.,N/A,437,437,"Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.",Terminated,"October 07, 2010",749,885,Not_Computer,N/A,N/A,N/A
Z-1510-2008,45894,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143",Axis Gamma Camera,3,"September 19, 2008", 2008,Philips Medical Systems (Cleveland) Inc,"Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.",DESIGN: Component Design/Selection,"Consignees were sent an Urgent Field Safety Notice on 1/30/08. The letter instructs users who experience a failure to remove the system from service and contact the recalling firm for immediate correction. The recalling firm will schedule appointments with users to replace the affected part beginning in March 2008. For additional information, contact 1-800-722-9377.",N/A,N/A,Unknow at this time since the recall was expanded.,"Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.",Open,N/A,N/A,N/A,Hardware,Device Operation,Replace,Remove or Replace
Z-1685-2008,45908,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Stryker Medical Secure II Med/Surg Bed, 115 V, Stryker Medical, Portage, MI.; Model 3002.",Stryker Medical Secure II Med/Surg Bed; Model 3002.,2,"September 19, 2008", 2008,Stryker Medical Div. of Stryker Corporation,The brakes may not have adequate holding power to lock the bed in place.,DESIGN: Device Design,Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.,N/A,66558,"66,558 of all models.","Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.",Terminated,"November 05, 2010",777,66558,Not_Computer,N/A,N/A,N/A
Z-1678-2008,47343,"tourniquet, pneumatic",KCY,Pneumatic tourniquet.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet.","Color Cuff II, Double Port Single Bladder ",2,"September 19, 2008", 2008,"Ascent Healthcare Solutions, Inc.",Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.,PRODUCTION CONTROLS: Process Control,"A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.",No consumer action necessary,20,20 of 20,Class II Recall - Nationwide Distribution.,Open,N/A,N/A,8306,Not_Computer,N/A,N/A,N/A
Z-1504-2008,47233,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5300-004-10.",Zimmer Surgivac Wound Drainage Device,2,"September 19, 2008", 2008,Zimmer Inc.,The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.,DESIGN: Packaging Design/Selection,Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.,N/A,N/A,N/A,"Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.",Terminated,"November 12, 2009",419,N/A,Not_Computer,N/A,N/A,N/A
Z-1808-2008,47881,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.",Convenience Kit,2,"September 19, 2008", 2008,"Merit Medical Systems, Inc.",Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used.,N/A,30,30 kits,Class II Recall - Nationwide Distribution --- including state of NY.,Terminated,"September 22, 2008",3,30,Not_Computer,N/A,N/A,N/A
Z-2212-2008,48684,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547.Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms.",ACUSON CV70 Ultrasound systems,2,"September 19, 2008", 2008,"Siemens Medical Solutions USA, Inc.","System may either display incorrect mechanical and thermal index values, or fail to display them altogether.",DESIGN: Software Design,"Recall initiated on 06/04/2008. Under the Siemens update program, all consignees will receive a visit from Siemens service personal to install the revised software version. Siemens staff will coordinate with foreign distributors to arrange for service abroad.",N/A,1230,1230 units,Worldwide Distribution.,Open,N/A,N/A,1230,Software,Display/Image,Software update,Software Update
Z-2240-2008,48702,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.,Nobel Replace Tapered Groovy RP 4.3x10mm,3,"September 19, 2008", 2008,Nobel Biocare USA LLC,"This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as ""4.3x8"". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A ""Urgent Medical Device Recall"" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products.Contact Kam Leung at 714-282-4800 if you have questions.",N/A,197,197,"AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA",Terminated,"September 22, 2008",3,197,Not_Computer,N/A,N/A,N/A
Z-2239-2008,48701,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity.",ARCHITECT i1000SR System Assay CD ROM WW (excluding US),2,"September 19, 2008", 2008,Abbott Laboratories,"When running the Automated Dilution Protocol with the assay files ""CMV IgG"" or ""Toxo IgG"" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated.",DESIGN: Software Design,"Abbott affiliates were e-mailed copies of the recall letter Urgent Field Safety Notice Product Correction on 6/16/08 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated June 16, 2008 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed when running the Automated Dilution Protocol of the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System, software error code [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops. The accounts were advised to not use the Automated Dilution Protocol of either the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System and report results for samples requiring dilution as """,N/A,75,75 CD-ROMs,"Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, India, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Sweden, Saudi Arabia, Spain, United Arab Emirates",Terminated,"March 18, 2010",545,75,Software,Device Operation,Software update,Software Update
Z-2238-2008,48699,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile",Reflex Revision Screwdriver Inner Shaft,2,"September 19, 2008", 2008,Stryker Spine,The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.,PRODUCTION CONTROLS: Process Control,"URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008.If you have questions, contact Michelle Klein at 201-760-8256.",N/A,35,35,The product was distributed to 13 Stryker branches/agencies.,Terminated,"September 22, 2008",3,35,Not_Computer,N/A,N/A,N/A
Z-2309-2008,48731,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.",ArthroCare ArthroWands,2,"September 19, 2008", 2008,ArthroCare Corporation,"Product is not secure in packaging, and movement may damage the product or render it non-sterile.",PRODUCTION CONTROLS: Packaging,"Recall initiated April 9, 2008. All consignees were sent a letter of the recalled product on April 9 and May 13, 2008. All non-responding consignees were sent a second letter titled Recall - Covator with Integrated Cable Wand Recall No. 2951580-06/24/08 on June 24, 2008.Contact Bruce Prothro at 408-735-6229 if you have questions.",N/A,3644,3644 units,"Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland.",Open,N/A,N/A,3644,Not_Computer,N/A,N/A,N/A
Z-2428-2008,49083,"antimitochondrial antibody, indirect immunofluorescent, antigen, control",DBM,Antimitochondrial antibody immunological test system.,Immunology,Immunology,510(k),"Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled ""BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette"". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.",Kallestad (TM) HEp2,3,"September 19, 2008", 2008,Bio-Rad Laboratories,The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.,TRAINING: Employee Error,"On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, ""Please use this to replace the card in any kits remaining in your facility."" If customers have any questions or require additional QC cards, they are to contact Technical Support.",Contact the recalling firm for information,4400,"4,400 total kits","Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.",Open,N/A,N/A,4400,Not_Computer,N/A,N/A,N/A
Z-2343-2008,48759,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Ultraview SL Command Module, Model 91496The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.",Command Module,2,"September 19, 2008", 2008,"Spacelabs Healthcare, Incorporated",Potential for module to fail to obtain a NIBP reading on hypertension patients.,PRODUCTION CONTROLS: Process Control,"On July 22, 2008 an ""Urgent MEDICAL DEVICE CORRECTION"" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.",N/A,22079,"22,079",The product is distributed nationwide and internationally to medical facilities.,Open,N/A,N/A,27219,Not_Computer,N/A,N/A,N/A
Z-2144-2008,49471,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USAThe product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.",GE Precision MPi,2,"September 19, 2008", 2008,GE Healthcare,The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,GE Field Engineers visited affected customers to make the correction.,N/A,54,54 (24 US / 30 OUS),"Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,",Open,N/A,N/A,54,Not_Computer,N/A,N/A,N/A
Z-2432-2008,49090,giardia spp.,MHI,Entamoeba histolyticaserological reagents.,Microbiology,Microbiology,510(K) Exempt,"Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use.A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.",Xpect Giardia/Cryptosporidium Kit,2,"September 19, 2008", 2008,"Remel, Inc",Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive,PRODUCTION CONTROLS: Process Control,"The recalling firm issued letters dated 6/19/08 flagged ""IMPORTANT PRODUCT INFORMATION"" which advised their customers of the issue with the faint grey test lines but did not request any action be taken, such as return or destruction of the affected lot numbers. The recalling firm issued a second letter flagged ""IMPORTANT MEDICAL DEVICE CUSTOMER ADVISORY NOTICE"" dated 8/11/08 and was issued via regular mail on 8/14/08. This letter asked users to review their inventory for the product lots indicated in the letter, discard all remaining units of this product lot, complete and return the Product Inventory Checklist regardless if they have affected product. A ""PRODUCT INVENTORY CHECKLIST"" was enclosed to report whether the firm had product to discard and the amount to be replaced.",Contact the recalling firm for information,3974,"3,974 kits",Worldwide Distribution --- including USA and countries of Canada and U.K.,Terminated,"January 21, 2010",489,3974,Not_Computer,N/A,N/A,N/A
Z-2433-2008,49094,"forceps, ophthalmic",HNR,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440Used during cataract and other ophthalmic surgery procedures to grasp lens capsule.",BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps,2,"September 19, 2008", 2008,Becton Dickinson and Company,Metal particulates present.,PRODUCTION CONTROLS: Manufacturing Material Removal,"BD notified customers by telephone via a script on July 7, 2008 and requested customers to examine their inventory, dispose of product, and replacement product would be provided.",Contact the recalling firm for information,260,260 units,"Nationwide Distribution --- including states of CA, IL, KY, MS, PA, and TX.",Open,N/A,N/A,260,Not_Computer,N/A,N/A,N/A
Z-1610-2008,49467,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.",GE Precision 500D,2,"September 19, 2008", 2008,GE Healthcare,GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.",Contact the recalling firm for information,2863,2863 total (2744 US / 119 OUS),"Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,",Open,N/A,N/A,2863,Not_Computer,N/A,N/A,N/A
Z-2349-2008,49087,broach,HTQ,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Rejuvenate BroachCatalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010Stryker Orthopaedics,Mahwah, NJ. 07430Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone.The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application.",Rejuvenate Broach,2,"September 19, 2008", 2008,Stryker Howmedica Osteonics Corp.,Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.,DESIGN: Device Design,"Stryker notified all branches and agencies to return the product on January 25, 2008. A formal recall letter was not written as all product was in their control.",N/A,78,78 devices,Nationwide Distribution.,Terminated,"September 22, 2008",3,78,Not_Computer,N/A,N/A,N/A
Z-2145-2008,49473,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE Precision RXi Digital remote X-Ray Imaging R&F; System, model 5117828. GE Medical Systems - Americas, Milwaukee, USAThe product is used for performing general R&F;, radiology, fluoroscopy, interventional and angiography procedures/applications.",GE Precision RXi ,2,"September 19, 2008", 2008,GE Healthcare,The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,GE Field Engineers will visit affected customers to make correction.,Contact the recalling firm for information,61,61 (32 US / 29 OUS),"Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.",Open,N/A,N/A,61,Not_Computer,N/A,N/A,N/A
Z-1690-2008,47519,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Universal Notch Preparation Guide, Size #3;Non Sterile;Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430;authorized representative in Europe:Stryker France ZAC Satolas Green Pusignan;Cedex, France.",N/A,2,"September 20, 2008", 2008,Stryker Howmedica Osteonics Corp.,Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.,DESIGN: Device Design,"Urgent Product Correction notification letters were sent via Federal Express, return receipt to all users on March 18, 2008. Questions should be directed to Rita Intorella, Divisional Regulatory Reporting at (201) 831-5825.",N/A,739,739 units in US; 1213 units internationally,Products were distributed worldwide.,Terminated,"October 25, 2010",765,739,Not_Computer,N/A,N/A,N/A
Z-2108-2008,48453,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, ""ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115"".",5 Hole Locking 1st Tarsometatarsal Plate,2,"September 20, 2008", 2008,Acumed LLC,Product sterility may be compromised.,PRODUCTION CONTROLS: Packaging Process Control,"The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, ""return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level."" The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.",N/A,3,3 pcs,"Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece.",Terminated,"February 03, 2010",501,265,Not_Computer,N/A,N/A,N/A
Z-2303-2008,48640,"reagent, schiff",HZT,Dye and chemical solution stains.,Hematology,Pathology,510(K) Exempt,"Histochemical PAS (Periodic Acid Schiff) Reaction Set'Class I, IVD;Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL'EMD Chemicals, Inc.480 S. Democrat Road,Gibbstown, NJ 08027Each kit provides reagents sufficient for a maximum of 100 tests.",Histochemical PAS (Periodic Acid Schiff) Reaction Set',3,"September 20, 2008", 2008,EMD Chemicals Inc,Two complaints that kit was not performing properly with positive controls.,PRODUCTION CONTROLS: Process Control,"Distributors were notified of the recall on June 4, 2008 by e-mail, followed by a letter. The letter dated June 4, 2008, describes the problem, instructs customers to discontinue use of the product and contact EMD Chemicals for product replacement. An Important Product Recall form was also included in each letter, asking that the form be completed and returned to EMD.Contact EMD Chemicals Technical Service Department at 1-800-222-0342.A.",N/A,29,29 kits,Nationwide.,Terminated,"September 22, 2008",2,29,Not_Computer,N/A,N/A,N/A
Z-2305-2008,48725,"pump, infusion, enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(k),Flexiflo Quantum Pump Set with Piercing Pin and Flush BagThe product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.,Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag,2,"September 20, 2008", 2008,Abbott Laboratories,"Product was incorrectly labeled as ""Top-Fill Enteral Nutrition Bag"" instead of ""Flexiflo Quantum Pump Set.""",PRODUCTION CONTROLS: Labeling Mix-Ups,"On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance.",Contact the recalling firm for information,57120,"57,120 units","Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY.",Open,N/A,N/A,57120,Not_Computer,N/A,N/A,N/A
Z-2311-2008,48737,"filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction",MPW,N/A,N/A,Physical Medicine,PMA,Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.Catalog Number: 100-25,Stryker Biotech,3,"September 20, 2008", 2008,Stryker Biotech,Product Package Insert misprint-text offset,PRODUCTION CONTROLS: Labeling Mix-Ups,"Stryker Biotech notified by letter dated June 24, 2008 via UPS Certified Mail. Physician letters were mailed 30 Jun 2008 and IRB letters were mailed July 01, 2008; letters included a correctly printed package insert.Contact Judith Sernatinger at 508-416-5200 if you have questions.",N/A,803,803 units,Nationwide,Terminated,"October 16, 2008",26,803,Not_Computer,N/A,N/A,N/A
Z-2327-2008,48963,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),Evita XL Critical Care Ventilator. Continuous (Respirator),Evita XL Continuous Ventilator,2,"September 20, 2008", 2008,"Draeger Medical, Inc.",audible power failure alarm was not enunciated at the required volume,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.,N/A,83,83 units,"The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.",Terminated,"September 01, 2009",346,83,Not_Computer,N/A,N/A,N/A
Z-2301-2008,48717,impactor,HWA,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..",Zimmer NEXGEN Tibial Broach Impactor,2,"September 20, 2008", 2008,Zimmer Inc.,"The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.",DESIGN: Device Design,"Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.",N/A,1439,1439,"Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.",Terminated,"November 12, 2009",418,1439,Not_Computer,N/A,N/A,N/A
Z-2302-2008,48722,"conformer, ophthalmic",HQN,Ophthalmic conformer.,Ophthalmic,Ophthalmic,510(K) Exempt,"Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265.The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.",Ocular Conformer,3,"September 20, 2008", 2008,"Porex Surgical, Inc.",The Ocular Conformers were distributed with an expired expiration date.,TRAINING: Employee Error,"Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance.",Contact the recalling firm for information,9,9 units,"PA, Canada and Germany",Terminated,"October 10, 2008",20,9,Not_Computer,N/A,N/A,N/A
Z-2313-2008,48740,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"The St. Jude Medical Livewire TC"" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EOThe St. Jude Medical Livewire TC"" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter.","Livewire TC"" Ablation Catheter",2,"September 20, 2008", 2008,St. Jude Medical Cardiovascular Division,"St. Jude Medical has initiated a recall of one lot of Livewire TC"" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were sent a ""St Jude Medical Urgent Product Recall"" letter addressed to ""Dear Doctor"" and a ""Doctor's Acknowledgement Form"" . The letter described the product, problem and the possibility of a health hazard. They also requested discontinue of product and gave instructions for return of product.Contact St. Jude Medical at 952-933-4700 if you have questions.",Contact the recalling firm for information,39,39,Canada and Belgium,Open,N/A,N/A,39,Not_Computer,N/A,N/A,N/A
Z-2312-2008,48738,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.",Advantage Workstation,2,"September 20, 2008", 2008,GE Healthcare,GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.,DESIGN: Software Design,"Consignees were sent a GE ""Urgent Field Safety Notice"" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409).Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.",Contact the recalling firm for information,5249,"5,249 (2,104 US/ 3,145 OUS)",AK AL ARAZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY AlgeriaArgentinaAustraliaAustriaBelgiumBosniaBrazilBulgariaByelorussian SSRCanadaChileChinaColumbiaCroatiaCyprusCzechDenmarkDominican RepublicEcuadorEgyptFinlandFranceFrench PolynesiaGeorgiaGermanyGreeceGuadeloupeGuatemalaGuyanaHondurasHungaryIndiaIndonesiaIranIrelandIsraelItalyJamaicaJapanKoreaKuwaitLebanonLibyan Arab JamahiriyaLithuaniaLuxembourgMacedoniaMalaysiaMexicoMoroccoNetherlandsNew ZealandNorwayOmanPakistanPanamaParaguayPeruPhilippinesPolandPortugalPuerto RicoPuerto RicoRomaniaRussiaSaudi ArabiaSingaporeSouth AfricaSpainSwedenSwitzerlandTaiwanThailandTrinidadTunisiaTurkeyUkraineUnited Aran EmiratesUnited KingdomUruguayVenezuelaVietnamYugoslavia,Open,N/A,N/A,5249,Not_Computer,N/A,N/A,N/A
Z-2334-2008,48753,"electrode, electrodcardiograph, multi-function",MLN,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"ZOLL OneStep Multi-Function Electrode; Adult CompletePart #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.",Zoll MultiFunction Electrode,2,"September 20, 2008", 2008,"Bio-Detek, Inc.",Multi-function electrode programmed as a Pediatric instead of Adult,PRODUCTION CONTROLS: Process Control,"Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided.Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.",N/A,25,25 cases of 8/cs for each lot # ; Total of 400 units,MA,Open,N/A,N/A,25,Not_Computer,N/A,N/A,N/A
Z-2323-2008,48752,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,PMA,"Medtronic Patient programmer, model 37742. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to tun therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.","Medtronic Patient programmer,",3,"September 20, 2008", 2008,Medtronic Neuromodulation,Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.,PRODUCTION CONTROLS: Process Control,"A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation.If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.",N/A,2,2,"GA, MO, NC, TXno OUS distribution",Terminated,"November 21, 2008",62,2,Computer,N/A,N/A,N/A
Z-2314-2008,48744,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads ""TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA""",Medical Integrated Multiparameter: Temperature Probe Adaptor,2,"September 20, 2008", 2008,"Spacelabs Healthcare, Incorporated",Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Starting July 3, 2008 the firm issued a ""MEDICAL DEVICE CORRECTION"" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter that is being recalled. Technical Support will be available for customer questions and technical questions and to ensure each unit is upgraded.Contact Spacelabs Healthcare at 425-657-7200 ext 5970 if you have questions.",N/A,3733,"3,733",Nationwide and Worldwide to medical facilities.,Open,N/A,N/A,3733,I/O,Device Operation,replace adaptor,Remove or Replace
Z-2315-2008,48747,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking S, Viking M, Viking L Patient Lifts",Liko Universal Patient lift,2,"September 20, 2008", 2008,Liko AB,"A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall.",DESIGN: Component Design/Selection,"Liko North America ,the US Distributor, notified accounts by letter dated June 30, 2008 and provided a Field Safety Notice with Safety Inspection Procedures to performed on the lift prior to use. Replacement slingbars are being provided.If you have questions, contact the Liko product distributor in your country. Contact information can be found at www.liko.com/int/distributors.asp.",N/A,N/A,N/A,Nationwide,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-2321-2008,48749,"gauze/sponge, internal, x-ray detectable",GDY,Nonabsorbable gauze for internal use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8"" x 4"", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF",Medline RF Detect Sterile XRay Detectable USP Type VII Gauze,2,"September 20, 2008", 2008,Medline Industries Inc,There is the potential for the RF ID tag to separate from the retaining pouch.,DESIGN: Device Design,"Initially a recall letter dated 6/13/08 was sent to the direct accounts identifying 5 lots of affected lots with two reorder numbers involved, explaining that there was a lack of integrity of the retaining pouch material for the RFID gauze, and that there was a potential for the RFID tag to separate from the retaining pouch during use. It was subsequently discovered that there was only one reorder number affected by the problem and that an additional lot had been gamma sterilized. Therefore a second letter dated 6/19/08, listing the correct reorder number and the six affected lots, was sent via FedEx overnight on the same date. The accounts were requested to remove RFID gauzes with the listed lot numbers from all stock rooms, materials storage, and OR's, and return it to Medline for replacement. The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the amount and lot numbers of the gauzes being returned. Any questions were directed to 866-359-1704, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.If you have questions about this recall, contact Kathy Dunne at 847-970-4678 or at kdunne@medline.com.",N/A,295,295 cases,"California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington",Terminated,"January 09, 2009",111,295,Not_Computer,N/A,N/A,N/A
Z-2324-2008,48958,"bag, reservoir",BTC,Reservoir bag.,Anesthesiology,Anesthesiology,510(K) Exempt,"Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.",Ventlabassembled Anesthesia breathing bags,2,"September 20, 2008", 2008,Ventlab Corporation,"During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.",N/A,"Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility.Contact James Cochie at 336-753-5000 if you have questions.",Contact the recalling firm for information,1071,"571, 500 units",IL,Terminated,"October 15, 2008",25,571500,Not_Computer,N/A,N/A,N/A
Z-2328-2008,48964,"device, dermal replacement",MDD,N/A,N/A,General & Plastic Surgery,N/A,"Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile;Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA",N/A,3,"September 20, 2008", 2008,Integra LifeSciences Corp,"Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008.Contact Integra at 609-799-3297 if you have questions.",N/A,10,10 units,"Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.",Terminated,"September 22, 2008",2,10,Not_Computer,N/A,N/A,N/A
Z-2464-2008,48967,N/A,N/A,N/A,N/A,N/A,N/A,"Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8",Nebion HLX8 magnetic resonance,1,"September 20, 2008", 2008,"Nebion, LLC","Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the FDA.",PREMARKET APPROVAL: No Marketing Application,"Nebion LLC contacted each holder of a device by telephone on July 2, 2008, and then mailed the recall letter titled URGENT MEDICAL DEVICE RECALL FOR NEBION HLX-8 by with attached recall response form. The customers were requested to completed the questionnaire (recall response form) and mail or fax it back to the company.The Letter instructed customers to stop using the device immediately and contact Nebion to have the device picked up at Nebion's expense by UPS. They were also instructed to report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax (information given regarding the FDA's MedWatch program).If you have questions, contact David LaPoint at 714-614-3141.",N/A,8,8,"Nationwide to CA, FL, HI, and RI.",Open,N/A,N/A,8,Not_Computer,N/A,N/A,N/A
Z-2330-2008,48969,"indicator, physical/chemical sterilization process",JOJ,Sterilization process indicator.,General Hospital,General Hospital,510(k),"Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101",GasChex sterilization indicators,2,"September 20, 2008", 2008,Propper Mfg Co Inc,The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.,PRODUCTION CONTROLS: Equipment Maintenance,"On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).",N/A,1757,1757 cases (7030 boxes),Nationwide and Puerto Rico,Open,N/A,N/A,1757,Not_Computer,N/A,N/A,N/A
Z-2335-2008,48971,"patient examination glove, specialty",LZC,Patient examination glove.,General Hospital,General Hospital,510(k),"Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.",Radiation Reduction Gloves,2,"September 20, 2008", 2008,Integra Pain Management,"Radiation reduction gloves were labeled as ""Latex-free"", but contain natural rubber latex.",PRODUCTION CONTROLS: Labeling Mix-Ups,"On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210.",N/A,140,140 boxes,"AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.",Terminated,"October 29, 2008",39,140,Not_Computer,N/A,N/A,N/A
Z-2434-2008,49102,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560)Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.",BHM Kwiktrak Gate System,2,"September 20, 2008", 2008,"Arjo, Inc.","There is a possibility that the Kwiktrak Gate System could malfunction, resulting in the gate locks opening even though the corresponding tracks are not properly aligned.",DESIGN: Device Design,"Arjo Inc. USA sent Urgent Field Safety Notice letters dated 8/1/08 to the direct accounts on 8/1/08, informing them that there is a remote possibility that the gate system could malfunction. The result of this malfunction is that the gate locks could open even though the corresponding tracks are not properly aligned. This could result in the lift/cassette falling off the track system, possibly resulting in serious personal injuries and or property damage. The letters requested the customer to immediately implement special operating instructions in their facility to ensure great care is used when the gate system is operated. All personnel must be made aware that the tracks need to be properly aligned before using the gate. Illustrations of an unaligned gate system with an open lock and properly aligned tracks and gate system with open locks were included. Any questions the customers may have were directed to the Arjo Quality Department at 1-800-323-1245, ext. 6125. The accounts were informed that Arjo personnel will contact them in September 2008 to install a permanent add-on improvement to prevent the occurrence of a malfunction. The accounts were requested complete the enclosed response form indicating that they have read and understood the 8/1/08 letter, and fax it back to Arjo at 888-594-2756.",N/A,230,230 units,"Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, New York, North Carolina, Ohio, Oklahoma, Texas, and Wisconsin.",Terminated,"January 05, 2010",472,230,Not_Computer,N/A,N/A,N/A
Z-2340-2008,49104,"agent, absorbable hemostatic, collagen based",LMF,Absorbable hemostatic agent and dressing.,General & Plastic Surgery,General & Plastic Surgery,N/A,"FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.",FloSeal Endoscopic Applicator,2,"September 20, 2008", 2008,Baxter Bioscience,The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator.,N/A,"An Urgent Product Recall Letter dated August 4, 2008, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (addressed to """"Risk Manager"" & ""Surgery""). The recall letter informed the consignees of the reason for the recall and requested their customers:1. Examine your inventory to determine the presence of product.2. Immediately stop dispensing and distributing this product.3. Quarantine the product affected by this recall immediately.4. Contact any customers who may have received the recalled shipment.5. Carry out a physical count and record the count on the Business Reply Form.6. Complete and Fax the enclosed Business Reply Form to 888-871-7109.7. Return all units of the recalled product and accompanying packing slip using the prepaid UPS Return shipping label to:Stericycle, Inc.2670 Executive Dr.Suite AIndianapolis,IN 46241The US recall notification letters were sent via commercial carrier (UPS Next Day Service & US Postal Service Next Day Air Saver). International recall notification will utilize local contacts in each region and countries. The notifications were handled by Baxter regional representative and coordinated to be initiated in the same time.If you have questions, contact Stericycle, Inc. at 1-800-668-4391.",N/A,10751,"10,751 units worldwide (2,742 units in US)","Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.",Open,N/A,N/A,10751,Not_Computer,N/A,N/A,N/A
Z-2457-2008,49142,"c-reactive protein, antigen, antiserum, and control",DCK,C-reactive protein immunological test system.,Immunology,Immunology,510(k),"Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.",Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette,3,"September 20, 2008", 2008,Cholestech Corp,"Test results are high, outside of control material upper limit specification. Results could be as high as 15%.",DESIGN: Device Design,"Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.",N/A,912,"2, 910 cassettes","Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.",Terminated,"September 30, 2009",375,2910,Not_Computer,N/A,N/A,N/A
Z-2461-2008,49376,"prosthesis, penis, inflatable",JCW,Penile inflatable implant.,Gastroenterology/Urology,Gastroenterology/Urology,PMA,"AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20.",Penile Prosthesis,2,"September 20, 2008", 2008,American Medical Systems,The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump.,TRAINING: Employee Error,"On July 17, 2008, the physician who implanted the device received a phone call from AMS to discuss the event and be sure he understands what went wrong (Ultrex cylinders implanted instead of CX) and any new risks introduced to his patient so he can properly assess any impact it may have. A follow up letter "" AMS Important Product Recall"" dated July 21, 2008 was also sent to document the event and the call. The letter requested to return of the ""Recall Acknowledgement Form"".The second physician (tried not used) has already returned the device and will not receive further communication. A complaint was assigned to document the event.",Contact the recalling firm for information,5,5 units,LA,Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-2436-2008,49105,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.",GE Innova 2100IQ Fluroscopic xray system,2,"September 20, 2008", 2008,GE Healthcare,The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.,DESIGN: Device Design,"Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a ""GE Urgent Medical Device Correction"" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.",N/A,229,229,"Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.",Open,N/A,N/A,1573,Not_Computer,N/A,N/A,N/A
Z-2445-2008,49122,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.",Universal Optical Tracker Fixation,2,"September 20, 2008", 2008,Zimmer Inc.,"Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.",DESIGN: Device Design,Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.,N/A,39,39,"Nationwide Distribution including states of California, Florida and Washington.",Terminated,"March 11, 2009",172,39,Not_Computer,N/A,N/A,N/A
Z-2440-2008,49110,"apparatus, suction, ward use, portable, ac-powered",JCX,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.",500 mL InfoV.A.C. Canister,2,"September 20, 2008", 2008,"KCI USA, Inc.",The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.,PRODUCTION CONTROLS: Equipment Maintenance,"Urgent - Medical Device Recall letters were sent within the US on 07/29/08 via UPS next day delivery service and a return receipt was maintained to demonstrate delivery of the recall to all consignees. Additionally, firm is sending representatives into accounts which received more than three sales units of canisters and to all foreign consignee locations to facilitate quarantine and replacement of affected stock. Consignees asked to confirm that adequate flow is being delivered and that the dressing is being drawn down for those patients currently using the InfoV.A.C. Canisters. Also, consignees are to locate and quarantine all packaged 500 ml canisters without the green inspection stickers from within the affected lot numbers in their inventory. A KCI Rep will contact them to help facilitate this process. Consignees are to complete and return the Recall Acknowledgement and Inventory Accounting Form. KCI will replace any affected product at their facility and arrange for the return of any affected product.",N/A,79275,"79,275 canisters.","Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.",Terminated,"July 13, 2009",296,229400,Not_Computer,N/A,N/A,N/A
Z-2446-2008,49129,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.",Platelet Concentrator ,2,"September 20, 2008", 2008,Smith & Nephew Inc,Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.,OTHER/UNDETERMINED: Pending,"Prior to the dissemination of the official notices, the firm notified personnel at our field offices of the BD syringe recall and advised that a subsequent recall of our Caption devices would follow. High volume users were contacted via phone on July 30th and the 31st and personnel at all affected field offices were notified via email on July 30, 2008 with an Urgent Medical Device Recall Letter. The firm requedsted that usere immediately cease distribution, examin the stock on hand and the stock of the accounts that have been suppplied and remove any affected ecices from all inventory. A verification notification was included with letter.",N/A,364,364 units,Nationwide Distribution,Terminated,"May 28, 2010",615,932,Not_Computer,N/A,N/A,N/A
Z-1709-2008,49483,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.",Mobile Fluoroscopy System,2,"September 20, 2008", 2008,"OEC Medical Systems, Inc","Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE",PRODUCTION CONTROLS: Equipment Maintenance,Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.,N/A,660,660 units,"Nationwide Distribution including states of CA, FL, MS, and TX.",Terminated,"January 20, 2009",122,660,Not_Computer,N/A,N/A,N/A
Z-2304-2008,48724,artificial heart,LOZ,N/A,N/A,Cardiovascular,PMA,Abiomed : Abiocor Implantable Heart Replacement Kit SystemCatalog Number:: 0034-8401-HDThe product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.,Abiocor,2,"September 20, 2008", 2008,"Abiomed, Inc.",Subassembly incorrectly aligned,PRODUCTION CONTROLS: Process Control,Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.,N/A,1,1 unit,NJ,Terminated,"October 08, 2008",18,1,Not_Computer,N/A,N/A,N/A
Z-1816-2008,48102,"stent, superficial femoral artery",NIP,N/A,N/A,Cardiovascular,N/A,"ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.",IntraCoil,3,"September 21, 2008", 2008,"Ev3, Inc",An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.,PRODUCTION CONTROLS: Labeling Mix-Ups,ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.,N/A,1,1,CA,Terminated,"May 27, 2009",248,1,Not_Computer,N/A,N/A,N/A
Z-2385-2008,48186,"electrode, ion specific, sodium",JGS,Sodium test system.,Clinical Chemistry,Clinical Chemistry,510(k),SYNCHRON LXi 725 System,SYNCHRON LXi 725 System,2,"September 21, 2008", 2008,Beckman Coulter Inc,The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced.If you have questions, contact Customer Technical Support at 1-800-854-3633.",N/A,694,694 Worldwide; 656 in US & 38 in Canada total for all products,"Nationwide, and in Canada",Open,N/A,N/A,694,Not_Computer,N/A,N/A,N/A
Z-2358-2008,48961,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.",Digital Fluoroscopic Imaging System,2,"September 21, 2008", 2008,GE Healthcare,"GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems.The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab",TRAINING: Employee Error,"The consignees were sent a ""GE Urgent Medical Device Correction"" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.",N/A,252,252,"USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WIOUS:ALGERIAAUSTRALIAAUSTRIABELARUSBELGIUMBRASILCANADACHILECHINACHINACOLUMBIACZECH REPUBLICDENMARKDV EGYPTFINLANDFRANCEGEORGIAGERMANYGREECEGUATAMALAHONG KONGHUNGARYINDIAINDONESIAIRANIRAQIRELANDISRAELITALYJAPANKOREAKUWAITLATVIALEBANONMACEDONIAMALAYSIAMEXICOMOROCCONETHERLANDSNEW ZEALANDNORWAYPAKISTANPANAMAPOLANDPORTUGALPUERTO RICORUSSIASAUDI ARABIASINGAPORESLOVAKIASPAINSUDANSWEDENSWITZERLANDSYRIATAIWANTUNISIATURKEYUNITED ARAB EMIRATESUNITED KINGDOM andVENEZUELA",Open,N/A,N/A,1065,Not_Computer,N/A,N/A,N/A
Z-2392-2008,49027,"catheter, urethral",GBM,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Apogee Intermittent Catheter, 10 Fr 15"", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.",Urological catheter,2,"September 21, 2008", 2008,"Apogee Medical, Inc",Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.,PRODUCTION CONTROLS: Packaging Process Control,"Distributors and Retailers that have received any of the Catalog Numbers listed in the letter titled URGENT MEDICAL DEVICE RECALL were notified on/about July 17, 2008. Recipients of the letter are being requested to review their inventory and return any of the applicable Catalog Items from the specific lot numbers listed in the recall letter. Distributors are being instructed to notify their customers and inform them of the recall with a copy of the recall letter. Their notification should instruct their customers to return the recalled product to them so that they could return the product to Apogee Medical LLC. In addition to the initial letter, follow-up letters, telephone calls and emails will be utilized to assess the effectiveness of the recall. A spreadsheet has been set up and will be maintained in order to easily identify the customers that have been contacted, those who have responded and those who have returned product.If you have questions, contact Diane Peper at 919-435-5409.",N/A,5940,5940 pcs,U.S. Nationwide and Canada,Terminated,"June 04, 2009",256,24300,Not_Computer,N/A,N/A,N/A
Z-2306-2008,48726,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22"" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.",Corflo AntiI.V. NG Tube,3,"September 21, 2008", 2008,Cardinal Health,The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Cardinal Health notified the accounts who ordered the affected feeding tubes via letter dated 6/25/08, informing them that the feeding tube may have the wrong male Luer adapter component, which can cause leakage around the tube outside of the body. Upon review of the letter, the accounts were requested to inspect their inventory and immediately destroy any affected product found and to telephone Cardinal Health/VIASYS MedSystems Technical Service at 1-800-323-6305 for arrange for credit. Dealers were requested to notify their customers. Any questions were directed to Cardinal Health/VIASYS MedSystems at 800-403-3400, ext. 3473. The accounts were also requested to complete and fax back the enclosed acknowledgement form indicating if they have any remaining inventory of the recalled scissors or not.",N/A,807,807 tubes,"California, Illinois, Kentucky and Missouri",Terminated,"September 26, 2008",5,807,Not_Computer,N/A,N/A,N/A
Z-2388-2008,48748,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.,Lifepak Defribrillator/Monitor,2,"September 21, 2008", 2008,"Physio Control, Inc.",Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 06/18/08 the firm, via regular postal service , mailed an ""IMPORTANT MEDICAL DEVICE NOTIFICATION"" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule.If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.",N/A,45209,"45,209 devices","There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.",Open,N/A,N/A,45209,Battery,Alarm/Message,Replace,Remove or Replace
Z-2368-2008,49002,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.",Coronary Control Syringe,2,"September 21, 2008", 2008,"Merit Medical Systems, Inc.",Control Syringes may be non-sterile due to holes in the packaging.,PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters dated 07/09/08, were faxed on 07/09/2008 to consignees/sales reps. The letter instructed consignees/sales reps to contact their customers by phone or visit to provide recall information and instructions. Customers were told to immediately discontinue use and to quarantine all affected products. A Product Retrieval Form was provided that was to be signed by the site representative. Contact Merit Medical at 1-801-208-4408 for assistance.",N/A,100,100 units,"CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.",Terminated,"November 03, 2008",43,1298,Not_Computer,N/A,N/A,N/A
Z-2365-2008,49001,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.",Boston Scientific Platinum Plus Guidewire,2,"September 21, 2008", 2008,Boston Scientific Corporation,"Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of the PTFE coating to detach from the wi",N/A,"An urgent Voluntary medical Device Recall or Correction - Immediate Action Required letter was sent to all affected customers. The letter describes the issue and clinical effects. A list of affected devices is attached to the letter. The customer is to cease use or distribution of affected product, and return it immediately to Boston Scientific. Return directions are provided in an attached document. A Reply Verification Tracking Form is to be completed and faxed back to Customer Service. If any product is being returned the completed form is to accompany the returned product. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.",Contact the recalling firm for information,22397,"22,397 single units total (18,261 US, 4,136 OUS)","AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates",Open,N/A,N/A,22397,Not_Computer,N/A,N/A,N/A
Z-2389-2008,48758,full-montage standard electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(k),NicoletOne photic adapter cable 085-463700,Bravo Multimodality system,2,"September 21, 2008", 2008,Cardinal Health NeuroCare Division,"Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A ""Cardinal Health Urgent: Medical Device Correction"" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card.If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email shane.sawall@cardinalhealth.com.",Contact the recalling firm for information,92,92,CAFLGAIDINLAMDMEMIMONCNYPATNTXWAWIChinaDenmarkIndonesiaJapanKoreaMexicoNetherlandsRussiaSaudi ArabiaSlovenia,Terminated,"October 13, 2010",752,92,Hardware,Treatment/Delivery/Therapy,Replace,Remove or Replace
Z-2395-2008,49039,"motor, surgical instrument, ac-powered",GEY,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.,Synthes Power Drive.,2,"September 21, 2008", 2008,Synthes U S A,"The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization parameter is a minium of 24 minutes prevacuum.",PRODUCTION CONTROLS: Error in Labeling,"All Synthes Trauma customers and sales consultant s were notified of the correction via return receipt letters sent via UPS. This notification communication contains product literature documenting the validated sterilization parameters. Instructions detail disposal of the previously received literature and replacement with the provided literature. A toll free number with a dedicated extension has been established for questions. The firm has requested that all recipients acknowledge understanding of instructions by returning a Verification Section via fax or email.If you have questions, call 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.",N/A,584,584 units,The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.,Terminated,"May 05, 2009",226,584,Not_Computer,N/A,N/A,N/A
Z-2352-2008,48613,"system, dialysate delivery, single patient",FKP,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.","HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Product 811909",2,"September 21, 2008", 2008,Hach Co,Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm initiated phone calls on 5/22/08 and explained the reason for recall and requested the product be quarantined. The customer was informed they would receive a recall letter providing instructions for return, replacement, or credit. During the phone call, some of the customers asked if they should recall to the end user level and they were told to do so, but this instruction was not verbally given to everyone. The recalling firm issued a letter dated 5/23/08 via overnight mail which explained the reason for recall and requested return of the product. The letter requests the customer to notify the end users. A Return Form was enclosed to report the amount of product being returned. The firm telephoned all nonresponders on 7/1-2/08 to assure they received the recall notification.On 7/21/08, the firm issued two different letters flagged as ""Expanded Recall Notification"" dated 7/21/08. One of the letters covered Product/Part numbers 811909, 812144, and 821972, which were all HACH brands. The other letter covered Product/Part number 812004, which was a private brand. Reason for recall expansion was explained and return of product was requested. If the product was further distributed, subrecall was requested to the end user level. A ""Return Form"" was enclosed to be completed to indicate the amount of product being returned.Some customers who tried to order product #811909 received a letter dated 7/28/08 informing them they could use their Total Chlorine DPD Test Kit, product #811902, as an alternative method for testing. For assistance, contact Hach Customer Service at 1-800-548-4381, ext. 3563.",Contact the recalling firm for information,80110,"80,110 bottles",Nationwide and Foreign distribution to Canada and Denmark.,Open,N/A,N/A,163090,Not_Computer,N/A,N/A,N/A
Z-2458-2008,48195,"camera, surgical and accessories",KQM,Surgical camera and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500",ConMed Linvatec Surgical Video Cart,2,"September 21, 2008", 2008,Conmed Linvatec Endoscopy Division,The recall was initiated because ConMed Linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the VP8500 Video Cart. The potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.,DESIGN: Device Design,"The recall was initiated by the firm sending the recall information packet via UPS overnight delivery to the Distribution and Sales Force in May 2008. The packet included:1. Recall Notification and reply form for each consignee.2. Instructions on the procedure to conduct the recall of the VP8500.3. A list of affected consignees in their territory.The Recall Notification informed the customers of the potential for the wheel caster(s) to fall out of the base of the cart which may result in a potential tip hazard. The customers were instructed to discontinue the use of the VP8500 Video Cart immediately if the wheel caster(s) show any signs of being loose and to complete the recall reply form.Upon receipt of notification, distributors are supposed to :1. Visit the affected accounts and provide them with a copy of the Recall Notification to inform them of the recall and the Recall Acknowledgment Reply Form which is to be mailed or faxed back to the firm.2. Schedule the delivery and installation of refurbished carts to replace the recalled cart(s) by contacting Jill Cover, ConMed Linvatec Endoscopy Division at (888) 292-0100, ext. 8157 or e-mail jcover@livatec.com to arrange for replacement.3. Move medical devices, etc. from the recalled cart(s) and set up the refurbished cart(s) with the required equipment at the account's location. (ProMEDICA will arrange for shipping of the recalled cart(s) back to ProMEDICA.).",N/A,45,45 Units Worlwide (42 in US),"Worldwide Distribution including states of: AK, AZ, CA, FL, GA, IL, IN, KS, MD, NC, NY, OH, and PA and country of Canada.",Terminated,"September 22, 2008",1,45,Not_Computer,N/A,N/A,N/A
Z-2452-2008,49139,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),SOMATOM Emotion 6. Computed tomography X-ray system,SOMATOM Emotion 6,2,"September 21, 2008", 2008,"Siemens Medical Solutions USA, Inc",Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.,Contact the recalling firm for information,53,53 units,"Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI.",Terminated,"November 07, 2008",47,53,Hardware,Physical Safety Hazards,Replace component,Remove or Replace
Z-2454-2008,49140,"stylet, tracheal tube",BSR,Tracheal tube stylet.,Anesthesiology,Anesthesiology,510(K) Exempt,"Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.",Orotracheal Lighted Stylet,2,"September 21, 2008", 2008,Vital Signs Colorado Inc.,Light protector may detach from lighted stylet during intubation.,DESIGN: Device Design,"Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.",No consumer action necessary,55560,"55,560 pieces","Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.",Open,N/A,N/A,56754,Not_Computer,N/A,N/A,N/A
Z-2451-2008,49132,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field.,DYONICS 25 Fluid Management System,2,"September 21, 2008", 2008,"Smith & Nephew, Inc. Endoscopy Division",Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008.Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397.",N/A,4044,"4,044 units","Worldwide Distribution including USA and countries of Canada, Chile, Colombia, Greece, France, Australia, Netherlands, South Africa, United Kingdom, Japan, Dubai, Germany, India, Malaysia, Switzerland, Belgium, Italy, and Puerto Rico.",Open,N/A,N/A,22239,Not_Computer,N/A,N/A,N/A
Z-2329-2008,35369,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.",SoftPath GUI Release Software Versions 3.17 and 4.1,2,"September 22, 2008", 2008,SCC Soft Computer,"Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading ""J"" was removed and the diagnosis appeared under the specimen heading ""I"" as a result the specimen with the heading ""I"" had two diagnosis.",DESIGN: Software Design,"Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.",N/A,335,335,Worldwide Distribution including USA and the country of Canada.,Terminated,"November 20, 2008",59,335,Software,Output/Calculation,Software update,Software Update
Z-2463-2008,35372,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.","SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.",2,"September 22, 2008", 2008,SCC Soft Computer,"In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.",DESIGN: Software Design,Consignees were notified of recall and provided with a software correction patch ICC number 3618.,N/A,201,201,Distributed to 106 consignees located throughout the United States and Canada.,Terminated,"November 20, 2008",59,201,Software,Output/Calculation,Software update,Software Update
Z-2007-2008,48131,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.",6.5 Cancellous Bone Screw 25 mm,2,"September 22, 2008", 2008,Stryker Howmedica Osteonics Corp.,The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.,PRODUCTION CONTROLS: Labeling Mix-Ups,"The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.",N/A,29,29 units,nationwide,Terminated,"September 23, 2008",1,29,Not_Computer,N/A,N/A,N/A
Z-1896-2008,48639,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001",Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump,2,"September 22, 2008", 2008,Curlin Medical Llc,Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.,OTHER/UNDETERMINED: Pending,"On May 30, 2008, Curlin Medical began distribution of a ""Voluntary Field Correction Advisory Notice"" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the ""caution"" statement related to dropped pumps to a ""warning"" statement, and (3) A warning label to be located on the pump: ""Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use"".A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.",N/A,39366,"39,366 units for all affected products/models total","Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.",Terminated,"June 11, 2009",262,39366,Not_Computer,N/A,N/A,N/A
Z-2404-2008,49068,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"GE Voluson¶_ E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01.Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).",GE Voluson E8 Ultrasound System ,2,"September 22, 2008", 2008,GE Healthcare,Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson¶_ E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.,DESIGN: Software Design,"Consignees were sent a GE ""Urgent Medical device Correction"" letter dated April 1, 22008. The letter was addressed to Healthcare Administrator/Risk Manger; Chief of Intensive Care and Director of Clinical Engineering. The letter described the safety issue; affected product details; safety instructions stating that use of the system may be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge; and contact information.",N/A,1637,1637,"Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV,NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT,WA, WI, WV, WY, and PUERTO RICO, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PARAGUAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.",Open,N/A,N/A,1637,Software,Output/Calculation,Software update,Software Update
Z-2427-2008,49082,"antigens, all groups, streptococcus spp.",GTY,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).","Mainline Confirms Strep A,",2,"September 22, 2008", 2008,"Mainline Technology, Inc.",Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were notified by phone and follow-up letter on or about 11/6/06 advising them of the problem. Consignees were give the option of returning the product and receiving the correct tip, or keeping the product and adding extra drops. Additional written notice was provide to each consignee.",N/A,11520,"11,520",Nationwide Distribution.,Terminated,"March 16, 2009",175,11520,Not_Computer,N/A,N/A,N/A
Z-1605-2008,47482,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Deltec¶_ Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.Reorder number 21-5311-01The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.",Deltec Micro 3100 Large Volume Infusion Pump or Graseby or 3M 3100 Large Volume Infusion Pump,2,"September 23, 2008", 2008,"Smiths Medical MD, Inc.","The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.",PRODUCTION CONTROLS: Process Control,"A Smiths Medical ""Urgent Medical Device Correction"" letter dated 2/5/08 was sent to consignees on 2/27/08. The letter was addressed to Risk/Safety Managers, Clinicians, Nursing Staff and other users of the above products. The letter also included Details on affected devices, Description of the problem , Advice on action to be taken by the user, Warning and requested the return the confirmation form. Contact Smiths Medical at 1-800-426-2448 for assistance.Please note: The 3M was the original brand for the large volume infusion pump models 3000 and 3100 marketed in the USA from 1994 through 1997. The Graseby large volume infusion pump models 3000 and 3100 were marketed from 1997 through 1999. Since 1999, the current marketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the event these brands of infusion pumps are still in use.",N/A,2303,2303 (total),"AL, AR, AZ, CA, CO, CT, DC, FL. GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, ,MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK OR,PA, RI,SC, TN, TX, UT,VA, VT, WA, WI, WV, and WY",Open,N/A,N/A,2303,Not_Computer,N/A,N/A,N/A
Z-1612-2008,46902,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48",Eclipse TPS,2,"September 23, 2008", 2008,Varian Medical Systems Oncology Systems,A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.,DESIGN: Software Design,"An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.",N/A,90,90 units,"Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).",Open,N/A,N/A,90,Software,Output/Calculation,Software update,Software Update
Z-1472-2008,46904,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215)Used with:Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.",Varta EasyPack XL Lithium Polymer Battery (PoLiFlex) ,2,"September 23, 2008", 2008,Nova Biomedical Corporation,Lithium batteries may fail if the glucose or creatinine meters have been dropped.,DESIGN: Component Design/Selection,"Nova Biomedical notified consignees by telephone and followed by the Recall Notification letter for the Vata Easy Pack XL Lithium Polymer Battery, dated 2/2108 and mailed 2/26/08. Users are notified of the problem with the battery in the Nova Stat Strip Blood Glucose Hospital Meter System and is replacing batteries by on site visit.E-Z-EM , Inc. notified their customers by letter dated 3/17/08. Contact Nova Biomedical Corporation at 1-800-545-6682 for assistance.",N/A,4432,4432 batteries,"Worldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.",Terminated,"October 28, 2008",35,4432,Not_Computer,N/A,N/A,N/A
Z-1693-2008,47759,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538",iLab Ultrasound Imaging System,2,"September 23, 2008", 2008,Boston Scientific Corporation,"Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.",PRODUCTION CONTROLS: Process Control,"On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.",N/A,120,120 units,"Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.",Terminated,"April 06, 2009",195,120,Hardware,Device Operation,Correction,Repair
Z-2339-2008,48662,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),Sunrise Medical Quickie Groove Power Wheelchair with Transit optionThe product is a powered wheelchair for human use.,Quickie Groove Power Wheelchair ,2,"September 23, 2008", 2008,Sunrise Medical Inc,"Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.",DESIGN: Device Design,"Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.",N/A,36,36 units,"Worldwide: US, Canada, New Zealand and Australia.",Terminated,"December 22, 2009",455,36,Not_Computer,N/A,N/A,N/A
Z-2331-2008,48970,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.Used to train obstructed biliary ducts.",CottonLeung Biliary Stent,2,"September 23, 2008", 2008,Cook Endoscopy,"The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.",PRODUCTION CONTROLS: Process Control,Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.,N/A,20,20 units,"Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.",Terminated,"June 04, 2009",254,20,Not_Computer,N/A,N/A,N/A
Z-2338-2008,48979,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.",Fabius Trio Gas machine,2,"September 23, 2008", 2008,"Draeger Medical, Inc.",The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.,PRODUCTION CONTROLS: Process Control,"The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.",N/A,111,111 units,Nationwide,Terminated,"March 08, 2010",531,111,Not_Computer,N/A,N/A,N/A
Z-2406-2008,49075,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"ACIST"" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico.Catalogue No: 800608-013Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.",AT P54 AngioTouch Kit ,2,"September 23, 2008", 2008,Acist Medical Systems,"Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.",DESIGN: Packaging Design/Selection,"Consignees were sent a ""Urgent: Medical Device Recall"" letter dated July 9. 2008. The letter addressed to ""Manager"" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.",N/A,33980,"11,750 (USA), 22,230 (OUS)","Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.",Open,N/A,N/A,33980,Not_Computer,N/A,N/A,N/A
Z-2408-2008,49078,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.",Adult Metriset w/Cassette,2,"September 23, 2008", 2008,"B. Braun Medical, Inc.",incorrect burette was packaged with the product,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.",Contact the recalling firm for information,280,280 units,Nationwide.,Terminated,"May 05, 2009",224,29180,Not_Computer,N/A,N/A,N/A
Z-2459-2008,49350,full-montage standard electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(k),NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.,NicoletOne 5.30.2 Software ,2,"September 23, 2008", 2008,Cardinal Health NeuroCare Division,NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.,DESIGN: Software Design,"Consignees were sent a ""Cardinal Health Urgent: Medical Device Correction"" letter dated June 23, 2008. The letter identified the product and problem. It also provided instructions (Field Correction) to install the software patch and requested return of the verification form. Contact Cardinal Health NeuroCare Division at 1-608-271-3333 for assistance.",Contact the recalling firm for information,274,274,"US: AL, AR, CA, CO, FL, GA, IL IN, KY, LA, MO MS, NC, NJ, NY, OH, PA, TN, TX, WA, and WI.OUS: CH, CN, DK, GB, HK, IN, NO, RU, and UK.",Open,N/A,N/A,274,Software,Device Operation,Software update,Software Update
Z-2460-2008,49359,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).,Cholestech GDX A1C Test Cartridge,2,"September 23, 2008", 2008,Cholestech Corp,Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.",N/A,9324,"9,324 Cartridges","U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico",Terminated,"October 07, 2009",379,9324,Not_Computer,N/A,N/A,N/A
Z-2441-2008,49113,"lens, guide, intraocular",KYB,Intraocular lens guide.,Ophthalmic,Ophthalmic,510(K) Exempt,"MONARCH¶_ II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof¶_ IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.",MONARCH II,2,"September 23, 2008", 2008,"Alcon Laboratories, Inc",Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,The recalling firm notified healthcare professional consignees and affiliated foreign distributors by letter on 07/07/08 and advised of the mislabeled device and potential hazard associated with delivery of the IOL. Consignees were instructed to return identified lots in their inventory and to return the enclosed business reply card for product replacement. Contact Stericycle Inc at 1-800-668-4391 for assistance with returning the recalled product. Contact Alcon Customer Service at 1-800-862-5266 for questions about the recall.,Contact the recalling firm for information,7962,7962 units,"Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.",Terminated,"August 26, 2009",337,7962,Not_Computer,N/A,N/A,N/A
Z-2444-2008,49121,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.",Quicklock Tracker,2,"September 23, 2008", 2008,Zimmer Inc.,"The three-point array may break during use, resulting in surgical delay and an increased risk of infection.",DESIGN: Device Design,Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.,N/A,239,239,Nationwide,Terminated,"March 11, 2009",169,239,Not_Computer,N/A,N/A,N/A
Z-2443-2008,49117,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.",SERVOs Ventilator System,2,"September 23, 2008", 2008,MAQUET Inc.,Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.,TRAINING: Employee Error,"Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.",N/A,122,122 total (SERVO-i and SERVO-s) in US.,Worldwide.,Terminated,"December 23, 2008",91,122,Not_Computer,N/A,N/A,N/A
Z-2462-2008,49390,"sterilant, medical devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(k),Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.,Quick Connect ,2,"September 23, 2008", 2008,Steris Corp,"During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen.",DESIGN: Device Design,"A Steris Field Service Representative will make arrangements to visit each facility to modify the affected Quick Connects. Until that time customers may use the work around instructions for use in the notification letter dated August 4, 2008. Contact Steris Corporation at 1-800-548-4873 or 1-440-392-7455 for assistance.",N/A,4121,QPC1713 Quick Connects - 116 units & QPC1724 Quick Connects - 568 units,"AK, AL, AR, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WI, WV and WY. OUS: Canada, Australia, Italy, Spain, and Thailand.",Open,N/A,N/A,684,Not_Computer,N/A,N/A,N/A
Z-1829-2008,48080,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.",GE DatexOhmeda Engstrom Carestation,2,"September 24, 2008", 2008,GE Healthcare,"There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation. This issue affects all of the Engstr¶_m Carestations shipped between 12/4/2006",DESIGN: Device Design,"Consignees were sent a ""GE Urgent Medical Device Correction"" letter on 5/12/08 addressed to Health Care Administrator/Risk Manger, Chief of Intensive Care & Director of Clinical Engineering. The letter described the affected product and the problem and provided a short term recommendation and a long term solution which included installation of a revised board on all affected Engstrom Carestations. A GE Healthcare Field Service Engineer to contact the facility to schedule the update.If you have questions, contact Melissa Davis at GE Healthcare at 1-800-345-2700 extension 3439.",N/A,1130,1130,"WI, GA, SC, TX, RI, NY, NM, INVIETNAM, VENEZULA, UNITED KINGDOM, TURKEY, KOREA, JAPAN, ITALY, INDIA, ICELAND, HONG KONG, GREECE, GERMANY, GEORGIA, FRANCE, TUNISIA, THAILAND, SWITZERLAND, SPAIN, SOUTH AFRICA, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CANADA, BRAZIL, BELGIUM, BANGLADESH, BAHRAIN, SLOVENIA, SINGAPORE, SAUDI, RUSSIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, NETHERLAND,MOROCCO, MEXICO, MAYLASIA, LYBIA, LEBANON, KUWAIT, AUSTRIA, AUSTRALIA.",Open,N/A,N/A,1130,Not_Computer,N/A,N/A,N/A
Z-2333-2008,48678,permanent pacemaker electrode,DTB,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor.Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.",Permanent Pacing Lead ,2,"September 24, 2008", 2008,"Oscor, Inc.",The O-rings are over tolerance making it hard to connect the leads to the pacemaker.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On January 24, 08, Oscor sent out a letter to doctors/ customers with the subject line of ""Re: Market Withdrawal of Permanent Pacing Leads due to the lead connector insertion difficulty,"" stating they experienced some difficulties with the insertion of pacing lead connectors into the pacemaker headers. They asked that customers review the inventory list and remove all products, whose serial numbers match the serial numbers on the list and have not been implanted. Also, customers should call Oscor customer service for a Return Goods Product number and return the product back to the firm for replacement.",N/A,N/A,N/A,Nationwide Distribution,Terminated,"November 14, 2008",51,N/A,Not_Computer,N/A,N/A,N/A
Z-2397-2008,49042,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY USA 12804.",Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set ,2,"September 24, 2008", 2008,"Angiodynamics, Inc.","The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.",DESIGN: Process Design,"AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to AngioDynamics. 3. Ship the recalled product(s) to AngioDynamics. Consignees will be credited for the returned products. Credits will only be issued for returned product that is within the scope of the recall. Reference Return Authorization Number ___ on the outside of the shipping box and include a copy of the Centros Recall Reply Form with the return shipment. --- The letters also provide actions to be taken for product(s) in use: ANGIODYNAMICS recommends that physicians continue to follow facility protocols for inserting dialysis catheters and monitoring dialysis catheter patients. It is recommended that physicians consider evaluation of patients with an indwelling Centros catheter to assure the catheter is properly secured. As stated in the product's instructions for use, it is recommended that the catheter be secured/sutured for the entire duration of implantation. If the sutures have been cut, consider re-suturing to maintain proper catheter position. Do not rely on ingrowth of the cuff to maintain proper catheter position. This failure does not affect the function or integrity of the catheter itself and there have no reports of patient injury due to this problem. For questions, concerns, or more detailed instructions on how to.",N/A,N/A,N/A,Nationwide Distribution,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-2383-2008,48761,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm pump segment with attached sutureless pump connector, spinal segment strain-relief sleeves (2), Pump segment strain-relief sleeves (2), Connector pin.",Medtronic Intrathecal Catheter Pump Segment Revision Kit,1,"September 25, 2008", 2008,Medtronic Neuromodulation,"Disconnection of the Medtronic sutureless connector (SC) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump.",DESIGN: Component Design/Selection,"Medtronic sent A Safety Alert dated June 2008, on June 27, 2008, to healthcare professionals, which described the issues of occlusion and disconnect. The letter identifies the affected catheter and revision kit model numbers and the associated implantable infusion pumps. The issues do not involve Medtronic MiniMed insulin pump. The letter refers the HCP to recommendations for Implant Techniques and Recommendations for Patency Verification that are included with the letter. The letter also includes recommendations for managing patients with implanted SC catheters.",N/A,21674,"21,674 total","Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.",Open,N/A,N/A,21674,Not_Computer,N/A,N/A,N/A
Z-2336-2008,48973,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Ultraview Digital Telemetry Transmitter, Model 91341-09The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.",Ultraview Digital Telemetry Transmitter,2,"September 25, 2008", 2008,"Spacelabs Healthcare, Incorporated",During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.,DESIGN: Device Design,"On 07/17/08 the firm issued a ""URGENT - MEDICAL DEVICE CORRECTION"" letter to their customers who received the Spacelabs Medical 1400 MHz Telemetry System - Model 91341-09. The letter states the circumstances in which the device malfunctions, instructions for staff to confirm at the time of the battery insertion that the data is appearing and to remove it from service if information is not appearing. Letters will be sent with a return receipt acknowledging each customer receives the Medical Device Correction letter. Spacelabs Technical Support will respond to all technical questions and personally upgrade all switches with resisters. Contact Spacelabs Medical at 1-800-522-7025 for assistance.",N/A,2055,"2,055 transmitters",Nationwide,Open,N/A,N/A,2055,Not_Computer,N/A,N/A,N/A
Z-2405-2008,49069,"colorimetry, acetaminophen",LDP,Acetaminophen test system.,Toxicology,Toxicology,510(k),"Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma.",Synchron Acetaminophen (ACTM) Reagent,2,"September 25, 2008", 2008,Beckman Coulter Inc,This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.,PRODUCTION CONTROLS: Process Control,"The initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete and return the enclosed response form within 10 days.In addition, the customers were informed that the contaminated Heparin was used in the following Beckman Coulter, Inc., products: Synchron Theophylline (THE) Reagent (lot # M701460), Synchron Phenytoin (PHY) Reagent and Synchron C-Reactive Protein (CRP) Reagent (lot# M703222, M703266, M703267 & M703268), however Beckman Coulter has verified through testing that the performance of these products are not affected.",Contact the recalling firm for information,7764,7764 test kits,Nationwide and Canada,Open,N/A,N/A,7764,Not_Computer,N/A,N/A,N/A
Z-1878-2008,48623,"needle, aspiration and injection, disposable",GAA,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.,Hawkins III (BLN) Breast Localization Needle,2,"September 25, 2008", 2008,"Medical Device Technologies, Inc.",The sterility of the product cannot be guaranteed.,TRAINING: Employee Error,"The firm sent a letter to its consignees on 5/6/08, informing of the recall and requesting that they complete and return by fax the attached customer acknowledgement form. For assistance, contact Medical Device Technologies, Inc., dba Angiotech at 1-352-338-0440 ext. 350 or ext. 353.",Contact the recalling firm for information,490,490 units.,Nationwide and to Mexico.,Open,N/A,N/A,490,Not_Computer,N/A,N/A,N/A
Z-1882-2008,49503,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),GE Healthcare Definium 8000 Digital Radiographic System.,GE Definium 8000,2,"September 25, 2008", 2008,GE Healthcare,Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea,DESIGN: Software Design,"GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.",N/A,454,454 (277 US / 177 OUS),"Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.",Open,N/A,N/A,454,Software,Display/Image,Software update,Software Update
Z-1885-2008,49486,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.",Fluoroscopic XRay System,2,"September 25, 2008", 2008,"OEC Medical Systems, Inc",Beam limitation may be non-compliant on some X-ray units.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378.,N/A,335,335 systems,Nationwide,Open,N/A,N/A,536,Not_Computer,N/A,N/A,N/A
Z-1883-2008,49487,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A.The intended use of this product is to generate tomographic images of human anatomy.",GE Definium 8000,2,"September 25, 2008", 2008,GE Healthcare,Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.,Contact the recalling firm for information,668,668 (419 US / 249 OUS),"AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,",Open,N/A,N/A,668,Not_Computer,N/A,N/A,N/A
Z-1822-2008,49504,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.,GE Definium 8000,2,"September 25, 2008", 2008,GE Healthcare,Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover).,DESIGN: Software Design,"GE sent a Product Safety Notification, dated March 7, 2008, to all customers. The letter described the safety issue, products affected, and stated that a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification.",N/A,127,127,"Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.",Open,N/A,N/A,127,Software,Display/Image,Software update,Software Update
Z-2337-2008,48975,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStarMRtX Defibrillator/MonitorModels: M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memorycard with date code ""0308. The product is used for the termination of ventricular tachycardia and ventricular fibrillation.",Philips HeartStarMRtX ,2,"September 25, 2008", 2008,Philips Medical Systems,"Defective internal memory cards may exhibit one or more of the following behaviors:""Device repeatedly restarts approximately every 20 seconds""Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start-up screen prior to displaying the selected mode of operation (i.e. Monitor, AED, Pacing or Manual Defib",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips issued an Urgent Medical Device Correction notification on July 17, 2008. Customers in the US received their communication package via UPS. Letters to internationalcustomers mailed via a tracked method by local Philips representatives. Customers were informed on how to locate the serial number on their devices to determine whether or not they have affected units in their inventory. Customers are asked to follow the ""Action To Be Taken By Customer/User"" while they await , their correction. If users continue to use prior to correction, a back up defibrillator should be readily available. Devices that exhibit repeated restart or slow start -up should be removed from service. The correction will come in the form of an internal memory card replacement.Philips will contact customers to arrange for the correction of their devices. Contact Philips Medical at 1-978-687-1501 for assistance.",N/A,523,523 units,"NationwideCanadaAustralia, Brazil , China, France, Germany, Great Britain,Hong Kong, Indonesia, Italy,Latvia, New Zealand,Saudi Arabia, and South Africa",Open,N/A,N/A,523,Hardware,Device Operation,Remove/Replace memory,Remove or Replace
Z-2202-2008,47501,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),MEDTOXscan Reader,MEDTOXscan ,2,"September 26, 2008", 2008,Medtox Diagnostics Inc,Reader was marketed without a 510(k).,OTHER/UNDETERMINED: Pending,"Consignees were notified by telephone starting 02/08/2008. They were being read the following script.: This is (company representative) calling regarding the MEDTOXscan Reader , Serial Number #######, that we sent to you on (date). Based on recent discussions with the FDA it has been determined that the reader should have had FDA clearance prior to MEDTOX marketing the reader. Since the MEDTOXscan Reader was marketed without 510(k) clearance it is considered mis-branded. MEDTOX is voluntarily recalling all readers until we receive this clearance.The PROFILE III ER devices sold for use with the readers are appropriately cleared by the FDA, and can be read visually, independent of the reader and therefore are not affected by the recall. Please discontinue using the reader immediately. We will send you shipping materials and instructions on how to return the reader to MEDTOX. You will receive these materials within the next 7 days and we request that you return the reader to MEDTOX within 5 days. Your assistance is appreciated and necessary. The Food and Drug Administration is aware of this recall.",Contact the recalling firm for information,391,391 Readers,Nationwide Distribution.,Open,N/A,N/A,391,Not_Computer,N/A,N/A,N/A
Z-1860-2008,48148,"set, tubing, blood, with and without anti-regurgitation valve",FJK,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.",Cartridge Blood Set,2,"September 26, 2008", 2008,"Gambro Renal Products, Inc.",Dialysis tubing sets may have occlusions restricting blood flow.,PRODUCTION CONTROLS: Process Control,"Customers were sent an ""Urgent Product Safety Notice"" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an ""Urgent Product Recall"" letter was sent to all customers requesting the return of all remaining affected blood sets.",N/A,N/A,N/A,"Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-2399-2008,49044,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.",PLAC Test Reagent Kit,2,"September 26, 2008", 2008,"DiaDexus, Inc",Product may give Lp-PLA2 values at up to 22% lower than accurate values.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.",N/A,65,65 (total),"US, OUS: UK and Germany.",Terminated,"December 22, 2009",452,65,Not_Computer,N/A,N/A,N/A
Z-2401-2008,49049,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.",ThinFlex Venous Return Cannulae,3,"September 26, 2008", 2008,"Edwards Lifesciences Research Medical, Inc.",Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.,PRODUCTION CONTROLS: Process Control,"All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.",N/A,707,707 units,"Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.",Terminated,"December 23, 2008",88,1487,Not_Computer,N/A,N/A,N/A
Z-2415-2008,49079,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer, Winterthur, Switzerland; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)",Durom cup,2,"September 26, 2008", 2008,Zimmer Inc.,Instructions for use/surgical technique instructions are inadequate.,MISBRANDING: Labeling False and Misleading,"A press release issued on 7/23/08. A letter was sent to implanting surgeons on 7/22/08 advising them of the problem and instructing them to stop implanting these devices until they receive training. Zimmer suspended all marketing and distribution in the U.S. pending completion of user training and revision of the instructions for surgical technique. Zimmer will conduct a removal of all copies of the current surgical technique document and replace it with revised surgical technique document(s). Contact Zimmer, Inc. at 1-866-946-5633 for assistance. Update: A dear surgeon letter was mailed 8/4/08 and provided patient management guidelines. A correction update was sent 8/16/08 with updated surgical technique and instructions for use documents. A dear surgeon letter was mailed 9/25/08 providing additional information regarding the training program.",N/A,19014,"19,014 of all products",Nationwide.,Terminated,"October 21, 2009",390,19014,Not_Computer,N/A,N/A,N/A
Z-1548-2008,49366,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ev3"" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,","VisiPro"" Biliary Stent System ",2,"September 26, 2008", 2008,"Ev3, Inc","ev3, Inc. has determined that specific lots of the Visi-Pro"" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.",TRAINING: Employee Error,"Consignees were sent a ""Medical Device Recall"" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700.",Contact the recalling firm for information,212,212,"Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.",Open,N/A,N/A,278,Not_Computer,N/A,N/A,N/A
Z-2431-2008,49086,"pack, hot or cold, disposable",IMD,Hot or cold disposable pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"Ace Heat Therapy, A BD ProductUp to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain.Apply Directly to Skin, Instant, Air-Activated Heat PatchesDistributed by: BD Medical, Franklin Lakes, NJ 07417Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.",Ace Heat Therapy,2,"September 26, 2008", 2008,Becton Dickinson & Company,Potential for skin irritation and burns associated with the use of this product.,DESIGN: Device Design,"Important: Product Recall Letters were sent by UPS second day air with tracking on April 25, 2008 to all customers asking them to please contact Customer Service at 866-228-7265 to have a Return Goods Authorization issued. The letter also states that neither customers nor a third party should destroy product.",N/A,703000,"approximately 703,000 patches",Nationwide Distribution.,Terminated,"March 27, 2009",182,703000,Not_Computer,N/A,N/A,N/A
Z-2034-2008,49501,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),BI-700-00027 0-arm 1000 Imaging System Mobile X-ray SystemGenerating 2D and 3D images of human anatomy for surgical applications.,BI70000027 0arm 1000 Imaging System Mobile Xray System,2,"September 26, 2008", 2008,"Medtronic Navigation, Inc.",Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii),RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Medtronic Navigation notified service engineers to retest units for compliance.,N/A,10,10 units,"CA, DC, LA, FL. IN, OH, PA, VA",Terminated,"December 04, 2008",69,10,Not_Computer,N/A,N/A,N/A
Z-2147-2008,49509,"system, x-ray, mammographic",IZH,Mammographic x-ray system.,Radiology,Radiology,510(k),"GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.",GE Stenographe,2,"September 26, 2008", 2008,GE Healthcare,"GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade.Contact GE Healthcare at 1-262-544-3894 for assistance.",Contact the recalling firm for information,12,12,"AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.",Open,N/A,N/A,39,Computer,N/A,N/A,N/A
Z-1517-2008,45538,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.,GE Innova fluoroscopic imaging system with bolus chasing,2,"September 29, 2008", 2008,GE Healthcare,"Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a c",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed at their site at no cost.",N/A,146,146 total,"Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia.",Open,N/A,N/A,146,Computer,N/A,N/A,N/A
Z-1755-2008,47226,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.",Mevatron KD2,2,"September 29, 2008", 2008,"Siemens Medical Solutions USA, Inc","Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.",DESIGN: Device Design,"Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.",Contact the recalling firm for information Contact the recalling firm for information,168,168 total,"Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.",Open,N/A,N/A,168,Computer,N/A,N/A,N/A
Z-1751-2008,46823,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system",Siemens syngo Dynamics,2,"September 29, 2008", 2008,"Siemens Medical Solutions, USA, Inc",Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.,DESIGN: Software Design,"Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.",N/A,18,18,"Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.",Terminated,"November 18, 2009",415,18,Software,Output/Calculation,Software update,Software Update
Z-0071-2008,48721,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator",NeoMedix Trabectome I/A,2,"September 29, 2008", 2008,Neomedix Corp,"Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you.The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.",N/A,7,7,"Nationwide to: CA, HI, IA, NY & PA",Terminated,"September 29, 2008",0,7,Not_Computer,N/A,N/A,N/A
Z-2370-2008,49013,"blade, saw, general & plastic surgery, surgical",GFA,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.",Biomet Exact Calcar Planer Rasp Style Blade,2,"September 29, 2008", 2008,"Biomet, Inc.",The blades will oxidize after the first cleaning.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.",N/A,141,141 of all products,Nationwide and China.,Terminated,"June 26, 2009",270,141,Not_Computer,N/A,N/A,N/A
Z-1765-2008,47490,"prosthesis, spinous process spacer/plate",NQO,N/A,N/A,Orthopedic,N/A,"X-STOP Interspinous Process Decompression (lPD) System,(With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device);Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk.Product is manufactured and distributed by Medtronic Spine LLC (formerly Kyphon Inc.); Spinal implants.",XSTOP,2,"September 29, 2008", 2008,Kyphon Inc,"Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw.",DESIGN: Labeling Design,"On January 30, Kyphon sent a letter to all consignees, and a teleconference was held with sales management informing them of the recall and the need to contact consignees. The product labeling including the Physician Training and Physician's Guide have been updated to reflect the potential risk of breakage.",N/A,25000,"25,000","Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Philippines, Portugal, Singapore, South Africa, Spain Switzerland, Turkey and UAE.",Terminated,"July 14, 2009",288,25000,Not_Computer,N/A,N/A,N/A
Z-2467-2008,49368,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital Visual Interface (DVI) Extender is a converter and transmitter for copper and fiber optic DVI signals.",OPHIT Optical DVI Extension Module,3,"September 29, 2008", 2008,Stryker Communications Corp,Product at times experiences intermittent signal loss due to electromagnetic interference.,PRODUCTION CONTROLS: Process Control,Firm sent notification letters to consignees on 4/1/2008. The letter informed the customers. The firm plans to replace the affected product. Contact Stryker at !-972-410-7100 for assistance.,N/A,7599,"7,599 units",Nationwide,Terminated,"January 26, 2010",484,7599,Not_Computer,N/A,N/A,N/A
Z-2468-2008,49377,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.",Sonoline G50/G60 Ultrasound System,2,"September 29, 2008", 2008,"Siemens Medical Solutions USA, Inc.","As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.",DESIGN: Software Design,"The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.",N/A,2541,2541 units,Worldwide,Open,N/A,N/A,2541,Software,Display/Image,Software update,Software Update
Z-2466-2008,49116,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.",Impactor,2,"September 29, 2008", 2008,"Encore Medical, Lp",Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.,DESIGN: Device Design,"Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.",N/A,68,68 units.,FL and TX and OUS: Japan.,Terminated,"August 03, 2009",308,68,Not_Computer,N/A,N/A,N/A
Z-0368-2008,49536,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),GE Healthcare OEC 9900 mobile fluoroscopic x-ray system,OEC 9900,2,"September 29, 2008", 2008,"OEC Medical Systems, Inc",Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.",N/A,710,710,"Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.",Open,N/A,N/A,710,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1708-2008,49541,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.",Aquilion,2,"September 29, 2008", 2008,Toshiba American Med Sys Inc,"Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.",DESIGN: Device Design,"Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.",N/A,1203,1203 total,"Worldwide distribution, including USA and Japan.",Open,N/A,N/A,1203,Not_Computer,N/A,N/A,N/A
Z-1518-2008,48977,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.",GE Healthcare Innova,2,"September 30, 2008", 2008,"Datex - Ohmeda, Inc","User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.",N/A,281,281,"within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom",Terminated,"June 09, 2009",252,484,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2198-2008,49367,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Plastic Cannula Holdex¶_ Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.",PC Holdex,2,"September 30, 2008", 2008,"Greiner Bio-One North America, Inc.",At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.,DESIGN: Process Design,"Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.",N/A,150000,"150,000 pcs","AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.",Open,N/A,N/A,150000,Not_Computer,N/A,N/A,N/A
Z-2471-2008,49433,"adaptor, stopcock, manifold, fitting, cardiopulmonary bypass",DTL,"Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.",Cardiovascular,Cardiovascular,510(k),"Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems to reduce blood loss during percutaneous catheter procedures. It consists of an adjustable valve and flush port.",Medtronic Adjustable valve,2,"September 30, 2008", 2008,Medtronic Inc. Cardiac Rhythm Managment,Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised.,PRODUCTION CONTROLS: Process Control,"An Urgent Device Recall letter, dated August 28, 2008, was sent to affected consignees. The letter describes the issue, identifies affected product, and requests that affected product be removed from inventory and returned to Medtronic. Medtronic representatives with assist in returning unused valves and kits and provide replacements. Contact Medtronic at 1-763-526-0000 for assistance.",N/A,35193,"35,193 total","Worldwide Distribution --- including USA and except states OR, RI, and SD. Puerto Rico and Washington D.C. , and countries of Algeria , Argentina , Australia , Austria , Belgium , Bosnia And Herzegovina , Canada , Chile , Croatia , Czech Republic , Denmark , Egypt , Finland , France , Georgia , Germany , Greece , Guadeloupe , Hong Kong , Hungary , India , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Kuwait , Lithuania , Malta , Martinique , Morocco , Netherlands , Norway , Pakistan , Poland , Portugal , Puerto Rico ,Qatar , Reunion , Romania , Saudi Arabia , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syrian Arab Republic , Tunisia , Turkey , UK , Ukraine , United Arab Emirates , Uruguay , and Venezuela.",Open,N/A,N/A,35193,Not_Computer,N/A,N/A,N/A
Z-2470-2008,49391,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS.The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.",Maxi Move Patient Lift with Lock & Load System (Combi Hanger),2,"September 30, 2008", 2008,"Arjo, Inc.",There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from the t-bar attached to the lifter jib of the Maxi Move patient lift.,DESIGN: Device Design,"Arjo sent the Field Safety Notice (FSN) dated 8/11/08 to all Maxi Move with Lock & Load system (Combi Hanger) customers on 9/8/08. The accounts were informed of the problem unintended dislocation of the hanger and possible detachment during patient transfer. The notice provided details, including serial number ranges, to identify the affected patient lifts affected, and instructed the accounts to re-train caregivers on how to ensure the hanger is properly attached to the T-bar before and during the initial phase of all lifting operations. Included with the FSN was a package containing a repair/replacement kit for the bushings in the T-bar with instructions, and updated copies of the Operating and Product Care instructions as well as a Preventative Maintenance Schedule manuals. The accounts were requested to complete and return to Arjo Inc. the enclosed customer response form indicating that they have received the notification package, that they installed the bushings kits in their affected Maxi Moves, or if they would like an Arjo Service Technician to perform the installation. Those locations needing a T-bar replacement will be contacted by an Arjo representative within 2 months to arrange a replacement of the T-bars.",N/A,4400,"4,400 patient lifts",Nationwide Distribution,Open,N/A,N/A,4400,Not_Computer,N/A,N/A,N/A
Z-2469-2008,49378,"oxygenator, cardiopulmonary bypass",DTZ,Cardiopulmonary bypass oxygenator.,Cardiovascular,Cardiovascular,510(k),"Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir",Hollow Fiber Oxygenator,2,"September 30, 2008", 2008,"Sorin Group USA, Inc.","Under certain conditions, venous reservoir on oxygenator may allow air into the system.",MISBRANDING: Labeling False and Misleading,"The firm sent out a notification letter, by certified letter, on Aug 8,2008. Instructions on how to prevent air from entering the system were provided. Sorin Group USA, Inc. can reached at 1-303-467-6306.",N/A,35,35 units,NC,Terminated,"September 30, 2008",0,35,Not_Computer,N/A,N/A,N/A
Z-1521-2008,49538,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System),GE Innova,2,"September 30, 2008", 2008,"Datex - Ohmeda, Inc",GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.",N/A,107,107,"Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.",Open,N/A,N/A,194,Software,Device Operation,Software update,Software Update
Z-2465-2008,49500,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.",Ferno Model 35X PROFlexX Ambulance Stretcher,2,"September 30, 2008", 2008,Ferno-Washington Inc,The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation.,DESIGN: Device Design,On 9-03-2008 the firm sent via certified mail Urgent Voluntary Correction letters to their customers instructing them to immediately inspect the stretcher according to the 35X PROFlexx¶_ Leg Inspections instruction sheet. Customers are to also telephone the firm upon completion of the inspection to arrange for a replacement kit. Contact Ferno Technical Support at 1-866-987-3776 for assistance.,Contact the recalling firm for information,2100,"2,100","Worldwide Distribution --- USA including states of AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY,OH, OK, PA, SC, TN, TX, VA, WI, and WV, and countries of Austria, China, Egypt, Germany, Hong Kong, Japan, Lebanon, Mexico, Poland, United Kingdom, and South Africa.",Open,N/A,N/A,2100,Not_Computer,N/A,N/A,N/A
Z-1713-2008,49533,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.,GE Precision XR/a,2,"September 30, 2008", 2008,GE Healthcare,The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.,DESIGN: Device Design,GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.,N/A,132,132,"Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.",Open,N/A,N/A,132,Not_Computer,N/A,N/A,N/A
Z-0021-2009,49435,"suture, absorbable, synthetic, polyglycolic acid",GAM,Absorbable poly(glycolide/l-lactide) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP.Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876The product is used for Soft Tissue approximation.",VICRYL RAPIDE ,2,"October 02, 2008", 2008,"Ethicon, Inc.","Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.",PRODUCTION CONTROLS: Packaging,"Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.",N/A,6912,6912,"Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.",Open,N/A,N/A,6912,Not_Computer,N/A,N/A,N/A
Z-0034-2009,49494,"suture, nonabsorbable, synthetic, polyamide",GAR,Nonabsorbable polyamide surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.",30 Black Mono Nylon Suture,3,"October 02, 2008", 2008,Surgical Specialties Corp,mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture,TRAINING: Employee Error,"The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.",N/A,956,956 boxes,"USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.",Terminated,"March 27, 2009",176,956,Not_Computer,N/A,N/A,N/A
Z-0031-2009,49462,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Platinum Plus"" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus"" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.",Platinum Plus,3,"October 02, 2008", 2008,Boston Scientific Corporation,"Boston Scientific is initiating a voluntary recall of the Platinum Plus"" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to",PRODUCTION CONTROLS: Labeling Mix-Ups,"A ""Boston Scientific Urgent Voluntary Medical Device Recall or Correction - Immediate Action Required"" letter dated 8/25/08 was sent to each affected account (To The Hospital Field Action Contact). The letter includes the customer steps for recall, a complete listing of all product batches/lots being recalled, the Reply Verification Tracking Form(s), and a return shipping label. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.",N/A,35,35,"USA: CAFLGAILINLAMNMONJNVNYOHPATNTXUTWAWI andWVOUS: France, Germany, Great Britain, Italy, and the Netherlands.",Open,N/A,N/A,82,Not_Computer,N/A,N/A,N/A
Z-0014-2009,49022,"system, radiation therapy, charged-particle, medical",LHN,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.",Mobetron Model 1000,2,"October 03, 2008", 2008,Intraop Medical Corporation,"Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.",DESIGN: Component Design/Selection,"Recall initiated on 06/20/2008, advising users via Advisory Notice that a safety upgrade would be available. Two options are given to either self inspect the product or schedule an Intraop Authorized Field Service Engineer to visit their facility to perform the inspection. The letter notes that if no nut failure was evident, the machine could still be used. The firm continues to send retrofit kits.",N/A,24,24 units,Worldwide Distribution,Open,N/A,N/A,24,Not_Computer,N/A,N/A,N/A
Z-0013-2009,49003,"catheter, intravascular occluding, temporary",MJN,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy CatheterIs indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.",Fogarty Fortis Arterial Embolectomy Catheter,2,"October 03, 2008", 2008,"Edwards Lifesciences, LLC",Potential for tubing fracture near the tip of the catheter.,N/A,"The firm sent Urgent Field Safety Notices dated June 23, 2008 to customers. The letter gave details on affected products, a description of the problem, and advise on action to be taken. Edwards has decided to recall these lots of Fogarty Fortis catheters which were manufactured between 9 June 2007 and 20 June 2008. The expiration date for these lots is between 11 September 2009 and 26 September 2009. The attached sheet lists product by model and lot number which you have ordered during that time frame. Please stop using these lots of catheter products immediately. Edwards requests that you return all Fogarty Fortis catheters from these lots that are still in your inventory. Please call Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. After you have verified your inventory, please complete the attached Confirmation Form, even if you no longer have any affected units at your facility. This will allow us to verify the completion of this recall action. Please return the Confirmation Form by FAX to: +31.412.47.66.99 , Attention: Mark vanSchijndel Transmission of this Field Safety Notice: This notice needs to be passed on all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact and where or to any organization where the potentially affected devices have been transferred. Please maintain awareness on this notice and resulting action for an appreciate period to ensure effectiveness of the corrective action. We sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. If you have specific questions about this notification, please contact Customer Service.",N/A,2975,"2,975 units","International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.",Open,N/A,N/A,2975,Not_Computer,N/A,N/A,N/A
Z-0032-2009,49465,"prosthesis, elbow, constrained, cemented",JDC,Elbow joint metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.",Biomet brand Discovery Elbow,2,"October 03, 2008", 2008,"Biomet, Inc.",The component in the package is not the correct size.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.",N/A,6,6,"USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.",Terminated,"September 22, 2009",354,11,Not_Computer,N/A,N/A,N/A
Z-0022-2009,49436,"cannula, ophthalmic",HMX,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.",BD Ophthalmic,2,"October 03, 2008", 2008,Becton Dickinson and Company,Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.,TRAINING: Employee Error,BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.,Contact the recalling firm for information,1485,1485 units,"AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VAForeign: Australia and Japan.",Open,N/A,N/A,1485,Not_Computer,N/A,N/A,N/A
Z-0020-2009,49379,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda AisysIntended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.",GE DatexOhmeda Aisys,2,"October 06, 2008", 2008,"Datex - Ohmeda, Inc","The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.",PRODUCTION CONTROLS: Manufacturing Material Removal,"GE Healthcare ""Urgent Medical Device Correction"" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed:1. Carry out the daily system checkout for any system in use.2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition.3. Have an alternative method of anesthesia available at all times.Once each machine has been corrected an ""Update"" will be provided by the service technician responsible for the correction. Each customer/machine will receive a ""GE Healthcare Urgent Medical Device Correction Update"" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.",N/A,1571,1571,"Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH AFRICA, TURKEY, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MEXICO, LIBYA, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, UNITED KINGDOM, FRANCE FINLAND, SPAIN, ESTONIA, DENMARK, GERMANY, COLOMBIA, CHINA, SWITZERLAND, CANADA, BRAZIL, BAHRAIN, BELGIUM, AUSTRALIA, AUSTRIA, and UNITED ARAB EMIRATES.",Open,N/A,N/A,1571,Hardware,N/A,Instructions to verify,Safety Notice/Insructions
Z-0023-2009,49445,"laparoscope, gynecologic (and accessories)",HET,Gynecologic laparoscope and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.",15mm Separator Access System,2,"October 07, 2008", 2008,Applied Medical Resources Corp,"Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar canstretch into a configuration that blocks the flow of insufflation gas (C02).",PRODUCTION CONTROLS: Process Control,"Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.",N/A,14113,"14,113 total",Nationwide and Canada distribution.,Open,N/A,N/A,14113,Not_Computer,N/A,N/A,N/A
Z-0088-2009,49490,"bed, flotation therapy, powered",IOQ,Powered flotation therapy bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC.The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11"" and 6' 4"" in height.",Envision E700 Low Airloss Therapy Surface,2,"October 07, 2008", 2008,"Hill-Rom Manufacturing, Inc.",A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"An internal Modification Notice dated 9/1/08 was sent via email to Service Centers (because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the consignee). Each Service Center will perform the correction on the units affected. Each device in the affected serial number range will be tested for the software defect. If the defect is found, the circuit board that contains the defective software will be replaced. The Field Action Plan is expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 months from July, 2008.",N/A,779,779 units,Worldwide Distribution --- including USA and country of Canada.,Terminated,"May 21, 2009",226,779,Software,Output/Calculation,Replace circuit board containing software,Software Update
Z-0087-2009,49442,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Draeger Medical Apollo Anesthesia Machine, catalog number 8606500",Apollo Anesthesia Machine,2,"October 08, 2008", 2008,"Draeger Medical, Inc.","Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures.",Contact the recalling firm for information,214,214 units,Nationwide Distribution.,Terminated,"September 01, 2009",328,214,Other,Output/Calculation,Replace,Remove or Replace
Z-0086-2009,49411,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.",Acuson/Sonovista X300,2,"October 08, 2008", 2008,"Siemens Medical Solutions USA, Inc.",Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.,DESIGN: Software Design,"Siemens initiated a Field Correction 08/19/2008. Service personnel will conduct a site visit and distribute a Customer Safety Advisory Notice, correct the problem and install a revised software version.",Contact the recalling firm for information,169,169 units total,"Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.",Open,N/A,N/A,169,Software,Output/Calculation,Software update,Software Update
Z-0006-2009,48638,"system, test, low density, lipoprotein",MRR,Lipoprotein test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322.An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.",Roche Diagnostics LDL_C,2,"October 09, 2008", 2008,Roche Diagnostics Corp.,"Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions. The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen. If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.",N/A,623,623,Nationwide Distribution,Terminated,"September 22, 2009",348,3624,Not_Computer,N/A,N/A,N/A
Z-0017-2008,49107,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,N/A,"Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060",Medline Latex Free Labor Kit & Postpartum CDSLF,2,"October 10, 2008", 2008,Medline Industries Inc,The latex free labor & delivery packs contain a latex Nuk pacifier. The pacifier is packaged separately and offers no risk of exposure of latex particles to other components of the pack.,PRODUCTION CONTROLS: Packaging Process Control,"Recall letters dated 8/4/08 were sent to the direct accounts on the same date, informing them that the labor and delivery packs were labeled Latex Free, but contained a Latex Nuk pacifier. The letters were customized for each account, listing the specific affected reorder numbers and lot numbers shipped to each account. The accounts were requested to immediately check their stocks for the affected lot numbers and quarantine the affected product found. The accounts were given three options: A) Attach the enclosed stickers to the packs so that the user is aware of the latex Nuk pacifier, B) Call Medline to receive replacement non-latex pacifiers, but also place the stickers on the packs, C) Return the packs to Medline for replacements. The accounts were requested to complete the enclosed response form, indicating which option the account selected and whether they needed any additional stickers, and fax the form back to Medline at 847-643-4482 by 8/18/08. Any questions were directed to Kathy Dunne at 1-866-359-1704.",N/A,279,279 cases,"Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.",Terminated,"February 02, 2010",480,2115,Not_Computer,N/A,N/A,N/A
Z-0101-2009,49417,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"AXIOM Luminos TF, model number 10093902Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.",AXIOM Luminos TF,2,"October 10, 2008", 2008,"Siemens Medical Solutions USA, Inc","Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.",DESIGN: Device Design,"The recalling firm was made aware of a potential problem with the device from the manufacturer in Germany. The recalling firm sent a copy of the Customer Safety Advisory Notice, dated June 18, 2008, received from Germany to their customers. The recalling firm has representatives visiting each location to modify the units.",N/A,211,211 units,Nationwide Distribution,Terminated,"October 05, 2009",360,211,Not_Computer,N/A,N/A,N/A
Z-0035-2009,49405,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.",LifeStent FlexStar Stent System,2,"October 10, 2008", 2008,Bard Peripheral Vascular Inc,Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.,PRODUCTION CONTROLS: Process Control,"The customer letters for the tip to sheath gap were sent on 8/29/2008 with return receipt. The letter advises that C.R. Bard has determined that some LifeStent FlexStar Systems may exhibit a gap between the tip ofthe delivery system and the primary sheath such that the guidewire lumen is visible. Per the letter, the firm's analysis has determined that a gap between the tip of the delivery system and the delivery system sheath may be associated with difficult advancement to the treatment site. Users are instructed to inspect all devices to verify that there is not a gap between the tip and sheath (orange colored guidewire lumen is visible), prior to use and to not use any devices that exhibit a tip to sheath gap condition. If devices that exhibit a tip to sheath gap are identified, customers are advised to call Customer Service at 1-800-321-4254 to return the device and a replacement will be provided at no cost. The letter also advises that the Instructions for Use for the LifeStent FlexStar System will be updated to include the inspection step which is provided in the letter.",Contact the recalling firm for information,45,45 units,Nationwide,Open,N/A,N/A,9844,Not_Computer,N/A,N/A,N/A
Z-0100-2009,49402,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.",Philips Telemonitoring System,2,"October 10, 2008", 2008,Philips Medical Systems,Multiprint report may contain incorrect vital data for patients,DESIGN: Software Design,Philips contacted customers by sending an Urgent Medical Device Correction Notification on 9/11/08. Letters to customers sent via certified mail and receipt of delivery will be tracked.Customers are asked to follow the Action To Be Taken By Customer/User section of the Urgent Medical Device Correction Notification. This section instructs users to allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for assistance.,Contact the recalling firm for information,52,52 units,Nationwide,Open,N/A,N/A,52,Software,Output/Calculation,Software update,Software Update
Z-0111-2009,49412,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound",AcusonX300,2,"October 10, 2008", 2008,"Siemens Medical Solutions USA, Inc.",Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.,TRAINING: Employee Error,"Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database.",N/A,72,72 units,"Worldwide Distribution --- including USA and countries of France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada.",Open,N/A,N/A,72,Software,Display/Image,Software update,Software Update
Z-0105-2009,49061,temporary carotid catheter for embolic capture,NTE,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific FilterWire EZ"" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA 94043-4655. Filter wire EZ"" Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.","FilterWire EZ"" Embolic Protection System",2,"October 14, 2008", 2008,Boston Scientific Corporation,"Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ"" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing. If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU. This may",TRAINING: Employee Error,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"" letter dated May 20, 2008. The letter addressed to Risk Mangers, described the issue and product. A Reply Verification Tracking Form was requested to be completed and returned. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.",N/A,4338,A total of 4338 units distributed.,"US: AL AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD. TN, TX. UT, VA, VT, WV, WA, WI, WY, and PR.European Countries: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Great Britain, Germany, Greece, Hungary, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, and Switzerland, Intercontinental: Taiwan, Korea, Australia, China, Singapore, Canada, Columbia, and Mexico.",Open,N/A,N/A,4338,Not_Computer,N/A,N/A,N/A
Z-0114-2009,49416,"lancet, blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)",Safety Lancet ,2,"October 14, 2008", 2008,Sarstedt Inc,The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.,N/A,"The consignee was notified via letter that was hand delivered on 08/27/2008. All of the distributed product was picked up from the consignee and returned to Sarstedt, Inc. None of the product had been used. All action was completed on 8/27/2008. Contact Sarstedt at 1-828-465-4000 for assistance.",N/A,1000,1000 pieces,NC,Open,N/A,N/A,1000,Not_Computer,N/A,N/A,N/A
Z-0113-2009,49518,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.",Zilver Expandable Metal Biliary Stent System,2,"October 14, 2008", 2008,Cook Endoscopy,A section of the introduction system may detach after the stent has deployed.,PRODUCTION CONTROLS: Process Control,"The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance.",N/A,12,12,USA: IL and OUS: China,Terminated,"April 01, 2009",169,12,Not_Computer,N/A,N/A,N/A
Z-0102-2009,49496,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.",Syngo Imagaing,2,"October 15, 2008", 2008,"Siemens Medical Solutions USA, Inc",Image may not be visible after merge.,DESIGN: Software Design (Manufacturing Process),"The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.",N/A,59,59 units,"Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.",Terminated,"November 19, 2008",35,59,Software,Display/Image,Software update,Software Update
Z-0112-2009,49459,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010",Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision ,2,"October 15, 2008", 2008,GE Healthcare Integrated IT Solutions,"On the I&O; chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.",DESIGN: Software Design (Manufacturing Process),"GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.",N/A,470,470 units,Worldwide Distribution --- including USA and country of Canada.,Terminated,"May 17, 2010",579,470,Software,Output/Calculation,Software update,Software Update
Z-0089-2009,48432,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1Medical charged-particle radiation therapy system.",Coherence AG Therapist ,2,"October 16, 2008", 2008,"Siemens Medical Solutions USA, Inc",Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.,DESIGN: Software Design (Manufacturing Process),"Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.",N/A,14,14 units.,Worldwide Distribution,Open,N/A,N/A,251,Computer,N/A,N/A,N/A
Z-0161-2009,49545,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Accessory Head Rest for Alphastar Operating Tables, Accessory Head Rest for Alphastar Operating Tables,2,"October 16, 2008", 2008,MAQUET Inc.,During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.,DESIGN: Labeling Design,"Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.",N/A,88,88 units in US; 1884 units worldwide,Nationwide Distribution,Terminated,"April 16, 2009",182,88,Not_Computer,N/A,N/A,N/A
Z-0115-2009,48995,impactor,HWA,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000Non SterileHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430The Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.",Scorpio Series 7000 ,2,"October 20, 2008", 2008,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware that there is a potential inability to release the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during use.,DESIGN: Component Design/Selection,"US recall notification (product correction) letters were send out by Federal Express with return receipt on July 2 and 9, 2008.Advisory notices were sent to foreign customers on July 2, 2008.Both letters include a Product Correction Bulletin that instructs all used to lubricate the divide with an approved medical lubricant, especially the extractor shaft and threads. It is recommended that all moving parts be evaluated for functionality and useful service prior to each surgery and instructions on how to perform this process. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5918 for assistance.",N/A,5126,5126,"Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.",Open,N/A,N/A,5126,Not_Computer,N/A,N/A,N/A
Z-0116-2009,49024,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.",Artiste MV system,2,"October 20, 2008", 2008,"Siemens Medical Solutions USA, Inc","Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"A letter marked ""Urgent"" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.",N/A,16,16,"Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France",Open,N/A,N/A,16,Software,Physical Safety Hazards,Software update,Software Update
Z-0117-2009,49399,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.",Exact Couch with Exact Couch Top,2,"October 20, 2008", 2008,Varian Medical Systems Oncology Systems,"During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.",DESIGN: Device Design,"Recall initiated on 08/11/2008. Notification will be sent to Varian Sales, Marketing and Service organizations as well as to all affected users. Contact Varian Medical Systems Oncology Systems, at 1-650-424-5731 for assistance.",N/A,3296,3296 units,"Worldwide including to the US and to Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, United Kingdom, Algeria, Australia, Bahrain, Bangladesh, Belorussia, Bolivia, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guadeloupe, Hong Kong, India, Indonesia, Iran, Israel, Jamaica, Japan, Kazakhstan, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russian Fed., Saudi Arabia, Serbia, Montenegro, Singapore, South Africa, South Korea, Sudan, Syria, Taiwan, R.O.C., Thailand, Turkey, U.A.E, Ukraine, Uruguay, Venezuela, and Vietnam.",Open,N/A,N/A,3296,Not_Computer,N/A,N/A,N/A
Z-0151-2009,49439,"intervertebral fusion device with bone graft, lumbar",MAX,Intervertebral body fusion device.,Orthopedic,Orthopedic,N/A,Ray TFC Device with End Caps:Single Patient use; Sterile;Stryker SpineRay Cage 7-2021 20 (catalog #) mm diameter x 21 mm long.Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.,Ray TFC Device with End Caps,2,"October 20, 2008", 2008,Stryker Spine,The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.",N/A,69,69 units,Nationwide Distribution,Terminated,"November 04, 2008",15,69,Not_Computer,N/A,N/A,N/A
Z-0119-2009,49407,"table, radiographic, tilting",IXR,Radiologic table.,Radiology,Radiology,510(K) Exempt,"Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden",Sonesta 6210 Fluoroscopy Procedure Table ,2,"October 20, 2008", 2008,Stille AB,"The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w",DESIGN: Component Design/Selection,"Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.",N/A,114,114 units,Nationwide and Canada,Open,N/A,N/A,114,Battery,Physical Safety Hazards,Instructions until upgrade,Repair
Z-0163-2009,49567,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.",Axiom Aristos FX,2,"October 20, 2008", 2008,"Siemens Medical Solutions USA, Inc",Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.,PRODUCTION CONTROLS: Equipment Maintenance,Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.,N/A,7,7 units,"Nationwide distribution including states of CA, IN, KY, UT, VA and WI.",Terminated,"October 20, 2008",0,7,Not_Computer,N/A,N/A,N/A
Z-0152-2009,49443,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.",Baxter Auto Syringe AS50 Infusion Pump,2,"October 21, 2008", 2008,Baxter Healthcare Corp.,"Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly.",N/A,509,509 units,"Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea.",Terminated,"February 03, 2010",470,509,Hardware,Alarm/Message,Repair,Repair
Z-0103-2009,47839,"keratome, ac-powered",HNO,Keratome.,Ophthalmic,Ophthalmic,510(k),"Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.",Zyoptix XP Microkeratome maxon motor,2,"October 22, 2008", 2008,Bausch & Lomb Inc,The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.,DESIGN: Device Design,Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.,Contact the recalling firm for information,69,69 motors,"Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.",Open,N/A,N/A,113,Not_Computer,N/A,N/A,N/A
Z-0164-2009,48661,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian RV SoftwareVarian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043;Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CADesigned to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.",Varian RV Software,2,"October 22, 2008", 2008,Varian Medical Systems Oncology Systems,"A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.",DESIGN: Software Design (Manufacturing Process),"Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.",Contact the recalling firm for information,18,18,"Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.",Open,N/A,N/A,18,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-0165-2009,48711,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.",Roche/Hitachi Modular E Module,2,"October 22, 2008", 2008,Roche Diagnostics Corp.,A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.,N/A,N/A,N/A,"Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.",Terminated,"October 22, 2009",365,N/A,Software,Output/Calculation,Instructions for workaround,Safety Notice/Insructions
Z-0166-2009,49128,"system, applicator, radionuclide, manual",IWJ,Manual radionuclide applicator system.,Radiology,Radiology,510(K) Exempt,"Alpha-Omega Services, Inc. Product No: NFV0001-004Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITHFEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.",FLEXIGUIDE: SERIES15,2,"October 22, 2008", 2008,Alpha Omega Services Inc,"There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.",N/A,29,29 pkgs (10 each pkg),"NV, AZ, CA, MI, UT, MO, CO, and OH",Terminated,"December 09, 2008",48,198,Not_Computer,N/A,N/A,N/A
Z-0171-2009,49131,"nadh oxidation/nad reduction, ast/sgot",CIT,Aspartate amino transferase (AST/SGOT) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum",Liquid AST,2,"October 22, 2008", 2008,"Pointe Scientific, Inc.","The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.",N/A,109,109 kits,"Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.",Terminated,"November 27, 2009",401,134,Not_Computer,N/A,N/A,N/A
Z-0182-2009,49514,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted device to support a medical grade flat panel monitor or camera in the patient area. The Circlip within the flat panel and navigation arms is part of the mechanical stop designed to prevent the arm from rotating infinitely. It also prevents the cables routed through the arm from becoming twisted during routine movement and rotation of the arm.,Circlip,2,"October 22, 2008", 2008,Stryker Communications Corp,Circlip component used to suspend flat panel and navigation arm system may become dislodged.,DESIGN: Device Design,"Notification letter was sent to consignees September 5, 2008. Field service will be performed at all affected sites. Old Circlips will be replaced with new clamps that do not allow the arm to fall. Contact Stryker Communications Corp. at 1-972-410-7310 for assistance.",N/A,705,705 units,Nationwide and International Distribution,Terminated,"October 02, 2009",345,705,Not_Computer,N/A,N/A,N/A
Z-0183-2009,49540,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.,Bard Vacora Biopsy Vacuum Assisted Biopsy Probe,3,"October 22, 2008", 2008,Bard Peripheral Vascular Inc,Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option.,DESIGN: Device Design,"Product Recall Notification Letter sent dated September 11, 2008 Attention: Risk Managers ""All VB10118 and VB10140 catalog numbers with expiry dates prior to September 2008 are now beyond their expiration date. In accordance with accepted medical practice, they should have been discarded and not used. Do not use or further distribute any affected products. Once the product affected by the recall has been removed from your inventory; fill out the recall & effectiveness check form, call Silvia Carrillo at 1-800-321-4254 ext 2727 to issue your with either a Return Authorization Number or Consignment Recall Number. fax the form to BVP at 1-800-440-5376.",N/A,225,225,"Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.",Open,N/A,N/A,225,Not_Computer,N/A,N/A,N/A
Z-0181-2009,49464,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet brand Modular Microplasty Cup Inserter, 3/8"" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.",Biomet brand Modular Microplasty Cup Inserter,2,"October 24, 2008", 2008,"Biomet, Inc.",The pin and clip may fracture during use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.",N/A,85,85,"Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.",Terminated,"September 22, 2009",333,85,Not_Computer,N/A,N/A,N/A
Z-0173-2009,49393,"system, test, vitamin d",MRG,Vitamin D test system.,Clinical Chemistry,Clinical Chemistry,510(k),"IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma",IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay ,3,"October 24, 2008", 2008,Immunodiagnostics Systems Inc,A small number of customers have experienced low absorbance values when using kits from this batch.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.",N/A,691,691 kits,Nationwide,Open,N/A,N/A,691,Not_Computer,N/A,N/A,N/A
Z-0196-2009,49549,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"26"" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San JoseIntended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.",Vision Elect HDTV Surgical Viewing Monitor,3,"October 24, 2008", 2008,Stryker Endoscopy,"Knob parts stick together, resulting in poor functionality of the knob.",DESIGN: Device Design,"Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.",N/A,2265,2265 devices,"Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and countries of Australia, Canada, China, England, France, Germany, Greece, Iberia, India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia, Singapore, South Africa, Switzerland, and Taiwan.",Open,N/A,N/A,2265,Not_Computer,N/A,N/A,N/A
Z-0199-2009,49565,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.,Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra,2,"October 24, 2008", 2008,"B. Braun Medical, Inc.",Product was assembled incorrectly and connected to the wrong part.,TRAINING: Employee Error,"The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the ""Product Removal Acknowledgement"" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.",Contact the recalling firm for information,3900,3900 units,"Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.",Terminated,"May 05, 2009",193,3900,Not_Computer,N/A,N/A,N/A
Z-0174-2009,49360,"lancet, blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.",Premier Value,2,"October 27, 2008", 2008,Facet Technologies,The Alternate Site Cap was not included in the package as indicated on the labeling.,PRODUCTION CONTROLS: Error in Labeling,"The consignees were notified by letter on/about 7/18/2008. The Return Material Authorization number was communicated to the customer. They were asked to place the items on hold and Can Am will obtain any quantities. The Returned Product Mechanics Process will: Inventory will be sent back to Facet in two stages, Inventory on hand at Cimetra will be sent back to Facet, Inventory received back from customers will be sent back to Facet in one shipment 30-60 days after notice. Inventory received back after this second shipment will be destroyed.",N/A,2976,2976 units,Nationwide--GA and FL.,Terminated,"August 24, 2009",301,2976,Not_Computer,N/A,N/A,N/A
Z-0185-2009,49446,"stimulator, electrical, implanted, for parkinsonian tremor",MHY,N/A,N/A,Neurology,N/A,"Medtronic DBS"" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145Implant manual: DBS"" Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.","Deep Brain Stimulation (DBS"") Lead Kits",2,"October 27, 2008", 2008,Medtronic Neuromodulation,"Medtronic has received reports of DBS"" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d",DESIGN: Process Design,"Consignees were sent a ""Medtronic Urgent: Medical Device Correction"" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment ""Updated Instructions for Using the Lead Cap"". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.",N/A,4591,4591,"AL, AZ, AR, CA, CO, CT, FL, DC, GA, HI, ID, IL , IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE , NV, NH, NJ, NM, NY, NC, ND, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI.ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROATIA, CYPRESS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, LUXEMBOURG, MEXICO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Open,N/A,N/A,26313,Not_Computer,N/A,N/A,N/A
Z-0189-2009,49456,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology applications.",Symbia T6 System,2,"October 27, 2008", 2008,"Siemens Medical Solutions USA, Inc.","The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 9/29/08 to all users of the Symbia T6 and Symbia T16 Systems. The accounts were informed of the potential risk that the protective plastic cap over the CT gantry power switch could come loose, causing an electrical hazard. The customers were advised to avoid contact with the gantry power switch until the protective plastic cap has been replaced, and to leave the power switch on at the line connection box and cycle the CT gantry on and off by toggling the CT gantry circuit breaker within the circuit box. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective update to their Symbia system free of charge. The accounts were requested to complete and return the enclosed mandatory fax-back form to 1-865-218-3019, acknowledging the receipt and understanding of the 9/29/08 letter and providing their Symbia System model number and serial number. Contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 for assistance.",N/A,11,11 units,"Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland.",Terminated,"December 09, 2009",408,21,Not_Computer,N/A,N/A,N/A
Z-0200-2009,49581,"generator, high-voltage, x-ray, diagnostic",IZO,Diagnostic x-ray high voltage generator.,Radiology,Radiology,510(K) Exempt,"Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems.General-purpose radiographic system component used to suspend the system's image monitor.","Monitor suspensions used with Advantix Legacy, RFX Classical, SFX90",2,"October 27, 2008", 2008,GE Healthcare,"GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, 1995 did not have the required thread locking agent applied to the setscrew, allowing the setscrew to back out over time, which can lead to the monitor dropping",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were sent a GE Healthcare ""Product Safety Notification"" letter dated September 13, 2007. The letter was addressed to Hospital Administrators/Managers of Radiology/Radiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information. The letter recommends that customers move the monitor suspension to an open area in the room where viewing is still possible and make sure to minimize the movement of the monitor until a Qualified GE Healthcare Field Engineer has inspected the suspension. The letter also states that a Qualified GE Healthcare Field Engineer will schedule a field visit to inspect the monitor suspension. Customers should contact their sales or service rep is they have any questions.",N/A,21,21,"Worldwide Distribution --- USA including states of AZ, CA, FL, GA, IA, MD, MO, NC, NY, OH, OK, TN, TX,WI, and LA, and country of Slovak Republic.",Open,N/A,N/A,21,Not_Computer,N/A,N/A,N/A
Z-0162-2009,49566,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.",VISTA Negative Pressure Wound Therapy Charger,2,"October 27, 2008", 2008,"Smith And Nephew, Inc. Wound Management Division",External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Each consignee was notified by recall letter (Field Correction Notification) dated 8/7/08 via FEDEX overnight. Within five (5) working days of the date of the customer notification a Smith & Nephew representative will contact the customers to assess their inventory and schedule delivery of replacement battery chargers. Contact Smith & Nephew, Inc. (Customer Care Center) at 1-800-876-1261 for for assistance.",N/A,2550,"2,550","Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.",Terminated,"October 01, 2009",339,2550,Battery,N/A,Replace chargers,Remove or Replace
Z-0202-2009,49578,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.,Oxylog 3000,2,"October 27, 2008", 2008,"Draeger Medical, Inc.",May experience an interruption of ventilation for approximately 5 seconds,DESIGN: Software Design,"The firm issued an Urgent - Medical Device Recall letter dated September 2008. Software version 1.10 may under specific conditions experience an interruption of ventilation for approximately 5 seconds. During that time period, the patient airway pressure may drop to zero. This phenomenon was identified by Draeger engineers and to date has not been reported by any user. The firm's investigations revealed that when ventilating in BIPAP mode with the pressure rise time (Ramp) set to the highest setting and the expiration time set to exactly 0.5 seconds, the inspiration phase can coincide with the internal auto zero function of the device. Under these circumstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.",N/A,50,50 units,"Nationwide Distribution --- including states of AZ, CA, FL, IL, IN, KY, LA, ME, MI, MO, NC, NE, NJ, NY, OH, PA, TX, UT, VT, WA, WV, and WY.",Terminated,"October 16, 2009",354,50,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0153-2009,49444,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool;IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35;DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630Monoaxial Screw Winged, Size 6 x 30;DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm HexIntended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.",Allez Spine Laguna Pedicle Screw System,2,"October 28, 2008", 2008,"Allez Spine, LLC",This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.,DESIGN: Process Design,"Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration.The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.",N/A,6472,6472 units for all systems,"Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.",Terminated,"January 19, 2010",448,6472,Not_Computer,N/A,N/A,N/A
Z-0118-2009,49403,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x.The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.",iSite PACS software versions 3.6.28.x and 4.1.x.,2,"October 28, 2008", 2008,"Philips Healthcare Informatics, Inc.",Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot,DESIGN: Software Design,"A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.",N/A,27,27 units.,"Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.",Open,N/A,N/A,27,Software,Output/Calculation,Software update,Software Update
Z-0176-2009,49406,"catheter, femoral",LFK,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-001. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE¶_ Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.",VCARE,2,"October 28, 2008", 2008,ConMed Corporation,The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The domestic recall notices were mailed on 9/08/08 by USP Priority Mail pouches. The international notices were sent via FedEx International Priority on 9/08/08. The letter described the problem, the health risk and requested that customers inventory the product and return them back to the firm. Customers are requested to fax the reply form to the firm. Contact ConMed Corporation at 1-800-765-8375, ext 3237 for assistance.",N/A,32453,"32,453 (total devices)","Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland",Open,N/A,N/A,32453,Not_Computer,N/A,N/A,N/A
Z-0191-2009,49497,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Osteosynthesis Reduction Spoon;1 single unit to a package; non-sterile;Stryker Trauma GmbH, 2432 Schonkirchen, Germany.Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.",Stryker Osteosynthesis ,2,"October 28, 2008", 2008,Stryker Howmedica Osteonics Corp.,Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.,DESIGN: Process Design,"Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.",N/A,1070,1070 units,Nationwide,Open,N/A,N/A,1070,Not_Computer,N/A,N/A,N/A
Z-0132-2009,49520,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.",Philips Medical,2,"October 28, 2008", 2008,Philips Medical Systems (Cleveland) Inc,Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images.,DESIGN: Process Design,On 9/8/2008 Philips Medical Systems sent recall notification letters to their customers requesting they inventory their stock. They sent instructions to verify that the product is working properly. They are also sending Field Service Engineers to each customer to conduct field test.,N/A,507,507 units,"Worldwide distribution: USA, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic, Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea, Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa, Saudi Arabia, Spain, Switzerland, Sweden, and Thailand.",Open,N/A,N/A,507,Not_Computer,N/A,N/A,N/A
Z-0130-2009,49558,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.",Adelante,2,"October 29, 2008", 2008,"Oscor, Inc.","Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.",DESIGN: Process Design,Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.,N/A,396,396,Product was distributed to one direct account in MN.,Terminated,"December 09, 2008",41,396,Not_Computer,N/A,N/A,N/A
Z-0150-2009,49056,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges.LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.",LIFEPAK Express AED,2,"October 30, 2008", 2008,"Physio Control, Inc.",The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.,N/A,"On 07/24/08, the firm sent an ""URGENT MEDICAL DEVICE RECALL"" letter with a confirmation sheet via certified return receipt to customers. The letter notified the customer of the recall and the hazard associated with the recall and provided instructions to customers: 1) Immediately verify the AED powers on and voice prompts begin. After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. 2) Keep the AED in use and perform monthly inspections that include the additional AED power on test. Perform a monthly inspection which is consistent with the device labeling. 3) If ""OK"" is visible on the Readiness Display and AED powers on, it is ready for use. 4) If, at any time, the AED does not power on or if any other indicator displays (i.e. battery or CHARGE-PAK symbol, attention symbol or wrench symbol) immediately call Physio-Control Technical Support (1-800-442-1142). The letter advises customers a Physio-Control representative will contact them within 60 days to arrange a replacement. A confirmation sheet was sent with the letter; to be returned to Physio-Control, Inc. For specific questions or additional information, contact Physio-Control, Inc. at 1-800-442-1142 weekdays between 6:00 a.m. and 4:00 p.m. (PST) or at www.physio-control.com.",Contact the recalling firm for information,2230,"2,230 Units","Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.",Open,N/A,N/A,39020,Not_Computer,N/A,N/A,N/A
Z-0205-2009,44852,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.",Terumo APS 1,2,"October 31, 2008", 2008,Terumo Cardiovascular Systems Corporation,"Local pump controls including start/stop button, select button and manual button may not function.",DESIGN: Component Design/Selection,Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.,N/A,626,626,"Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",Terminated,"July 07, 2009",249,926,I/O,N/A,Instructions,Safety Notice/Insructions
Z-0207-2009,48174,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include:1) Autoverify results directly from analyzers and reference laboratories2) Track tubes and containers from order to final disposition3) Monitor key metrics such as turnaround time and utilization using management reports4) Produce pathology results with Structured Reports5) Suggest microbiology workups online according to defined SOPs and rules6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools7) Any change to patient results (inquiry, reports) is logged and available for review",Sunquest Laboratory ,2,"October 31, 2008", 2008,"Sunquest Information Systems, Inc.",Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat,DESIGN: Software Design,"Customers were sent a preliminary notice on 4/17/2008 followed by customer notice PSN-08-04 on 05/07/2008 via email. The notice advises that this notice is follow-up to the Preliminary notice distributed on 4/17/08 and applies to all clients who have an Instrument Generated Order (IGO) interface.Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong patient. When this occurs, Sunquest generated reports and inquiry contains the incorrect results.The letter provides the various steps that cause the issue to occur. Sites Potentially Affected by this Problem:Sunquest Laboratory using Instrument Generated Orders (IGO) Interface, Version 5.3 and laterAction Sunquest Information Systems is taking to eliminate this Problem:Change Request 1-62VWLJ has been created to address this issue. This will be available as part of Sunquest Laboratory Instrument Build version 1.6.0023 and later.To request the software correction, customers can create a Service request via the Client support Webpage at www.sunquestinfo.com/supportweb. The notice also provides temporary procedural instructions:Effective immediately, do NOT perform Online File Cleanup (OFC) on any IGO instrument interface methods.-Manual OFC should not be performed using functions OFC, or Instrument Maintenance (IX or IXM), option 11 for IGO interfaces only.-If using function Instrument Maintenance (IX or IXM), option 1, 2, 2, Method, 2 (Automatic File Cleanup). This should be set to ""N"". Then stop and re-start the Instrument Results Processor.Note: Online file cleanup for non-IGO interfaces needs to be performed as usual.-Pending and Overdue Logs need to be monit.",Contact the recalling firm for information,419,419 clients had the affected code,"Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia.",Open,N/A,N/A,419,Software,Output/Calculation,Software update,Software Update
Z-0224-2009,49466,"hexokinase, glucose",CFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry),Glucose Hexokinase (Hitachi) Reagent HEX,2,"October 31, 2008", 2008,"Pointe Scientific, Inc.",The inability of the product to maintain stated performance specifications through the stated shelf life.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.",N/A,8,8,"Nationwide, Canada, China, Romania and Trinidad.",Terminated,"November 27, 2009",392,131,Not_Computer,N/A,N/A,N/A
Z-0226-2009,49470,"system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen",NQX,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.",BD GeneOhm MRSA ,2,"October 31, 2008", 2008,"BD Diagnostics (GeneOhm Sciences, Inc)",BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphylococcus aureus.The potential health hazard related to a false positive result from this assay would be that a patient may be misclassified as having MRSA colonization when in fact they do not have,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BD Diagnostics GeneOhm (BDDG) initial recall notification was made on 07/21/2008 by telephone and followed up with written notification on 07/22/2008. Domestic customers were advised to check their stock to determine if they have inventory remaining of the recalled lot. If so, BD GeneOhm Technical Service will arrange for return of unused product from the customer. The were provided with a Recall Verification form to complete and return. The customers were instructed if they have remaining tests from the affected referenced lot, please discontinue use immediately. They were also told that BD GeneOhm recommend that they review the results of samples tested using this lot of product. Look for any trends outside of the normal expected results, including any changes in MRSA positivity rates compared to your normal prevalence. If they have any questions or concerns following the review, please contact BDDG Technical Service to arrange for consultation with our Medical Director.An telephone number 1-858-334-6356 was given for customers to contact BDDG Technical Service.",N/A,60,60 kits (48 test/kit) =2880 test,"Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium",Terminated,"March 04, 2010",489,77,Not_Computer,N/A,N/A,N/A
Z-0279-2009,49392,"catheter, peripheral, atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(k),"Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol needle that is used to re-enter the true lumen of the vessel.",LuMend OUTBACK LTD ,2,"October 31, 2008", 2008,Cordis Corporation,The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.,DESIGN: Process Design,"U.S. Customers - A Notification of Recall Letter with an Acknowledgement Form was sent overnight to 5 individuals in each account on 08/18/2008. For non-U.S. customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries (08/18/2008). Contact Cordis special Customer Service at (800) 551-7683 for assistance.",N/A,11893,"11,893",Worldwide,Terminated,"December 01, 2008",31,11893,Not_Computer,N/A,N/A,N/A
Z-0227-2009,49484,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Hipstar V40 Femoral StemHowemedica:Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.",Hipstar V40 Femoral Stem,2,"October 31, 2008", 2008,Stryker Howmedica Osteonics Corp.,"The warning label ""do not use with heads more than +10, offset"" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Recall notification letters were sent by Fed Ex on August 20, 2008 to Stryker branches/agencies and Hospital Risk Management departments. Letters to Branches stated the reason for the recall and the potential hazard. Both letters state that it is recommended that physicians follow patients in a manner that is consistent with a physicians routine standard of care for total hip arthroplasty. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5000 for assistance.",N/A,77,77 units,Nationwide,Terminated,"June 01, 2009",213,77,Not_Computer,N/A,N/A,N/A
Z-0192-2009,49515,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Hydrophobic HALO360 Filter that ispackaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.",HALO360 Ablation Catheter,2,"October 31, 2008", 2008,"Barrx Medical, Inc.","Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.",N/A,650,650 units,"Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .",Open,N/A,N/A,650,Not_Computer,N/A,N/A,N/A
Z-0228-2009,49492,"flowmeter, tube, thorpe, back-pressure compensated",CAX,Compensated thorpe tube flowmeter.,Anesthesiology,Anesthesiology,510(K) Exempt,Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assembly features a non-breathing valve and an Emergency Air Intake located on the bag tee which comply with the American Dental Association guidelines.,Bag Tee Assembly,2,"October 31, 2008", 2008,Porter Instrument Co Inc,inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas,TRAINING: Employee Error,"On 9/2/08, the firm issued an Important Field Correction Notice to their customers informing them of the problem and how to determine if their product was defective and needed to be returned. Contact Porter at 1-800-457-2001 and ask for Dental Customer and refer to the Bag Tee Field Correction Notice.",N/A,220,220 units,Nationwide,Terminated,"September 24, 2010",693,220,Not_Computer,N/A,N/A,N/A
Z-0271-2009,49525,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS CORP 12740 San Fernando Rd. Sylmar, CA 91342 USA. The Precision Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable 16-output, multi-channel stimulator (IPG - Implantable Pulse Generator) with a rechargeable battery power source. The IPG, commonly implanted in the abdomen or buttock area (less frequently in the subclavicular area), can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. An externally used Charger is utilized to transcutaneously recharge the IPG (Implantable Pulse Generator) battery. Currently, Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For improved heat management, Charger 2.0 is equipped with thermistor (temperature sensing component), designed to activate/deactivate charging at a set temperature.",Precision Charger 1.0 ,2,"October 31, 2008", 2008,Advanced Bionics Corp,"Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on",OTHER/UNDETERMINED: Pending,"In the United States, notification will be sent to patients with the affected devices. Additionally, their physicians on record will be provided with the notification. The Company is currently planning to initiate this field action on September 22, 2008. The U.S. notification will be sent via Fed Ex or U.S. Postal Service certified mail. The letter advises that Boston Scientific Neuromodulation is voluntarily recalling its first generation charging device, Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System. The Charger 1.0 devices are being recalled and will be replaced with the new second generation Precision Charger 2.0 (SC-5312, currently in distribution) that features a temperature limiter for improved temperature management. The Charger 1.0 can be used until replacement with Charger 2.0 by following the instructions on Page 2 of the letter. Customers are asked to complete the acknowledgement form at the end of the letter and return it to Boston Scientific in the return envelope provided. A representative from Boston Scientific will contact them upon receiving the completed form to schedule an in-person visit at their physician's office to exchange the device. Contact Boston Scientific Technical Serives at (866) 566-8913 for assistance.",N/A,6549,6549 units,"Nationwide and Internationally - Ireland, Korea, Mexico, The Netherlands, United Kingdom, Canada, Australia and Israel",Open,N/A,N/A,6549,Not_Computer,N/A,N/A,N/A
Z-0212-2009,49385,"antigens, cf (including cf control), influenza virus a, b, c",GNX,Influenza virus serological reagents.,Microbiology,Microbiology,510(K) Exempt,"BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027",In vitro diagnostic for influenza A and B. ,2,"November 03, 2008", 2008,Inverness Medical BioStar Inc.,Diagnostic kits for flu were distributed with incorrect components.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.",N/A,509,509 kits,Nationwide Distribution --- including state of IL.,Terminated,"November 04, 2008",1,509,Not_Computer,N/A,N/A,N/A
Z-0201-2009,49590,N/A,N/A,N/A,N/A,N/A,N/A,"Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.",VIBE,1,"November 03, 2008", 2008,VIBE Technologies,"Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.",N/A,"Vibe Technologies notified their customers by letter on October 1, 2008 and were told to discontinue use as a medical device. This letter notification included: 1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such.2. An updated operation manual/users guide containing no medical conditions or human body claims.3. A certification to be signed by the user and returned acknowledging that they: received the letter; affixed the warning label to the Vibe machine; understand that the Vibe machine does not affect the structure/function of the human or animal body; will not promote the Vibe machine as a medical device; will remove any medical claims from their website; destroy any Vibe literature making medical claims. Approximately three weeks after the certified mailing, the firm will begin performing recall effectiveness checks.",Contact the recalling firm for information,851,851 units,Worldwide,Open,N/A,N/A,851,Not_Computer,N/A,N/A,N/A
Z-0131-2009,49531,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).",18 gage XTW needles,2,"November 03, 2008", 2008,Thomas Medical Products Inc,Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.,PRODUCTION CONTROLS: Process Control,"On 9/11/08, Thomas Medical Products issued letters to the distributors informing them of the problem, to cease distribution and await further instructions. Additional instructions to the distributors were to notify all their account via an advisory notice and request that the user not use the needle supplied with the kit and to replace with another commercially available sterile 18 gage introducer needle.",N/A,246585,"246,585 needles","Nationwide distribution via distributors in CA, MA, and MN.",Terminated,"May 06, 2009",184,246585,Not_Computer,N/A,N/A,N/A
Z-0278-2009,48739,"drink, glucose tolerance",MRV,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"S/P¶_ Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.",S/P Orange ,2,"November 04, 2008", 2008,Nerl Diagnostics LLC,Beverage may contain glass particles.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The recalling firm notified distribution centers by letter dated 04/23/08 and advised of a single report of glass found in a bottle. The notifications further advised distributors to quarantine referenced product, notify their customers and return the enclosed reply form. Distributors were requested to return or destroy product for replacement. Please contact NERL Diagnostics, LLC at 1-401-824-2046 for assistance.",N/A,25908,25908 bottles,Nationwide.,Open,N/A,N/A,25908,Not_Computer,N/A,N/A,N/A
Z-0137-2009,49426,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Bicor X-Ray System, Model number 9023136.",Bicor XRay System,2,"November 04, 2008", 2008,"Siemens Medical Solutions USA, Inc",Unintended movement of the system table and/or C arm.,DESIGN: Software Design,Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.,N/A,20,20 units,Nationwide.,Terminated,"April 16, 2009",163,975,Computer,N/A,N/A,N/A
Z-0193-2009,49529,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),AXIOM Artis. Angiographic X-ray System.,Axiom Artis,2,"November 04, 2008", 2008,"Siemens Medical Solutions USA, Inc","Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.",DESIGN: Labeling Design,"The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table.For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.",N/A,1530,"1,530 units",Nationwide Distribution.,Terminated,"September 23, 2009",323,1638,Not_Computer,N/A,N/A,N/A
Z-0282-2009,50113,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.",HT XDRIVE SCREW,2,"November 04, 2008", 2008,"Biomet Microfixation, Inc.","The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.",PRODUCTION CONTROLS: Labeling Mix-Ups,"An ""Urgent Medical Device Recall Notice"" was sent to customers on 07/11/2008 by certified letter. The letter described the problem, the risk and asked that customers discontinue use of the product and return them to Biomet. Also, customers were provided with a Inventory Reconciliation sheet and asked to fax it back to Biomet. Please contact Biomet Microfixation at 1-800-874-771 or 904-741-4400, ext. 448 for assistance.",N/A,10,10,Nationwide and Canada,Terminated,"September 11, 2009",311,10,Not_Computer,N/A,N/A,N/A
Z-0213-2009,49440,"system,network and communication,physiological monitors",MSX,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB05 software.GE Healthcare 8200 West Tower Avenue, Milwaukee, WI 53223Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda network or Unity Network and Web Viewer clients.Web Viewer can be used for viewing or otherwise processing information from several bedside monitors or other networked devices.Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other network devices.Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.","Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT",2,"November 05, 2008", 2008,GE Healthcare,Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server could cause excessive CIC Pro memory consumption. This excessive memory consumption may lead to potential loss of audio at the CIC or a system reset or reboot. Issue 2 - Mobile Care software/Mobile Viewers don not recognize ApexPro FH Telemetry transmitter: Mobile Care server does not ac,DESIGN: Software Design,"Consignees contacted via a GE Healthcare Urgent Medical device Correction letter dated 8/26/08 and supplemental instruction for installation of software"" Mobile care server with software, L-WEB05 and iCentral with software, L-NET05 supplemental Instruction for installation"". The letter was addressed to Healthcare Administrator/Risk manger, chief of Nursing and director of Biomedical engineering / IT. The letter also described the problem, affected Products,and Short Term Recommendations .",N/A,292,292,"Worldwide Distribution --- USA including states of CALIFORNIA, IOWA, INDIANA, VERMONT, and WASHINGTON and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CROATIA, CYPRUS, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, and UNITED KINGDOM.",Open,N/A,N/A,292,Software,Alarm/Message,Software update,Software Update
Z-0273-2009,49554,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Gyrus ACMI, Inc. dissector PlasmaKnife (DPK)Catalog No: 7035-3005A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.",dissector PlasmaKnife (DPK),2,"November 05, 2008", 2008,Gyrus ACMI Corporation,Sterility may be compromised,PRODUCTION CONTROLS: Process Control,"Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.",Contact the recalling firm for information,1340,1340 units,"Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.",Open,N/A,N/A,1340,Not_Computer,N/A,N/A,N/A
Z-0284-2009,49606,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"ReliOn Insulin syringes - 1cc, 31 GDistributed by: Can-Am Care, Corp., Alpharetta, GA",ReliOn,1,"November 05, 2008", 2008,Covidien LP,Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.,DESIGN: Process Design,"Tyco Healthcare Group LP (Covidien) notified Can-Am Care, Corp. by letter sent by e-mail and by Federal Express on 10/9/08. The letter requests that they immediately inventory, quarantine any remaining stock they may have of the product, return, and notify their customers. Wal-Mart conducted a consumer mailing on October 14, 2008, and is posting placards in their stores. Can-Am Care, whose name appears on the label of the product has concurrently posted a recall notice on their website.",N/A,471000,"471,000 (4710 boxes of 100)",Nationwide,Terminated,"July 06, 2010",608,471000,Not_Computer,N/A,N/A,N/A
Z-0188-2009,49448,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table",Alphastar ,2,"November 05, 2008", 2008,MAQUET Inc.,Table tilts: The Alphastar Surgical Table piston rod head may break and cause a full inclination of the table top during Trendelenberg positioning if there is insufficient lubrication.,PRODUCTION CONTROLS: Equipment Maintenance,"Maquet sent Recall Notification letters to all customers on September 16, 2008 by Federal Express. Letters inform customers of the potential problem with the Alphastar tables, a description of the failure and hazards involved. Hospitals are asked to confirm whether yearly maintenance by an authorized technician have been performed. If preventive maintenance has not been performed, customers are requested to contact their Maquet Service rep. A Customer Service Response form is included and customers are to complete if to acknowledge whether of not the facility is still in possession of an affected table. If so, the model number, serial number and facility name & address is to be completed so that Maquet reps can visit the facility and perform the corrective action.",N/A,141,141 in US,Nationwide,Terminated,"January 12, 2010",433,141,Not_Computer,N/A,N/A,N/A
Z-0203-2009,44851,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.",Terumo APS 1,2,"November 06, 2008", 2008,Terumo Cardiovascular Systems Corporation,"The pumps may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.",PRODUCTION CONTROLS: Process Control,Consignees were notified via letter dated 7/18/08 and instructed to use the central control module should the problem occur. Contact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.,N/A,626,626,"Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",Terminated,"July 07, 2009",243,926,Other,Device Operation,Notification,Safety Notice/Insructions
Z-0274-2009,49600,"laser, ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(k),"PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.",Next Generation Laser,2,"November 06, 2008", 2008,"Alcon Laboratories, Inc.","Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.",TRAINING: Employee Error,"An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual:Updated:""AMD; Wet or Dry to include macular degeneration"" has been updated to read ""Choroidal neovascularization secondary to age-related macular degeneration (AMD)"".""Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle ClosureGlaucoma (AACG), and refractory glaucoma"" has been updated to read ""Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma""Removed:Macular photocoagulation; including grid, focal, laser drusen scatter (panretinal)Transcleral cyclophotocoagulationIntra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastomaOtosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.",N/A,41,41 units,"Worldwide Distribution --- USA including states of IL, WI, TX, MI, PA, NY, CT, SC, NC, LA, FL, GA, CA, OR, WA, CO, and NV, and countries of India, Bulgaria, Barbados, and Dominican Republic.",Open,N/A,N/A,41,Not_Computer,N/A,N/A,N/A
Z-0209-2009,49092,"tube, collection, capillary blood",GIO,Capillary blood collection tube.,Hematology,Hematology,510(K) Exempt,"Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090.Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.",Iris Sample Processing SafeCrit 40mm Tubes,2,"November 07, 2008", 2008,Drummond Scientific Co,presence of OSCS contaminant,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.,N/A,4000,4000 vials,Nationwide Distribution --- including states of FL and MA.,Terminated,"December 18, 2008",41,19000,Not_Computer,N/A,N/A,N/A
Z-0281-2009,49451,"accessories, cleaning, for endoscope",FEB,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.",ASP Automatic Endoscope Reprocessor ,2,"November 07, 2008", 2008,Advanced Sterilization Products,"Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor. If high-level disinfectant, or other fluids, remains in the endoscope after reprocessing, contact with the mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms.",DESIGN: Component Design/Selection,"ASP is mailing customer notification CL-101367 and AD-52976-001 in an Urgent Product Correction envelope starting the week of September 8, 2008. The letter advises that the firm has received customer reports of residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor (AER). If high-level disinfectant, or other fluids, remain in the endoscope after reprocessing, contact with patient mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms. ASP has tested the PENTAX 70 series endoscopes containing FWJ (Forward Water Jet) and has confirmed that residual fluids may remain in the PENTAX 70 series endoscopes with a FWJ after reprocessing. To eliminate any residual fluids, ASP is recommending customers follow the revised instructions when reprocessing PENTAX 70 series endoscopes with a FWJ. A copy of the revised instructions is provided with the notification letter.",Contact the recalling firm for information,367,"1,578 units installed in the US and 367 units installed internationally","Worldwide Distribution --- including USA and countries of Italy, UK, Uruguay, Argentina, Chile, Colombia, Ecuador, Puerto Rico, Mexico, Australia, China, Singapore, Taiwan, Middle East, Canada, Czech Republic, Portugal, South Africa, Spain, Hungary, Poland, Brazil, Russia, Egypt, and Slovenia.",Open,N/A,N/A,1954,Not_Computer,N/A,N/A,N/A
Z-0215-2009,49371,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"VACUETTE¶_, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.",VACUETTE,3,"November 07, 2008", 2008,"Greiner Bio-One North America, Inc.","Labeling Error: Incorrect tube label reads ""Z Serum Clot Activator"" instead of ""LH Lithium Heparin"" tube.All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The ""Product Disposition Form"" must be completed by the consignee and returned to Greiner Bio-One North America, Inc.For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800.",Contact the recalling firm for information,33,"33 cases (39,600 pieces)","Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada.",Terminated,"August 26, 2009",292,33,Not_Computer,N/A,N/A,N/A
Z-0283-2009,49475,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),"One Touch Ping Glucose Monitoring SystemCombines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.",One Touch Ping Glucose Monitoring System,2,"November 07, 2008", 2008,Animas Corporation,"display old, inaccurate values for bolus amount delivered and amount of planned bolus totals",DESIGN: Software Design,"On 8/6/08, the recalling firm telephoned all users to inform them of problem and the need to return the system.",N/A,251,251 units,Nationwide Distribution,Terminated,"November 12, 2008",5,251,Other,Display/Image,Return,Remove or Replace
Z-0197-2009,49553,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)",Lap Appy TraceCart,2,"November 07, 2008", 2008,DeRoyal Industries Inc,Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.",N/A,4,4 kits,LA & KY,Terminated,"December 02, 2009",390,34,Not_Computer,N/A,N/A,N/A
Z-0280-2009,49575,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),7F Bard SSV 13 cm Split Sheath with Valve and sideportCatalog Number: 808700Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and catheters, Bard SSV Split Sheath with Valve Introducer System ,2,"November 07, 2008", 2008,"C. R.Bard, Inc./BardElectrophysiology Division",Failure to insert the guidewire through the introducer needle.,PRODUCTION CONTROLS: Process Control,Bard issued a recall notice on 1 October 2008 [note that the letter is dated 29 September 2008] to all recipients of affected product via certified mail. Users are requested to discontinue use and return inventory. Contact Bard Customer Service at 1-800-824-8724 for assistance.,N/A,3105,"3,105 kits",Nationwide,Terminated,"March 09, 2010",487,3105,Not_Computer,N/A,N/A,N/A
Z-0295-2009,49604,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195215. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base.Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.",Terumo Perfusion System,2,"November 07, 2008", 2008,Terumo Cardiovascular Systems Corporation,"The level sensor may not properly couple to the reservoir, resulting in a sensor ""not attached"" message, an alert or alarm condition, or a failure to detect a low level condition.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008.For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.",N/A,574,574,"Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.",Terminated,"August 04, 2009",270,1121,Not_Computer,N/A,N/A,N/A
Z-0275-2009,49602,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20.Intended for partial or complete removal of tissue samples for diagnostic testing.",ATEC Breast Biopsy and Excision System ,2,"November 07, 2008", 2008,"Hologic, Inc.","The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.",PRODUCTION CONTROLS: Process Control,"Consignees were notified via an Urgent Medical Device Recall letter dated 9/17/08 asking them to immediately check their inventories and quarantine all affected product from the listed lots. Also, if the product had been further distributed, users were to be identified and notified of the recall. Products are to be held in quarantine until they are returned to Hologic. The response form must be completed and returned to fulfill regulatory requirements and document actions taken at your facility. Handpieces whose pouches had been opened were to be destroyed, as they could potentially shift during transport and expose dangerous sharp points to personnel handling the boxes. Upon receipt of the attached response form, Hologic will promptly send an equivalent amount of replacement product free of charge.",N/A,5120,"5,120 (1,024 cases of 5)","Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.",Terminated,"November 18, 2009",376,5120,Not_Computer,N/A,N/A,N/A
Z-0276-2009,50068,digital display monitor,RHF,N/A,N/A,N/A,N/A,"Barco Surgical Display, Model MDSC-2124The 24-inch MDSC-2124 is a near-patient surgical display that uses widescreen (16:10) LCD technology featuring full High Definition resolution (1920 x 1200). Featuring broad input connectivity, the MDSC-2124 offers a versatile display solution for HD endoscopy cameras, room and boom cameras, ultrasound, PACS and patient information.",Surgical Display,2,"November 07, 2008", 2008,Barcoview,The front protective cover may loosen and completely fall off.,DESIGN: Component Design/Selection,"Consignees were notified via a Field Safety Notice letter on 09/09/2008. They were instructed to inspect the units to check if the front panel is tightly secured to the display housing. Any front panel found to be lose or showing a gap between the front plate and the back shell of the monitor is to be reported the BARCO Service & Support organization and is to be secured using adhesive tape. Follow up Field Safety Notice was sent to consignees on 09/26/2008 indicating the root cause and the firm's corrective field actions implemented October 15, 2008.",N/A,25,25 units,"Nationwide Distribution --- including states of AK, GA, IL, and MA.",Terminated,"June 02, 2009",207,25,Not_Computer,N/A,N/A,N/A
Z-0287-2009,49571,"oxygenator, cardiopulmonary bypass",DTZ,Cardiopulmonary bypass oxygenator.,Cardiovascular,Cardiovascular,510(k),"NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.",NAMIC Custom Angiographic Kit,2,"November 09, 2008", 2008,Navilyst Medical,Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.,DESIGN: Process Design,"On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.",N/A,16220,"Domestic - 20 units; Foreign - 16,200 bulk units",Worldwide Distribution --- USA including state of MO and country of Ireland.,Terminated,"June 16, 2009",219,16220,Not_Computer,N/A,N/A,N/A
Z-0288-2009,49709,"cerclage, fixation",JDQ,Bone fixation cerclage.,Orthopedic,Orthopedic,510(k),"Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805.Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.",Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve,3,"November 09, 2008", 2008,"Biomet, Inc.","The outer package is properly labeled, but the inner package may be labeled as a femoral component.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed ""Dear Biomet Customer"" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.",N/A,48,48,"Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.",Terminated,"June 29, 2009",232,48,Not_Computer,N/A,N/A,N/A
Z-0218-2009,49463,"refrigerant, topical (vapocoolant)",MLY,N/A,N/A,Physical Medicine,510(k),"Gebauer's Fluro-Ethyl¶_ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl¶_ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.",FluroEthyl.,2,"November 12, 2008", 2008,Gebauer Company,Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user.,DESIGN: Component Design/Selection,"A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.",Contact the recalling firm for information,12717,"12,717 Units",Nationwide Distribution.,Terminated,"October 13, 2010",700,12717,Not_Computer,N/A,N/A,N/A
Z-0214-2009,49136,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.",Sunquest Laboratory System.,2,"November 12, 2008", 2008,"Sunquest Information Systems, Inc.","While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache)was not communicated or displayed in the Graphic UserInterface (GUI) application so the activity continued. While this error was registered in the error log in the SystemU",DESIGN: Software Design,"A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.",N/A,139,139,"Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.",Open,N/A,N/A,139,Other,Alarm/Message,Error trap setting correction,Repair
Z-0195-2009,49546,audiometer,EWO,Audiometer.,Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"GSI Audera (version 2.6 software) Viasys Healthcare, Inc.Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.",GSI AUDERA,2,"November 12, 2008", 2008,"Cardinal Health, Inc",GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction:GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using 2.6 software in split-screen mod,DESIGN: Software Design,"Consignees were sent a Cardinal Health ""Urgent: Medical Device Correction"" letter dated September 16, 2008 on 9/22/08 and 9/26/08. The letter was addressed to the Customer/Distributor. The letter instructed consignees to perform installations if they have the following software: 1) For Version 2.6 software, you must install Version 2.6.5 software to correct a Split- Screen performance issue and to remove the VEMP function. 2) For Version 2.0 or 2.1 software, you must install the Protocol Update Software to remove the VEMP function. Versions 2.0 and 2.1 do not contain Split-Screen capability. ""Attachment A-Verification Form"" must be completed by the recipient/distributor.If you need assistance in making the software revision determination or have further questions, please contact the Cardinal Health (formerly VIASYS) Neurocare/GSI Technical Support Group at 1-800-356-0007, 1-800-700-2282, 608-273-5000, or by e-mail at gsiservice@viasyshc.com or gsiservice@cardinalhealth.com.",Contact the recalling firm for information,297,297,Nationwide including states of AL AZ CA CO CT DC FL GA HI IA IA IL IN KS LA MA MD ME MN MO MS NC NC NH NJ NM NY OH OK PA RI SC TN TX UT VA WA and WI.,Open,N/A,N/A,297,Software,Device Operation,Software update,Software Update
Z-0216-2009,49427,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064.ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.",Architect LH MasterCheck.,3,"November 13, 2008", 2008,Abbott Laboratories,"The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements.",PRODUCTION CONTROLS: Error in Labeling,"A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Customer Reply Form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for the Architect LH MasterCheck testing, and fax it to Abbott by 9/19/08 at 1-800-777-0051. Follow-up telephone calls will be placed to customers who do not provide a written reply via the Customer Reply Form. U.S. Customers please contact Abbott Laboratories Customer Service at 1-877-422-2688 for questions regarding this information.",Contact the recalling firm for information,30,30 kits,"Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia.",Terminated,"March 18, 2010",490,30,Not_Computer,N/A,N/A,N/A
Z-0272-2009,49544,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. ""J"" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.",Bone Marrow Aspiration Kit,2,"November 18, 2008", 2008,Theken Spine LLC,The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.,EXPIRATION DATING: Incorrect or No Expiration Date,On 8/27/2008 the firm sent recall notification letters to each of their customers notifying them of the problem with the product. They were requested to return any remaining product back to the recalling firm and to call Customer Service at (866) 942-8698 for an RGA and to arrange shipment. On 8/28/2008 the firm conducted follow up contact each distributor via telephone.,Contact the recalling firm for information,115,115 total,"Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.",Open,N/A,N/A,115,Not_Computer,N/A,N/A,N/A
Z-0217-2009,49441,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile).Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ.The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.",REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM,3,"November 20, 2008", 2008,Stryker Spine,"The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.",N/A,183,183 units,Nationwide Distribution.,Terminated,"June 19, 2009",211,183,Not_Computer,N/A,N/A,N/A
Z-0303-2009,48712,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-02 and 00-6428-032-02.The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.",Zimmer Alumina Ceramic Femoral Head,2,"November 21, 2008", 2008,Zimmer Inc.,"When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.",DESIGN: Device Design,"The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.",N/A,49474,"49,474 of all products","Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.",Terminated,"November 10, 2009",354,49474,Not_Computer,N/A,N/A,N/A
Z-0004-2009,49413,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count.Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.",One Touch Ultra Test Strips,2,"November 21, 2008", 2008,Lifescan Inc,"Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.",PRODUCTION CONTROLS: Process Control,"Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.",N/A,35308,35308 vials,Nationwide Distribution --- including Puerto Rico.,Open,N/A,N/A,35308,Not_Computer,N/A,N/A,N/A
Z-0306-2009,49397,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.",CELLDYN Sapphire Hematology Analyzer,2,"November 21, 2008", 2008,Abbott Laboratories,Exposed wire resulted in minor electrical shock and burn to the service technician,DESIGN: Device Design,"Recall issued August 22, 2008. Technical service bulletin was issued for all field personnel via internal database. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area.",N/A,958,958 units,"Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.",Open,N/A,N/A,958,Not_Computer,N/A,N/A,N/A
Z-0297-2009,48628,"enzyme immunoassay, digoxin",KXT,Digoxin test system.,Toxicology,Toxicology,510(k),"AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02)The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.",AxSYM Digoxin II Reagent Pack.,3,"November 21, 2008", 2008,"Abbott Diagnostic International, Ltd.",AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file.The instrument might require installation of the AxSYM Digoxin II assay file.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"A Product Information letter, dated May 22, 2008, was issued to customers. It requested that one of the following two actions be taken if the AxSYM Digoxin II assay file is not installed on your AxSYM instrument and you want to run the AxSYM Digoxin II assay. If you have one of the previously manufactured software disks listed, [AxSYM Digoxin II Assay Disk, LN 2C43-01, or higher; or AxSYM TDM/Transplant Assay Disk Version 1.0 (3D53-01) or Version 2.0 (3D53-02)], install the AxSYM Digoxin II assay file. Do not install any other assay file. If you do not have one of the assay disks listed, contact your local Customer Service representative to have this assay file installed or install the file from a previous version if you have it on hand.",N/A,9069,9069 kits,"Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.",Open,N/A,N/A,9069,Computer,N/A,N/A,N/A
Z-0305-2009,49097,"incubator, neonatal",FMZ,Neonatal incubator.,General Hospital,General Hospital,510(k),"Giraffe OmniBed¶_, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.",GE Healthcare/Ohmeda Medical Giraffe OmniBed.,2,"November 21, 2008", 2008,"Datex Ohmeda, Inc. dba GE Healthcare",Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.,PRODUCTION CONTROLS: Equipment Maintenance,"A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed¶_¶_ cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual.Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.",N/A,7878,"7,878 beds",Worldwide Distribution: The devices were widely distributed to national and international medical facilities.,Terminated,"March 24, 2010",488,7878,Not_Computer,N/A,N/A,N/A
Z-0289-2009,49867,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN.A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.",Biomet Vanguard DCM PS Plus Tibial Bearing. ,2,"November 21, 2008", 2008,"Biomet, Inc.","The package is properly labeled, but the laser etch for size incorrectly reads ""16 X 63/63"" instead of the correct size, ""16 X 63/67"".",PRODUCTION CONTROLS: Error in Labeling,"A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem.Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).",N/A,11,11,"Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.",Terminated,"September 22, 2009",305,11,Not_Computer,N/A,N/A,N/A
Z-0340-2009,50073,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.",STERRAD 100S Sterilizer ,2,"November 21, 2008", 2008,Advanced Sterilization Products,1) Inability of the sterilizer to detect when an injectiontakes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstructionin the door travel path while the door is closing. This situation can result in a hand b,DESIGN: Component Design/Selection,"Customer notifications will be sent the week of November 24, 2008. The notification letter (URGENT: Product Correction) will advise of two situations that could cause the STERRAD 100S Sterilizer to malfunction. The first situation involves the failure of the STERRAD 100S System to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bowl. This can occur under combinations of the following conditions:- the pneumatic pressure is low on the machine, or- the injector valve has a small leak,AND- a cassette fails to advance, or- a used cassette is re-inserted into the sterilizer.This situation can result in a cycle completion with insufficient hydrogen peroxide. The second situation involves the failure of the STERRAD 100S System to detect an obstruction in the door travel path while the door is closing. Under some conditions, the door sensors may become mechanically unsecured/disconnected and will not detect an obstruction. This situationcan result in an operator's hand becoming pinched and bruised while the door is closing. To correct both situations above, Advanced Sterilization Products(ASP) has revised the software and is making physical hardware additions to the STERRAD 100S System.Contact ASP Customer Care Center at 888-783-7723, option 2 for questions or assistance.",N/A,6324,"In the U.S., there are 2,623 units installed. There are also 3,701 units internationally.","Worldwide Distribution including USA and countries of France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India and Slovenia.",Open,N/A,N/A,6324,Software,Output/Calculation,Software update,Software Update
Z-0323-2009,50079,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; BHM Medical Inc., Magog, QC, CanadaThe Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities.",Arjo Maxi 500 ,2,"November 24, 2008", 2008,"Arjo, Inc.","The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Arjo sent an Urgent Device Recall Customer Notification letter dated 10/20/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/20/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to shearing of the pivot bolt. The accounts were advised to review the enclosed Safety Advisory Notice, note the affected model and serial numbers, and avoid using the lift under load on a high friction floor like carpet or soft tile while using the hanger bar to move the lift. The accounts were advised that an Arjo Field Service Technician would contact them within two weeks to schedule a visit to the account to perform repairs on their Maxi 500 lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Urgent Device Correction.",N/A,336,336 units,Nationwide Distribution.,Terminated,"August 19, 2010",633,374,Not_Computer,N/A,N/A,N/A
Z-0309-2009,46312,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.",Terumo Advanced Perfusion System 1,2,"November 25, 2008", 2008,Terumo Cardiovascular Systems Corporation,The pumps may fail to power up or experience unplanned pump stops.,PRODUCTION CONTROLS: Process Control,"Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.",N/A,1119,1119,"Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.",Terminated,"July 07, 2009",224,2548,Not_Computer,N/A,N/A,N/A
Z-0123-2009,49584,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078.",Axiom Artis dTC,2,"November 25, 2008", 2008,"Siemens Medical Solutions USA, Inc",Incorrect contour finding: Image may be calibrated to the wrong size catheter.,DESIGN: Software Design,Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.,N/A,49,49 units,Nationwide.,Terminated,"October 05, 2009",314,577,Not_Computer,N/A,N/A,N/A
Z-0233-2009,49506,"material, tooth shade, resin",EBF,Tooth shade resin material.,Dental,Dental,510(k),"PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite",PREMISE,2,"November 25, 2008", 2008,Kerr Corp,Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.,DESIGN: Component Design/Selection,"Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit.The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739.If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers.Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement.",N/A,22478,"22,478 packs for all affected lots","Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.",Open,N/A,N/A,22478,Not_Computer,N/A,N/A,N/A
Z-0308-2009,49564,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm.The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis.",Proven Cemented Semi Constrained Total Knee,2,"November 25, 2008", 2008,Stelkast Co,Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.,TRAINING: Employee Error,"On 9/4/08, the recalling firm telephoned their customers to inform them of the problem and asked them to immediately recover all SC1591-38 with lot number 19906-052008. Once the product is in their possession, customers should contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast.",N/A,5,5 units,Nationwide Distribution --- including states of IA and WV.,Terminated,"December 04, 2008",9,5,Not_Computer,N/A,N/A,N/A
Z-0293-2009,49476,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),Battery Caps used with Animas IR1200 Insulin Pump.The pump is used to help maintain blood glucose targets.,Animas IR1200 Insulin Pump,1,"November 25, 2008", 2008,Animas Corporation,Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.",Contact the recalling firm for information,990,990 units,"Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.",Terminated,"February 04, 2010",436,7152,Not_Computer,N/A,N/A,N/A
Z-0327-2009,50123,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048.Universal fluoroscopic x-ray diagnostic system.,Axiom Luminos dRF ,2,"November 28, 2008", 2008,"Siemens Medical Solutions USA, Inc",Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued Update Instruction AX042/08/S dated August 2008, to affected customers. This Update instruction provided Siemens service engineers with instructions for the replacement of the joystick module at each facility.",N/A,1,1 unit,"Nationwide Distribution --- including states of KY, NJ and PA.",Terminated,"September 23, 2009",299,4,Not_Computer,N/A,N/A,N/A
Z-0415-2009,50149,"retractor, fiberoptic",FDG,Gastroenterology-urology fiberoptic retractor.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485.A fiber optic retractor used in plastic surgery procedures to retract tissue.",Fredrick's Converse Retractor F/O,3,"November 28, 2008", 2008,"Biomet Microfixation, Inc.",Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignee was notified by certified mail via an Urgent Medical Device Recall Notice dated 10/24/08, with return receipt. The letter identifies the product and states the issue with the product. The letter required the customer to discontinue use of the item and return it to Biomet Microfixation so that they may rework the instrument. It also asked the customer to notify any hospital personnel responsible for receiving recall notices of this action if the product had been further distributed. The RGA number should be utilized to return the products. The Inventory Reconciliation sheet should be filled out and faxed to 904-741-9425.",N/A,3,3,"Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.",Terminated,"September 11, 2009",287,3,Not_Computer,N/A,N/A,N/A
Z-0331-2009,50096,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific Easy Core"" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas.UPN for inner pouch M001434530. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.","EASY CORE"" 18G X 15CM (BX5)",3,"November 28, 2008", 2008,Boston Scientific Corporation,"Boston Scientific Corporation initiated a recall of its easy Core"" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.",DESIGN: Device Design,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall"" letter dated October 21, 2008. The letter was addressed to The Hospital Field Action Contact. The letter described the problem and products being recalled. The letter stated that it was very important that the attached product table be used carefully and consider both inner and outer packaging product codes when searching for affected/recalled product as the UPN numbers on the inner and outer labeling are different. Requested to discontinue use of product, identify, and segregate and return affected products to BSC. Letter also requested to complete and return the Reply Verification Tracking Form.",N/A,3808,3808 total for all products,"Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR.",Open,N/A,N/A,3808,Not_Computer,N/A,N/A,N/A
Z-0298-2009,48645,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"""LOCATOR Abutment for 5.7 Screw-Vent & Compatibles."" Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant.The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.","""LOCATOR Abutment for 5.7 ScrewVent Compatibles""",3,"December 01, 2008", 2008,Zest Anchors Inc,"The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11, TSV6B13, TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator Abutment bottoms out in the pilot hole of these implants c",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recall notification letter (Recall Notice) was sent to consignees on April 23,2008. The letter includes the following information on how to handle the recall.It is very important that you determine the use of the Locator Abutment(s) as follows, mark the appropriate box, ,and return this letter to Zest Anchors, Inc. in the stamped, self-addressed envelope:1. The Locator Abutment(s) listed above WERE NOT used on any Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants. THE FIT IS CORRECT AND NO ACTION IS NECESSARY.2. The Locator Abutment(s) listed above WERE used on a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE R PLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. and3. We have current STOCK of the Locator Abutment(s) listed above with planned use for a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE REPLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT.For questions or additional information, contact Zest Anchors, Inc. at 800-262-2310 or 760-743-7744.",N/A,996,996 units,"Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.",Terminated,"December 02, 2008",1,996,Not_Computer,N/A,N/A,N/A
Z-0307-2009,49561,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Uni-CP Compression Forceps (spreader);Non-sterile, R only, Catalog number: 339001NDNewdeal, Lyon, France;Integra, 411 Enterprise Drive, Plainsboro, NJ 08536Intended to open the UNI-Compression Plate olive, which creates a compression.",UniCP Compression Forceps (spreader),2,"December 01, 2008", 2008,Integra LifeSciences Corp,Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Recall Notice letters were sent to all Integra Sales Specialists on September 30, 2008 by first class mail. The letter informed them of the product and the problem concerning the product. The Sales Specialists were asked to return all inventories under their control with part number 339001ND from lots E6WS, E7UY, & E86M. They are required to fill out the attached form identifying the lot number for all Newdeal Compression Forceps (Spreader) in their inventory along with the serial number(s) of their Uni-CP set(s). The form should be filled out even if the sales specialist does not have a Uni-CP. The form should be faxed or mailed back to Walt Ryan in Customer Service, 609-799-3297. A RMA number will be generated for the return of any affected inventory. A replacement will be sent and upon receipt, the forceps (spreader) should be replaced and returned to the address indicated on the letter.",N/A,90,90,Nationwide Distribution,Terminated,"May 11, 2009",161,90,Not_Computer,N/A,N/A,N/A
Z-0358-2009,46313,"blade, saw, general & plastic surgery, surgical",GFA,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.",Sarns Sternal Saw II System Power Unit,2,"December 02, 2008", 2008,Terumo Cardiovascular Systems Corporation,"The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified via Urgent Medical Device Removal letter dated 2/14/08 to not use the device if it exhibited the problem, provided a response card, and stated that replacement motors will be shipped to the person listed on the returned response card.",N/A,69,69 total,"Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.",Terminated,"July 07, 2009",217,69,Not_Computer,N/A,N/A,N/A
Z-0441-2009,50078,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"5 F BardSelect 11 cm Percutaneous Catheter Introducer SetRef: 050A11Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.",Medtronic Percutaneous Catheter Introducer Set,2,"December 02, 2008", 2008,"Medtronic, Inc.",Failure to insert the guidewire through the 18 gauge introducer needle,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.",N/A,1830,"1,830","Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.",Open,N/A,N/A,6555,Not_Computer,N/A,N/A,N/A
Z-0286-2009,49498,"restraint, protective",FMQ,Protective restraint.,General Hospital,General Hospital,510(k),"Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B",Posey,2,"December 02, 2008", 2008,J T Posey Company,Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. A second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a Posey 221 7SL unit,DESIGN: Component Design/Selection,"On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall letter for the affected facilities to fax back to inform Posey of their existing inventory.An RMA number was issured to each facility and a return UPS label was provided for any product that will be returned to Posey. Additionally, the sales representatives for each of the customers will be contacted by Posey Customer Service.",Contact the recalling firm for information,145,145 units,"Worldwide, USA, Australia, Canada, France & The Netherlands.",Open,N/A,N/A,145,Not_Computer,N/A,N/A,N/A
Z-0484-2009,50071,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"STERRAD NX Sterilizer, Product Code 10033Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments.",STERRAD NX Sterilizer,2,"December 02, 2008", 2008,Advanced Sterilization Products,ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The Urgent: Product Correction customer notifications, dated October 6, 2008, were hand delivered by field representatives starting October 7, 2008. The letter advises that Advanced Sterilization Products has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. A list of the affected sterilizer serial numbers is included with the letter. The letter advises that the Field Service Engineer has come to their facility to inspect and, if necessary, replace this power supply. Customers are asked to sign the letter acknowledging receipt of this letter upon completion of the work by the Field Service Engineer.",Contact the recalling firm for information,32,"32 potentially affected systems in the US - 20 installed, 5 uninstalled, 7 potentially affected. There are also 15 units internationally.","Worldwide Distribution --- USA including states of WV, CA, TN, AZ, WI, NC, MO, NJ, DE, GA, SC, WA, FL, MA, NM, MI, and AL and countries of Ecuador, China, Israel, Japan, Korea, Middle East, Australia, Czech Republic, Spain, Brazil, and Russia.",Open,N/A,N/A,32,Hardware,Output/Calculation,Replace component,Remove or Replace
Z-0456-2009,49460,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010Intended for use as a clinical data management system.",Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder ,2,"December 03, 2008", 2008,GE Healthcare Integrated IT Solutions,"Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.",DESIGN: Software Design,"The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.",N/A,1,1 unit,Nationwide Distribution --- state of Ohio.,Terminated,"December 03, 2008",0,1,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0457-2009,49468,"electrode, ion specific, calcium",JFP,Calcium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.",ABL7XX Calibration 1 Solution S1720 ,2,"December 03, 2008", 2008,Radiometer America Inc,"The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.",PRODUCTION CONTROLS: Process Control,"On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.",N/A,3400,"3,200/200ml bottles","Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.",Open,N/A,N/A,3200,Not_Computer,N/A,N/A,N/A
Z-0324-2009,50085,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.,Syngo MultiModality WorkPlace,2,"December 03, 2008", 2008,"Siemens Medical Solutions USA, Inc",Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.,DESIGN: Software Design,The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.,N/A,130,130 units,Nationwide Distribution.,Terminated,"September 23, 2009",294,130,Software,Output/Calculation,Software update,Software Update
Z-0408-2009,50081,"catheter, hemodialysis, implanted, coated",NYU,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the ""sport pack"" and ""kit"" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.",PALINDROME EMERALD Cuffed Dual Lumen Catheter ,3,"December 04, 2008", 2008,Covidien,Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact jim.welsh@covidien.com or 508-216-8532.",N/A,10,10 units,"Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.",Terminated,"December 04, 2008",0,117,Not_Computer,N/A,N/A,N/A
Z-0319-2009,49713,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"AS3000 Anesthesia Delivery System. Datascope Patient Monitoring;A Mindray Global Company.The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.",NAVIGATOR ANESTHESIA DELIVERY SYSTEM,2,"December 05, 2008", 2008,"Mindray DS USA, Inc., dba Datascope Patient Monitoring","Two issues have been identified with the AS3000 unit.1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit.2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate",DESIGN: Component Design/Selection,"Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.",N/A,2,2 units,"Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.",Terminated,"December 08, 2008",3,2,Not_Computer,N/A,N/A,N/A
Z-0318-2009,49572,"chair, adjustable, mechanical",INN,Mechanical chair.,Physical Medicine,Physical Medicine,510(K) Exempt,"Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877.The product is used as a hip strap chair for children.",Rifton Toddler Chair,3,"December 05, 2008", 2008,"Community Products, LLC","Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.",PRODUCTION CONTROLS: Process Control,"On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps.For questions or additional information, contact Rifton Equipment at 1-800-571-8198.",N/A,147,Potentially 147 units may be affected.,Worldwide Distribution including USA and countries of Spain and Great Britain.,Terminated,"March 15, 2010",465,147,Not_Computer,N/A,N/A,N/A
Z-0312-2009,49569,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors.¶_AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.,AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM,2,"December 09, 2008", 2008,"Siemens Medical Solutions USA, Inc",System may switch to emergency fluoroscopy mode.,DESIGN: Software Design,A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.,N/A,4,4 units,"Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.",Terminated,"January 26, 2010",413,21,Computer,N/A,N/A,N/A
Z-0414-2009,50105,"humidifier, respiratory gas, (direct patient interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(k),"Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of the humidified gas, to reduce condensation.",Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.,2,"December 10, 2008", 2008,Fisher & Paykel Healthcare Inc,"The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Fisher & Paykel Healthcare, Inc. (FPH) issued an URGENT-PRODUCT RECALL letter (dated October 8, 2008) including a Customer recall letter for consignees/customers to Cardinal Health. Cardinal Health will, in turn, send the Customer recall letter dated October 10, 2008 to its consignees/customers. Fisher & Paykel Healthcare (FPH) also issued a similar set of recall notification letters to Norco on October 15, 2008.Recipients of the recall letter must perform the following:1) Check all Cardinal Health stock of the product for the affected lots, 2) Immediately quarantine the affected product, 3) Complete a Device Recall Response Sheet, and 4) Fax or e-mail the completed Device Recall Response Sheet. Fisher & Paykel Healthcare, Inc.'s ""Dear Customer Letter"" for Cardinal Health and Norco instructs consignees to complete a customer response (i.e. fax enclosed Customer Acknowledgement Form) to FPH. The customer letter also provides instructions for product return.Fisher & Paykel Healthcare, Inc. recall communication instructions to Cardinal Health and Norco was for all affected product to be returned and quarantined by the distributors. The distributors will return any affected stock to Fisher & Paykel Healthcare, Inc. for documented destruction.",N/A,229320,"229,320 units",Worldwide Distribution including US and country of Canada.,Open,N/A,N/A,229320,Hardware,Device Operation,Return,Remove or Replace
Z-0343-2009,50179,"aid, surgical, viscoelastic",LZP,Intraocular fluid.,Ophthalmic,Ophthalmic,N/A,"AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size",Healon D ,1,"December 10, 2008", 2008,"Advanced Medical Optics, Inc.",Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.,PRODUCTION CONTROLS: Process Control,"On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form.The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions:(1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654. (2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days.The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.",Contact the recalling firm for information,1450,1450,"Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico",Open,N/A,N/A,1450,Not_Computer,N/A,N/A,N/A
Z-0311-2009,46314,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240.Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.",Terumo Sarns Level Sensor II Pads,2,"December 10, 2008", 2008,Terumo Cardiovascular Systems Corporation,"The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.,N/A,31980,"31,980 pads (25,620 to U.S. and 6,360 international)","Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.",Terminated,"July 07, 2009",209,31980,Not_Computer,N/A,N/A,N/A
Z-0354-2009,44839,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040).Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.",Terumo APS 1,2,"December 11, 2008", 2008,Terumo Cardiovascular Systems Corporation,"Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.",DESIGN: Component Design/Selection,"Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.",N/A,1834,"1,834","Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",Terminated,"July 07, 2009",208,5116,Not_Computer,N/A,N/A,N/A
Z-0447-2009,48470,"prosthesis, shoulder, hemi-, humeral, metallic uncemented",HSD,Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, ""Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 """,Orthopedic implant,2,"December 11, 2008", 2008,Acumed LLC,The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.,PRODUCTION CONTROLS: Labeling Mix-Ups,The firm issued a Urgent Notice: Device Recall on 5/13/08. The firm notified consignees of the issue and asked them to return the product to Acumed with the enclosed product recall effectiveness form for customers. For further information contact Acumed customer service at 1-888-627-9957.,N/A,20,20 units,"World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.",Terminated,"May 13, 2010",518,20,Not_Computer,N/A,N/A,N/A
Z-0407-2009,49522,"tubing, noninvasive",GAZ,Vacuum-powered body fluid suction apparatus.,General Hospital,General Hospital,510(K) Exempt,"Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).",Mentor Aseptic Transfer Set,2,"December 12, 2008", 2008,"Mentor Texas, Inc","The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.",DESIGN: Process Design,"Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.",N/A,32480,"32,480 Aseptic Transfer Sets (4 syringes/set)","Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and South Africa.",Terminated,"August 26, 2010",622,32480,Not_Computer,N/A,N/A,N/A
Z-0458-2009,50065,"shunt, central nervous system and components",JXG,Central nervous system fluid shunt and components.,Neurology,Neurology,510(k),"Gravity Compensating Accessory;High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France;distributed by: Integra NeuroSciences, Plainsboro, NJ 08536The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.",GCA (Gravity Compensating Accessory),1,"December 12, 2008", 2008,Integra LifeSciences Corp.,Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.,PRODUCTION CONTROLS: Process Control,"Urgent: Product Recall Notification letters, dated 10/3/08, were sent out on October 9, 2008. Letters explain the reason for the recall and the catalog and lot numbers affected. If the product has been implanted, it is recommended that the patient be monitored periodically using the standard of care determined appropriate by the patient's attending physician. If the product is found in inventory, customers are asked to quarantine the product and contact their Integra Sales Rep for assistance and for arrangements for product return. A Recall Acknowledgement and Return Form is to be completed and returned to Integra for reconciliation purposes.",N/A,49,49 units,"Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.",Terminated,"October 06, 2009",298,49,Not_Computer,N/A,N/A,N/A
Z-0418-2009,49523,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract.The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.",Replacement Gastrostomy Device,2,"December 12, 2008", 2008,C R Bard Inc,Gastrostomy device anti-reflux valve may allow leakage from the stomach.,DESIGN: Component Design/Selection,"Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.",N/A,1399,1399 units,"Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.",Open,N/A,N/A,20263,Not_Computer,N/A,N/A,N/A
Z-0460-2009,49458,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity"" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity"" PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"December 13, 2008", 2008,GE Healthcare Integrated IT Solutions,"Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the curr",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.",N/A,546,546 units,"Worldwide Distribution including USA and countries of Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela.",Terminated,"September 06, 2010",632,546,Software,Display/Image,Software update,Software Update
Z-0485-2009,50075,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.",Dimension Enzymatic Creatinine Flex reagent cartridge ,2,"December 13, 2008", 2008,"Dade Behring, Inc.",Reagent may exhibit unflagged inaccurate patient sample results.,DESIGN: Component Design/Selection,"The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.",N/A,12773,"12,773 cartons",Nationwide Distribution.,Terminated,"March 27, 2009",104,12773,Not_Computer,N/A,N/A,N/A
Z-0483-2009,49586,paraquat assay,LTD,N/A,N/A,Toxicology,Contact ODE,"RNAgents¶_ Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents¶_ Total RNA Isolation System.The RNAgents¶_ Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.",Phenol: Chloroform:Isoamyl Alcohol,2,"December 15, 2008", 2008,Promega Corpopration,"Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents¶_ Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmful.",PRODUCTION CONTROLS: Packaging,"Consignees were sent a ""Promega Urgent Product Alert-Risk of Injury"" letter dated June 9, 2008. The letter described the product, problem and provided instructions on handling, inspection and disposition of product. In addition, E-mail notifications were sent to distributors and branch offices on May 29,2008. For questions and additional information, contact your local Promega representative or Promega Technical Service at 800-356-9526 and press ""4"", or e-mail at techserv@promega.com.",Contact the recalling firm for information,836,836,"Worldwide Distribution: USA including states of IN, ME, NE, NY, WI, PA, NC, FL, OR, UT, MI, IL, AL, OR, GA, CA, MD, TX, MA, UT, MO, OH, and LA, and countries of Canada, Mexico, Brasil, China, Japan, Germany, Singapore, Great Britain, Australia and France.",Open,N/A,N/A,836,Not_Computer,N/A,N/A,N/A
Z-0454-2009,48660,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41",Vidiera NsP Nucleic Sample Preparation,2,"December 16, 2008", 2008,Beckman Coulter Inc,"Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the ""Run Results"" report. The software error associated with the excluded sample appears as ""Liquid was not successfully transferred to well#..........the sample will be excluded from further proce",DESIGN: Software Design,"The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to:(1) Review the ""run Summary"" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records.The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to.For questions regarding the PCA, please contact firm at 714-961-3634.",N/A,6,6,"Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.",Terminated,"January 13, 2009",28,6,Software,Output/Calculation,Software update,Software Update
Z-0338-2009,49420,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA."," iLab Ultrasound Imaging System, models 120INS and 240INS",2,"December 16, 2008", 2008,Boston Scientific Corporation,Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.,PRODUCTION CONTROLS: Process Control,"Customer letters sent on Friday, Sept 5 via FedEx, 2008 to all customers. This letter will be followed up by a customer service visit. Package delivery will be tracked, as well as Reply Verification tracking forms.For further information, please contact firm at 508-652-5594.",N/A,357,357 units,"World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan.",Terminated,"May 18, 2009",153,357,Other,Output/Calculation,Service,Repair
Z-0504-2009,50157,N/A,N/A,N/A,N/A,N/A,N/A,Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds:Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.,Singleuse sterile puncture attachment UA1256U,2,"December 16, 2008", 2008,Bk Medical,No 510k approved,PREMARKET APPROVAL: No Marketing Application,"BK Medical notified accounts via a Recall Notice letter dated 9/03/08 to inform customers of the unapproved status and to remove the device from use and it will be replaced with B-K Medical's reusable metal guide UA1256. Customers were to fill out the attached ""Reply Form"" and return it via fax or the postage paid envelope. Any questions should be directed to B-K Medical Systems, Inc. at 1-800-876-7226.",N/A,664,664 pieces,"Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.",Open,N/A,N/A,664,Not_Computer,N/A,N/A,N/A
Z-0503-2009,50151,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.",Maxi Move ,2,"December 16, 2008", 2008,"Arjo, Inc.","The battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.",DESIGN: Component Design/Selection,"Arjo sent the Urgent Device Recall Customer Notification dated 11/5/08 and Field Safety Notice (FSN) dated 10/31/08 to all affected Maxi Move customers on 11/5/08. The accounts were informed of the problem with the connector of the battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift (model numbers starting with KMC)or as replacement parts. They instructed the accounts to discontinue use of the battery pack if it does not recharge or has an intermittent electrical contact. The accounts were requested to complete and return to Arjo Inc., the enclosed customer response form indicating that they have received the notification package. The accounts will be contacted by an Arjo representative within a week to arrange the replacement of the battery pack and corresponding connectors (male part/plug) on the lift and battery charger.",N/A,273,273 battery packs,Nationwide Distribution,Terminated,"January 05, 2010",385,273,Hardware,Device Operation,Replace component,Remove or Replace
Z-0482-2009,49563,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators.Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only.Alfa Wassermann Diagnostic Technologies, LLC.,4 Henderson Drive,West Caldwell, NJ 07006.ACE EZA1c Reagent is intended for the quantitative determination of stable hemoglobin A1c in human whole blood samples using the ACE and Ace Alera clinical chemistry systems. Measurement of hemoglobin A1c is a viable indicator for long-term diabetic control.","ACE EZA1c Reagent, Glycosylated hemoglobin assay.",2,"December 17, 2008", 2008,"Alfa Wassermann, Inc.",Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems.,DESIGN: Component Design/Selection,"An initial URGENT: CUSTOMER ADVISORY NOTICE dated August 22, 2008 was sent to all customers and distributors. The letter stated the problem and asked customers to cease using the EZA1C reagent, controls and calibrators. Customers were asked to hold any affected inventory while additional testing was conducted by Alfa Wassermann Diagnostic Technologies, LLC. (AWDT). A second communication, URGENT: CUSTOMER ADVISORY NOTICE (and Product Response Form) dated September 18, 2008 was sent instructing customers to destroy all product and package inserts in stock for the EZA1C products listed in the letter. Information was provided on receiving credit and an alternative product for use. Customers are requested to complete and return the Product Response Form by fax (888-646-2535) to AWDT indicating their receipt of the letter and the amount of product destroyed. Distributors' letters requested their customers be notified of the recall and that the Product Response Form be sent directly to AWDT. Direct questions to AWDT Customer Solution Center at 866-419-2532.",N/A,264,Reagent Lot F2481 = 264 kits and Reagent Lot F2603 = 69 kits. (Control Lot HBC00507-1=322 kits and Calibrator Lot HBS00907-1=262 kits).,Nationwide Distribution.,Terminated,"April 15, 2009",119,264,Not_Computer,N/A,N/A,N/A
Z-0412-2009,50098,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with the optional scale kit 700.05505.The Maxi 500 is a mobile passive lifter, intended to be used for lifting and transferring of patients in hospitals, nursing homes of other health care facilities.",Arjo Maxi 500 Patient Lift with 2Point Spreader Bar and Scale,2,"December 18, 2008", 2008,"Arjo, Inc.","If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.",TRAINING: Employee Error,"Arjo, Inc. sent an Urgent Device Recall Customer Notification letter dated 10/29/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/30/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale if the spring pin is not replaced into the pivot bolt after performing maintenance on the lift. The accounts were advised to review the enclosed Urgent Field Safety Notice, note the affected model and serial numbers, and inspect their lifts for the presence of the spring pin in the pivot bolt. If the user finds that the spring pin is missing, they are instructed to immediately stop using the lift and contact their Arjo representative. The accounts were also instructed to remove previous versions of the Operating and Product Care instructions, and replace them with the current version 001.20815.EN Rev3 dated October 2008 provided with the letter, ensuring that the proper personnel are made aware of the changes outlined in the Field Safety Notice. Direct questions to the Arjo, Inc. Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax (888-594-2756) to Arjo, Inc. the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Field Safety Notice.",N/A,46,"44 lifts, 2 scale kits",Nationwide Distribution.,Terminated,"August 19, 2010",609,427,Not_Computer,N/A,N/A,N/A
Z-0481-2009,49562,"enzyme immunoassay, cannabinoids",LDJ,Cannabinoid test system.,Toxicology,Toxicology,510(k),Cannabinoids Intercept Micro Plate EIA 100 plate kit,Cannabinoids Intercept Micro Plate EIA,3,"December 18, 2008", 2008,"OraSure Technologies, Inc.","Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.",N/A,1,1 kit,The product was shipped to one customer in New York.,Terminated,"December 18, 2008",0,1,Not_Computer,N/A,N/A,N/A
Z-0498-2009,50103,"electrode, depth",GZL,Depth electrode.,Neurology,Neurology,510(k),"FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe¶_ and Nexdrive¶_Distributed by Medtronic Inc., Minneapolis, MNREF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each)Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.",FC4000 microTargeting Electrode Kit 5x ,2,"December 18, 2008", 2008,"FHC, Inc.",Mislabeled: May contain an electrode longer than labeled size,PRODUCTION CONTROLS: Process Control,FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.,N/A,3,3 Kits (30 electrodes-10 electrodes/kit),"Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.",Open,N/A,N/A,62,Not_Computer,N/A,N/A,N/A
Z-0502-2009,50125,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,N/A,"STA Neoplastine CI Plus 10; Product Catalogue Number: 0667Manufactured by Diagnostica Stago, Asnieres, France.",STA Neoplastine CI Plus 10,2,"December 18, 2008", 2008,"Diagnostica Stago, Inc.",Internal investigation has determined the potential lack of homogeneity between product vials.,PRODUCTION CONTROLS: Process Control,"Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached ""Product Recall Response Form"" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.",N/A,31207,"31,207 units",Nationwide Distribution.,Terminated,"June 24, 2010",553,32487,Not_Computer,N/A,N/A,N/A
Z-0509-2009,50172,"material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction",KKY,Polytetrafluoroethylene with carbon fibers composite implant material.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101.Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.",Stryker Custom Cranial Implant Kit,1,"December 18, 2008", 2008,Stryker Craniomaxillofacial Division,Lack of assurance of sterility.,PRODUCTION CONTROLS: Process Control,"The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.",N/A,322,322 of all products.,Nationwide Distribution.,Terminated,"December 31, 2009",378,322,Not_Computer,N/A,N/A,N/A
Z-0496-2009,50091,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,"Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139.Product is manufactured and distributed by Thoratec Corporation,Pleasant, CA. The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.",THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM,2,"December 22, 2008", 2008,Thoratec Corp,"The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.",DESIGN: Device Design,"An initial ""Urgent: Medical Device Correction"" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return response (Acknowledgement Form) was included with the letter for consignees to complete and fax it to Thoratec Regulatory Affairs at 925-847-8628. Direct questions to the Thoratec Regulatory Affairs Department at 925-730-4135 (Monday-Friday, 8 a.m.-5 p.m. PST). Clinicians and patients with questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.",N/A,2335,"2,335 units",Worldwide Distribution.,Open,N/A,N/A,2335,I/O,Treatment/Delivery/Therapy,Replace,Remove or Replace
Z-0500-2009,50115,prostate-specific antigen (psa) for management of prostate cancers,LTJ,Tumor-associated antigen immunological test system.,Immunology,Immunology,510(k),FastPack(R) Total PSA Immunoassay; Catalog #: 25000001Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.,FastPack Total PSA Immunoassay,2,"December 22, 2008", 2008,Qualigen Inc,The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.,DESIGN: Process Design,"The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with ""a patient's medical history, clinical examination, and other findings"". In addition, they may wish to retest any patients that were run with a different FastPack lot.Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter.The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.",N/A,720,720 kits,"Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.",Open,N/A,N/A,720,Not_Computer,N/A,N/A,N/A
Z-0593-2009,50108,"needle, assisted reproduction",MQE,Assisted reproduction needles.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: K¶_LN-750, and K¶_LN-750.Retrieval of Oocytes.","Wallace Occyte Recovery Needles, Oocyte Recovery sets",2,"December 22, 2008", 2008,Irvine Scientific Sales Co Inc,Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.,PRODUCTION CONTROLS: Packaging,"The recall was initiated by Smiths Medical on October 22, 2008 with the forwarding a recall notification to Irvine Scientific. Smiths Medical International sells the products to Irvine Scientific for distribution in the U.S. Irvine Scientific is the U.S. Agent. Irvine Scientific issued an Urgent Field Safety Notice Letter, dated 10/22/2008, with attached fax-back Customer Response form to their customers via US Postal service beginning on October 24, 2008. Irvine Scientific requested their customers to complete an inventory summary on the Customer Response form and contact the firm to arrange for the return of any remaining product in their inventory to the firm.",Contact the recalling firm for information,71,71 units,"Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.",Open,N/A,N/A,71,Not_Computer,N/A,N/A,N/A
Z-0486-2009,50086,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"FHC microTargeting Platform DBS Measuring Fixture,a component of the micro-targeting Drive System (Catalog Number 66-FA-SF).The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.",FHC Microtargeting Drive System,2,"December 22, 2008", 2008,"FHC, Inc.",Measuring fixture is incorrectly graduated.,PRODUCTION CONTROLS: Process Control,"FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.",N/A,5,5 units,"Nationwide Distribution including states of CO, FL, NC and NM.",Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-0524-2009,49077,"radioimmunoassay, progesterone",JLS,Progesterone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.","IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)",2,"December 23, 2008", 2008,Siemens Medical Solutions Diagnostics,"Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens initiated the recall on 07/22/2008 by forwarding A Customer Bulletin by fax or mail to all affected Siemens Healthcare Diagnostic Branches for communication with the affected customers.The Customer Bulletin informed their customers that the firm is conducting a field correction and requested that they discontinue using any IMMULITE/IMMULITE 1000 kit lot prior to LKPG 1,5 330. They were also instructed to complete attached Completion Notification Form and return to their local Siemens Healthcare office or distributor as soon as possible. The were informed that replacement kits will be provided once the completed forms have been received.The Customer Bulletin recommend their customer discuss the content of the letter with their laboratory director regarding the need to review previous test results, conduct patient follow up, and/or repeat testing. The bias should not impact the in-vitro fertilization clinical application because the average change for samples within the range of 1-3 ng/mL is less than 5%. Although there is a greater degree of shift at higher concentrations, the clinical impact is considered to be relatively low when using the test for the diagnosis of ectopic pregnancy and luteal phase defects because in these situations, the progesterone result should always be considered in conjunction with other tests. PROGESTERONE DETERMINATIONS USED IN THE DIAGNOSIS OF PLACENTAL INSUFFICIENCIES OR FOR MONITORING PROGESTERONE THERAPY MAY HAVE BEEN AFFECTED BY THE HIGH BIAS.The letter also indicated SIEMENS IS INTRODUCING A RE-CALIBRATED IMMULITE PROGESTERONE KIT BEGINNING WITH KIT LOT LKPG1, 5 300, WHICH WILL BEGIN ROUTINELY SHIPPING AUGUST 15 TH. AT THAT TIME, KITS WITH THE PREVIOUS CALIBRATION WILL ONLY BE AVAILABLE UPON REQUEST AND AVAILABILITY OF INVENTORY FOR CUSTOMERS WHO STILL NEED TO PERFORM BASELINING STUDIES. An Important Notice, which is reproduced at the end of this notice below, will be included with the recalibrated kits.",N/A,12908,"12,908","Worldwide Distribution --- including USA and countries of Argentina, Aruba, Australia, Austria, Bangladesh, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Nicaragua, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Republic of Panama, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,12908,Not_Computer,N/A,N/A,N/A
Z-0479-2009,49557,"enzyme immunoassay, cannabinoids",LDJ,Cannabinoid test system.,Toxicology,Toxicology,510(k),Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.,Micro Plate EIA Oral Fluid Cutoff Calibrator,3,"December 23, 2008", 2008,"OraSure Technologies, Inc.","Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued a letter entitled ""URGENT PRODUCT RECALL NOTICE"" dated 9/8/08 to their customers to inform them of the problem and the need to return the product.",N/A,2198,2198 units,"Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.",Terminated,"May 05, 2009",133,2198,Not_Computer,N/A,N/A,N/A
Z-0476-2009,49550,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.",VASOVIEW 4 Endoscopic Vessel Harvesting System,2,"December 23, 2008", 2008,"CTS, Inc. dba Guidant Cardiac Surgery","Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.",DESIGN: Packaging Design/Selection,"The firm issued a letter entitled ""URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)"" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.",N/A,7935,"7,935 units",Worldwide Distribution --- including USA and country of Australia.,Open,N/A,N/A,7935,Not_Computer,N/A,N/A,N/A
Z-0459-2009,50092,"laryngoscope, rigid",CCW,Rigid laryngoscope.,Anesthesiology,Anesthesiology,510(K) Exempt,"Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.",GreenLine/D Laryngoscope Blades,1,"December 24, 2008", 2008,"Sun Med, Inc.","A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.",DESIGN: Device Design,"SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.",N/A,2682,"2,682 boxes (20 per box)",Nationwide Distribution,Terminated,"July 06, 2010",559,2682,Not_Computer,N/A,N/A,N/A
Z-0621-2009,50487,"catheters, transluminal coronary angioplasty, percutaneous",LOX,Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.,Cardiovascular,Cardiovascular,N/A,"Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of Ireland. US Customer Service 888-272-1001. The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as Atherotomy, allows dilation of the target lesion with less pressure. Indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.",Flextome Cutting Balloon Device OvertheWire Delivery System,2,"December 24, 2008", 2008,Boston Scientific Corporation,"For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural delay as users seek to explain the discr",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"An Urgent medical Device Field Correction, dated November 21, 2008, was sent to affected customers/hospitals for delivery on November 24, 2008. The letter described the issue; identified product affected; use or further distribution of the affected product should be ceased immediately; and a correct compliance chart included with the notification is to be secured to the outer sterile pouch. Affected product is not asked to be returned as the correct compliance chart is enclosed and is to be secured to the outer sterile pouch. A Reply Verification Tracking Form is to be completed and faxed to Customer Service Call Center.",N/A,75,75,"Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, GA, HI, ID, IL KS, MA, MD, MI, MN, MO, MS, NV, NY, OH, PA, TN, TX, UY, VA, and WI.",Open,N/A,N/A,75,Not_Computer,N/A,N/A,N/A
Z-0622-2009,50489,"cannula, surgical, general & plastic surgery",GEA,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002.Used for incisions made for positioning the laparoscopic cannulas or ports.",5mm Pyramidal Trocar,2,"December 24, 2008", 2008,"Genico, Inc., dba Genicon",The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.,PRODUCTION CONTROLS: Manufacturing Material Removal,"Consignees were notified with a letter, dated 9/19/2008, by e-mail and fax on 09/25/2008. The letter stated a description of the issue, analysis and reliability data, indications of Device Malfunction, and recommendations. There was also a request for all defective devices to be returned to the distributor or Genicon for replacement. Genicon Customer service was to be contacted at 407-657-4851.",N/A,1625,"2,965 units (1340 OUS and 1625 US)","Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.",Terminated,"January 09, 2009",16,2965,Not_Computer,N/A,N/A,N/A
Z-0445-2009,44838,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",Terumo APS 1,2,"December 29, 2008", 2008,Terumo Cardiovascular Systems Corporation,The power supply may fail to charge the batteries due to various hardware malfunctions.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.,N/A,256,256,"Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam.",Terminated,"July 07, 2009",190,417,Hardware,N/A,Notification,Safety Notice/Insructions
Z-0449-2009,49712,"densitometer, bone",KGI,Bone densitometer.,Radiology,Radiology,510(k),"Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software",Hologic,2,"December 29, 2008", 2008,"Hologic, Inc.",Software error may lead to a high estimate of major fracture probability.,DESIGN: Software Design,"Hologic notified customers by telephone on 9/23 and 24/08 and instructed them to not use the software. A customer notification letter was sent via FedEx to customers on September 25, 2008.The letter requested de-installation of the software and return of the software to Hologic in a pre-paid envelope.",N/A,15,15 software discs,"Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.",Open,N/A,N/A,15,Software,Output/Calculation,Deinstall and return,Remove or Replace
Z-0467-2009,49495,"infusor, pressure, for i.v. bags",KZD,Pressure infusor for an I.V. bag.,General Hospital,General Hospital,510(K) Exempt,"CASMED 500cc Unifusor Classic with piston gauge and stopcock valveModel: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.",Unifusor Classic,2,"December 29, 2008", 2008,"CAS Medical Systems, Inc.","Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.",PRODUCTION CONTROLS: Equipment Maintenance,"CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled ""UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE."" For further information, please contact the firm at 203-488-6056.",N/A,6384,"6,384 pc","NationwideForeign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.",Terminated,"August 05, 2010",584,64880,Not_Computer,N/A,N/A,N/A
Z-0480-2009,49560,"reagent, occult blood",KHE,Occult blood test.,Hematology,Hematology,510(k),"INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits.Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions.Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.",InSure(R) Quik FIT(TM),2,"December 29, 2008", 2008,"Enterix, Inc.","False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.",DESIGN: Device Design,"Medical Device Recall Letters were sent on October 3, 2008 to all customers by certified mail. The letters were entitled ""URGENT *** MEDICAL DEVICE RECALL (U.S. ONLY). Questions are to be directed to Enterix at 1-800-531-3681,.",N/A,45,45 kits (includes 25 patient collection kits and 1 developer kit),Product was distributed to medical facilities and laboratories throughout the US.,Terminated,"March 26, 2009",87,45,Not_Computer,N/A,N/A,N/A
Z-0617-2009,50220,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),"DeVilbiss Model 515A Oxygen ConcentratorIntended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.",DeVilbiss Model 515A Oxygen Concentrator,2,"December 30, 2008", 2008,Sunrise Medical,potential for sieve beds to have been incorrectly assembled,DESIGN: Device Design,"On 10/30/08, the recalling firm began to telephone customers of the problem. The recalling firm followed up with Urgent: Medical Device Recall letters, dated 11/7/2008. The letters requested that users cease the use of the affected device and immediately contact their provider to make arrangements to have the Concentrator replaced. The firm has set up a toll free line to assist customers with identification of affected units and the return process.",N/A,428,428 units,"Worldwide Distribution --- USA including states of AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, and WI, and countries of Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom.",Open,N/A,N/A,428,Not_Computer,N/A,N/A,N/A
Z-0604-2009,50154,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis NeurovascularIntended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.",MassTRANSIT Infusion Catheter Kit,2,"December 30, 2008", 2008,Cordis Corporation,Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.,PRODUCTION CONTROLS: Process Control,"A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.",N/A,27,27,"Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.",Terminated,"January 02, 2009",3,27,Not_Computer,N/A,N/A,N/A
Z-0618-2009,50225,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Flexi-Seal Fecal Management System Advanced Odor Control Kit.Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104ConvaTecSkillman, NJMade in USA with imported components""For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool.""",FlexiSeal Fecal Management System Advanced Odor Control Kit,2,"December 30, 2008", 2008,ConvaTec,It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Product Correction Letters were sent by first class mail on November 18, 2008 to Healthcare Professionals and ConvaTec Reps. The reason for the recall was identified along with possible risk to patient. Healthcare professionals were asked to use sufficient lubricating jelly during the insertion process with special care given to those who have a tendency to bleed or are on anti-coagulant medication. Physician should be notified if rectal bleeding or abdominal symptoms develop. ConvaTec reps were asked to contact all health care professionals to whom product or samples were given and reinforce the importance of proper lubrication and following the directions. A return form is to be completed by ConvaTec reps for each visit indicating the name of the Health Care Provider and that the they personally received notice of the product correction. All remaining sample products are to be returned to Besta, Franklin, WI.",N/A,795,795,Worldwide Distribution --- including USA and country of Canada.,Terminated,"March 09, 2009",69,795,Not_Computer,N/A,N/A,N/A
Z-0610-2009,50180,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.",Stryker Leibinger New Generation/Universal Mandibular System,2,"December 30, 2008", 2008,Stryker Leibinger USA,"A template is supposed to accompany the product, but it was not included with this lot.",PRODUCTION CONTROLS: Process Control,Consignees were notified via an Urgent Medical Device Recall letter dated September 2008 and requested to examine their inventory for the affected lot and return the recalled product. Customers are to fill out the attached forms to confirm the return-shipment and send it back. The firm will inform customers immediately regarding replacement deliveries.,Contact the recalling firm for information,23,23,Nationwide Distribution,Terminated,"December 15, 2009",350,23,Not_Computer,N/A,N/A,N/A
Z-0508-2009,48177,spinal vertebral body replacement device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.",Novel VBR Spinal System,2,"December 31, 2008", 2008,"Alphatec Spine, Inc.","Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.",PRODUCTION CONTROLS: Process Control,"The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.",N/A,4,4 units,"Nationwide Distribution --- including states of AZ, FL, NY & TX.",Terminated,"January 12, 2009",12,7,Not_Computer,N/A,N/A,N/A
Z-0522-2009,49065,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021.Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.",Philips Diagnostic Ultrasound System ,2,"December 31, 2008", 2008,Philips Medical Systems,The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.,DESIGN: Software Design (Manufacturing Process),"On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. ""In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system."".",Contact the recalling firm for information,4279,4279 units,"Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).",Open,N/A,N/A,6181,Software,Output/Calculation,Software update,Software Update
Z-0472-2009,49517,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.",GE Centricity Ultra Laboratory System,2,"December 31, 2008", 2008,GE Healthcare Integrated IT Solutions,"Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.",DESIGN: Software Design,"GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled ""PRODUCT SAFETY NOTIFICATION."" The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.",N/A,3,3 units,Globally - United States including the states of New York and Texas; and the country of Canada.,Terminated,"May 18, 2010",503,3,Software,Alarm/Message,Software update,Software Update
Z-0543-2009,49457,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235.Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.",Siemens KinetDx 4.2 Workplace,2,"January 02, 2009", 2009,"Siemens Medical Solutions, USA, Inc","If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.",DESIGN: Software Design,"Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.",N/A,306,306 of all products.,Nationwide Distribution.,Terminated,"October 18, 2010",654,306,Not_Computer,N/A,N/A,N/A
Z-0594-2009,50111,fixation accessory,LYT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Ossur 3'"" Titanium Skull Pin, 1 pack, Model Number: 516V2S","3'"" Titanium Skull Pin",2,"January 02, 2009", 2009,Ossur,Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.,PRODUCTION CONTROLS: Packaging Process Control,"Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008with the Product Manager for this device contacting each consignee by phone.The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available.If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?.",N/A,27,27 pouches (1 pin/per pouch) = 27 pins,"Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.",Terminated,"April 27, 2010",480,31,Not_Computer,N/A,N/A,N/A
Z-0651-2009,50206,"support, head and trunk, wheelchair",IMS,Wheelchair accessory.,Physical Medicine,Physical Medicine,510(K) Exempt,High-low:x frame for the x:panda mechanical chair.,Highlow:x ,2,"January 05, 2009", 2009,Snug Seat Inc,Breakage in the welds was discovered in a section of the chair frame.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by letter dated 11/6/2008. Snug Seat sent a repair kit to their retail dealers on 11/18/2008. The kit includes a safety plate, written and video replacement instructions as well as the tools (allen wrench, crescent wrench and two nuts) necessary to make the safety update. Customers were identified using purchase order numbers, and product serial numbers to enable the dealers to identify the purchaser of the product. Due to HIPPA regulations, purchaser information was not available to Snug Seat, Inc. to contact directly. Written notification will be followed up with a telephone call to each dealer to ensure they have received the retrofit kit. Snug Seat will also insure they understand the importance of the kit and how to properly install and document receipt of the update for their customers.",N/A,67,67 units,Nationwide.,Open,N/A,N/A,67,Not_Computer,N/A,N/A,N/A
Z-0285-2009,49135,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment",GE Healthcare Solar 8000M System,2,"January 05, 2009", 2009,GE Healthcare,"A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a",DESIGN: Software Design,"A GE Healthcare consignee letter was sent out 9/9/08. The letter dated August 26, 2008 was addressed to Healthcare Administrator/Risk Manger. The letter described the problem, product and provided recommendation.",Contact the recalling firm for information,2782,2782,"Nationwide to: AL, AR, AZ, CA, FL, GA, IA, ID, IL, IN, MA, MI, MN, MO, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, and WI. OUS to include: Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia, Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Pakistan, Saudi Arabia, Spain, Sweden, United Kingdom, and Venezuela.",Open,N/A,N/A,2782,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-0339-2009,49607,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.",Radiation Therapy System,2,"January 05, 2009", 2009,TomoTherapy Incorporated,TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume,DESIGN: Software Design,"Consignees were sent on 9/18/08 a ""TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice"" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.",N/A,165,165,AKALARAZCACOCTDCFLHIIAILINKYLAMAMDMIMNMONENJNMNVNYOHOKORPAPRSCSDTNTXVAWAWI andWYBelgiumCanadaSwitzerlandGermanySpainFranceGreat BritainIndiaItalyJapanKoreaNetherlandsTurkey andTaiwan,Open,N/A,N/A,165,Not_Computer,N/A,N/A,N/A
Z-0440-2009,49580,dialysate concentrate for hemodialysis (liquid or powder),KPO,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"SteriLyte¶_¶_ Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure¶_¶_ Liquid Acid Concentrate or DC-Series Dri-Sate¶_¶_ Dry Acid Concentrate in artificial kidney (hemodialysis) machines.",Liquid Bicarbinate,2,"January 05, 2009", 2009,"Rockwell Medical Technologies, Inc",Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.,PRODUCTION CONTROLS: Environmental Control,"Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08. A follow-up response form was faxed to consignees starting 10/01/08.Consignees asked to return product for a credit. For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.",N/A,695,695 cases (4 units per case),"Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.",Terminated,"July 29, 2010",570,2976,Not_Computer,N/A,N/A,N/A
Z-0325-2009,50118,"unit, electrosurgical, endoscopic (with or without accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.","FSOMNI, Fusion OmniTome",2,"January 05, 2009", 2009,Cook Endoscopy,The wire control port may have been omitted during manufacture.,PRODUCTION CONTROLS: Process Control,"Cook Ireland (distributor) was contacted via email on 10/30/08 and was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. A response sheet was attached. Recall status reports will be issued monthly. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Should you have any questions, please contact Cook Endoscopy Customer Quality Assurance Department at 1-336-744-0157.",N/A,11,11,Ireland,Terminated,"April 07, 2009",92,11,Not_Computer,N/A,N/A,N/A
Z-0342-2009,50083,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.",GE OEC 9900 Elite GSP fluoroscopic xray system ,2,"January 05, 2009", 2009,"OEC Medical Systems, Inc","Under certain conditions, x-ray system may experience operational impairment.",DESIGN: Device Design,Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.,Contact the recalling firm for information,448,448 units,"Nationwide, including AK, KY, NC, VA WA. and WI",Open,N/A,N/A,1054,Not_Computer,N/A,N/A,N/A
Z-0320-2009,50077,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.",Somatom Sensation 40 XRay System,2,"January 05, 2009", 2009,"Siemens Medical Solutions USA, Inc",software error - does not allow protocol to properly synchronize with ECG triggers,DESIGN: Software Design,"The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.",N/A,168,168 units,Nationwide,Terminated,"September 23, 2009",261,177,Software,Device Operation,Instructions to avoid,Safety Notice/Insructions
Z-0644-2009,50502,"clamp, vascular",DXC,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.",CardioVations Endoclamp(TM) Aortic Catheter,2,"January 05, 2009", 2009,"Edwards Lifesciences Research Medical, Inc.","Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled ""PRODUCT RECALL."" Questions could be referred to the Edwards representative or call 800-424-3278.",N/A,1267,1267 units,"Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.",Open,N/A,N/A,2230,Not_Computer,N/A,N/A,N/A
Z-0448-2009,48734,urinary homocystine (nonquantitative) test system,LPS,Urinary homocystine (nonquantitative) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads ""CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632"". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads ""EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341"". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.",Test Kit,2,"January 06, 2009", 2009,Catch Incorporated,A high homocysteine level can be reported as falsely low.,DESIGN: Device Design,"On 01/18/07 an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter was sent to the consignees. The letter states the circumstances in which a high homocysteine rate can result in a false low homocysteine rate, a work around for the problem which a flag must be programmed into the user defined homocysteine test parameters and instructions to advise their customers about the situation was addressed in the letter so the consignees can take the recommended corrective action. A confirmation sheet was included with the letter to be signed by a representative of each distributor and returned to Catch Inc. Contact Catch Inc. at 1.425.402.8960 for assistance.",N/A,2699,"2,699 kits",CA and PA.,Terminated,"September 28, 2010",630,2699,Not_Computer,N/A,N/A,N/A
Z-0542-2009,49382,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.",Roche ISE Internal Standard Gen.2,2,"January 06, 2009", 2009,Roche Diagnostics Corp.,"Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.",DESIGN: Packaging Design/Selection,"Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled ""URGENT MEDICAL DEVICE CORRECTION."" For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.",N/A,7909,7909,Nationwide Distribution.,Terminated,"December 01, 2009",329,7909,Not_Computer,N/A,N/A,N/A
Z-0452-2009,50156,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.",TLOK Bone Marrow Biopsy Needle,2,"January 06, 2009", 2009,"Medical Device Technologies, Inc.",Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.,PRODUCTION CONTROLS: Packaging,"Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance.",N/A,180,180 Units,"Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.",Terminated,"April 21, 2009",105,430,Not_Computer,N/A,N/A,N/A
Z-0455-2009,49010,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2",FC 500 with CXP Acquisition Software,2,"January 07, 2009", 2009,Beckman Coulter Inc,"Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature.The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size.The softwa",DESIGN: Software Design,"The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.",N/A,565,565,Globally to the United States and Canada.,Terminated,"January 13, 2009",6,565,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0607-2009,50162,"enzyme linked immunoabsorbent assay, rubeola igg",LJB,Rubeola (measles) virus serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.",IsMeasles IgG Enzyme Immunoassay Test Kit,2,"January 07, 2009", 2009,Diamedix Corporation,"Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.,N/A,974,974Test Kits,Worldwide Distribution --- including USA and country of England.,Terminated,"May 12, 2010",490,974,Not_Computer,N/A,N/A,N/A
Z-0603-2009,50144,"mattress, air flotation, alternating pressure",FNM,Alternating pressure air flotation mattress.,General Hospital,General Hospital,510(K) Exempt,"Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613Designed to provide enhanced static and pulsation pressure relieving therapies.",Pro 2000,2,"January 07, 2009", 2009,"Hill-Rom Manufacturing, Inc.",These devices have the potential to overheat.,DESIGN: Device Design,"All end users (those who either purchased the device and any customer that has rented) were notified by an Urgent Field Safety Notice on/about 10/31/2008. The letter informed the customers of the safety risk and list steps they can take to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that were sold, the consignee of each device was notified by letter for the safety risk and what they can do to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that are rented, an internal notification was sent via e-mail to Service Centers (Because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the Consignee). Each Service Center will perform the correction on the units affected.",N/A,2083,"2,083 units (Total all four units)",Nationwide Distribution.,Terminated,"December 10, 2009",337,2083,Not_Computer,N/A,N/A,N/A
Z-0520-2009,49014,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF CP460193.Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.","Compress Short Instruments Anchor Plug Holder, 12mm",2,"January 07, 2009", 2009,"Biomet, Inc.","The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.",PRODUCTION CONTROLS: Process Control,"Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed ""FAX Back Response Form,"" fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.",N/A,41,41 of all products.,"Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.",Terminated,"July 07, 2009",181,41,Not_Computer,N/A,N/A,N/A
Z-0579-2009,49573,"prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer",MBH,Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile.Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland.The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.",Total Knee Joint Replacement Prosthesis,2,"January 08, 2009", 2009,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.,N/A,10,10,"PA, GA, AL, WI, UT, and OR.",Terminated,"January 09, 2009",1,10,Not_Computer,N/A,N/A,N/A
Z-0608-2009,50167,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.",CXR4 Computed Tomography Scanner,2,"January 08, 2009", 2009,Hitachi Medical Systems America Inc,Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).,DESIGN: Software Design (Manufacturing Process),"On 11/5/2008 Hitachi Medical Systems sent recall notification letters entitled ""URGENT - DEVICE RECALL CORRECTION"" to its customers informing them of the problem with the software. They stated that a Hitachi service representative will contact each customer to schedule a software upgrade. For further information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313.",Contact the recalling firm for information,42,42,"Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI.",Open,N/A,N/A,42,Software,Display/Image,Software update,Software Update
Z-0647-2009,50500,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833.Picture Archiving and Communications System.",syngo Dual Energy Viewer,2,"January 08, 2009", 2009,"Siemens Medical Solutions USA, Inc",Indicated orientation does not match actual orientation of the patient.,DESIGN: Software Design (Manufacturing Process),"The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider ""no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via ""Save Sets CT""-button."" The firm also highly recommends for customers ""to check the correct display of ""left"", ""anterior"" and ""posterior""markings, e.g. by checking the position of the spine with respect to the posterior marking in the image."" The error should be fixed within certain upgrade and installation activities on the affected software.",N/A,374,374 units,Nationwide Distribution,Open,N/A,N/A,374,Software,Output/Calculation,Software update,Software Update
Z-0643-2009,50501,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.",ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems ,2,"January 08, 2009", 2009,Acist Medical Systems,Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.,DESIGN: Software Design (Manufacturing Process),"ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.",Contact the recalling firm for information,18,18 cables,"Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.",Open,N/A,N/A,18,Not_Computer,N/A,N/A,N/A
Z-0505-2009,50168,"accessories, implant, dental, endosseous",NDP,Endosseous dental implant accessories.,Dental,Dental,510(K) Exempt,"Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology,The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.",SinuLift(TM) System,2,"January 09, 2009", 2009,Innovative Implant Technology,"Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All consignees will be notified by letter entitled ""URGENT: MEDICAL DEVICE RECALL"" dated September 30, 2008, using priority mail. Consignees will also be contacted by telephone. Consignees will be asked to return the product using the prepaid FedEx label included with the letter. The returned product will be quarantined. For further information, please telephone Innovative Implant Technology at 305-975-4101.",N/A,299,299,"Worldwide Distribution --- including USA and countries of Canada, Mexico, Japan, Australia, Japan, Egypt, and Turkey.",Terminated,"October 01, 2009",265,299,Not_Computer,N/A,N/A,N/A
Z-0871-2009,50546,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230.The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact.These are single use implantable devices sold sterile.",Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate,2,"January 09, 2009", 2009,Zimmer Inc.,"Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.",PRODUCTION CONTROLS: Packaging Process Control,"Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled ""URGENT: DEVICE RECALL."" Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131.",N/A,10,10,"Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.",Terminated,"November 12, 2009",307,10,Not_Computer,N/A,N/A,N/A
Z-0491-2009,50087,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081.For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.",Boston Scientific TruPath Biopsy Device,3,"January 12, 2009", 2009,Boston Scientific Corp,"These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.",N/A,14254,"14,254 of all devices.","Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.",Terminated,"December 15, 2009",337,15114,Not_Computer,N/A,N/A,N/A
Z-0870-2009,50540,"system, digital image communications, radiological",LMD,Medical image communications device.,Radiology,Radiology,510(K) Exempt,"Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.",Centricity Web,2,"January 12, 2009", 2009,GE Healthcare Integrated IT Solutions,"Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity Enterprise Web software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomalies resulting in patient safety issues involving a forced log off during an open session while using the Centricity Enterprise Web and measurements displayed in Centricity Enterprise Web will use the calibration provided by the original scanning modality. Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653. For further information, please contact GE Customer Care Center by telephone at 800-437-1171.",N/A,742,742 units,"Worldwide Distribution including USA and countries of Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Terminated,"May 18, 2010",491,742,Software,Device Operation,Software update,Software Update
Z-0580-2009,49597,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04.The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.",ABBOTT Clinical Chemistry Calibrator,2,"January 12, 2009", 2009,Abbott Laboratories Inc.,"The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias. Because of these findings, a new Total Bilirubin calibrator value assignm",DESIGN: Component Design/Selection,"On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions:1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory;2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet;3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appropriate calibrator lot number and reagent list number.ARCHITECT cSystems: Refer to System Configuration in Section 2, Installation Procedures and Special Requirements in the Architect System Operations Manual.AEROSET: Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual;4. Calibrate the Total Bilirubin assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory;5. Evaluate your quality control. Shifts in quality control and proficiency testing samples may vary among laboratories and should be evaluated according to your laboratory procedures. NOTE: Refer to the Attachments (E and F) for the representative shift with the revised calibrator values (Patient sample and Control/QC recovery); and6. Evaluate your reference range and any shifts in patient results. It is recommended that each laboratory established its own expected ranges, which may be unique to the population it serves.Please retain this communication for future reference. If you have forwarded any Clinical Chemistry Bilirubin Calibrator to another laboratory, please provide a copy of this letter to them.For questions, please contact ABBOTT Customer Service at 877-422-2688 (or 877-4ABBOTT). Customers outside of the.",Contact the recalling firm for information,7101,"7,101 units worldwide (2,267 units in US).","Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.",Open,N/A,N/A,7101,Not_Computer,N/A,N/A,N/A
Z-0869-2009,50535,"prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer",HRY,Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEETriathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEEIntended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau.These components are intended for implantation with bone cement.Stryker Orthopaedics;Howmedica Osteonics Copr.325 Corporate DriveMahwah, NJ 07430",Triathlon PKR Insert X3 1,2,"January 12, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Recall notifications entitled ""URGENT PRODUCT RECALL"" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.",N/A,29,8 mm - 1 unit; 12 mm - 8 units.,Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.,Terminated,"August 30, 2010",595,20,Not_Computer,N/A,N/A,N/A
Z-0129-2009,48188,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.",Cytomics FC 500 Flow Cytometry System with CXP Software,2,"January 13, 2009", 2009,Beckman Coulter Inc,Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made.,DESIGN: Software Design,"Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled ""URGENT: PRODUCT CORRECTIVE ACTION."" Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates.Customer were instructed to review all data plots and results before reporting results out. any uncharacteristic patterns in the data or unexpected results must be verified by running Quality Control and if necessary, preparing new samples.In addition, customer were instructed to please share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Also they were asked to complete and return the an attached Customer Response Form within ten days.Customers with questions or concerns regarding the notification, could call Beckman Coulter Customer Service at 1-800-526-7694 in the United States or Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representative.",N/A,594,594 Worldwide: 518 in the United States and 76 in Canada,Globally - United States and Canada,Terminated,"January 13, 2009",0,594,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-0578-2009,49526,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095",Custom Waste Management Kit,3,"January 13, 2009", 2009,"Merit Medical Systems, Inc.","Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.",PRODUCTION CONTROLS: Process Control,"All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.",N/A,399,399 kits,"United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.",Terminated,"January 13, 2009",0,399,Not_Computer,N/A,N/A,N/A
Z-0581-2009,49608,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.",Dimension EXL,2,"January 13, 2009", 2009,"Dade Behring, Inc.","Error messages, ""Wash Aspirator Failure"" and ""Wash station unable to recover"" are not generated when one or both HM wash probes are totally occluded.",DESIGN: Labeling Design,"The recalling firm notified consignees by telephone to inform them of the problem. A follow-up letter, ""Urgent Field Safety Notice"" dated 9/30/08 was issued with information describing the problem, the possible impact of an occluded wash probe on assay results, and emphasizing regular performance of routine wash probe maintenance as detailed in the operator guide to prevent wash probe occlusion. For questions, please contact the Siemens Technical Solution Center at 800-441-9250.",Contact the recalling firm for information,57,57 units,"Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.",Terminated,"May 05, 2009",112,57,Not_Computer,N/A,N/A,N/A
Z-0817-2009,50088,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30.Product shipped between 6/03/08 and 9/12/08 as follows:M1013A IntelliVue G1 Gas ModuleM1019A IntelliVue GS Gas ModuleM8001A option E22 Quick release mount for IntelliVue MP20M8002A option E22 Quick release mount for IntelliVue MP30M8003A IntelliVue MP40M8004A IntelliVue MPSOM8005A IntelliVue MP60M8007A IntelliVue MP70M8105A option E22 IntelliVue MP5 Quick Release MountM8105AT option E22 IntelliVue MPST Quick Release MountM8040A option U02 U02 Table top mount kitM8040A option E22 Quick release kit for MP20MP30The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.",Philips,2,"January 13, 2009", 2009,Philips Medical Systems,Table Mounts assembled with incorrect length hardware may fall,PRODUCTION CONTROLS: Process Control,"Philips issued an ""Urgent Medical Device Correction"" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method.The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.",N/A,14292,"14,292 units","NationwideCanadaForeign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, SloveniaSouth Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia",Open,N/A,N/A,14292,Not_Computer,N/A,N/A,N/A
Z-0551-2009,49510,"catheter, angiography, reprocessed",NLI,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Cardiac Imaging CatheterModel #'s: ACU08267996 andACU55790Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart.",Cardiac Imaging Catheter,2,"January 13, 2009", 2009,Sterilmed Inc,"SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end.A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable",PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a ""Urgent Product Removal"" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.",N/A,58,58,"AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA",Open,N/A,N/A,5070,Not_Computer,N/A,N/A,N/A
Z-0619-2009,50235,"syringe, antistick",MEG,Piston syringe.,General Hospital,General Hospital,510(k),"BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298BD, Franklin Lakes, NJ 07417. Made in USASyringes for use in aspiration and injection of medications.",BD 1 ml Integra TB Syringe ,3,"January 13, 2009", 2009,Becton Dickinson & Company,"Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.",EXPIRATION DATING: Incorrect or No Expiration Date,"Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.",N/A,334400,"334,400 units","GA, KS, OH, MO, FL, PA, KY and NY.",Terminated,"March 27, 2009",73,334400,Not_Computer,N/A,N/A,N/A
Z-0646-2009,50480,"system, simulation, radiation therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(k),Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.Radiation therapy simulation system.,SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.,2,"January 13, 2009", 2009,"Siemens Medical Solutions USA, Inc","Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.",DESIGN: Device Design,"Firm has reissued the Urgent Medical Device Customer Letter regarding the belt replacement and a reminder message to replace the belts yearly during the annual Preventative Maintenance. The letter requests that customers follow the guidelines, which consist of making any required SAD adjustments utilizing the Image Intensifier drive, the X-Ray Head Drive, or both; being vigilant of any change in the type or level of noise from either of the drive belt assemblies while they are in use as this may be an indication of wear; discontinuing clinical operation if there is any doubt, and contacting their local Siemens Service organization to inspect the belts. Currently, the firm is distributing the current belt kit to replace the entire installed base of active SIMVIEW Simulators (3000 and NT models).",N/A,223,223 units,Worldwide Distribution,Open,N/A,N/A,223,Not_Computer,N/A,N/A,N/A
Z-0838-2009,50136,"probe, radiofrequency lesion",GXI,Radiofrequency lesion probe.,Neurology,Neurology,510(k),NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SIThe lesioning of neural tissue.,NeuroTherm,2,"January 13, 2009", 2009,"Neurotherm, Inc.",Distal tip may detach from the probe,DESIGN: Labeling Design,"NeuroTherrn sales representatives were notifiedtelephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916.",N/A,71,71 units,"CO, FL, IL, OH, TN, TX , VA, and WYForeign: Australia, China, and UK,",Terminated,"September 24, 2009",254,71,Not_Computer,N/A,N/A,N/A
Z-0874-2009,50698,"instrument, cutting, orthopedic",HTZ,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.",Microplasty Elite Instruments Vanguard Femoral Cutting Blocks,2,"January 13, 2009", 2009,"Biomet, Inc.","Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.",DESIGN: Device Design,"Consignees were notified by letter entitled ""URGENT MEDICAL DEVICE REMOVAL NOTICE"" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.",Contact the recalling firm for information,444,444 of all products,"Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.",Terminated,"January 20, 2010",372,444,Not_Computer,N/A,N/A,N/A
Z-0611-2009,50193,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.Used for drainage of bile within the biliary system.",Locking biliary catheter.,2,"January 13, 2009", 2009,"Merit Medical Systems, Inc.",Biliary drainage catheter tips may separate from the catheter shaft after placement.,PRODUCTION CONTROLS: Process Control,"Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.",N/A,284,284 units,"Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.",Terminated,"August 05, 2009",204,1164,Not_Computer,N/A,N/A,N/A
Z-0582-2009,49609,N/A,N/A,N/A,N/A,N/A,N/A,"QuantumPulse machine. Vibe Technologies, Greeley, CO.The device is used to create light wave frequencies to effect cellular activity.",QuantumPulse machine,2,"January 14, 2009", 2009,VIBE Technologies,"Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.",PREMARKET APPROVAL: No Marketing Application,"Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included: 1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such;2. An updated operation manual/users guide containing no medical conditions or human body claims; and3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides.Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.",Contact the recalling firm for information,58,58,Worldwide Distribution.,Open,N/A,N/A,58,Not_Computer,N/A,N/A,N/A
Z-0856-2009,50208,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),"RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CAThe CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.",CyberKnife Robotic Radiosurgery System,2,"January 14, 2009", 2009,Accuray Inc,"Product may not be tensioned properly, potentially causing unexpected rotation or descent.",PRODUCTION CONTROLS: Process Control,"All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or customersupport@accuray.com.",Contact the recalling firm for information,13,13 units,Worldwide Distribution --- including USA and countries of France and Turkey.,Terminated,"September 10, 2009",239,13,Not_Computer,N/A,N/A,N/A
Z-0858-2009,50483,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400.Indicated for use in cardiac ablation procedures.",RF Ablation System Foot Switch,2,"January 14, 2009", 2009,Boston Scientific Corp,Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.,PRODUCTION CONTROLS: Process Control,"Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled ""Instructions for Determining Affected Product,"" which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled ""Recall Instructions"" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the ""Recall Instructions,"" and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.",N/A,322,322 units,"Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.",Open,N/A,N/A,322,Not_Computer,N/A,N/A,N/A
Z-0857-2009,50477,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System.Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.",Artiste MV Digital Linear Accelerator,2,"January 14, 2009", 2009,"Siemens Medical Solutions USA, Inc","Under certain conditions, the flat panel may move unexpectedly and collide with the patient.",DESIGN: Labeling Design,"The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.",N/A,31,31 consignees have the configuration noted above.,"Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.",Open,N/A,N/A,31,Software,Physical Safety Hazards,Software update,Software Update
Z-0360-2009,47848,"motor, surgical instrument, pneumatic powered",GET,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ConMed Linvatec Hall Surgical Blades, Sterile OSC/SAG BLADE, Catalog # U655, U554, and U551.ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.","ConMed Linvatech Hall Surgical Blades, Sterile OSC/SAG BLADE ",2,"January 15, 2009", 2009,Linvatec Corp.,"Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.",PRODUCTION CONTROLS: Process Control,An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.,N/A,86,86,Worldwide Distribution,Terminated,"January 15, 2009",0,199977,Not_Computer,N/A,N/A,N/A
Z-0527-2009,49100,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR.",Mainline Confirms III ,2,"January 15, 2009", 2009,"Mainline Technology, Inc.","Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.",PREMARKET APPROVAL: No Marketing Application,"Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.",N/A,N/A,not available,Worldwide Distribution --- including USA and countries of Belgium and Switzerland.,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0538-2009,49112,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.",Depuy DELTA Xtend,2,"January 15, 2009", 2009,"Depuy Orthopaedics, Inc.","Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.",DESIGN: Device Design,"A letter, ""Urgent Device Correction"" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.",N/A,1521,"1,521 of all devices.",Nationwide Distribution.,Terminated,"October 28, 2009",286,1521,Not_Computer,N/A,N/A,N/A
Z-0855-2009,50143,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA.Indicated for planning proton treatment of neoplasms of the eye.",Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22,2,"January 15, 2009", 2009,Varian Medical Systems Oncology Systems,"When using the multiple static segment option, the device may alter dose delivery.",DESIGN: Software Design (Manufacturing Process),"An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of ""Eclipse External Beam Planning Instruction for Use"", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.",Contact the recalling firm for information,64,64 units,Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.,Open,N/A,N/A,64,Not_Computer,N/A,N/A,N/A
Z-0620-2009,50472,"accessories, operating-room, table (kit)",FWZ,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany.The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.",Maquet Foot switch,2,"January 15, 2009", 2009,MAQUET Inc.,"A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.",DESIGN: Device Design,"An Urgent Device Correction letter (with an enclosed Customer Response form) was sent via Federal Express on Monday, December 8, 2008 to all customers who had received tables. Customers were notified in the letter of the problem and actions to be taken including not to use any affected foot pedal for safety reasons. In addition, customers were instructed to complete and return the Customer Response Form via fax (732-667-1903) to Maquet Inc. Please call USA Maquet, Inc. at toll free number 1-888-627-8383 #1 (then select the option for Surgical Workplace products) for questions.",N/A,587,587 units total (54 units in US),Worldwide Distribution.,Open,N/A,N/A,587,Not_Computer,N/A,N/A,N/A
Z-0625-2009,49568,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.",Stryker Vision 3 /Stryker Vision Elect Monitor,2,"January 16, 2009", 2009,Stryker Communications Corp,"Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Communications Corporation by telephone at 97",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Firm began notifying consignees of recall via letter on 09/02/08. Consignees advised that a representative would shortly visit the facility to replace the shroud with one that complies with specifications. The recall letter is entitled ""URGENT: Device Recall."".",N/A,116,116 units.,"Worldwide distribution; Product distributed nationwide to consignees in the states of CA, FL, IL, IN, MA, MN, NC, NM, OH and TX and to the following countries: Canada, Spain and the United Kingdom,",Terminated,"January 08, 2010",357,116,Not_Computer,N/A,N/A,N/A
Z-0597-2009,50120,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners.The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner.,Vertical drive brake,2,"January 16, 2009", 2009,Philips Medical Systems (Cleveland) Inc,The product is being recalled because the patient support may travel downwards without being commanded to move.,PRODUCTION CONTROLS: Process Control,A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.,Contact the recalling firm for information,559,559,"Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.",Open,N/A,N/A,559,Not_Computer,N/A,N/A,N/A
Z-0506-2009,50181,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.",HillRom 70 SemiElectric Bed,2,"January 16, 2009", 2009,"Hill-Rom, Inc.","Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at 800-445-3720.",DESIGN: Component Design/Selection,"Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled ""Urgent Medical Device Correction."".",N/A,567,567,Nationwide.,Terminated,"December 31, 2009",349,567,Not_Computer,N/A,N/A,N/A
Z-0615-2009,50198,"bandage, elastic",FQM,Elastic bandage.,General Hospital,General Hospital,510(K) Exempt,"Esmark Elastic Bandage, 3"" x 4 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787.The device is used to promote blood flow from the extremities by compressing the superficial vessels.","Esmark Elastic Bandage, 3"" x 4 yards",2,"January 16, 2009", 2009,Cardinal Health,The natural rubber latex bandages were mislabeled as latex free.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.",N/A,9521,"9,521 units (of all devices)","Worldwide Distribution including USA, Guam and Korea.",Terminated,"November 04, 2009",292,9521,Not_Computer,N/A,N/A,N/A
Z-0868-2009,50525,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Manufactured by Stryker Endoscopy Puerto Rico",DriLok Disposable Cannula,2,"January 16, 2009", 2009,Stryker Endoscopy,"Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled """"Urgent: Device Removal"" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124.",N/A,4194,"4,194 boxes (24,750 units)","Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.",Open,N/A,N/A,4194,Not_Computer,N/A,N/A,N/A
Z-0513-2009,48190,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),Quantimetrix QuanTscopics Urine Microscopics Control.QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.,QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL,2,"January 17, 2009", 2009,Quantimetrix Corporation,"This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.",TRAINING: Employee Error,"The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail.Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.",N/A,24937,"24,937 sets for all products.","Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.",Terminated,"February 18, 2009",32,24937,Not_Computer,N/A,N/A,N/A
Z-0629-2009,50207,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0.Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",Cyberknife Robotic Radiosurgery System,2,"January 17, 2009", 2009,Accuray Inc,System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.,DESIGN: Software Design,"An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes.Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.",Contact the recalling firm for information,4,4 units,Nationwide Distribution. Product was distributed to 4 medical facilities in the US.,Open,N/A,N/A,4,Software,Treatment/Delivery/Therapy,Instructions to not change settings,Safety Notice/Insructions
Z-0473-2009,49539,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.",Innova 2100IQ,2,"January 21, 2009", 2009,"GE Medical Systems, LLC","Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no X-rays being emitted. But the message ""Acquisition in progress"" was displayed on the DL monitor, even after the foot switch was r",DESIGN: Software Design,"Consignees sent a ""GE Urgent Medical Device Correction"" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894.",N/A,427,427,"USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL IN, KS, KY, LA, ME, MD, MA, MI,MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX UT,VT, VA, WA,WV, and WI; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.",Open,N/A,N/A,1127,Software,Display/Image,Notification,Safety Notice/Insructions
Z-0652-2009,50141,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.",FloControl Arthroscopy Pump ,2,"January 21, 2009", 2009,Stryker Endoscopy,"Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.",PRODUCTION CONTROLS: Process Control,"Stryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.",N/A,1440,1440 devices,Nationwide.,Open,N/A,N/A,1440,Not_Computer,N/A,N/A,N/A
Z-0598-2009,50127,"aid, transfer",IKX,Daily activity assist device.,Physical Medicine,Physical Medicine,510(K) Exempt,"Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54""Model: 72108",Alimed Gait Belt (Transfer Aid),2,"January 22, 2009", 2009,AliMed Corporation,Misassembled gait (transfer aid) belt.,TRAINING: Employee Error,"Alimed notified accounts via U.S. Postal Service (Return Receipt Requested) with a Recall Notice dated 10/30/2008 and instructs users to review their records and notify all users to whom the product may have been issued. If any of the product has been issued outside of their facility, customers are to forward the correspondence to them in it's entirety. Customers are to complete the enclosed form for return of their product (new or used) and the issuance of replacement product or credit.",N/A,993,993 units total,Nationwide Distribution,Open,N/A,N/A,993,Not_Computer,N/A,N/A,N/A
Z-0628-2009,50147,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal.TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.",Radiation Therapy System,2,"January 22, 2009", 2009,TomoTherapy Incorporated,"TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the ""Superuser"" and ""Field Service engine",DESIGN: Software Design,"A TomoTherapy Incorporated ""Urgent Medical Device Correction Field Safety Notice"" letter dated October 17, 2008 was sent to all consignees. The letter addressed the Issue, Product Affected, Recommended Actions and Resolution. Please direct questions to the TomoTherapy, Inc. Customer Care Center by email (www.support@tomotherapy.com) or by telephone, North America: 1-866-368- 4807 and all other locations: 1-608-824-2900 or 32-2-400-44-44.",N/A,215,215,"Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and DC, and countries of BELGIUM, CANADA, SWITZERLAND, CHINA, GERMANY, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, NETHERLANDS, SINGAPORE, TAIWAN and TURKEY.",Open,N/A,N/A,215,Not_Computer,N/A,N/A,N/A
Z-0626-2009,49591,"lubricant, personal",NUC,Condom.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant.Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.",PRE' VAGINAL LUBRICANT,2,"January 23, 2009", 2009,"INGfertility, LLC","Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.",N/A,N/A,Unknown***,Worldwide Distribution including USA and country of Ireland.,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0854-2009,50112,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Integra Ruggles Surgical Instrument ACF Distraction ScrewsSterile, Rx onlyCatalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536",Integra Ruggles Surgical Instrument ACF Distraction Screws,2,"January 23, 2009", 2009,Integra LifeSciences Corp.,A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.,PRODUCTION CONTROLS: Packaging,"Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached ""Recall Acknowledgement and Return Form"" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413.A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.",N/A,351,351 units,Nationwide Distribution,Terminated,"July 15, 2009",173,351,Not_Computer,N/A,N/A,N/A
Z-0908-2009,50750,"tourniquet, pneumatic",KCY,Pneumatic tourniquet.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Expressaire, Disposable Tourniquet Cuff 34"", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011.The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital).",Disposable Tourniquet Cuff ,2,"January 23, 2009", 2009,"Virtus, Inc.",The inflation tube may come loose at the connection to the cuff during use.,TRAINING: Employee Error,"Sammons Preston was notified of the recall by letter dated 11/24/08, which instructed them to examine their inventory immediately for the specific lot numbers. The quantity on hand should be indicated on the table attached tothe letter and the info should be faxed to Virtus at 812-933-0749. Customers that may have tourniquet cuff inventory of identified lot numbers should be contacted. Once recall items have been located in quarantine, Tara Collins, Quality Technician, should be contacted at 812-933-1121 for Return Material Authorization number.",N/A,2304,2304,Nationwide Distribution --- including state of Wisconsin.,Terminated,"October 22, 2010",637,5958,Not_Computer,N/A,N/A,N/A
Z-0886-2009,50544,template,HWT,Template for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12.Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.",Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional Articular surface,2,"January 23, 2009", 2009,Zimmer Inc.,"Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.",PRODUCTION CONTROLS: Process Control,"Zimmer sales force and distribution sites were notified of the recall via email on 12/15/08 and instructed to inventory, return the affected products and to provide a copy of the recall letter to those customers to whom they had further distributed the products. The 'Urgent: Device Recall"" letter dated 12/12/08, described the problem and the potential risks. For additional information, contact Zimmer, Inc., at 1-800-613-6131.",N/A,131,131 of both products.,"Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.",Terminated,"November 12, 2009",293,131,Not_Computer,N/A,N/A,N/A
Z-0818-2009,50232,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.",Tornier AFFINITI Humeral Stem ,2,"January 23, 2009", 2009,"Tournier, Inc.","Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"An Urgent Product Recall letter, dated 10/17/08, was hand delivered to end users by distributors and sales representatives beginning 10/20/08. The recall letter identified the issue and requested end users to immediately discontinue use of the affected products and return any unused affected products to Tornier. Distributors were to notify any and all accounts that may be end users or to provide this information to Tornier, whom will contact the end users. A questionnaire and return instructions were provided with the letter. The questionnaire was asked to be completed and returned to Tornier as soon as possible. For additional information, contact Tornier Customer Service at 1-888-494-7950.",Contact the recalling firm for information,401,401 total,"AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI",Open,N/A,N/A,401,Not_Computer,N/A,N/A,N/A
Z-0859-2009,50491,"accessories, blood circuit, hemodialysis",KOC,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / caseCombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device",CombiSet True Flow Series ,2,"January 23, 2009", 2009,Fresenius Medical Care North America,Port may crack and separate resulting in potential blood exposure/blood loss for the patient,PRODUCTION CONTROLS: Process Control,"Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.",N/A,57,57 units,Worldwide Distribution --- including USA and country of Canada.,Terminated,"September 24, 2009",244,351800,Not_Computer,N/A,N/A,N/A
Z-0836-2009,50538,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"January 23, 2009", 2009,GE Healthcare Integrated IT Solutions,There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.,DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomaly resulting in a patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653.",N/A,138,138 units,"Worldwide Distribution including USA and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom",Terminated,"May 18, 2010",480,138,Software,Output/Calculation,Software update,Software Update
Z-0929-2009,50770,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Somatom Definition AS, Model number 8098027.Computed tomography x-ray system",Somatom Definition AS,2,"January 23, 2009", 2009,"Siemens Medical Solutions USA, Inc",possible improper installation of tilt transport lock/tilt limiter,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed.",N/A,42,42 units,"Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.",Terminated,"September 23, 2009",243,42,Not_Computer,N/A,N/A,N/A
Z-0843-2009,48760,"stent, ureteral",FAD,Ureteral stent.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent.",Cook Urological Endoureterotomy Stent Set,2,"January 23, 2009", 2009,Vance Products Incorporated,"The bond may break where the two materials meet, resulting in separation of the stent.",PRODUCTION CONTROLS: Process Control,"Consignees were notified via ""Urgent: Recall Notice"" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.",N/A,1739,1739 of all products.,"Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam",Terminated,"November 27, 2009",308,1739,Not_Computer,N/A,N/A,N/A
Z-0584-2009,49603,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.",Medtronic SynchroMed EL Programmable Pump,2,"January 26, 2009", 2009,Medtronic Neuromodulation,"Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure for all SynchroMed pump",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.",Contact the recalling firm for information,76253,"Approx 76,253 of all devices.","Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.",Open,N/A,N/A,76253,Not_Computer,N/A,N/A,N/A
Z-0001-2009,50138,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.",NEUVIZ DUAL MULTISLICE CT SCANNER SYSTEM,2,"January 26, 2009", 2009,Philips Medical Systems North America Co. Phillips,"An issue associated with the ""Timed Scan"" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.",N/A,"A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.",N/A,19,19 units in the US.,"Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.",Terminated,"October 29, 2010",641,19,Software,Device Operation,Software update,Software Update
Z-0609-2009,50173,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.",DLP Pericardial/Intracardial Sump,2,"January 26, 2009", 2009,Medtronic Cardiovascular Revascularization & Surgical Therap,Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a ""Medtronic Urgent Medical Device Recall Notice"" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate ""Medtronic Recall Certificate (FCA 0902)"". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.",N/A,560,380 US ; 180 OUS,"Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.",Open,N/A,N/A,560,Not_Computer,N/A,N/A,N/A
Z-0887-2009,50230,"diathermy, shortwave, for use other than applying therapeutic deep heat",ILX,Shortwave diathermy.,Physical Medicine,Physical Medicine,510(k),"Regenesis Biomedical PROVANT WoundTherapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.",Regenesis Biomedical PROVANT Wound,2,"January 26, 2009", 2009,Regenesis Biomedical Inc,"In the course of device testing, the firm determined that the affected devices may, under certain unusualclinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such,for these few devices, the effectiveness of Provant therapy may be impaired.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.",N/A,7,7 units,"WY, VA, and NC",Terminated,"July 08, 2009",163,7,Not_Computer,N/A,N/A,N/A
Z-0889-2009,50485,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),Triathlon Cemented Stem - KneeThese devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.,Triathlon Cemented Stem,2,"January 26, 2009", 2009,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.,PRODUCTION CONTROLS: Packaging Process Control,"Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.",N/A,322,322 total units - all types,"Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.",Terminated,"January 20, 2010",359,322,Not_Computer,N/A,N/A,N/A
Z-0884-2009,50498,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Restoration Modular Conical Distal Stem;Sterile, Titanium Alloy. One unit per package.Stryker IrelandCarrigtwohill County Cork, Ireland.Authorized Representative in Europe: Stryker France, Cedex France.This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.",Restoration Modular Conical Distal Stem,2,"January 26, 2009", 2009,Stryker Howmedica Osteonics Corp.,Stryker became aware of a lot for lot mix up.,N/A,"Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.",N/A,4,4,Class II Recall - Nationwide Distribution,Open,N/A,N/A,4,Not_Computer,N/A,N/A,N/A
Z-0904-2009,50694,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904000. NOTE: This product is not sold in the United States.The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile.",Zimmer Tivanium Self Tapping Screw,2,"January 26, 2009", 2009,Zimmer Inc.,"The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.",PRODUCTION CONTROLS: Process Control,"The firm's facility in Japan was notified via letter, ""Urgent: Device Recall"" (dated 12/11/08) and requested to complete an enclosed Inventory Return Certification form. The letter instructed distributors to notify accounts to the user level to stop using the affected implants and return them to the Zimmer Distribution Center in the U.S. and fax (574-372-4265) a copy of the completed Inventory Return Certification form to Zimmer, Inc. For questions about the recall, please contact Zimmer, Inc. at 1-800-613-6131.",N/A,100,100,International Distribution including country of Japan.,Terminated,"October 30, 2009",277,508,Not_Computer,N/A,N/A,N/A
Z-0926-2009,50189,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000.The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management, the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous.",Stryker PainPump2 BlockAid,2,"January 27, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.",DESIGN: Process Design,"Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056.",N/A,2009,"2,009 boxes",Worldwide Distribution including USA and country of Canada.,Terminated,"November 30, 2009",307,2009,Other,Treatment/Delivery/Therapy,Remove,Remove or Replace
Z-0930-2009,50169,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),"Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCGTo provide mobility to a person restricted to a sitting position.",Invacare Storm TDX SP Power Wheelchair with Stability Lock,2,"January 27, 2009", 2009,Invacare Corporation,"Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.",PRODUCTION CONTROLS: Process Control,"On 11/27/2007 the firm sent Urgent Field Correction Needed recall notification letters and response forms to their customers informing them of the problem. They instructed their customers to immediately inspect and adjust the Stability Lock feature, distribute the enclosed update to the Owner's Manual to all end-users, and return the enclosed response form notifying them that the inspection and/or adjustments have been completed.",Contact the recalling firm for information,4171,4171 Wheelchairs,"Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.",Open,N/A,N/A,4171,Not_Computer,N/A,N/A,N/A
Z-0606-2009,50155,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Liko AB Uno Lifts, Powered (non-AC) Patient Lift:Old Uno 102: S/N 20001 through 21300New Uno 102 EM/EE/ES: S/N 30001 through 48100Production Dates: Manufactured prior to June 26, 2008Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor.",Liko AB Uno Lifts ,2,"January 27, 2009", 2009,Liko North America Inc,Actuator of the lift has the potential to separate when the upper arm is fully extended.,PRODUCTION CONTROLS: Process Control,"Hill Rom notified customers with a Field Safety Notice, dated December 5, 2008 to notify customers of the issue, potential risks, and to inspect units per their instructions and remove units from service if the unit fails inspection. Hill-Rom will provide a permanent fix, using an ""OuterTube"" to be placed on all units.",N/A,24070,24070 total units,Worldwide Distribution --- including USA and country of Canada.,Open,N/A,N/A,24070,Not_Computer,N/A,N/A,N/A
Z-0928-2009,50539,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"January 27, 2009", 2009,GE Healthcare Integrated IT Solutions,"There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 11/21/08 of the software anomaly resulting in a patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. The letter provided the users with safety instructions to follow until the software is updated. Please direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653.",N/A,476,476 units,Worldwide Distribution including USA and country of Canada.,Terminated,"September 06, 2010",587,476,Software,Display/Image,Software update,Software Update
Z-0654-2009,50503,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.",PrecisionPoint,2,"January 27, 2009", 2009,"iCAD, Inc.",Software modules not approved for this indication.,PREMARKET APPROVAL: No Marketing Application,"iCAD initiated a voluntary field correction by telephone and letter on 12/5/08 by disabling these features at all affected sites. Since Precision Point and TheraMap are controlled by a software license key, iCAD will disable these features by updating the license at the affected sites.",N/A,35,35,"Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.",Open,N/A,N/A,35,Computer,N/A,N/A,N/A
Z-0663-2009,50510,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),Ethicon Endo-Surgery ENDOPATH¶_ Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09),ENDOPATH Probe Plus II,2,"January 27, 2009", 2009,Ethicon Endo-Surgery Inc,"Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens",DESIGN: Process Design,"On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.",Contact the recalling firm for information,2461,"13 lots, 2,448 pieces","Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.",Terminated,"October 20, 2010",631,48372,Not_Computer,N/A,N/A,N/A
Z-0932-2009,50680,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA.The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.",AMS InteXen LP Collagen Dermal Matrix,3,"January 27, 2009", 2009,American Medical Systems,The product size shown on the carton labeling does not match the size on the product inside.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Customers were first notified by phone on 12/05/08. They were told of the situation and were requested to return the devices. Customers were also provided an Important Product Recall letter, dated 12/05/08. This letter identified affected product, told customers to discontinue use of product and to return it. An acknowledgement form was also asked to be returned. AMS Customer Service should be contacted at 1-800-328-3881 to receive a Return Authorization number and arrange for shipment of replacement product.",Contact the recalling firm for information,5,5,Nationwide Distribution --- including states of TN and TX.,Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-0883-2009,50119,wearable automated external defibrillator,MVK,N/A,N/A,Cardiovascular,N/A,Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor.The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.,Defibrillator PCA wihtin the monitor of the LifeVest,2,"January 28, 2009", 2009,Zoll Lifecor Corporation,The charging circuit will not shut down properly.,DESIGN: Component Design/Selection,"Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.",N/A,1685,1685 units,"Nationwide. OUS: Germany, United Kingdom, Italy, and France.",Terminated,"November 04, 2009",280,1685,Hardware,Device Operation,Remove,Remove or Replace
Z-0664-2009,50128,"prosthesis, hip, semi-constrained, metal/polymer, uncemented",LWJ,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439",Dual Taper Wedge Pressed Fit Femoral Component,2,"January 28, 2009", 2009,Stelkast Co,Sterility may be compromised due to breach in packaging.,DESIGN: Packaging Design/Selection,"On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.",N/A,6,6 units,USA distribution to dealers in TX and WV.,Terminated,"April 01, 2009",63,6,Not_Computer,N/A,N/A,N/A
Z-0837-2009,50140,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA.Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.","Atlantis PV Peripheral Imaging Catheter,",2,"January 28, 2009", 2009,Boston Scientific Corporation,"Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.",Contact the recalling firm for information,1033,1033 units,Worldwide Distribution --- USA including Puerto Rico and country of Panama,Terminated,"July 27, 2009",180,1033,Not_Computer,N/A,N/A,N/A
Z-0669-2009,50129,"culture media, antimicrobial susceptibility test, mueller hinton agar/broth",JTZ,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box",McFarland Standard,2,"January 28, 2009", 2009,Trek Diagnostic Systems,Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.,Contact the recalling firm for information,4,4 vials,USA distribution in OH and IL.,Terminated,"July 06, 2010",524,4,Not_Computer,N/A,N/A,N/A
Z-0668-2009,49711,"fluorometric method, cpk or isoenzymes",JHX,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.",Stratus CS Acute Care Troponin I TestPak,2,"January 28, 2009", 2009,"Dade Behring, Inc.",Incorrect result: Potential for false elevation of CTnI results,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.,N/A,5868,5868 cartons,"Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.",Terminated,"January 29, 2009",1,5868,Not_Computer,N/A,N/A,N/A
Z-0666-2009,50137,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.",Medtronic Maximo II VR,2,"January 28, 2009", 2009,Medtronic Inc. Cardiac Rhythm Managment,"Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm",DESIGN: Process Design,"A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.",Contact the recalling firm for information,376,376,"No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.",Open,N/A,N/A,1108,Not_Computer,N/A,N/A,N/A
Z-0935-2009,50479,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard 3D Max Mesh, Left large , SterilePre-formed Knitted PolypropyleneProduct Code: 0151531Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - ""Right"" and ""Left"" for use to the right or left side of the human body. There is a blue monofilament Medial marker ""M"" and a small arrow stitched into each orientation to designate the right or left medial edge of the product",Bard/Davol,3,"January 28, 2009", 2009,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeled: Product labeled as Left large, may contain a Right Large",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product.For additional information, contact Davol at 1-401-463-7000.",N/A,232,232 units,Nationwide,Open,N/A,N/A,232,Not_Computer,N/A,N/A,N/A
Z-0911-2009,50749,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471.The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.",Boston Scientific Endovive 20F (6.7 mm) Safety PEG Kit,2,"January 28, 2009", 2009,Boston Scientific Corp,"The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by ""Urgent Medical Device Recall"" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.",N/A,2460,2460 of all products,Nationwide.,Terminated,"October 30, 2009",275,2460,Not_Computer,N/A,N/A,N/A
Z-0673-2009,44850,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1 Pressure Venous Occluder, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 803480.For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.",Terumo APS 1,2,"January 29, 2009", 2009,Terumo Cardiovascular Systems Corporation,The system may malfunction due to t-filter corrosion on an internal circuit board.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"U.S. consignees were notified of the problem by letter on 11/16/07. International affiliates were informed via email on 11/21/07. Consignees were informed that Terumo would schedule appointments to install new pressure modules and reconfigure the systems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the work themselves. For additional information, contact Terumo CVS Customer Service at 1-800-521-2818.",N/A,1219,1219 (total),"Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",Terminated,"August 06, 2009",189,1219,Not_Computer,N/A,N/A,N/A
Z-0867-2009,50516,N/A,N/A,N/A,N/A,N/A,N/A,"REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4""X4.9"") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport DriveReply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.",Office System ,2,"January 29, 2009", 2009,"Biomet Microfixation, Inc.","Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.",PRODUCTION CONTROLS: Packaging Process Control,An IFU and correction letter will be issued to the field. Each distributor will receive instructions for delivering the correction letter to all customers. The customer letter will contain a reconciliation form to be returned once the customer receives the IFU for the twist drill. Contact Biomet Microfixation for additional information at 1-800-874-7711.,N/A,33,33,"Distributed domestically throughout the U.S. Distributed internationally to Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela.",Terminated,"September 11, 2009",225,420,Not_Computer,N/A,N/A,N/A
Z-0927-2009,50515,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.",Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122,2,"January 29, 2009", 2009,"Siemens Medical Solutions USA, Inc","If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc",DESIGN: Software Design,"An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.",N/A,36,36 units,"Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.",Open,N/A,N/A,36,Other,Display/Image,Notification,Safety Notice/Insructions
Z-0903-2009,50512,cadriovascular catheter sheath introducer kit,OEX,Catheter introducer.,Cardiovascular,Cardiovascular,Enforcement Discretion,"Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.",Spectranetics SLS II 14Fr. Laser Sheath Kit,2,"January 30, 2009", 2009,Spectranetics Corporation,Catheter pouch was mislabeled with the wrong size.,PRODUCTION CONTROLS: Error in Labeling,"Consignees were notified by sales representatives who visually inspected their inventory. The sales representatives were given a form to fill out to confirm whether the consignee had the catheters with the serial number still in inventory. The forms were faxed back to Spectranetics indicating if the catheters were used or not and if they were not used, were they labeled correctly. For assistance, contact Spectranetics Corporation at 1-719-447-2319.",N/A,24,24 units,"CA, FL, MI, NC, NY, OH, PA, TX, and VA.",Terminated,"February 26, 2009",27,24,Not_Computer,N/A,N/A,N/A
Z-0946-2009,50521,"surgical device, for ablation of cardiac tissue",OCL,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,Cardiovascular,510(k),"Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CADisposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.","Epicor LP Connecting Cable, CC6LPCE",2,"January 30, 2009", 2009,St. Jude Medical Inc,Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm issued notification by ""Urgent Product Recall"" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.",N/A,158,158 units distributed.,"Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.",Open,N/A,N/A,158,I/O,Device Operation,Remove,Remove or Replace
Z-0949-2009,50787,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CAMedical charged-particle radiation therapy system.",Siemens,2,"January 30, 2009", 2009,"Siemens Medical Solutions USA, Inc","The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.",DESIGN: Device Design,"On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall.Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.",N/A,43,43 units,Nationwide and Worldwide,Open,N/A,N/A,43,Not_Computer,N/A,N/A,N/A
Z-0931-2009,50523,"intervertebral fusion device with bone graft, lumbar",MAX,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),"Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231.The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.",Low Profile U Joint Driver for the SynFix Mini Open System,2,"January 30, 2009", 2009,Synthes Spine,screwdriver tip may break off and lodge in the screw head,DESIGN: Device Design,"The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of the information, the Verification Section of the letter needs to be completed and returned to Synthes by either fax: 610-719-5120 or scan/e-mail: lewis.lynne@synthes.com. An Urgent: Medical Device Recall letter, dated 1/16/2009, was also sent out. This latter letter requested that users examine their stock immediately and remove any of the affected devices from their inventory. Customers are also to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the Verification Section; and return the letter with the recalled product to the address listed. There are also actions for those who do not have the affected product. Questions should be directed to 800-620-7025 x 5453 or 610-719-5453.",N/A,381,381 units,"Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.",Terminated,"October 27, 2009",270,381,Not_Computer,N/A,N/A,N/A
Z-0948-2009,50751,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA.Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage",iSite PACS Versions 4.1.x up to and including 4.1.51.3,2,"January 30, 2009", 2009,"Philips Healthcare Informatics, Inc.","Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.",DESIGN: Software Design,"Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in ""Q1 2009"". For additional information, contact Philips at 650-293-2624.",N/A,40,40 units,"International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.",Open,N/A,N/A,40,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-0933-2009,50756,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.",Ergolift and Ergolift2 Floor LIfts,2,"January 30, 2009", 2009,"Arjo, Inc.","The manufacturer, BHM Medical, has received reports of structural failure of the mast during use.",PRODUCTION CONTROLS: Process Control,"Arjo sent the Urgent Device Recall letter dated 12/22/08 and Field Safety Notice (FSN) dated 12/8/08 to their Ergolift customers on 12/22/08. The accounts were informed of the potential structural failure of the mast on the BHM Medical Ergolift. The letter instructed the accounts to discontinue use of the lifts immediately. Those lifts with serial numbers ERLI-0001 and ERLI-0899 will be taken out of service permanently, and will be replaced with a new device at a significant discount. Those lifts with serial numbers ERLI-0900 and ERLI-1717 will be corrected by a reinforcement kit installed by a qualified technician. The accounts were requested to complete and return to Arjo Inc. within 10 days the enclosed customer response form indicating that they have received the notification, indicating the serial numbers on hand needing correction, and whether they need any replacement lifts. The accounts will be contacted by an Arjo technician within weeks to arrange for the correction of the lifts and/or an Arjo representative for the replacement lifts.",N/A,220,220 lifts,Nationwide Distribution.,Open,N/A,N/A,220,Not_Computer,N/A,N/A,N/A
Z-0923-2009,50184,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump, Two Site Infusion Kit with ExFen 2.5"", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25.A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.",Stryker PainPump ,2,"February 02, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,There is a potential for the pump to overinfuse.,PRODUCTION CONTROLS: Process Control,"A ""Medical Device Recall Notification"" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808.",N/A,118,118 boxes of all products.,Nationwide Distribution.,Terminated,"December 01, 2009",302,118,Not_Computer,N/A,N/A,N/A
Z-0675-2009,48991,"circuit, breathing (w connector, adaptor, y piece)",CAI,Anesthesia breathing circuit.,Anesthesiology,Anesthesiology,510(K) Exempt,"King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # CP-05204. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.","King Systems, DatexOhmeda, Universal Flex2 Breathing Circuit",2,"February 03, 2009", 2009,King Systems Corp.,"The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels.",DESIGN: Process Design,"Consignees were notified by an Urgent Product Recall letter on or about 7/29/2008 to cease sales, notify their customers to the hospital level, and to return product on hand.",N/A,500000,"Approx. 500,000 units of all products.","Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.",Terminated,"November 12, 2009",282,500000,Not_Computer,N/A,N/A,N/A
Z-0938-2009,50192,"stent, coronary",MAF,N/A,N/A,Cardiovascular,N/A,"VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm.The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.",VOYAGER NC Coronary Dilatation Catheter,2,"February 03, 2009", 2009,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,"The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the",DESIGN: Packaging Design/Selection,"An Urgent Device Recall letter (dated November 6, 2008) with an Efficacy Check Reconciliation form was issued and hand-carried to affected customers by their respective Sales Representative who assisted in locating and returning the recalled units. The letter described the problem and informed customers that Abbott Vascular will replace returned recalled product with like product or with VOYAGER NC sizes when they become available. Additionally, customers were instructed to contact their Abbott Vascular local account representative to review their inventory, complete and return the attached Efficacy Check Reconciliation Form and return affected products to Abbott Vascular.",Contact the recalling firm for information,98,98 units,Worldwide Distribution.,Open,N/A,N/A,224,Not_Computer,N/A,N/A,N/A
Z-0956-2009,50204,"implant, cochlear",MCM,N/A,N/A,Ear Nose & Throat,N/A,"HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.",HiRes90K Platinum Series Headpiece,2,"February 03, 2009", 2009,Advanced Bionics LLC,"Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks, but cann",TRAINING: Employee Error,"Advanced Bionics is notifying clinicians of this situation so that they can provideappropriate clinical management. The notification letter sent to clinicians in theUnited States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are notaffected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device.Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in thenumber of headpiece-related complaints, firm advises of the potential clinicalsymptoms:-No lock-Intermittent lock-Implant locks, but cannot measure impedances-Reduction in battery life, primarily for C1 patients with thick flaps.Per the letter, as long as the system maintains lock, there is no degradation in sound quality orstimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal.Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affectedheadpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.",N/A,2049,"2,049 units",Nationwide,Open,N/A,N/A,4409,Not_Computer,N/A,N/A,N/A
Z-0934-2009,50134,"restraint, protective",FMQ,Protective restraint.,General Hospital,General Hospital,510(k),Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.,Posey Connecting Straps & Belts/Locking Cuffs. ,2,"February 03, 2009", 2009,J T Posey Company,"The recall was initiated after an investigation conducted by the Posey Company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. In some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.",DESIGN: Labeling Design,"An ""Urgent Medical Device Recall (Correction)"" letter dated August 15, 2008 was mailed via US Postal Service to affected customers. The letter described the issue, instructed customers to secure a replacement label with the correct application technique over the picture in the 2008 Posey Catalog and provided a corrected Posey Locking Cuffs Instruction Sheet (19273). The Posey Company also provided updated literature for the Posey Locking and Non-Locking Connecting Straps 19270 and 19254.The Posey Company asked customers to complete and return the ""Reply Fax-Back Acknowledgment"" Form via fax (626-443-5418) or e-mail (vcimmarusti@posey.com) within 7 days. Contact your Sales Representative with any questions or concerns.",N/A,51200,"51,200 (Approximately)","Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.",Open,N/A,N/A,51200,Not_Computer,N/A,N/A,N/A
Z-0936-2009,50774,"instrument, manual, surgical, general use",MDM,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker AVS AL Spacer Trial Inserter;Non Sterile. Catalog number: 48329800Manufactured by Stryker Spine SAS, Cestas, France.Distributed in USA by Osteonics Corp., Mahwah, NJ.",Stryker AVS AL Spacer Trial Inserter,2,"February 03, 2009", 2009,Stryker Spine,"DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.",DESIGN: Device Design,"Market Withdrawal letters were sent out on September 8, 2006 to all branches who received device. The letter asked customers to examine their inventory and hospital consignment locations to identify the product. Also, customers needed to reconcile all products on the attached Product Accountability Form and fax a copy back. The affected products were to be retrieved and returned using the ""Product Returns Procedure"".",N/A,37,37,Nationwide Distribution --- including state of NJ.,Terminated,"February 05, 2009",2,37,Not_Computer,N/A,N/A,N/A
Z-0969-2009,50758,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"February 03, 2009", 2009,GE Healthcare Integrated IT Solutions,"If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 1/12/09 of the software anomaly resulting in a patient safety issue involving Default Display Protocols. The issue may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.",N/A,778,778 units,"Nationwide, Canada, Bermuda, Mexico, Ecuador, Chile, and Brazil",Terminated,"September 06, 2010",580,778,Software,Display/Image,Software update,Software Update
Z-0961-2009,50545,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N; 75005271, Rx only, QTY(1), non-sterileInstrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer","PROMOS Reverse, Glenosphere Loosening Adapter",2,"February 03, 2009", 2009,Smith & Nephew Inc,The product was breaking during use.,DESIGN: Device Design,All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.,N/A,51,51 units,"Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress",Open,N/A,N/A,210,Not_Computer,N/A,N/A,N/A
Z-0966-2009,50677,"posterior metal/polymer spinal system, fusion",NQP,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02Sspinal fusion surgery",TI NHance Rod 150 mm ,2,"February 03, 2009", 2009,Synthes Spine,the dimensional specifications are incorrect,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.,N/A,1508,1508 (total),"Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.",Terminated,"October 05, 2009",244,1508,Not_Computer,N/A,N/A,N/A
Z-0872-2009,50676,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden.The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.",SERVO Ventilator 300A ,2,"February 03, 2009", 2009,MAQUET Inc.,"SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to ""On"" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.",DESIGN: Device Design,"URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a ""Device Correction-Customer Fax Response"" to indicate number of units of the affected product and that they followed the instructions for including the attached supplemental instructions to the operating manual. For questions about the recall, contact your local Maquet, Inc. representative.",N/A,3688,"3,688 units in US",Nationwide,Terminated,"July 08, 2009",155,3688,Not_Computer,N/A,N/A,N/A
Z-0962-2009,50699,"prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing",NRA,N/A,N/A,Orthopedic,N/A,"Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; .Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.",Biomet Oxford Unicompartmental Knee,2,"February 03, 2009", 2009,"Biomet, Inc.","Packages labeled as ""right"" actually contain a ""left"" component.",PRODUCTION CONTROLS: Packaging Process Control,Biomet salesmen were notified by phone and instructed to retrieve the products. One customer was notified by letter dated 12/19/08 that use of the product should cease and that a salesman would pick up the product. A second customer had implanted the product and was hand delivered a letter dated 12/19/08 instructing that the patient should be monitored and symptoms treated as necessary. Contact Biomet at 574-362-3983 for assistance.,N/A,2,2,Massachusetts and West Virginia.,Terminated,"July 07, 2009",154,2,Not_Computer,N/A,N/A,N/A
Z-0970-2009,50759,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"February 03, 2009", 2009,GE Healthcare Integrated IT Solutions,Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.,DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.",N/A,22,22 units,"California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.",Terminated,"February 03, 2010",365,22,Software,Output/Calculation,Software update,Software Update
Z-0945-2009,50755,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000.IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.",IMPAX Cardiovascular Polling Procedure version 1.00.09,2,"February 03, 2009", 2009,AGFA Corp.,Polling procedure may fail when multiple merge/split is carried out.,DESIGN: Software Design,"All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.",N/A,5,5 units,"Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.",Terminated,"April 01, 2010",422,5,Software,N/A,Software update,Software Update
Z-0624-2009,45967,"system, x-ray, mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027,OARM(R),2,"February 04, 2009", 2009,"Medtronic Navigation, Inc",Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.,DESIGN: Software Design,"Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.",N/A,54,54 units,"Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore",Open,N/A,N/A,54,Software,Output/Calculation,Software update,Software Update
Z-0540-2009,49114,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611",MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels,2,"February 04, 2009", 2009,Siemens Microscan,"Falsely lowered imipenem MICs may result, leading to major errors in results.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.",N/A,569375,"Total of both Negative and Synergy: 569,375 boxes",Worldwide,Open,N/A,N/A,569375,Not_Computer,N/A,N/A,N/A
Z-0648-2009,50178,"stretcher, hand-carried",FPP,Hand-carried stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.",Stryker Medical StairPRO StairChair,2,"February 04, 2009", 2009,Stryker Medical Div. of Stryker Corporation,"Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.",N/A,6,6,"Worldwide Distribution: USA, India, Netherlands and United Kingdom.",Terminated,"October 27, 2010",630,213,Not_Computer,N/A,N/A,N/A
Z-0951-2009,49474,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.",ACCELERATOR APS Cetrifuge Module,2,"February 05, 2009", 2009,"Abbott Laboratories, Inc",ACCELERATOR APS Centrifuge Module being recalled due to potential for micro-cracks to form over time in the metal centrifuge rotor buckets that may cause the centrifuge buckets to disconnect from the rotor in the centrifuge during centrifugation.,DESIGN: Device Design,"Notification letters sent to consignees on 09/09/08. Consignees provided instructions for inspecting the buckets for cracks and were asked to contact customer service reps for replacement buckets. Consignees also asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter.",N/A,6,6,"Nationwide Distribution --- including states of TX, UT, and VA.",Terminated,"October 04, 2010",606,6,Not_Computer,N/A,N/A,N/A
Z-0950-2009,48172,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200For use in the calibration of the Iron and Magnesium assays.",Clinical Chemistry Iron/Magnesium Calibrator,2,"February 06, 2009", 2009,Abbott Laboratories Inc.,An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8mEq/L (1.0 mg/dL or 0.4 mmol/L).,PRODUCTION CONTROLS: Error in Labeling,"On April 24, 2008, a Product Correction letter with attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. Customer reply form were included in all US customers letter. The letter instructed customers to:1. Identify the lot number of Clinical Chemistry Iron/Magnesium Calibrator currently used in your laboratory2. If you have lot number 54187M200, cross out the incorrect Magnesium CAL 2 value in the value sheet, commodity 30-3535/R1, June 2005. Place a copy of this letter in all calibrator kits with this lot number.3. Enter the revised Magnesium CAL 2 value provided in this letter in your system. NOTE: Ensure that the value used corresponds to the units of concentration used in your laboratory. *ARCHITECT cSystems - Refer to Enter a calibrator concentration (cSystem) in Section 2, Installation procedures and special requirements of the ARCHITECT System Operations Manual. *AEROSET - Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual.4. Calibrate the Magnesium assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory.Customers were also instructed to please retain this communication for future reference and if they have forwarded any Clinical Chemistry Iron/Magnesium Calibrator to another laboratory, please provide a copy of this letter to them. An 800 number was provided in the recall letter for any questions the affected customers or any of the health care providers they serve may have.",N/A,1287,1287,"Worldwide Distribution --- USA including states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI, and countries of Mexico, Chile, Puerto Rico, Canada, Thailand, Curacao, Guatemala, Argentina, Dominican Republic, Germany, New Zealand, Jamaica, Ecuador, Brazil, El Salvador, Hong Kong, and Bermuda.",Terminated,"July 09, 2009",153,1287,Not_Computer,N/A,N/A,N/A
Z-0952-2009,50209,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"EPOC BGE Test CardThe EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions.The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.",EPOC BGE Test Card,2,"February 06, 2009", 2009,Epocal,elevated range of potassium levels,DESIGN: Device Design,"The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.",N/A,1000,1000 test cards,Nationwide Distribution --- including state of CA.,Terminated,"February 06, 2009",0,1000,Not_Computer,N/A,N/A,N/A
Z-0971-2009,50790,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.",3.7 V LiPolymer Battery,2,"February 06, 2009", 2009,Invivo Corporation,"Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. The firms investigation shows that the battery failure does not occur when a module is dropped with a ba",DESIGN: Process Design,"Urgent Medical Device Recall Notice letters, dated August 2008, and response forms were mailed to each consignee. Distributors were instructed to forward copies of the recall letter and response forms to their customers. The letters identified the affected products, gave the reason for the recall, the hazard involved, how to identify the product, actions to prevent the failure, and procedures to mitigate risk if failure occurs. The letter stated that Invivo would provide replacement batteries but until replacements were provided, customers should handle batteries over an elevated area and to make sure batteries are handled in the absence of paper or other flammable materials. If customers wish to remove the battery from the module in order to conserve battery life, they are to disengage the battery from the module and place the battery on a table or in the battery charger. Do not allow the battery to be disengaged and remain partially inserted in the module as this may cause the battery to slip from the module and fall to the floor.",N/A,8476,"8,476",Worldwide Distribution,Open,N/A,N/A,8476,Not_Computer,N/A,N/A,N/A
Z-0973-2009,50848,"saline, vascular access flush",NGT,Intravascular catheter.,General Hospital,General Hospital,510(k),"Sterile Field Saline Flush;0.9% Sodium Chloride Injection, USP; Rx Only; Single Use.Excelsior Medical, Neptune, NJ.This product is used for the flushing of venous access devices and intravenous tubing.",STERILE FIELD SALINE FLUSH ,2,"February 06, 2009", 2009,Excelsior Medical Corp,Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.,PRODUCTION CONTROLS: Packaging Process Control,"An Urgent Medical Device Recall letter (dated January 13, 2009) was sent to consignees via certified mail, with return receipt requested. The letter provided the reason for the recall and instructions to discontinue use and return (or destroy) the recalled product. The letter also instructed customers to complete the enclosed Customer Reply Form and fax (866-360-6211) to Excelsior Medical Corporation. If the affected product is destroyed on site, fax a copy of the certificate of destruction with the completed Customer Reply Form. Arrangements will be made by Excelsior Medical Corporation for the return of recalled product. Please direct questions to Excelsior Medical Customer Service at 800-487-4276.",N/A,341580,"341,580 units",Nationwide Distribution.,Terminated,"August 06, 2009",181,341580,Not_Computer,N/A,N/A,N/A
Z-0632-2009,50227,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.",Terumo TenderFlow Pediatric Arterial Cannulae,2,"February 06, 2009", 2009,Terumo Cardiovascular Systems Corporation,"The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.",DESIGN: Device Design,"An Urgent Medical Device Recall letter dated 10/16/08 was sent to consignees advising them of the problem; requesting that they immediately verify whether or not they had unused cannulae with the affected lot numbers; requesting that they isolate any affected product to prevent use; complete the Customer Response Form, indicate on form if it is medically necessary to use product without introducer; fax Customer Response Form to Terumo CVS at the number listed; and Terumo CVS would contact customers to arrange for the return of unused product. The letter stated that credit would be issued for any unused TenderFlow cannulae that were returned. The quantities to be returned should be indicated on the Customer Response Form. Consignees were advised that, if it was medically necessary to use the affected cannulae, they should be used without the introducer and in accordance with instructions for such use.",N/A,389,389 (200 plus 89 samples to US and 100 international),"Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.",Terminated,"August 04, 2009",179,2892,Not_Computer,N/A,N/A,N/A
Z-0974-2009,50887,"bone grafting material, synthetic",LYC,Bone grafting material.,Dental,Dental,510(k),"Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003.Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.",Zimmer Dental Calcitite 40602 ,2,"February 06, 2009", 2009,Zimmer Inc.,Fragments of the glass vial may be present in some of the packages from these lots.,PRODUCTION CONTROLS: Packaging Process Control,"The consignee in Japan was notified by e-mail and ""Urgent: Device Recall"" letter dated January 22, 2009 to stop using the product and to return it to the firm.",N/A,225,225 kits,International Distribution including the country of Japan.,Terminated,"October 23, 2009",259,225,Not_Computer,N/A,N/A,N/A
Z-0972-2009,50825,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe;Model Number: 279-351-300;Manufactured By: Stryker Endoscopy, Puerto Rico",3.5mm Super 90S SERFAS Energy Suction Probe,2,"February 09, 2009", 2009,Stryker Endoscopy,"The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.",PRODUCTION CONTROLS: Process Control,"On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed ""acknowledgment of receipt"" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.",N/A,2463,2463 units,Worldwide Distribution.,Terminated,"June 22, 2009",133,2463,Not_Computer,N/A,N/A,N/A
Z-0975-2009,50161,"oxygenator, cardiopulmonary bypass",DTZ,Cardiopulmonary bypass oxygenator.,Cardiovascular,Cardiovascular,510(k),"Medtronic Surgical Membrane Oxygenator.Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange.",Medtronic Surgical Membrane Oxygenator,2,"February 09, 2009", 2009,Medtronic Inc,"Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect ""Recommended maximum blood flow range"" on the label. The label on the device states a range of 5.0 - 8.5 L/min but should state a range of 5.0 - 6.5 L/min. These oxygenators are acceptable t",PRODUCTION CONTROLS: Error in Labeling,"A consignee letter "" Urgent Medical Deive Notice"" dated October 17, 2008 was sent to the impacted customers on October 17, 2008. The letter described the issue and product and confirmed the correct maximum internal flow of 6.5 L/min for the I-4500 Silicone Oxygenators. The letter states the product will not be removed from the field. Customers were instructed to complete the"" Medtronic Product Notification Certificate (FCA 0903)"" acknowledging receipt of the information and fax the completed certificate to 763-391-9603. Please direct questions about the recall to your Medtronic Sales Representative or call 763-391-9124.",N/A,408,408,"Worldwide Distribution USA including states of CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK PA, TN, TX, UT, VA, and WI, and countries of LATVIA, ITALY, ARMENIA, RUSSIAN FEDERATION, POLAND, CHILE and CHINA.",Open,N/A,N/A,408,Not_Computer,N/A,N/A,N/A
Z-0863-2009,50522,"apparatus, suction, ward use, portable, ac-powered",JCX,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.",VacuAide Compact Suction Unit,2,"February 10, 2009", 2009,Sunrise Medical,Improper suction: Regulator knob does not turn properly which can affect the suction level.,DESIGN: Device Design,"DeVilbiss notified dealers and users (through the dealers) to recall the units, by a telephone call October 27, 2008 followed by an Urgent Medical Device Recall mailing November 3, 2008. The letter advised customers what models are affected and how to contact the firm of dealer to have the affected unit replaced. Corrective and preventative action on current manufacturing has been implemented.",N/A,78,78 units,"Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.",Open,N/A,N/A,78,Not_Computer,N/A,N/A,N/A
Z-0980-2009,50223,"stent, ureteral",FAD,Ureteral stent.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word ""firm"" instead of ""soft"", but a product specific label stating ""soft"", as above, was also placed on the box.The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.",Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating,2,"February 10, 2009", 2009,Vance Products Incorporated,"""Soft"" stents were placed in ""firm"" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified via recall letter, ""Urgent: Recall Notice"" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.",N/A,23,23,"Nationwide Distribution including states of Georgia, Oregon and Texas.",Terminated,"November 25, 2009",288,23,Not_Computer,N/A,N/A,N/A
Z-0915-2009,48598,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002.Manufactured by: MAKO Surgical, Corp.The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.",MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS),2,"February 11, 2009", 2009,Mako Surgical Corporation,"The product in its current state may fail during use, which would cause the instrument to be in-accurate.",N/A,"A MAKO employee will visually verify product at each account for any product affected by this recall. In addition, a recall letter dated July 1, 2008 was mailed to users (surgeon and owner of system, e.g. hospital). Customers were instructed to complete the enclosed Acknowledgement form and return it to your Clinical Technical Specialist (CTS) or in the enclosed pre-paid addressed envelope to the Mako Surgical Corporation. Please direct questions to your CTS or call 954-927-2044, extension 604.",N/A,44,44,"Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.",Open,N/A,N/A,44,Other,N/A,N/A,Other
Z-0976-2009,50548,N/A,N/A,N/A,N/A,N/A,N/A,"Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907.The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch.The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.",Turbo Elite 0.9mm Turbo Elite RX,3,"February 11, 2009", 2009,Spectranetics Corporation,The catheter pouch label was incorrectly labeled with the wrong size.,PRODUCTION CONTROLS: Error in Labeling,The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly.,N/A,2,2 units,Nationwide Distribution including states of TX and FL.,Terminated,"February 13, 2009",2,2,Not_Computer,N/A,N/A,N/A
Z-0983-2009,50700,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL.The device is used in the treatment of fractures and osteotomies of the distal radius.",DePuy DNP Anatomic Fracture Repair System,2,"February 11, 2009", 2009,"Depuy Orthopaedics, Inc.","The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.",DESIGN: Device Design,"The firm's sales force was instructed via ""Urgent Device Correction"" letter issued December 29, 2008 to inspect all of these instruments in their possession, and those instruments at their hospital customers, and to leave a copy of the letter with each hospital customer who has the instruments on site.The letter describes the issue and corrective actions for customers. Please direct questions about this recall to Depuy Orthopaedics, Inc. at 888-783-7156.",N/A,3250,"Approx. 3,250 of all products",Nationwide Distribution.,Terminated,"October 18, 2010",614,3250,Not_Computer,N/A,N/A,N/A
Z-0977-2009,50697,"unit, electrosurgical, endoscopic (with or without accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA.The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.",MICROVASIVE GOLD PROBE,2,"February 13, 2009", 2009,Boston Scientific Corporation,Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.,PRODUCTION CONTROLS: Packaging Process Control,"A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time).Please direct questions about the recall to your local Sales Representative.",N/A,83435,"83,435",Worldwide Distribution.,Terminated,"May 11, 2010",452,109610,Not_Computer,N/A,N/A,N/A
Z-0862-2009,50499,"blade, scalpel",GES,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.,Stainless Steel Surgical Blades ,2,"February 20, 2009", 2009,"Miltex, Inc.",Blade may break: Over milling of the blade resulted in tip more narrow than specified.,PRODUCTION CONTROLS: Process Control,"An Urgent Medical Device Recall letter dated 11/17/08 with an accompanying fax back form was sent to each customer. Each distributor was instructed to review their inventory, complete the form, and return any affected product. The distributors were also instructed to conduct a sub recall notification.",N/A,200,200 boxes,Nationwide Distribution and Canada.,Terminated,"February 23, 2009",3,200,Not_Computer,N/A,N/A,N/A
Z-0861-2009,50496,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.",Eclipse treatment planning system,2,"February 20, 2009", 2009,Varian Medical Systems Oncology Systems,"Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.",DESIGN: Software Design,"An Urgent Device Correction product notification letter/field safetly letter dated November 21, 2008, was distributed to all affected users, with a description of the problem and user corrective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizations, informing them of the issue.",N/A,516,516 units,"Worldwide Distribution: USA, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom.",Open,N/A,N/A,516,Software,Treatment/Delivery/Therapy,Instructions for correction,Repair
Z-0910-2009,50554,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States).The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.",Terumo Advanced Perfusion System 1,2,"February 24, 2009", 2009,Terumo Cardiovascular Systems Corporation,"The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Urgent Medical Device Correction"" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.",N/A,515,515,"Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",Terminated,"July 07, 2009",133,1080,Not_Computer,N/A,N/A,N/A
Z-0942-2009,49610,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option.The device is intended to be used as an Intensive Care Unit bed.,Stryker InTouch Critical Care Bed,2,"February 25, 2009", 2009,Stryker Medical Div. of Stryker Corporation,"The touch screen on the footboard may display a ""tilt over range"" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the ""hold"" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho",DESIGN: Software Design,"Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a ""tilt over range"" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.",N/A,1288,"1,288 of all models","Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.",Terminated,"November 05, 2010",618,1288,Software,Device Operation,Software update,Software Update
Z-0921-2009,50064,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator",Cardio Vive ,2,"February 25, 2009", 2009,Cardiac Science Corporation,Potential for AED to not deliver defibrillation therapy.,DESIGN: Software Design,"On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who has the AED in their possession. A separate letter is being sent to distributors. The letter advised to install the software upgrades for any units in stock or to forward the software upgrade along with the end user letter enclosed and that the AED information text file generated by the update software must be returned to the firm. The firm will visit the locations of individual national account customers and install the update. OEM partners will be notified and provided the information and update kits to provide to their customers.",Contact the recalling firm for information,1064,"1,064 devices","Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, UK, and Ukraine.",Open,N/A,N/A,24183,Computer,N/A,N/A,N/A
Z-0944-2009,50541,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA.Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.Intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.",Hospira Symbiq Infusion System with MedNet Software.,2,"February 27, 2009", 2009,Hospira Inc,Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.,DESIGN: Software Design (Manufacturing Process),"Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements.",N/A,11840,"combined 11,840 units",Worldwide Distribution --- including USA and countries of Canada and Australia.,Open,N/A,N/A,11840,Not_Computer,N/A,N/A,N/A
Z-0991-2009,50552,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02.The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.",Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle,2,"February 27, 2009", 2009,Zimmer Inc.,The c-clip located near the connection end may fracture or fall off during use in surgical procedures.,DESIGN: Labeling Design,"U.S. consignees were notified by ""Urgent: Device Recall"" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.",N/A,1461,"1,461 of both products.","Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.",Terminated,"December 22, 2009",298,1461,Not_Computer,N/A,N/A,N/A
Z-0985-2009,50746,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.","Orthosoft Navitrack, OS Unicondylar Knee 1.0",2,"March 02, 2009", 2009,Zimmer Inc.,"Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for",DESIGN: Software Design,"Zimmer notified consignees via letter dated 8/19/08, which advised them not to change the selected surgeon profile after the acquisition of landmarks has begun, and the issued will be fixed with the next software release.",N/A,75,75 (34 U.S. and 41 international),"Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.",Terminated,"April 28, 2010",422,75,Software,Output/Calculation,Software update,Software Update
Z-1038-2009,50839,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product codes: 2M8153, 2M8163, 2M9163, DNM8153, DNM9163, BRM8153, BRM8153T, BRM8153RT, PNM8153, PNM8153T, PNM8153RT, CNM8153, GNM8153, HNM8153, TRM8153 and WNM8153.Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.","Colleague, Colleague CX and CXE Triple Channel Infusion Pumps",1,"March 02, 2009", 2009,Baxter Healthcare Corp.,"Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.",DESIGN: Device Design,"Baxter Healthcare Corporation sent an ""Urgent Device Correction"" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).",Contact the recalling firm for information,81775,"81,775 pumps","Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Open,N/A,N/A,302872,Battery,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-0955-2009,50796,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),Meter Remote for OneTouch Ping Glucose Management System,Meter Remote for OneTouch Ping Glucose Management System,2,"March 03, 2009", 2009,Animas Corporation,incorrect dosing recommendation,DESIGN: Software Design (Manufacturing Process),"The recalling firm issued Urgent: Medical Device Correction letters dated 10/27/08 to their customers/user to inform them of the problem. The letter stated that the firm was in the process of correcting the issue and that a new OneTouch Ping Meter-Remote would be provided as soon as one became available. In the interim, customers could still safely use their OneTouch Ping System provided that they use the ezCarb calculator on the meter-remote when it is paired and communicating with the pump. The letter listed guidelines to ensure that the device is properly communicating with the pump. The letter stated that customers should follow the directions in the Owner's Booklet to troubleshoot any communication issues. Questions regarding this letter were to be directed to Animas at 866-423-4087. A patient acknowledgment letter dated November 18, 2008 was also issued. Another Urgent: Medical Device Correction letter, dated November 2008, was issued along with the replacement device. This letter asked customers to download their current meter-remote data, set up their replacement meter-remote, and then return their current meter-remote.",Contact the recalling firm for information,5093,5093 units,"Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.",Terminated,"December 15, 2009",287,5093,Not_Computer,N/A,N/A,N/A
Z-0947-2009,50736,"stimulator, nerve",ETN,Surgical nerve stimulator/locator.,Ear Nose & Throat,Ear Nose & Throat,510(k),"VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves exposed during surgery for the purpose of identification or location.","STIMULUS/DISSECTION INSTRUMENTS, BALLTIP PROBES",2,"March 03, 2009", 2009,"Medtronic Xomed, Inc.",Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.,TRAINING: Employee Error,"All consignees were contacted by telephone (initiated on November 10, 2008). After telephone contact, each consignee was sent a follow-up fax/letter, ""Urgent Product Recall Notification"". The letter described the issue and actions for customers to take in response to the recall. Customers were instructed to check their inventories and return affected product to Medtronic Xomed, Inc. Customers were also instructed to fax their completed ""Customer Contact and Product Return Checklist"" to Medtronic Xomed, Inc. at 1-904-296-2386. Direct questions to Medtronic ENT Customer Service at 1-800-874-5797 (select Option 1 for Customer Service) and ask for the Vari-Stim Field Action Contact Person.",N/A,22,22 boxes (220 units),Worldwide Distribution --- including USA and country of Canada. (22 boxes were distributed within U.S. Three boxes were distributed to Medtronic Canada but returned),Terminated,"October 01, 2009",212,22,Not_Computer,N/A,N/A,N/A
Z-1013-2009,50738,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon X3 Posterior Stabilized Tibial InsertUse with Triathlon PS Femoral Components.Sze 7, THKNS 13 m and SZE 8, THKNS 13mm;Catalog number 5532-G-713, Catalog number 5532-G-813Stryker Orthopaedics",Triathlon X3 Posterior Stabilized Tibial Insert,2,"March 03, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm)",PRODUCTION CONTROLS: Labeling Mix-Ups,"Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.",N/A,9,9 of lot code LBD528; 14 of lot code LBD512,Nationwide Distribution: FL and IL.,Open,N/A,N/A,9,Not_Computer,N/A,N/A,N/A
Z-0992-2009,50132,"wax,bone",MTJ,N/A,N/A,General & Plastic Surgery,510(k),"Bone Wax. Ethicon, Inc.Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet.The device is indicated for use to control bleeding from the bone surface during surgical procedures.",Bone Wax,2,"March 04, 2009", 2009,"Ethicon, Inc.","A hospital reported to their Ethicon sales representative that they had an ""unmarked"" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. Upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. Further checks determined that two other boxes were missing.",DESIGN: Process Design,"Letters were sent via UPS next day air on October 28, 2008 to all customers who purchased finished product codes W31G and DW31B (on inner box labels) from January 1, 2008 through October 22, 2008.",N/A,2200,"2,200 foil pouches",Nationwide Distribution.,Terminated,"April 29, 2009",56,2200,Not_Computer,N/A,N/A,N/A
Z-0997-2009,51160,tube tracheostomy and tube cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers.The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.",Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube,1,"March 04, 2009", 2009,Covidien Limited,Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Consignees were sent an ""Urgent Device Alert"" letter dated 01/14/2009, by mail via Federal Express overnight delivery and instructed to evaluate any of the affected lot numbers of tracheostomy tubes prior to placement into a patient's stoma. If either the obturator or the desired sterile suction catheter does not fit properly into the tube, the tube must not be inserted into the patient. Further instructions are available at Nellcor Technical Services by calling 1-800-635-5267, option 3, then option 1. New product was expected by mid February, 2009, to address the issue.",N/A,8931,"8,931 units","Nationwide Distribution, including Puerto Rico.",Open,N/A,N/A,8931,Not_Computer,N/A,N/A,N/A
Z-1031-2009,50176,wrench,HXC,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01.Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.",Zimmer Silhouette Axial Torque Handle,2,"March 04, 2009", 2009,Zimmer Inc.,Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique.,PRODUCTION CONTROLS: Process Control,"The firm's sales force was notified by an Urgent: Device Recall letter dated 10/7/08, which instructed them to stop using the instrument and quarantine it immediately; physically count all affected product in their territory and record data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer Spine; and return the affected devices with the completed Inventory Return Certification Form. User accounts/implanting physicians were informed by an Urgent: Device Recall letter dated 12/10/08 and instructed to monitor their patients.",N/A,76,76,"Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.",Terminated,"December 22, 2009",293,76,Not_Computer,N/A,N/A,N/A
Z-1033-2009,49372,"bit, drill",HTW,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United KingdomIntended Use: Creating of holes for implant placement.","InteliFUSE, Drill Bit, 2.00 mm, JLatch",2,"March 05, 2009", 2009,Intelifuse Inc,"Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.",PRODUCTION CONTROLS: Process Control,"The firm initiated their recall on July 31, 2008 via telephone and Urgent Recall Notice to their current distributor, Integra. The letter asked them to complete, sign, and return the enclosed Recall Acknowledgment and Return Form. The letter also stated that InteliFUSE would travel to their designated Distribution Center(s) to ensure testing and replacement of all defective units once the form has been received. The firm sent follow-up Urgent Recall Notice letters on August 14, 2008 directing the distributor to recall from the hospitals to whom they distributed the product and to two hospitals which were shipped the products directly. The letter asked that use of the affected products be immediately ceased and that the any stock on hand be quarantined. The Recall Acknowledgment and Return Form should be completed, signed, and returned and the products should be returned to InteliFUSE for immediate replacement.",N/A,2149,2149 units,Nationwide Distribution - NY and NJ.,Open,N/A,N/A,4282,Not_Computer,N/A,N/A,N/A
Z-1034-2009,50899,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,N/A,"Integra Mosaik Putty, 15cc, Catalog # PTY10256Integra Lifesciences, Plainsboro, NJ",Integra Mosaik Putty,2,"March 06, 2009", 2009,Integra LifeSciences Corp,Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.,PRODUCTION CONTROLS: Packaging Process Control,"Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed ""Recall Acknowledgement and Return Form"" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.",Contact the recalling firm for information,88,88 units,"Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.",Terminated,"June 25, 2009",111,119,Not_Computer,N/A,N/A,N/A
Z-0953-2009,50511,"antisera, cf, influenza virus a, b, c",GNW,Influenza virus serological reagents.,Microbiology,Microbiology,510(K) Exempt,"LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121FOR IN VITRO DIAGNOSTIC USEAuthorized Representative:Millipore (UK) Ltd.Fleming Road,Kirkton CampusLivingstonEH54 7BNUK.Tel +44 1506 404000Fax +44 1506 404073MILLIPORE28820 Single Oak Drive Temecula, CA 92590 "" USA & CanadaPhone: +1(800) 437-7500 "" Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet",LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit ,2,"March 06, 2009", 2009,Millipore Corporation,Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail.Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.",N/A,404,404 units,"Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, andUnited Kingdom.",Open,N/A,N/A,662,Not_Computer,N/A,N/A,N/A
Z-1006-2009,50146,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively ""AED 10"")",AED 10,1,"March 09, 2009", 2009,"Welch Allyn Protocol, Inc",Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;,DESIGN: Software Design,"Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.",Contact the recalling firm for information,745,"10, 735",Worldwide Distribution.,Open,N/A,N/A,10735,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1018-2009,50711,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: Arterial, Epidural, Enteral, Intravenous, Spinal, Subcutaneous for delivering the following fluids: Intravenous solutions, drug solutions, blood or blood products and enteral feedings. Expanded recall includes:Medfusion Model 3500 Syringe Infusion Pump; Medfusion Model 3010A Syringe Infusion Pump, Software version 2.0.6; Medfusion Model 3500 - 414 Syringe Infusion Pump, Software version 4.1.4; Model 3500E Syringe Infusion Pump, Software version 3.0.6; Keypad 3500, G6000607; Top Case Assembly 3500, Service, G6000737; Keypad 3500, Enhanced G6000771",Medfusion Syringe Infusion Pump,2,"March 09, 2009", 2009,"Smiths Medical MD, Inc.","Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 (""Pump"") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were initially notified of the recall via a telephone conversation beginning December 18, 2008 and continued through January 2009. After the initial telephone contact, an ""Urgent Medical Device Recall"" letter dated December 22, 2008 was sent via electronic mail. The letter was addressed to ""Affiliates, Distributors, Clinicians, and other Customers"". The letter gave a Description of the Problem and Advise on Action to be Taken by the User. Direct questions to Smiths Medical Customer Service department at 1-800-426-2448 (option 1, then option 3).A Smiths Medical Customer Service Representative will have contacted customers. These pumps will be fitted with new keypads with gold connectors. A second Smiths Medical ""Urgent Medical Device Recall Additional Affected Units""recall letter was sent after the recall was expanded. The second letter dated March 6, 2009 was addressed to Safety/Risk Mangers, Healthcare Providers, Biomedical Engineers, Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investigation and Contact Details.",Contact the recalling firm for information,957,957,"Worldwide, including USA, AMERICAN SAMOA, AUSTRALIA, CANADA, CHILE, GERMANY, UNITED KINGDOM, HONG KONG, IRELAND, ISRAEL, SOUTH KOREA, NETHERLANDS, SAUDI ARABIA, SWEDEN",Open,N/A,N/A,3509,Not_Computer,N/A,N/A,N/A
Z-0996-2009,51039,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001.Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.",Zimmer Most Hinged Tibia Baseplate Spacer,2,"March 09, 2009", 2009,Zimmer Inc.,The package contains 11 mm screws instead of the specified 6 mm screws.,PRODUCTION CONTROLS: Packaging Process Control,"The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.",N/A,3,3,International Distribution only -- Country of Germany.,Terminated,"November 12, 2009",248,3,Not_Computer,N/A,N/A,N/A
Z-1005-2009,50142,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Welch Allyn AED 10 Automated External Defibrillator,Welch Allyn AED,1,"March 10, 2009", 2009,"Welch Allyn Protocol, Inc",Potential for device to shut down prematurely under certain circumstances.,DESIGN: Device Design,"On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.",N/A,89,89 units,"Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.",Open,N/A,N/A,89,Software,Device Operation,Software update,Software Update
Z-1022-2009,50084,"instrument, surgical, orthopedic, dc-powered motor and accessory/attachment",KIJ,N/A,N/A,Orthopedic,510(k),"Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.",Stryker System 6 Rotary Handpiece,2,"March 10, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.",DESIGN: Component Design/Selection,"Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.",N/A,25312,"25,312 of all units","Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.",Terminated,"October 27, 2010",596,25312,Not_Computer,N/A,N/A,N/A
Z-1007-2009,50532,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively ""AED 10"")",AED 10,1,"March 10, 2009", 2009,"Welch Allyn Protocol, Inc",Potential for device to deliver less than the programmed energy.,PRODUCTION CONTROLS: Process Control,"Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009.",Contact the recalling firm for information,14012,"14,012 devices",Worldwide distribution.,Open,N/A,N/A,14012,Other,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1060-2009,50856,"unit, electrosurgical, endoscopic (with or without accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System.PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico.Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3.",PROSTIVA RF Model 8929 Hand Piece ,2,"March 10, 2009", 2009,Medtronic Neuromodulation,Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System.,DESIGN: Device Design,"A Medtronic ""Urgent Medical Device Correction"" letter addressed to ""Healthcare Provider"" was sent August 6, 2008. The letter described the issue, product involved and the Prostiva hand piece Disassembly Procedure that should be followed in the event the user is unable to retract the needles during a procedure. The letter also requested the return of the ""Medtronic Reply Form/receipt Confirmation"" form.",N/A,40168,"40,168","Worldwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, IN, TX, UT, VA, VT, WA, WI, WY, and WV and countries of Australia, New Zealand, China, Austria, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Norway, Qatar, Russian Federation, Spain, Sweden, Switzerland, and United Kingdom.",Open,N/A,N/A,40168,Not_Computer,N/A,N/A,N/A
Z-1059-2009,51176,"unit, electrosurgical, endoscopic (with or without accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy.",AcuSnareAcuSnare Polypectomy Soft Snare,3,"March 10, 2009", 2009,Cook Endoscopy,The snare head is hexagonal but the handle and packaging indicate an oval reorder number.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified via USPC, Certified Mail and email on/about 1/21/2009 with an Urgent - Product Recall Notice. The distributor (Cook Australia) was instructed to return quarantined product to Cook Endoscopy. All medical users were instructed to review the attached list and quarantine any affected product remaining at their facility. They were to complete the form at the bottom of the page and send/fax it. Users are to return any affected product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed.",N/A,10,10 boxes (100 snares),"Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.",Terminated,"April 06, 2010",392,10,Not_Computer,N/A,N/A,N/A
Z-1010-2009,50861,"dislodger, stone, biliary",LQR,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511.The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.",Boston Scientific Stonetome Stone Removal Device,2,"March 11, 2009", 2009,Boston Scientific Corp,"The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.",PRODUCTION CONTROLS: Packaging,"Consignees were notified via letter dated January 8, 2009 to discontinue use of the affected product and to return it to Boston Scientific. Customers were instructed to complete and fax the Reply Verification Tracking Form to Boston Scientific at 508-683-5578. Direct questions about this recall to your local Sales Representative.",N/A,294,294 of all products.,Nationwide.,Terminated,"October 22, 2009",225,294,Not_Computer,N/A,N/A,N/A
Z-1091-2009,50131,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500.For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.",Pointe Scientific Glucose Oxidase Reagent,2,"March 12, 2009", 2009,"Pointe Scientific, Inc.",The product is unable to maintain the specification for linearity through the shelf life of the product.,PRODUCTION CONTROLS: Process Control,"Consignees were notified via an Urgent: Medical Device Recall letter dated 11/3/08 that all test results obtained with these lots are questionable and that attending physicians should be informed to determine whether additional testing is required. Also, consignees should examine their inventories for any of the lot numbers listed and dispose of them. If the product has been further distributed, identify customers and notify them of the product recall by including a copy of the recall letter. The Recall Return Response Form should be completed and returned and upon receipt Pointe Scientific will replace any disposed of reagent. Questions should be directed to the Technical Support Department at 1-800-757-5313.",N/A,1500,1500 liters,"Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.",Terminated,"December 03, 2009",266,1500,Not_Computer,N/A,N/A,N/A
Z-1014-2009,50185,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.",Medtronic TSRH 3DX Implant Set,2,"March 12, 2009", 2009,"Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK","The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.",PRODUCTION CONTROLS: Process Control,"Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new symptoms such as leg pain, back pain or irritation of local tissue). Customers were also instructed to complete and return the attached questionnaire to Medtronic SOFAMOR DANEK via mail (enclosed self-addressed stamped envelope) or fax at 901-399-2047. Direct questions to your Medtronic SOFAMOR DANEK Sales Representative or the firm's Global Quality Department at 800-876-3133, extension 6333.",N/A,43,43 sets,"Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.",Terminated,"November 18, 2009",251,4153,Not_Computer,N/A,N/A,N/A
Z-1092-2009,51159,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.",GE Healthcare Innova 3100 / 3100 IQ,2,"March 12, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.",DESIGN: Software Design (Manufacturing Process),On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.,N/A,4,4,"Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.",Open,N/A,N/A,5,Software,Device Operation,Software update,Software Update
Z-1074-2009,51205,"catheter, urological",KOD,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.Intended for use for bladder management including urine drainage, collection and measurement.",Magic3 Uncoated 6 French Pediatric Length,2,"March 16, 2009", 2009,Rochester Medical Corp,Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.,DESIGN: Packaging Design/Selection,"Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, ""Voluntary recall of magic product samples,"" was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.",Contact the recalling firm for information,12,12,"Worldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.",Open,N/A,N/A,1960,Not_Computer,N/A,N/A,N/A
Z-1070-2009,50471,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA",OneTouch SureStep Test Strips,2,"March 17, 2009", 2009,Lifescan Inc,"Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.",DESIGN: Process Design,"Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.",N/A,23288,"23,288 vials",Worldwide Distribution -- USA and the Caribbean.,Open,N/A,N/A,23288,Not_Computer,N/A,N/A,N/A
Z-1088-2009,50689,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"Triage Drugs of Abuse Panel, Model Number: 95000.Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.",Triage Drugs of Abuse Panel,2,"March 17, 2009", 2009,Biosite Inc,"The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result",OTHER/UNDETERMINED: Pending,"Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days.",N/A,2634,2634 kits,Worldwide Distribution -- USA and country of Canada.,Open,N/A,N/A,2634,Not_Computer,N/A,N/A,N/A
Z-0642-2009,50476,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.",Medtronic COMPLETE SE SelfExpanding Biliary Stent System,3,"March 18, 2009", 2009,Medtronic Cardiovascular,Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.,PRODUCTION CONTROLS: Process Control,"Medtronic sent a notification entitled ""URGENT - VOLUNTARY MEDICAL DEVICE RECALL"" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111.",N/A,23,23 units,"Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.",Terminated,"March 27, 2009",9,23,Not_Computer,N/A,N/A,N/A
Z-1090-2009,49548,"processor, cervical cytology slide, automated",MKQ,N/A,N/A,Pathology,N/A,"BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R.PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.",BD PrepStain System,2,"March 19, 2009", 2009,Bd Diagnostic Systems Tripath,Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.,N/A,662,662 units,Worldwide Distribution,Open,N/A,N/A,662,Software,Output/Calculation,Software update,Software Update
Z-1008-2009,50224,"kit, screening, staphylococcus aureus",JWX,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit.Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.",Dryspot (R) Staphytect Plus,3,"March 20, 2009", 2009,"Remel, Inc",Control and test wells are reversed on some of the reaction cards.,PRODUCTION CONTROLS: Process Control,The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.,N/A,32,32 kits dist. by recalling firm,"Nationwide Distribution -- including MN, MI, IL, and NC.",Terminated,"July 30, 2009",132,32,Not_Computer,N/A,N/A,N/A
Z-1009-2009,50170,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN.Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.",Roche COBAS c 111 Analyzer ,2,"March 24, 2009", 2009,Roche Diagnostics Corp.,"Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, con",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified via an Urgent Medical Device Correction letter dated 11/17/08 and instructed Roche will contact them to make an appointment to inspect their analyzers. A work around was provided, for interim use, in the letter. Customers were instructed to complete and fax back the ""ISE Controls Request - Purchased from a Distributor."" A no charge replacement product will be shipped to customers.",Contact the recalling firm for information,66,66,Nationwide Distribution,Terminated,"December 08, 2009",259,66,Not_Computer,N/A,N/A,N/A
Z-1041-2009,50174,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CAProvides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.",BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0,2,"March 24, 2009", 2009,Bio-Rad Laboratories Inc,"Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.",OTHER/UNDETERMINED: Pending,"An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.",N/A,92,92 units,Worldwide Distribution,Terminated,"November 12, 2010",598,92,Not_Computer,N/A,N/A,N/A
Z-1040-2009,50163,"microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity",NQN,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(k),"QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035.Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.",QCA and iQCA Software,2,"March 24, 2009", 2009,"Leica Microsystems, Inc.",A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Leica Microsystems sent Medical Device Correction letters dated 11/6/08 to the direct accounts, informing them that all versions 3.7 and above of QCA and iQCA software are not in compliance with the original 510(k) cleared software for scoring of immunohistochemical stains in clinical applications. The QCA/iQCA software is only cleared for Estrogen Receptor staining under clinical applications. The accounts were provided with red warning stickers that state: ""WARNING The clinical application of QCA software has been cleared only for the measurement of images from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuclear receptor protein only. Performance characteristics of the product, when used outside of this intended use, have not been established."" They were instructed to apply the stickers to any existing manuals and or at each point of use, and to instruct all users about the notification. The accounts were also requested to complete and return the enclosed reply form confirming that the changes have been made.",N/A,5,5 units,"Nationwide Distribution -- including states of CA, IL, KS, and NY.",Open,N/A,N/A,5,Software,N/A,Instructions for attahing stickers,Safety Notice/Insructions
Z-1160-2009,50867,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Tri-State Centurion PICC Insertion Tray, sterile, 15 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CVI2415A.",TriState Centurion PICC Insertion Tray,1,"March 25, 2009", 2009,Tri-State Hospital Supply Corporation,"Lack of assurance of sterility, as the package seals may be inadequate.",PRODUCTION CONTROLS: Packaging Process Control,"Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.",Contact the recalling firm for information,60,60,Nationwide.,Terminated,"December 31, 2009",281,1186,Not_Computer,N/A,N/A,N/A
Z-1135-2009,51287,"shunt, central nervous system and components",JXG,Central nervous system fluid shunt and components.,Neurology,Neurology,510(k),"Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.","Snap Shunt Ventricular Catheter, Standard, with BioGlide",1,"March 27, 2009", 2009,Medtronic Neurosurgery,The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.,DESIGN: Device Design,"An Urgent - Medical Device Recall notification was sent on February 13,2009 to the attention of risk managers, advising them to cease use of the Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782 ( all versions and all lot numbers), the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802 ( all versions and all lot numbers), and the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708 ( all version and all lot numbers). Each customer is to cease the use of the listed product and any unused unit needs to be returned to Medtronic. Further, each account is required to account for product used/implanted and to advise surgeons of the recall information. Each account will recieved an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.",N/A,3048,3048 of all units,"Worldwide Distribution -- USA, Ireland, and Australia.",Terminated,"November 08, 2010",591,3048,Not_Computer,N/A,N/A,N/A
Z-1052-2009,50896,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI.Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.",Stryker Impaction Bur Guard ,2,"March 30, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.",PRODUCTION CONTROLS: Process Control,"Customers were notified via a Medical Device Recall Notification letter dated 1/27/09 and instructed to immediately check all stock areas or operating room storage and inspect their bur guards for an expiration date. They were also instructed to quarantine any affected product found, to indicate on the Business Reply Form the quantity of affected product on hand, to destroy any affected product found without an expiration date by breaking off at least 3 of the tabs on the bur guard, then dispose of the affected product in normal trash, and complete and return the business reply form. Customers are to fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2760. Upon receipt of the Business Reply Form, a replacement bur guard(s) will be sent for any affected product destroyed.",N/A,70,70,Nationwide Distribution,Terminated,"December 17, 2009",262,70,Not_Computer,N/A,N/A,N/A
Z-1042-2009,50704,"colorimeter, photometer, spectrophotometer for clinical use",JJQ,"Colorimeter, photometer, or spectrophotometer for clinical use.",Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.", LIAISON Analyzer ,2,"March 30, 2009", 2009,Diasorin Inc.,DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.,DESIGN: Device Design,"DiaSorin Inc authorized Field Service Engineer has visited the sites and performed the necessary field correction. Upon completion of their work, the field service engineer generated a Field Service Report and a copy was left with the customer.",Contact the recalling firm for information,9,9,"Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of Canada.",Open,N/A,N/A,9,Not_Computer,N/A,N/A,N/A
Z-1089-2009,49438,"antinuclear antibody (enzyme-labeled), antigen, controls",LJM,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Sm ELISA Test SystemProduct number 2Z2831G and Product number 43270CEIndividual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70.Manufactured by Zeus Scientific, Raritan, NJ 08869-0038.Also manufactured for Wampole Laboratories, Princeton, NJ 08540Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.",Sm ELISA Test System,2,"March 31, 2009", 2009,Zeus Scientific Inc,"The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.",TRAINING: Employee Error,"Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.",N/A,33,"33 of lot 08041819, 27 of lot 08041811.",Nationwide Distribution,Terminated,"April 30, 2009",30,33,Not_Computer,N/A,N/A,N/A
Z-1073-2009,50520,"prosthesis, hip, semi-constrained, metal/polymer, uncemented",LWJ,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Dual Taper Wedge Pressed Fit Femoral Component.The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.",Dual Taper Wedge Pressed Fit Femoral Component,2,"March 31, 2009", 2009,Stelkast Co,A possible breach of the sterile barrier packaging (Tyvek pouch).,PRODUCTION CONTROLS: Packaging,The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.,N/A,187,187 units,"Nationwide Distribution -- states of NC, TX, and WV.",Terminated,"April 14, 2009",14,187,Not_Computer,N/A,N/A,N/A
Z-1020-2009,51177,"prosthesis, spinous process spacer/plate",NQO,N/A,N/A,Orthopedic,PMA,"Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518.The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried.by the attending physician.","Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).",2,"March 31, 2009", 2009,Theragenics Corporation,Some pouches were found to have weak seals potentially compromising sterility.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified first by telephone on December 8, 2008 and sent a follow up letter dated January 13, 2009. They were instructed to return any of the affected lots remaining in their inventory.",N/A,62,62 units,"Nationwide Distribution -- states of VA, WI, and CO.",Terminated,"April 06, 2009",6,62,Not_Computer,N/A,N/A,N/A
Z-1043-2009,50821,"candida spp., direct antigen, id",LRF,Cryptococcus neoformansserological reagents.,Microbiology,Microbiology,510(K) Exempt,"BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.",BEC Growth Chek Microbial Suspension Candida albicans CA1 (100 dose),3,"March 31, 2009", 2009,Lexamed,"Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.",PRODUCTION CONTROLS: Process Control,"The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail aschuler@lexamed.net.",No consumer action necessary,1,1 vial,USA: Utah,Terminated,"December 09, 2009",253,1,Not_Computer,N/A,N/A,N/A
Z-1204-2009,50482,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.",diaDexus PLAC Test Reagent Kit,2,"April 01, 2009", 2009,"DiaDexus, Inc",Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.,OTHER/UNDETERMINED: Pending,The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.,N/A,27,27 units,Nationwide Distribution,Terminated,"December 21, 2009",264,27,Not_Computer,N/A,N/A,N/A
Z-1122-2009,51236,"light, surgical, ceiling mounted",FSY,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K",ILED Surgical Light,2,"April 01, 2009", 2009,"Trumpf Medical Systems, Inc.","Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.",DESIGN: Device Design,"Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.",N/A,4480,4480 units (540 in U.S.),Worldwide Distribution.,Terminated,"October 22, 2009",204,4480,Not_Computer,N/A,N/A,N/A
Z-1206-2009,51053,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Zoll AED Plus Defibrillator,Zoll AED Plus ,1,"April 01, 2009", 2009,"ZOLL Medical Corporation, World Wide Headquarters",Device fails to discharge the defibrillation energy.,DESIGN: Process Design,"On 3/31/09, the firm revised their recall strategy and required all users to a perform a ""Mandatory Upgrade"" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009.In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update theirdevices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/.",N/A,183535,"183,535 units",Worldwide distribution,Open,N/A,N/A,183535,Battery,Device Operation,Software update,Software Update
Z-1053-2009,50914,"prosthesis, elbow, constrained, cemented",JDC,Elbow joint metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04.The device is utilized for a total elbow arthroplasty surgical procedure.",Zimmer Coonrad/Morrey Total Elbow,2,"April 02, 2009", 2009,Zimmer Inc.,"The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.",DESIGN: Labeling Design,"Consignees were notified by ""Urgent Device Correction"" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.",N/A,14613,"14,613 of all products","Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.",Terminated,"December 22, 2009",264,14613,Not_Computer,N/A,N/A,N/A
Z-1231-2009,51223,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550.","Stryker Electric Stretcher, Model 1550.",2,"April 05, 2009", 2009,Stryker Medical Div. of Stryker Corporation,"The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.",DESIGN: Device Design,"Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.",N/A,3607,3607,Worldwide Distribution,Open,N/A,N/A,3645,Not_Computer,N/A,N/A,N/A
Z-1044-2009,50518,"antinuclear antibody, indirect immunofluorescent, antigen, control",DHN,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA.The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.",ANA Flurescent Test System/Colorzyme Test System,3,"April 06, 2009", 2009,Immuno Concepts Inc,Samples can occasionally run out of the wells and cross contaminate adjacent wells.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm notified customers via a ""Notice of Market Withdrawal"" letter, e-mail and telephone. The letter described the problem and instructed customers to removed affected product from their inventory, complete the attached form and return it via fax to Immuno Concepts, Inc. at 916-363-2843. The firm will issue replacements as requested. Direct questions to Immuno Concepts, Inc. at 916-363-2649.",N/A,378,378 kits,"Worldwide Distribution, USA (NC, WI, MS, MD, IL, GA, CA, MI and Puerto Rico) and countries of Sweden, Mexico, Spain and Denmark.",Terminated,"November 10, 2009",218,378,Not_Computer,N/A,N/A,N/A
Z-1039-2009,51065,"system,network and communication,physiological monitors",MSX,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, S/5 iCentral and iCentral Client,Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE.The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only.","GE Healthcare S/5 iCentral LNET05, LNETC05",2,"April 06, 2009", 2009,GE Healthcare,"GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT",DESIGN: Software Design (Manufacturing Process),"Consignees were sent a GE Healthcare ""Urgent Medical Device Correction"" letter dated January 26, 2009 addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the safety issue, affected product details, safety instructions, product correction and contact information. Direct questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact your local GE Healthcare Distributor.",N/A,2146,"2,146","Worldwide Distribution, USA (and PR) including states of AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY,LA, ME, MI, MN, MS, MO, NH, NJ, NY, NC, OH, PA, SC, TX, VT, VA, WA, and WI and countries of AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GAYANA, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SLOVEN IA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIA ARAB REPUBLIC, THAILAND, TUNAS IA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA and YEMEN.",Open,N/A,N/A,2146,Software,Alarm/Message,Instructions,Safety Notice/Insructions
Z-1045-2009,50519,"extractable antinuclear antibody, antigen and control",LLL,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.",RELISA ENA Multiparameter Antibody Screening test,3,"April 06, 2009", 2009,Immuno Concepts Inc,"In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.",PRODUCTION CONTROLS: Process Control,"The firm has issued telephone calls, e-mails and notification letters to its consignees.",N/A,25,25 kits,"Worldwide Distribution including USA, Australia, England, Sweden and Austria.",Terminated,"November 17, 2009",225,25,Not_Computer,N/A,N/A,N/A
Z-0999-2009,50875,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral.The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.","Viasys Healthcare, Sonora Transcranial Doppler (TCD) System",2,"April 07, 2009", 2009,"Cardinal Health, Inc","Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not op",DESIGN: Device Design,"Consignees were sent a Cardinal Health ""Urgent: Medical Device Correction"" letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. The letter was addressed to customers describing the problems and systems affected and solutions. Cardinal Health requested customers to complete the actions listed in the letter to install the Field Correction and return the completed ""Verification Form"" via mail, e-mail or fax to Cardinal Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to 1-877-244-3805.",N/A,64,64 systems,"Worldwide Distribution -- USA including states of FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including THAILAND, SINGAPORE, SERBIA-MONTENEGRO, PORTUGAL, PHILIPPINES, POLAND, NORWAY, NETHERLANDS, KOREA, ITALY, ISRAEL, HUNGARY, HONG KONG, GREAT BRITAIN, SPAIN, GERMANY, CZECH REPUBLIC, SWITZERLAND, CANADA, BULGARIA, and BOSNIA-HERZEGOVINA.",Open,N/A,N/A,100,Software,Device Operation,Software update/Audio Driver update/OS update,Software Update
Z-1061-2009,51136,"pin, fixation, threaded",JDW,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491.The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.",Biomet Offset Tibial Tray Adaptor,2,"April 07, 2009", 2009,"Biomet, Inc.",A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by ""Field Safety Corrective Action"" letter dated February 13, 2009 to conduct a recall to the hospital level and to locate and return the recalled product to Biomet Orthopedics. Customers were also instructed to complete the enclosed ""Fax Back Response Form"" and return it via fax to Biomet Orthopedics at 1-574-372-1683. Direct questions about this recall to 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8 a.m. to 5 p.m.",Contact the recalling firm for information,17,17,"Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.",Terminated,"August 11, 2009",126,17,Not_Computer,N/A,N/A,N/A
Z-1171-2009,51173,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.,Internal Sterilizable Paddles and Handles without discharge control ,2,"April 07, 2009", 2009,"Physio Control, Inc.",Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.,OTHER/UNDETERMINED: Pending,"Recalling firm sent Urgent Medical Device Recall letters, dated 2/2009, advising customers to discontinue use of the listed sterilization methods and to remove them from service since there is no sterilization method that can be supported by current data. They are to use the enclosed form to identify and confirm if they have the listed products and follow the instructions on the form for returning information to the firm.",N/A,3218,"TOTAL: 3218 units; 2052 in the US, 1166 internationally",Worldwide Distribution,Open,N/A,N/A,3218,Not_Computer,N/A,N/A,N/A
Z-1174-2009,51402,"dressing, wound, drug",FRO,N/A,N/A,General & Plastic Surgery,510(k),"Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810.Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.",Integra Bilayer Matrix Wound Dressing,2,"April 07, 2009", 2009,Integra LifeSciences Corp.,Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the ""Recall Acknowledgement and Return Form"" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.",N/A,125,125 units,"Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.",Terminated,"June 26, 2009",80,125,Not_Computer,N/A,N/A,N/A
Z-1170-2009,50795,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167.Intended for self-administration of anti-microbial and antiviral agents.",ReadyMed Elastomeric Ambulatory Pump,2,"April 07, 2009", 2009,Cardinal Health 303 dba Cardinal Health,The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.,DESIGN: Process Design,"Cardinal sent an Urgent: Medical Device Recall Notification letter, dated 12/19/2008, to consignees on December 22, 2008 stating the Public Reason for Recall, and informing them of the Short Term and Long Term Actions. In addition a modification to the ""Dear Pharmacist"" letter, FAQ and Recall Response Card was mailed beginning January 26, 2009 to clarify that the pharmacist's ReadyMed products should be sent directly to their distributor and the credit for their product will also be provided through their distributor. Cardinal Health will work directly with the distributor and not the pharmacist as they are not Cardinal Health's direct consignee.Short Term: All ReadyMed elastomeric ambulatory infusion system models are subject to this recall. Cardinal Health is requesting that the use of the ReadyMed elastomeric ambulatory infusion system be discontinued and that the product be returned to Cardinal Health for credit.-Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card. Note on the card the ReadyMed elastomeric ambulatory infusion system models, lot numbers and quantities that will be returned. Cardinal will provide a courier mailing package for that return and will process consignees' credit.-Customers who purchased through a distributor will receive their credit through that distributor and not directly from Cardinal Health.-Consignee distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the Cardinal Health ReadyMed Recall Call Center at the number below.-Enclosed is a Frequently Asked Questions (FAQ) Letter for Pharmacists to address any questions or concerns related to the use of the ReadyMed elastomeric ambulatory infusion system.Long Term Actions: cardinal Health is continuing to investigate the out of specification condition of the ReadyMed elastomeric ambulatory infusion system and reviewing possible corrective measu.",N/A,2.6,Approximately 2.6 million units,Nationwide Distribution,Open,N/A,N/A,2600000,Not_Computer,N/A,N/A,N/A
Z-1096-2009,50696,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.",Enteral feeding replacement device.,2,"April 08, 2009", 2009,C R Bard Inc,Out of specification replacement gastrostomy device was distributed.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by ""Product Recall"" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689.",N/A,450,450 units,"Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.",Terminated,"May 18, 2010",405,29939,Not_Computer,N/A,N/A,N/A
Z-1172-2009,51135,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.",Lead Integrity Alert,3,"April 08, 2009", 2009,Medtronic Inc. Cardiac Rhythm Managment,"Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo"" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.",DESIGN: Software Design,"Between November 24 and December 9, 2008 US CRDM are responsible to hand deliver the consignee letter, a Medtronic ""Urgent Patient Management Information,"" dated November 2008, to impacted physicians to make them aware of the issue and continue to promote and install LIA (by using the new LIA tipcard). For any physician listed that a confirmation sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The letter also gave recommendations and informed consignees in regard to a future update to the LIA software for EnTrust devices.",N/A,55755,"55,755","Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.",Open,N/A,N/A,55755,Software,Alarm/Message,Software update,Software Update
Z-1072-2009,50771,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc.Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.",Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits,2,"April 09, 2009", 2009,Boston Scientific Corp,The marker band may detach from the sheath and a clinical failure could result in an embolism.,OTHER/UNDETERMINED: Pending,"The firm initiated the recall on December 24, 2009 and notified consignees via ""Urgent Company Initiated Medical Device Recall - Immediate Action Required"" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.",N/A,31340,"31,340 of all units",Worldwide Distribution.,Terminated,"April 06, 2010",362,31340,Not_Computer,N/A,N/A,N/A
Z-1181-2009,51300,"scissors, general, surgical",LRW,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, Teleflex Medical, Research Triangle Park, NC 27709",Pilling(R) Coronary Scissors,2,"April 09, 2009", 2009,Teleflex Medical,The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by an Urgent Medical Device Recall letter, dated 03/03/2009, via UPS Next Day. Hospitals were instructed to immediately discontinue use of the products, inspect the scissors for the date codes and to return the product to Teleflex Medical for replacement. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be completed and faxed back to Teleflex Medical. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected product retrieved by Teleflex Medical will be destroyed and replacement product provided to the consignee. Records of destruction will be maintained.",Contact the recalling firm for information,497,497 of all units,"Worldwide Distribution -- USA including states of AL, AZ, CA, CO, DC, DE, FL, IA, IN, KS, MA, MD, MI, MO, MS, NH, NJ, NY, NV, OH, OK, OR, PA, RI, TN, TX, UT, and WA, and countries of Australia, Canada, France, Germany, India, Japan, and Singapore.",Open,N/A,N/A,497,Not_Computer,N/A,N/A,N/A
Z-1065-2009,50171,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001.Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.",Roche/Hitachi Modular Analytics System,2,"April 10, 2009", 2009,Roche Diagnostics Corp.,"If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Consignees were notified via an Urgent Medical Device Correction letter dated 11/12/08 and instructed to only execute ""module unmasking"" when the unit is in ""standby"" mode and to consult with their physicians at the facility to determine the clinical implications and whether any clinical intervention is needed for patients treated based upon results obtained with this software. Questions should be directed to Roche Diagnostics Technical Support at 1-800-428-2336.",Contact the recalling firm for information,22,22 systems in all,"Nationwide Distribution -- including states of California, Florida, Georgia, Hawaii, Indiana, Maryland, New York, North Carolina, Pennsylvania, and Virginia.",Terminated,"September 22, 2009",165,22,Computer,N/A,N/A,N/A
Z-1064-2009,50478,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.",CELLDyn Ruby Hematology Analyzer,2,"April 10, 2009", 2009,Abbott Laboratories,Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.,OTHER/UNDETERMINED: Pending,Recall initiated on 11/17/2008. A Product Correction letter and customer reply form is sent to all currently active CELL-DYN Ruby customers. The customers are asked to keep the communication with their CELL-DYN Ruby System Operator's Manual and to note that the information listed in the table replaces the carryover specification provided in all applications of the manual. Questions from customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outside the US should contact their local hematology customer support representative.,Contact the recalling firm for information,899,899 units,Worldwide Distribution,Open,N/A,N/A,899,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0986-2009,50753,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Stryker Trio Small Offset ConnectorNon Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ.The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion.",STRYKER SPINE TRIO SPINAL FIXATION SYSTEM,2,"April 10, 2009", 2009,Stryker Spine,Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.,DESIGN: Device Design,"A notification letter dated September 12, 2006 and a Product Accountability Form were sent via Federal Express (with return receipt) to all affected branches/agencies. Further information can be found by calling 1-201-760-8256.",N/A,2417,"2,417 units","Nationwide Distribution including OR, CA, MA, VA, GA, FL, NY, NM, NJ, UT, KS, OH, MI, MN, IN, MT, TX, WI, AL, CO, and TN.",Terminated,"April 14, 2009",4,2417,Not_Computer,N/A,N/A,N/A
Z-1121-2009,50927,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"GE Healthcare, Infinia Hawkeye¶_ 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.",GE QUASAR NUCLEAR MEDICINE SYSTEM,2,"April 10, 2009", 2009,"GE Medical Systems, LLC","The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye¶_, and Infinia Hawkeye¶_ 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.",DESIGN: Labeling Design,"Consignees were sent a GE ""Product Safety Notification"" letter dated April 2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US).",N/A,288,122 US and 166 OUS,"Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries ofAustralia,Austria,Belgium,Brazil,Canada,China,Colombia,Czech,Denmark,Ecuador,Egypt,Finland,Finland,Egypt,Finland,France,Germany,Greece,Hungry,India,Indonesia,Ireland,Israel,Italy,Japan,Korea,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Norway,Pakistan,Panama,Philippines,Poland,Portugal,Republic of Georgia,Russia,South Africa,Spain,Sweden,Switzerland,Taiwan,Thailand,Turkey,Ukraine, and United Kingdom.",Open,N/A,N/A,1256,Not_Computer,N/A,N/A,N/A
Z-1094-2009,50990,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"GE Healthcare Infinia Hawkeye(R), Model numbers:H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.",GE Healthcare Infinia Hawkeye,2,"April 10, 2009", 2009,"GE Medical Systems, LLC",There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.,DESIGN: Software Design (Manufacturing Process),"Consignees were sent from September 2008 - Feb 2009 a GE ""Product Safety Notification"" letter dated 4/2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. It instructed consignees to continue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service reps should be contacted for further information regarding the notification.",Contact the recalling firm for information,417,"153 US, 264 OUS","Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, DC, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK ,OR, PA, PR, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of AUSTRALIA, BELGIUM , BRASIL, CANADA, CHINA, COLUMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GEORGIA, GERMANY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, NEW Zealand, NORWAY, POLAND, PUERTO RICO, RUSSIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM.",Open,N/A,N/A,639,Other,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1156-2009,51195,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"NurseMate with Physio Module;Remote Review, Monitoring and Charting Station;USA EPMedSystems, Inc.Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090.Outer box labeled as Smiths Medical.The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.",EPWORKMATE,2,"April 10, 2009", 2009,St. Jude Medical,"Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"St. Jude Medical received a recall notice dated January 16, 2009 from its supplier, Smiths Medical PM, Inc. St. Jude Medical prepared and sent their own recall letter dated February 13, 2009 to affected customers. The recall letter described the issue and possible associated risks and provided instructions to customers. A St. Jude Medical representative will contact customers to facilitate replacement of the fasteners. Questions should be directed to your St. Jude Medical sales representative.",N/A,4,4 units,"Nationwide Distribution -- CA, NV, and FL.",Terminated,"May 04, 2009",24,4,Not_Computer,N/A,N/A,N/A
Z-1154-2009,51297,"lamp, surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Alm Prismatic Surgical Light 5004 SF;Maquet SA.ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.","Lamp, surgical",2,"April 12, 2009", 2009,MAQUET Inc.,The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.,DESIGN: Device Design,"An ""Urgent Device Correction"" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed ""Customer Response Fax Form"" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the ""Customer Response Fax Form"" is received. Direct questions to your local Maquet, Inc. Representative.",N/A,54,"54 of all units, both article numbers",Nationwide Distribution.,Terminated,"September 29, 2009",170,54,Not_Computer,N/A,N/A,N/A
Z-1063-2009,50850,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile.Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ.The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.",AXSOS PLUS LOCKING PLATE SYSTEM,2,"April 13, 2009", 2009,Stryker Howmedica Osteonics Corp.,Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.,OTHER/UNDETERMINED: Pending,"""Urgent Product Recall"" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions:1. Examine your inventory and determine if you have any of the affected product,2. Remove and quarantine affected product from your inventory,3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and4. Return the affected product to your Stryker Orthopaedics Sales representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.",N/A,415,415 units,Nationwide Distribution.,Terminated,"April 06, 2010",358,882,Not_Computer,N/A,N/A,N/A
Z-1173-2009,51292,"electrode, pacemaker, temporary",LDF,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432",STREAMLINE Bipolar Temporary Myocardial Pacing Lead,3,"April 14, 2009", 2009,Medtronic Inc,"Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have b",PRODUCTION CONTROLS: Process Control,"Consignees were sent on 2/6/09 a Medtronic "" Urgent Medical Device Recall Notice"" dated February 6, 2009. The letter was sent to Risk Mangers. The letter described the product, problem, and requested the removal and quarantine of the affected, unused product. They asked consignees to sign and return the attached recall certificate regarding the status of affected product remaining at their facility. Their Medtronic Sales Representative will contact them to arrange the return of any affected inventory or customers may follow the instructions provided on the attached certificate.",Contact the recalling firm for information,612,612,"Nationwide Distribution -- including states of AK, AZ, CA, CO, CT, ID, IL, IN, KS, MI, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, TN, TX, VA, WA, and WI.",Open,N/A,N/A,612,Not_Computer,N/A,N/A,N/A
Z-1046-2009,50816,"test, hepatitis b (b core, be antigen, be antibody, b core igm)",LOM,N/A,N/A,Microbiology,N/A,"AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20;",AxSYM HBsAg Reagent Pack,2,"April 15, 2009", 2009,Abbott Laboratories,"Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.",OTHER/UNDETERMINED: Pending,"Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and discard any reagent packs that do not open properly. If a probe crash is observed prior to testing samples again, a probe crash recovery must be performed following the procedure in the Operations Manual. A copy of the communication needs to be provided to any laboratory that you may have forwarded affected lots to. Users were requested to return a customer reply letter acknowledging receipt and understanding of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.",N/A,1540,"1,540 kits","Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.",Terminated,"September 11, 2010",514,10123,Not_Computer,N/A,N/A,N/A
Z-1198-2009,51178,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),Low-Level Output Cable.The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.,DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP CONTROL SYSTEM ,2,"April 15, 2009", 2009,Datascope Corporation,Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.,DESIGN: Process Design,"An ""Urgent Medical Device Recall"" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.",Contact the recalling firm for information,20,20,Nationwide Distribution -- states of IL and FL.,Terminated,"August 11, 2009",118,20,Not_Computer,N/A,N/A,N/A
Z-0989-2009,50872,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),"Deltec Cozmo¶_ Insulin Pump, Model 1700 containing 1800 software.Deltec Cozmo¶_ Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility.","DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 211815, 211816, 21",2,"April 16, 2009", 2009,"Smiths Medical MD, Inc.","Smiths Medical has become aware of a display irregularity with the Deltec Cozmo¶_ Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w",DESIGN: Software Design (Manufacturing Process),"Consignees were sent a Smiths Medical ""Urgent Device Recall"" letter dated November 20, 2008. The letter was addressed to Distributors, Clinicians, Patients and other Customers. The letter included a Description of the Problem, Advice on Action to be Taken by the User and requested the return of the Confirmation Form.In particular, users were given the option to check the ""Replacement Pump"" option on the Confirmation Form initiating the process for pump replacement with a recertified pump followed by a return of the defective product. The Confirmation Form can be faxed to 1-800-628-6322 in the U.S. or 1-651-628-7485 outside the U.S., completed at www.cozmore.com/notice or calling 1-800-501-5748 in the U.S.",N/A,586,586,"Worldwide Distribution --- Including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MD, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and DC and countries of AUSTRALIA, NEW ZEALAND, UNITED KINGDOM, IRELAND, CANADA, CHINA, GREECE, POLAND, SLOVENIA, SWEDEN, ISRAEL and BRAZIL.",Open,N/A,N/A,17047,Computer,N/A,N/A,N/A
Z-1212-2009,51080,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),"8 Fr 30cc Ultra 8 IAB,IAB-05830-U, Intra-aortic balloon catheter.The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.","Arrow International, Inc. Intraaortic balloon catheter",1,"April 16, 2009", 2009,"Arrow International, Inc.","A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.",PRODUCTION CONTROLS: Process Control,"An ""Urgent Medical Device Recall"" letter dated February 2, 2009 was issued to consignees via US Certified Mail to notify users of the problem. Users were instructed to check their inventory for the affected products, quarantine, and return the them to Arrow International, Inc. Customers were also instructed to follow the ""Mitigation Directions"" in circumstances where alternate Intra-Aortic Balloon (IAB) catheters/adaptors or other forms of therapy are not available (until receipt of available product). Canadian accounts were notified on February 9, 2009 by courier and International accounts notified on 6 February 2009 and 10 February 2009 via Registered Post/UPS.Direct questions to your local Sales Representative or the Arrow International Customer Service at 1-800-523-8446 (US) or 1-919-361-4062 (outside US).Press Release issued April 13, 2009 is posted to firm's webiste:http://www.arrowintl.com/iab_recall.asp.",N/A,4258,"4,258 units","Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.",Terminated,"July 06, 2010",446,46793,Not_Computer,N/A,N/A,N/A
Z-1203-2009,50529,"device, microtiter diluting/dispensing",JTC,Microtiter diluting and dispensing device.,Microbiology,Microbiology,510(K) Exempt,"300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV.The products are a disposable product that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices.",300 microliter CORE tips,2,"April 17, 2009", 2009,Hamilton Co,Some tips may be occluded and are unable to aspirate or dispense liquid.,PRODUCTION CONTROLS: Process Control,"An ""Urgent: Product Recall Letter"" dated December 1, 2008 was issued to consignees via certified mail and e-mail. The letter described the problem and potential effects of use. Consignees were instructed to complete the enclosed ""Hamilton Company Product Recall Questionnaire"" and return it via e-mail or fax (775-856-7259) to the Hamilton Company. After receipt of the completed questionnaire, the firm's Customer Service Department will contact consignees to provide Returned Material Authorization information for returning affected product. Direct questions to the Hamilton Company at 775-858-3000, ext. 236.",N/A,28,28 cases,"Nationwide Distribution -- MA, CA, MN, CT, and NC.",Terminated,"July 21, 2009",95,28,Not_Computer,N/A,N/A,N/A
Z-1251-2009,51212,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319.The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.",Modular Replacement System (MRS) Cemented Stems,2,"April 17, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.",MISBRANDING: Labeling False and Misleading,"Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales rep if they weren't not contacted by them. Questions should be directed to Colleen O'Meara at 201-831-5970.",N/A,1161,1161 units,Nationwide Distribution,Terminated,"April 08, 2010",356,1161,Not_Computer,N/A,N/A,N/A
Z-1202-2009,51042,"diazo colorimetry, bilirubin",CIG,Bilirubin (total or direct) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.",HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT,3,"April 17, 2009", 2009,"Pointe Scientific, Inc.",The product performance fails due to precipitation of the R2 component.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by ""Urgent: Medical Device Recall"" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the ""Recall Return Response Form"" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc.Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.",Contact the recalling firm for information,24,24 kits,"Worldwide Distribution -- USA, Chile and Mexico.",Terminated,"October 13, 2010",544,24,Not_Computer,N/A,N/A,N/A
Z-1239-2009,51492,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.",SwanGanz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield ,2,"April 17, 2009", 2009,"Edwards Lifesciences, Llc","Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: ""Fault. CCO Catheter Verification. Use Bolus Mode"".",DESIGN: Software Design,"Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz"" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.",N/A,107,107 units,"Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.",Open,N/A,N/A,10754,Not_Computer,N/A,N/A,N/A
Z-1250-2009,51499,"catheter, peripheral, atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(k),"Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014"" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.","Diamondback 360, CSI ViperWire ",2,"April 17, 2009", 2009,"Cardiovascular Systems, Inc.",CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.,EXPIRATION DATING: Incorrect or No Expiration Date,"Customer letters were FedEx'd to CSI Sales Professionals on 03/16/2009, who delivered the letters and helped coordinate the removals of affected product. The letter identified the product, provided a description of the issue and provided instructions to immediately remove from use and return the affected guidewires to CSI. A Customer Acknowledgement Form was asked to be completed and returned with the devices.",N/A,10,10 devices,Nationwide Distribution,Open,N/A,N/A,10,Not_Computer,N/A,N/A,N/A
Z-1207-2009,51316,"centrifuges (micro, ultra, refrigerated) for clinical use",JQC,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A.The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.",MARROWSTIM CONCENTRATION KIT & MARROWSTIM MINI CONCENTRATION KIT,3,"April 17, 2009", 2009,"Biomet, Inc.",A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by ""URGENT MEDICAL DEVICE REMOVAL NOTICE "" dated March 5, 2009 and instructed to locate and return the recalled products. Direct questions about this recall to Biomet Orthopedics at 1-800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.",N/A,27,27 total kits of both products,Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.,Terminated,"July 07, 2009",81,27,Not_Computer,N/A,N/A,N/A
Z-0987-2009,50829,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO.CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.",CADD1 5100 AMBULATORY INFUSION PUMP,2,"April 20, 2009", 2009,"Smiths Medical MD, Inc.","Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due",PRODUCTION CONTROLS: Process Control,"An ""Urgent Medical Device Recall"" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the ""Advise on Action to be Taken by the User"". Smiths Medical MD, Inc. requested the user to complete and return the ""Urgent Medical Device Recall Confirmation Fax Return Form"" and fax to the firm at 1-651-628-7485 or e-mail to info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.",Contact the recalling firm for information,12,"17,868 cassettes (1,489 boxes 12 cassettes/box)","Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.",Open,N/A,N/A,17868,Not_Computer,N/A,N/A,N/A
Z-1004-2009,50543,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.","Reflection, Microstable Acetabular Liner",2,"April 21, 2009", 2009,Smith & Nephew Inc,Liners measuring 28 mm ID and were mismarked as 32 mm.,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled ""Urgent: Product Recall Notice - Immediate Action Required"", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately.Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.",Contact the recalling firm for information,19,19 units,"International Distribution to Canada, France, Germany and Switzerland.",Open,N/A,N/A,19,Not_Computer,N/A,N/A,N/A
Z-1003-2009,50918,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"GE Healthcare Infinia Hawkeye¶_ 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD.Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.",GE QUASAR NUCLEAR MEDICINE SYSTEM,2,"April 21, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye¶_, Infinia Hawkeye¶_ 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent po",DESIGN: Device Design,"Consignees were sent from June 2008 to February 2009 a GE ""Product Safety Notification"" letter dated April 2008. The letter was addressed to Hospital Administrators and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information.A GE Healthcare service representative will contact each consignee to schedule the installation of the Pressure Sensitive Device (PSD). Please contact your local sales or service representative for further information regarding this recall. Further information can be found by calling 1-800-437-1171 in the US or Canada or 1-262-896-2890 if outside the US.",Contact the recalling firm for information,288,"122 US, 166 OUS","Worldwide Distribution US (and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the United Kingdom.",Open,N/A,N/A,1256,Computer,N/A,N/A,N/A
Z-0995-2009,47442,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,N/A,"Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.",VNS Therapy System Generator,3,"April 22, 2009", 2009,"Cyberonics, Inc","Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.",DESIGN: Software Design,"Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered).Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician.If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.",N/A,108,108 units.,"Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.",Open,N/A,N/A,795,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-1205-2009,51215,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA.Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.",PLAC Test Calibrator Kit,2,"April 23, 2009", 2009,"DiaDexus, Inc","Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.",PRODUCTION CONTROLS: Process Control,"Distributors and Direct accounts were notified by phone followed by Notification letter and certificate of destruction via FedEx. International customers were notified via e-mail with PDF copies of notices, to be followed by hard copies via FedEx. Customers are requested to record the number of kits (full and partial ) they had on the Certificate of Destruction and to dispose of that number of kits with two people signing the form, and then to fax that form to diaDexus.",N/A,105,105 kits,Worldwide Distribution,Terminated,"January 05, 2010",257,105,Not_Computer,N/A,N/A,N/A
Z-1069-2009,50530,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.",Hemoglobin Reagent Syringe (CELLDYN Sapphire),2,"April 23, 2009", 2009,Abbott Laboratories,"Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.",PRODUCTION CONTROLS: Process Control,"Recall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.",N/A,30,30 syringes,"Worldwide Distribution -- USA, Australia, Canada, and Germany.",Open,N/A,N/A,30,Not_Computer,N/A,N/A,N/A
Z-1200-2009,51044,"ldl & vldl precipitation, hdl",LBR,Lipoprotein test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480.The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.",AUTOHDL CHOLESTEROL REAGENT SET,2,"April 27, 2009", 2009,"Pointe Scientific, Inc.",The R1 reagent has microbial contamination.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by ""Urgent: Medical Device Recall"" letter dated January 29, 2009, to conduct the recall to the retail level, to examine inventory and dispose of affected stocks on hand, and to complete the ""Recall Return Response Form"". Consignees were instructed to return their completed forms via mail, fax (1-734-483-1592) or e-mail to Pointe Scientific, Inc. (PS). Direct questions about the recall to PS Technical Support Department at 1-800-757-5313 or 1-734-487-8300.",Contact the recalling firm for information,590,"497 kits, 93L","Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.",Terminated,"October 20, 2010",541,1471,Not_Computer,N/A,N/A,N/A
Z-1123-2009,51276,"table, operating-room, electrical",GDC,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Operon Electrical Operating Room Table.The device is used as an electrical operating room table.,Operon,2,"April 27, 2009", 2009,Berchtold Corp.,Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece.,DESIGN: Device Design,"An official notification letter dated February 3, 2009 was hand-carried by a local Berchtold Corporation Technical Service representative to each account. The letter indicated that the Berchtold Corporation Service Technician will complete recommended upgrades. Direct questions concerning this recall to your BERCHTOLD Technician Service at 1-800-243-5135 and press the Number 2.",N/A,453,453 units,Worldwide Distribution -- US and Canada.,Terminated,"June 04, 2009",38,453,Not_Computer,N/A,N/A,N/A
Z-1197-2009,49019,prostate-specific antigen (psa) for management of prostate cancers,LTJ,Tumor-associated antigen immunological test system.,Immunology,Immunology,N/A,"Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205.The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.",Access Immunoassay Systems Hybritech PSA Calibrator,2,"April 28, 2009", 2009,Beckman Coulter Inc,Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.,PRODUCTION CONTROLS: Packaging Process Control,"An ""Urgent: Product Corrective Action"" letter dated January 10, 2008 was issued via fax or mail to customers. The letter described the issue and instructed consignees to discontinue use and discard the affected product. Consignees were also asked to complete and return a ""Fax-Back Form"" via fax (1-952-368-7610) or mail to Beckman Coulter, Inc. within 10 days of receiving the notification letter.Further questions should be addressed to Beckman Coulter Customer Technical Support at 1-800-854-3633.",Contact the recalling firm for information,123,123 Units,"Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV.",Open,N/A,N/A,123,Not_Computer,N/A,N/A,N/A
Z-1266-2009,51563,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A.Picture Archiving and communications system,syngo Imaging,2,"April 28, 2009", 2009,"Siemens Medical Solutions USA, Inc",An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).,DESIGN: Software Design,"A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.",N/A,20,20 units,"Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.",Terminated,"September 23, 2009",148,20,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1234-2009,51469,"post, root canal",ELR,Root canal post.,Dental,Dental,510(K) Exempt,"Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604",CYTCOK TITANIUM POST SYSTEM,2,"April 28, 2009", 2009,Dentsply Worldwide Headqrt,The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.,PRODUCTION CONTROLS: Process Control,"Dentsply notified their distributors and dentists of the recall by email sent on 03/20/2009 by Urgent Recall Notice letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter requests faxback response (enclosed with the recall notification) within five (5) working days. The letter included a response page to ensure the receipt of the notice. A second follow up letter will be sent to all that do not respond to the first letter.The firm identified another distributor within the company, DENTSPLY Tulsa Specialty Products, who also sent out identical recall letters to those they distributed the product on 03/25/09.",N/A,1588,1588 posts,"Worldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia.",Terminated,"February 12, 2010",290,1588,Not_Computer,N/A,N/A,N/A
Z-1208-2009,51431,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002",Cannulated Hex Screwdriver,2,"April 28, 2009", 2009,Wright Medical Technology Inc,"The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.",DESIGN: Process Design,"Wright Medical notified their distributors of the recall on 03/11/2009 by letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a ""fax back"" response page to ensure the receipt of the notice. The hospitals and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.",N/A,682,682 devices,"Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.",Terminated,"February 03, 2010",281,682,Not_Computer,N/A,N/A,N/A
Z-1235-2009,51423,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063",syngo Imaging,2,"April 28, 2009", 2009,"Siemens Medical Solutions USA, Inc","Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image",DESIGN: Software Design,"syngo Imaging has issued an Addendum to the User Manual, which was distributed to affected customers via Update Instructions IM118/08/S in November, 2008. Two safety related hotfixes (VB20G_HF4 and VB30A_HF26) will be released to those affected only after Update Instructions IM118/08/S has been performed. The addendum informs the user about safety relevant notes which pertain to syngo Imaging versions VB20G and VB30A. Update is a prerequisite for the following safety related hotfixes: VB20G_HF4 and VB30A_HF26.",N/A,55,55 units,Nationwide Distribution.,Terminated,"September 23, 2009",148,55,Software,Output/Calculation,Software update,Software Update
Z-1187-2009,51239,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-50.The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.",Stryker PainPump2,2,"April 30, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.",DESIGN: Process Design,"A ""Medical Device Recall Notification"" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the ""Business Reply Form"" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762.Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.",N/A,24675,"24,675 pumps","Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV and WY and countries of Argentina, Australia, Brazil, Canada, England, Singapore and South Africa.",Terminated,"December 01, 2009",215,24675,Not_Computer,N/A,N/A,N/A
Z-1319-2009,51439,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635.",TriState Centurion Endoscopy Tray,2,"April 30, 2009", 2009,Tri-State Hospital Supply Corporation,"Compromised sterility, as the package seals may be inadequate.",PRODUCTION CONTROLS: Process Control,"A letter titled ""Urgent Product Recall Notice"" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.",N/A,10,10,"Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.",Terminated,"December 24, 2009",238,550,Not_Computer,N/A,N/A,N/A
Z-1308-2009,51708,light based over the counter wrinkle reduction,OHS,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm.", Lumi 8 Intense LED Light Facial System,2,"April 30, 2009", 2009,"Sybaritic, Inc",Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System).No injuries or illness reported.,PREMARKET APPROVAL: No Marketing Application,"Letter sent to consignee on June 18, 2008 confirming a phone conversation on June 18 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA. The customer was asked to allow the technician access to their LUMI 8 system; allow technician to replace the computer chips and owner's manual; give current LUMI 8 owner's manual to technician; and sign the work order provided by the technician. Questions should be directed to Fred Berg at 800-445-8418 or fberg@sybaritic.com.",N/A,1,1,USA: MI,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-1236-2009,51319,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2.",Cerner Bridge Medical Transfusion Administration and Specimen Collections,2,"May 01, 2009", 2009,Cerner Corp,Specimen labels printing incorrect patient demographics.,DESIGN: Software Design,"Cerner Corporation issued a ""Priority Review Flash"" dated January 15, 2009 via e-mail to consignees using the software. The letter described the violative nature of the software and explained the proper navigation controls needed to prevent further issues.Further questions should be addressed to Bridge Client Support at 1-800-786-0239.",N/A,4,4,"Nationwide distribution to states of OH, NC, MO and MI.",Open,N/A,N/A,4,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1237-2009,51432,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.,Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1,2,"May 01, 2009", 2009,Cardinal Health 303 dba Cardinal Health,The Alaris PCA module can potentially infuse above or below the intended infusion dose.,DESIGN: Software Design,"The field action was initiated on March 11, 2009 with Cardinal Health sending by registered return receipt mail a Safety Alert to all customers using the Alaris PC Unit with software versions 8 through 9.1, which encompasses the subset of those customers that use the Alaris PCA Module. The Safety Alert was addressed to the Directors of Nursing, Pharmacy, Risk Management, and Biomedical Engineering at each hospital facility. If a customer did not respond to the Safety Alert, then Cardinal Heath notified that customer by telephone to verify receipt of the Safety Alert.This Safety Alert Informed the customers about a potential risk, and required them to: (1) Determine whether you use version 8 through 9.1 of the Alaris PC Unit. (2)Forward this Safety Alert to all Data Set owners (3) To immediately identify the potential risks review enclosed FAQs and Instructions for Data Set Review. (4)Continue to follow the Institute for Safe Medication Practices (ISMP) and the Joint Commission recommendation for safe medication administration - two nurses checking to ensure that the correct prescription is being entered into the PCA pump when first ordered and when there are any changes in the prescription (paying close attention to dosing units and infusion modes). The customers were also instructed to call our Support Center at 1-888-562-6018 with any questions. An updated Customer Recall Notification was forwarded by registered return receipt mail by Cardinal Health on April 15,2009. This notice reinforced the information in the first notice in addition to informing the customers of the hazard of an over-infusion or under-infusion of medication. Also, customers were given instruction for reporting any adverse reactions experienced with the use of the affected product and/or quality problems via the FDA's MedWatch Program.",N/A,164000,"Approximately 164,000 units","Worldwide Distribution -- USA, Canada, Germany, Malaysia, and Singapore.",Open,N/A,N/A,164000,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-1317-2009,51562,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom TotalCare Bed, Model P1900.The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post",HillRom TotalCare Bed ,2,"May 01, 2009", 2009,"Hill-Rom, Inc.","An e-ring may not have been installed during production, which could result in an inability to latch the siderail.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.",Contact the recalling firm for information,53,53 beds,Worldwide Distribution -- USA and Canada.,Terminated,"October 13, 2010",530,53,Not_Computer,N/A,N/A,N/A
Z-1232-2009,51253,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare CIC Pro"" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1.The CIC Pro"" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.",CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION,2,"May 04, 2009", 2009,GE Medical Systems Information Tecnology,"GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro"" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction.",DESIGN: Software Design,"Consignees were sent a GE Healthcare ""Urgent Medical Device Correction"" letter dated February 27, 2009. The letter was addressed to the Chief of Nursing/Chief of Biomedical Engineering and Risk Manager/Healthcare Administrator. The letter describes the Safety Issue, Affected Product Details, Safety instructions, Product Correction, and Contact Information.Direct questions to your local GE Healthcare Field Service Representative or the GE Healthcare Technologies Support Center by calling 1-800-558-7044 (Option 2, Technical Support).",N/A,12737,"12,737","Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY, WI, and WV) and countries of UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA, BOSNIA AND HERZEGOVINA, BANGLADESH, BELGIUM, BRAZIL, BAHAMAS, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CUBA, CYPRUS, CZECH REPUBLIC, GERMANY, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, GHANA, GREECE, HONG KONG, HUNGARY, HONDURAS, INDONESIA, IRELAND, ISRAEL, INDIA, IRAQ, BRITISH INDIAN OCEAN TERRITORY, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, MALTA, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SW DEN, SINGAPORE, SLOVENIA, SLOVAK REPUBLIC, SYRIA, THAILAND, TURKEY, TRINIAD, TOBAGO, TAIWAN, UKRAINE, UNITED KINGDOM, VENEZUELA, YEMEN, and SOUTH AFRICA.",Open,N/A,N/A,12737,Software,Device Operation,Correction,Repair
Z-1244-2009,51421,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device.",TEVADAPTOR ,2,"May 06, 2009", 2009,Migada Inc.,Syringe adaptor is disintegrating when attached to the end of the syringe.,DESIGN: Component Design/Selection,"A Field Safety Notice, dated 12/8/2008, was sent to all TEVADAPTOR customers advising them not to use drugs containing N,N-Dimethylacetamide. Teva Medical is presently revising the instruction leaflet supplied with each TEVADAPTOR to include a warning against the use of drugs containing N,N-Dimethylacetamide. Teva Medical will introduce this revised leaflet to current production as soon as practicable. In the meantime, Teva Medical will advise all users of the potential problem by means of the Urgent Field Safety Notice. Customers are to ensure that the safety notice is passed to all those who need to be aware within their organizations. Questions should be directed to their local contacts at B Braun, USA.",Contact the recalling firm for information,900000,"900,000 units",Nationwide Distribution,Terminated,"July 27, 2009",82,900000,Not_Computer,N/A,N/A,N/A
Z-1254-2009,51560,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.,AXIOM Sireskop SD ,2,"May 06, 2009", 2009,"Siemens Medical Solutions USA, Inc","During interventional use and applications, the possibility exists for liquids to enter the systems.",PRODUCTION CONTROLS: Equipment Maintenance,"A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications.Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.",N/A,240,240 units,Nationwide Distribution.,Terminated,"September 01, 2009",118,909,Not_Computer,N/A,N/A,N/A
Z-1328-2009,49127,"electrode, ion based, enzymatic, creatinine",CGL,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzerCatalog # 35238Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.",Stat Profile Critical Care Xpress (CCX and CCX),2,"May 07, 2009", 2009,Nova Biomedical Corporation,"Erroneous, low creatinine results on CCX analyzer",OTHER/UNDETERMINED: Pending,"Initial:USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites.International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call).Follow-up:USA and Canada - Sending the Customer Advisory Notice by email and/or fax to the key customer contact from the initial phone contact.International - Sending the Customer Advisory Notice by email and/or fax to the key contact.",N/A,1230,1230,"Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.",Open,N/A,N/A,1230,Not_Computer,N/A,N/A,N/A
Z-1233-2009,51494,"full field digital,system,x-ray,mammographic",MUE,Full-field digital mammography system.,Radiology,Radiology,N/A,"Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900.The device is used for full field digital mammography system.",Siemens Mammomat Novation DR,2,"May 07, 2009", 2009,"Siemens Medical Solutions USA, Inc","Image may appear dark, requiring repeat image acquisition.",DESIGN: Software Design,"A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available.",Contact the recalling firm for information,497,497 units,Nationwide Distribution.,Open,N/A,N/A,497,Software,Display/Image,Software update,Software Update
Z-1391-2009,51925,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and plasma specimens. These three cardiac biomarkers are used as an aid in the diagnosis of myocardial infarction (injury).",Triage Cardiac Panel,1,"May 08, 2009", 2009,Biosite Inc,"The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.",PRODUCTION CONTROLS: Process Control,"The recall was initiated with ""Urgent Medical Device Recall"" notices, dated 4/28/2009, with attached ""Customer/Distributor Verification Form"" being sent to the affected customers via fax, e-mail or direct mail on 04/28/2009. Customers were informed of the reason for the recall and instructed to immediately discontinue all use of the listed products and discard all affected product in accordance with your their regulations. The customers were give two options; ""Option 1: Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of kits discarded from your inventory and product replacement will be sent to you. Option 2: Contact inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt. A representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you.""Customers were also provided telephone, fax and e-mail contact information for Biosite should they have any questions about the information contained in the recall notification.",N/A,401,401 kits,Nationwide Distribution,Terminated,"July 06, 2010",424,401,Not_Computer,N/A,N/A,N/A
Z-1209-2009,51206,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.","KyphX Xpander Inflatable Bone Tamp, size 15/3",2,"May 11, 2009", 2009,"Medtronic Spine LLC, formerly Kyphon Inc",Product not sterile: 10 units were released for distribution without undergoing sterilization process.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees.",N/A,10,10 units affected.,Product was distributed to two hospitals in OH and FL.,Terminated,"July 14, 2009",64,10,Not_Computer,N/A,N/A,N/A
Z-1309-2009,51049,"suture, absorbable, synthetic, polyglycolic acid",GAM,Absorbable poly(glycolide/l-lactide) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ 08876Sutures are intended for general soft tissue approximation and/or ligation.",Coated VICRYL (Polyglactin 910) Suture,2,"May 12, 2009", 2009,"Ethicon, Inc.",Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.,PRODUCTION CONTROLS: Process Control,"Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative.5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.",N/A,1758360,"1,758,360 total","Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.",Terminated,"October 21, 2009",162,1758360,Not_Computer,N/A,N/A,N/A
Z-1252-2009,51473,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Servo Ventilator 300 (Model SV300) andServo Ventilator 300 (Model SV300A).The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.",SERVO VENTILATOR 300,2,"May 12, 2009", 2009,MAQUET Inc.,The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.,OTHER/UNDETERMINED: Pending,"An ""Urgent: Device Correction"" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the ""Device Correction -- Customer Fax Response"" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.",N/A,7847,"7,847 units",Nationwide Distribution.,Terminated,"November 16, 2009",188,7847,Hardware,Device Operation,Instructions,Safety Notice/Insructions
Z-1262-2009,51320,broach,HTQ,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07.A reusable cutting instrument that is used in total knee arthroplasty surgery.",Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach,2,"May 12, 2009", 2009,Zimmer Inc.,The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Distributors were notified by an ""Urgent: Device Recall"" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities.Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.",No consumer action necessary,37,37,"Worldwide Distribution -- US, Australia, and Germany.",Terminated,"December 22, 2009",224,37,Not_Computer,N/A,N/A,N/A
Z-1327-2009,47475,ferrozine (colorimetric) iron binding capacity,JMO,Iron-binding capacity test system.,Clinical Chemistry,Clinical Chemistry,Enforcement Discretion,Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25For the In Vitro quantitative determination of iron in serum.,Iron Assay ,3,"May 13, 2009", 2009,"Diagnostic Chemicals, Ltd.",Precipitate in product may cause elevated background absorbance interference.,PRODUCTION CONTROLS: Process Control,Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.,N/A,153,153 kits,Nationwide Distribution,Open,N/A,N/A,153,Not_Computer,N/A,N/A,N/A
Z-1263-2009,51447,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),Carina Home Ventilator.The device is used as a continuous respirator/ventilator for home use.,Carina Home Ventilator,2,"May 14, 2009", 2009,"Draeger Medical, Inc.","The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.",DESIGN: Software Design,"An ""Urgent - Medical Device Recall"" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the ""Urgent - Medical Device Recall"" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press ""1"" at the prompt and then press ""2349#""). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press ""4"" at the prompt).",Contact the recalling firm for information,40,40 units,"Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.",Terminated,"January 05, 2010",236,40,Software,Alarm/Message,Software update,Software Update
Z-1326-2009,50740,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325.Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.",BCI Advisor Vital Signs Monitor,2,"May 15, 2009", 2009,"Smiths Medical PM, Inc.","Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.",DESIGN: Device Design,"An Urgent Product Safety Information, Voluntary Recall Notification, dated 12/22/08, was sent to affected consignees. The notification contained a Safety Action Bulletin which provided actions to be taken. The Safety Action Bulletin described the issue, requested customer to contact Smiths Medical to ensure proper mounting hardware is utilized for those consignees using a roll stand or wall mount. If the consignee further distributed the product, they were asked to forward on the Safety Action Bulletin to the end user. Page 3 of the Safety Action Bulletin was asked to be completed and returned to Smiths Medical PM, Inc.A second ""Urgent Product safety Information Voluntary Recall Notification"" letter dated January 16, 2009 was sent to consignees. The second letter included a risk statement associated with the recalled product.",N/A,143,"143 monitors (17 US, 126 OUS)","Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay.",Open,N/A,N/A,143,Not_Computer,N/A,N/A,N/A
Z-1397-2009,50201,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.",Centricity TriWin Laboratory ,2,"May 15, 2009", 2009,GE Healthcare Integrated IT Solutions,"A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.",DESIGN: Software Design,"GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.",N/A,26,26 units,Worldwide Distribution -- USA and country of Canada.,Terminated,"September 11, 2010",484,26,Software,Output/Calculation,Software update,Software Update
Z-1261-2009,51687,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233.The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.",Zimmer Sirus Intramedullary Nail for Tibia,2,"May 18, 2009", 2009,Zimmer Inc.,"The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.",PRODUCTION CONTROLS: Process Control,"Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an ""Urgent: Device Recall"" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.",N/A,32,32,"Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.",Terminated,"October 23, 2009",158,32,Not_Computer,N/A,N/A,N/A
Z-1255-2009,51071,"equipment, laboratory, general purpose, labeled or promoted for a specific medical use",LXG,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi.",Roche MagNA Pure LC Workstation,2,"May 18, 2009", 2009,Roche Diagnostics Corp.,Protruding screw threads may cut the user when cleaning the interior of the instrument.,PRODUCTION CONTROLS: Process Control,"In a letter titled ""Urgent Medical Device Correction"" dated February 9, 2009, consignees were notified of the protruding screws and instructed to use caution when cleaning the instrument until a protective plate is installed by the firm's field representative.Further questions should be addressed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.",N/A,371,371,"Nationwide Distribution including Puerto Rico and states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV.",Terminated,"December 07, 2009",203,371,Not_Computer,N/A,N/A,N/A
Z-1395-2009,50531,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CAMeasurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.",Variant II Hemoglobin Testing System with CDM v 4.0,2,"May 19, 2009", 2009,Bio-Rad Laboratories Inc,The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.,PRODUCTION CONTROLS: Process Control,"Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers carefully review the Summary Report for duplicate barcode IDs or or tube position numbers within the same rack. If there are any questions or assistance needed, the local regional Bio-Rad office should be contacted.",N/A,42,42 units,"Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK.",Terminated,"November 12, 2010",542,42,Not_Computer,N/A,N/A,N/A
Z-1195-2009,51193,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.,Digital Fluoroscopic Imaging System,2,"May 19, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag",DESIGN: Device Design,"A GE Healthcare ""Urgent Medical Device Correction"" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.Further questions should be addressed to GE Healthcare at 1-800-437-1171.",N/A,85,85,"Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy.",Open,N/A,N/A,85,Other,Device Operation,Correction,Repair
Z-1199-2009,51455,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart XL Model M4735A Defibrillator, Automatic, ExternalDefibrillator-Monitor.The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.",Philips Healthcare ,2,"May 19, 2009", 2009,Philips Healthcare Inc.,"Rotary energy select switch in affected M4735A devices may fail and prevent the user from turningthe device on, rendering the device unusable for monitoring and defibrillation therapy.",DESIGN: Component Design/Selection,"An Urgent - Medical Device Recall Letter and Notice dated March 2009 were issued to affected customers. Mailings of the Urgent - Medical Device Recall Letter and Notice were handled by Philips Healthcare representatives in each affected geography. Customers were asked to follow the ""Actions to be taken by customer/user"" section of the Urgent - Medical Device Recall Notice. In this section, customers were instructed to remove the device from service if possible, while they await the correction of their device. If the customer is unable to remove the device from service, they are asked to identify a readily available backup device to use in the event that their device becomes unusable.All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the energy select switch in the affected devices (Mandatory Field Change Order FCO86100076). Contact your local Philips Healthcare representative for additional information or support concerning this issue.",N/A,26992,"26,992","Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT,EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG,HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND,ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA,KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND,PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA,SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN,TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA,VIETNAM, VIRGIN ISLANDS and YEMEN.",Open,N/A,N/A,26992,Not_Computer,N/A,N/A,N/A
Z-1400-2009,51131,antistreptolysin - titer/streptolysin o reagent,GTQ,Streptococcusspp. exoenzyme reagents.,Microbiology,Microbiology,510(K) Exempt,"Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.",Staphaurex Plus Kit,2,"May 19, 2009", 2009,"Remel, Inc",These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall. When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason for recall. The letter also asked consignees to review their inventories for the product lots indicated and requested that remaining units from the lots be discarded. This letter also had a Product Inventory Checklist enclosed for completion.",N/A,446,446 kits,Worldwide Distribution -- USA and Canada.,Terminated,"December 03, 2009",198,446,Not_Computer,N/A,N/A,N/A
Z-1411-2009,51886,"monitor, apnea, facility use",FLS,Apnea monitor.,Anesthesiology,Anesthesiology,510(k),SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.,SmartMonitor 2 Infant Apnea Monitor,1,"May 19, 2009", 2009,"Respironics, Inc.",Audible alarm failure.,DESIGN: Process Design,"A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to respironics1985@stericycle.com. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.",N/A,4992,"4,992 units",Nationwide and Canada.,Open,N/A,N/A,4992,Not_Computer,N/A,N/A,N/A
Z-1196-2009,50202,"sensor, glucose, invasive",MDS,N/A,N/A,Clinical Chemistry,N/A,"Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.",Abbott brand FreeStyle Navigator,2,"May 20, 2009", 2009,"Abbott Diabetes Care, Inc.",The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.,PRODUCTION CONTROLS: Packaging Process Control,"The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions.",Contact the recalling firm for information,2,2 units,US Distribution to states of NY and AZ.,Terminated,"June 03, 2009",14,2,Not_Computer,N/A,N/A,N/A
Z-1394-2009,51561,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001.The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.",Roche cobas 6000 analyzer (cobas c 501 and cobas e 601) ,2,"May 20, 2009", 2009,Roche Diagnostics Corp.,"Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.",DESIGN: Component Design/Selection,"Consignees were notified by ""Urgent Medical Device Correction"" letter dated April 1, 2009 and instructed to add error codes to the Instrument Manager driver and to contact the manufacturer of their LIS for instructions on adding data alarm codes to the LIS. Consignees were also instructed to complete the attached fax form after adding the error codes to their system and fax to 1-888-345-4690. Contact Roche Diagnostics Technical Support at 1-800-428-2336 for questions about information contained in the notification letter.",N/A,498,498 of all products.,Nationwide Distribution.,Terminated,"December 07, 2009",201,498,Not_Computer,N/A,N/A,N/A
Z-1331-2009,51334,"tube, drainage, suprapubic",FFA,Suprapubic urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific, Flexima¶_ and Percuflex¶_ Drainage Catheter Family (Pigtail Style) UPN DESCRIPTIONM001271770FLEXIMA NEPH FIRM 8F/25CMM001271780FLEXIMA NEPH FIRM 10F/25CMM001271790FLEXIMA NEPH REG 8F/25CMM001271800FLEXIMA NEPH REG 10F/25CMM001271810FLEXIMA NEPH REG 12F/25CMM001271820FLEXIMA NEPH REG 14F/25CMM001271830FLEXIMA NEPH SOFT 10F/25CMM001271840FLEXIMA NEPH SOFT 12F/25CMM001271850FLEXIMA NEPH SOFT 14F/25CMM001281790FLEXIMA NEPHROSTOMY 8/25 TTM001281800FLEXIMA NEPHROSTOMY 10/25 TTM001281810FLEXIMA NEPHROSTOMY 12/25 TTM001281820FLEXIMA NEPHROSTOMY 14/25 TTM001271860FLEXIMA NEPH 8F/25CM REG KITM001271870FLEXIMA NEPH 10F/25CM REG KITM001271880FLEXIMA NEPH 12F/25CM REG KITM001271890FLEXIMA NEPH 14F/25CM REG KITM001271900FLEXIMA NEPH 8F/25CM FIRM KITM001271910FLEXIMA NEPH 10F/25CM FIRM KITM001281650FLEXIMA NEPH 8/25 TEMP TIP KITM001281660FLEXIMA NEPH/10/25 TEMPTIP KITSingle Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080.Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.",Flexima and Percuflex Drainage Catheter Family (Pigtail Style),2,"May 21, 2009", 2009,Boston Scientific Corporation,"Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima¶_ and Percuflex¶_ Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.",MISBRANDING: Labeling False and Misleading,"Consignees were sent a Boston Scientific "" Urgent Medical Device Field Correction Notification"" letter dated March 18, 2009. The letter was addressed to ""The Hospital Field Action Contact"". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement Form.",N/A,862289,"586,276 US; 276,013 OUS total for all products","Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.",Open,N/A,N/A,862289,Not_Computer,N/A,N/A,N/A
Z-1640-2009,51702,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521SUsed with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.",In Situ Bender Cutter Kit Wide Sterile,2,"May 21, 2009", 2009,Synthes Spine,Sterility may be compromised due to a ineffective package design.,DESIGN: Packaging Design/Selection,"All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.",N/A,2706,2706 units total,"Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.",Terminated,"September 15, 2010",482,2706,Not_Computer,N/A,N/A,N/A
Z-1642-2009,51868,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325.Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement.",Restoration Modular Cone Bodies,2,"May 21, 2009", 2009,Stryker Howmedica Osteonics Corp.,Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.,PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Transfer and ship it to the attention of the individual listed; attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation #, and mark the box with the words ""PRODUCT RECALL"". Questions should be directed to Colleen O'Meara at 201-831-5970.",N/A,17,17 units,Nationwide Distribution,Open,N/A,N/A,17,Not_Computer,N/A,N/A,N/A
Z-1396-2009,48692,"myoglobin, antigen, antiserum, control",DDR,Myoglobin immunological test system.,Immunology,Immunology,510(k),"Access Myoglobin Reagents Kits, Part Number: 973243.The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.",MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,3,"May 22, 2009", 2009,Beckman Coulter Inc,"Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes",MISBRANDING: Labeling False and Misleading,"An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to:(1) Share this information with their laboratory staff and retain the letter for theirQuality System documentation,(2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and(3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.",N/A,20727,"20,727",Nationwide and Canada.,Terminated,"May 27, 2009",5,20727,Not_Computer,N/A,N/A,N/A
Z-1398-2009,51207,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA.Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes",CellDyn Ruby Hematology Analyzer,2,"May 22, 2009", 2009,Abbott Laboratories,"Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur.",PRODUCTION CONTROLS: Process Control,"A ""Product Correction"" letter dated February 12, 2009 and ""Customer Reply"" form were sent to all currently active CELL-DYN Ruby customers using Software Version 2.0 ML. The letter described the affected product, necessary actions and contact information for customers. Customers were instructed to acknowledge receipt of the ""Product Correction"" letter by completing the enclosed Customer Reply form and return via fax to 1-800-777-0051. A product information letter is being added to the accessory kits shipped with new instruments and version 2.0 ML System Software upgrade kits. For questions regarding this information, contact Abbott Laboratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact your local hematology customer support representative.",N/A,324,324 units distributed,"Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.",Open,N/A,N/A,324,Software,Physical Safety Hazards,Software update,Software Update
Z-1265-2009,51424,"system,x-ray,extraoral source,digital",MUH,Extraoral source x-ray system.,Dental,Radiology,510(k),"Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.",Gendex CB500 3D Dental Imaging System,2,"May 22, 2009", 2009,"Imaging Sciences International, LLC",faulty calibration,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed ""Acknowledgement Form"" by fax to the firm at 1-215-997-5665.Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.",Contact the recalling firm for information,24,24 units,"Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.",Terminated,"June 04, 2009",13,24,Not_Computer,N/A,N/A,N/A
Z-1256-2009,50695,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated.The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.",HemoSense INRatio2 ,3,"May 22, 2009", 2009,HemoSense Inc,INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Letters for each product titled ""Urgent: Medical Device Recall Notice"" dated December 19, 2008 were issued explaining the problem and instructing users to discontinue use, complete the provided reply form and return the device by mail to Inverness Medical. Distributors of the violative device were instructed to contact their customers and provide the same recall information.Further questions should be addressed to HemoSense Technical Service at 1-877-441-7440.",Contact the recalling firm for information,921,921 units,"Worldwide Distribution in the US, Germany, Spain and Australia.",Open,N/A,N/A,921,Hardware,Display/Image,Discontinue,Other
Z-1639-2009,51898,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8"" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham Lake, MN; REF 332263.The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.",Surgidyne SVac round fluted channel silicone drain kit,3,"May 22, 2009", 2009,"Aspen Surgical Products, Inc.","An adaptor, which may be required when connecting the drain to an external device, was not included in the package.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"An ""Urgent Medical Device recall"" letter dated April 13, 2009 was issued to consignees via certified mail. The letter described the affected product. and actions for customers. Consignees were instructed to carry out the recall to the retail level and to quarantine and return the product to Aspen Surgical Products, Inc. Consignees were also instructed to complete the enclosed response form and return it via mail, fax or e-mail. Direct questions about the recall by calling Aspen Surgical Products, Inc. at 1-616-698-7100, extension 142 or extension 141.",N/A,9,9 cases of both products,"Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.",Terminated,"November 23, 2009",185,9,Not_Computer,N/A,N/A,N/A
Z-1399-2009,50849,"ige, antigen, antiserum, control",DGC,"Immunoglobulins A, G, M, D, and E immunological test system.",Immunology,Immunology,510(k),"Immulite 2000 and Immulite 2500 digital Fluidics PC Board,Part Number 450116-0002.Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.",Digital Fluidics PCB,2,"May 26, 2009", 2009,Siemens Medical Solutions Diagnostics,Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.,DESIGN: Process Design,"Siemens Healthcare Diagnostics Inc. issued an ""Urgent: Device Recall"" notice dated January 2009 mailed to all direct customers of the affected product. The letter described the problem, provided ""work-around"" instructions and also provided a Recall Response Form to be returned to the firm via fax. For further information, please contact your local Siemens Healthcare support representative or Siemens Healthcare Diagnostics Inc. directly at 1-973-927-2828.",N/A,295,295 Digital Fludics PCB (88 IMMULITE 2000 and 2500 and 207 as spare parts).,"Worldwide Distribution to states including MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico.",Terminated,"April 19, 2010",328,295,Hardware,N/A,Remove,Remove or Replace
Z-1268-2009,51284,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .035/180cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.",Argoguide Hydrophilic Wire,2,"May 26, 2009", 2009,"Argon Medical Devices, Inc",Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.,N/A,"Argon Medical Devices Inc. issued an ""Urgent Field Safety Notice"" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396).For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.",No consumer action necessary,700,700 units,"Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands.",Terminated,"January 07, 2010",226,43940,Not_Computer,N/A,N/A,N/A
Z-1643-2009,51964,"cannula, trocar, ophthalmic",NGY,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.",25 GA Total Plus Pak,2,"May 26, 2009", 2009,"Alcon Laboratories, Inc",Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.,PRODUCTION CONTROLS: Process Control,"Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.",N/A,3523,"3,523 surgical paks.",Worldwide Distribution -- USA and Canada.,Terminated,"October 14, 2009",141,3582,Not_Computer,N/A,N/A,N/A
Z-1646-2009,51695,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),"Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.",Roche ACCUCHEK Spirit Plus insulin pump,2,"May 26, 2009", 2009,"Disetronic Medical Systems, Inc.","The ""up"" and ""down"" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.",OTHER/UNDETERMINED: Pending,"The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification.On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.",Contact the recalling firm for information,14929,"14,929",Worldwide Distribution -- USA and Canada.,Open,N/A,N/A,14929,I/O,Device Operation,Replace,Remove or Replace
Z-1645-2009,51959,vinyl patient examination glove,LYZ,Patient examination glove.,General Hospital,General Hospital,510(k),"Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Clark LLC, Roswell, GA",Kimberly Clark Synthetic PowderFree Vinyl Exam Gloves,2,"May 26, 2009", 2009,Kimberly-Clark Corporation,The product may contain defects/holes reducing the product's effectiveness as a barrier.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Consignees were contacted by an Urgent: Medical Recall letter on/about 4/30/2009. The letter instructs the Distributor to extend the recall to the end-user level by notifying each of their customers of the recall via a Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. Distributors were instructed to cease further shipment of the product and to physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. The customer was instructed to immediately cease further use of the gloves and physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, KC will arrange pick-up of the affected products and deliver it to a quarantine location at the contracted warehouse.",N/A,920,920 cases/10 boxes per case,"Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY.",Terminated,"January 07, 2010",226,920,Not_Computer,N/A,N/A,N/A
Z-1418-2009,51994,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028.The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.",Surgical Table Headrest,2,"May 26, 2009", 2009,Stryker Communications Corp,Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.,DESIGN: Device Design,"An ""URGENT: Device Recall"" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.",N/A,230,230 headrests.,Nationwide Distribution and Canada.,Terminated,"April 26, 2010",335,230,Not_Computer,N/A,N/A,N/A
Z-1417-2009,51962,"needle, aspiration and injection, reusable",GDM,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005.The device is used as a General Purpose Aspiration and Injection Needle.",Remington Medical,2,"May 26, 2009", 2009,Remington Medical Inc.,"Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.",PRODUCTION CONTROLS: Process Control,"The distributor was notified on Monday, April 6, 2009 via telephone by the QA Manager and a return authorization was issued. A notification letter dated April 13, 2009 was issued via certified mail to the affected customers. The letter described the affected product, reason for recall and actions for customers. Customers were also instructed to conduct recall to user level. For questions or additional information, contact Remington Medical, Inc. by calling 800-989-0057, extension 123.",N/A,60,60 units,Nationwide Distribution -- KY and NC.,Terminated,"May 27, 2009",1,60,Not_Computer,N/A,N/A,N/A
Z-1323-2009,51668,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL.LactoSorb¶_ Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb¶_ Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity.",BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER,2,"May 27, 2009", 2009,"Biomet Microfixation, Inc.","This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.Implantation of foreign materials can result in an inflammatory response or allergic reaction.",DESIGN: Device Design,"An ""Urgent Medical Device Recall Notice"" was issued via certified letter or email on March 20, 2009 to consignees. Customers were instructed to immediately remove and return the affected in-stock product to Biomet Microfixation, Inc. Customers were also asked to complete and return the enclosed Inventory Reconciliation sheet via fax (904-741-9425) to the firm, and to notify recipients of any recalled products that had been further distributed.For questions about the recall, contact Biomet Microfixation at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm EST.",Contact the recalling firm for information,2117,"2,117","Worldwide Distribution -- US (including DC and states of AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MI, MO, MN, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA and WI) and countries of Argentina, Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Israel, Italy, Lativa, Netherlands, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Terminated,"September 11, 2009",107,2117,Not_Computer,N/A,N/A,N/A
Z-1392-2009,51254,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01.The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.",ARCHITECT Reaction Vessel,2,"May 27, 2009", 2009,Abbott Laboratories,"Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were contacted by phone and sent an ""Urgent Field Safety Notice Product Recall"" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels.For additional information, contact Abbott Labs at 1-877-4ABBOTT.",N/A,27163,"27,163 cartons","Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway,Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia.",Terminated,"November 04, 2010",526,27163,Not_Computer,N/A,N/A,N/A
Z-1421-2009,51703,transcranial magnetic stimulator,OBP,Repetitive transcranial magnetic stimulation system.,Neurology,Physical Medicine,510(k),"NeuroStar TMS Therapy System/SenStar Treatment Link.The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly focused, pulsed magnetic fields to stimulate function in targeted brain regions.",NeuroStar TMS Therapy System/SenStar Treatment Link,2,"May 27, 2009", 2009,"Neuronetics, Inc.",SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients.,PRODUCTION CONTROLS: Process Control,"Neuronetics Inc. notified consignees by telephone and sent a follow-up fax/letter dated March 19, 2009 titled ""Urgent Product Recall Notification."" The letter describes the issue and actions for consumers to take in response to the recall. Neuronetics will visit each customer in person to complete a ""Returned Goods: SenStar Recall Inventory Form."" Customer questions should be directed to Neuronetics Customer Service at 1-877-600-7555.",No consumer action necessary,3123,3123 Units,"Nationwide Distribution to AZ, CA, DC, GA, FL, IL, MD, MI, MN, NH, NY, PA, RI, SC, and WA.",Terminated,"May 29, 2009",2,3123,Hardware,Physical Safety Hazards,Return,Remove or Replace
Z-1401-2009,51863,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7.Datascope Patient MonitoringIntended for use in a fixed location, in the healthcare facility setting, as a central viewing station.",Panorama Patient Monitoring Network ,2,"May 27, 2009", 2009,"Mindray DS USA, Inc., dba Datascope Patient Monitoring","Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.",DESIGN: Software Design,"Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.",N/A,294,294 sites,Worldwide Distribution -- USA and Australia.,Terminated,"August 03, 2010",433,294,Software,Device Operation,Software update,Software Update
Z-1436-2009,51982,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"CareVue Chart Release C.OPart Number: 862246Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.",CareVue Chart ,2,"May 27, 2009", 2009,Philips Healthcare Inc.,Software: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period,DESIGN: Software Design,"Philips Medical notified accounts by letter on 5/6/09 the Urgent - Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions:Clinicians should not rely solely on the worklist within CareVue Chart to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center at 1-800-722-9377.",N/A,103,103 units,"Worldwide Distribution -- USA including states of CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.",Open,N/A,N/A,103,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1224-2009,44848,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100.The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.",Terumo APS1,2,"May 29, 2009", 2009,Terumo Cardiovascular Systems Corporation,"The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.",DESIGN: Device Design,"Consignees were notified via an Urgent Medical Device Correction: Safety Advisory letter dated 1/12/09 advised of the reason for the correction, potential problems, and provided clinical information should the problem(s) arise. Customers are to review the notice, assure that all users are aware of the notice, and confirm receipt of the communication by completing the attached Customer Response Form and faxing it to the number indicated on the form. Questions or concerns should be directed to Terumo CVS Customer Service at 1-800-521-2818.",N/A,951,951,"Worldwide Distribution -- USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, and Viet Nam.",Terminated,"July 14, 2009",46,951,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-1226-2009,51220,replacement heart-valve,DYE,Replacement heart valve.,Cardiovascular,Cardiovascular,N/A,"Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID, T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID;Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca.Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.",Hancock II Bioprostheses with Cinch,3,"May 29, 2009", 2009,Medtronic Inc,Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.,PRODUCTION CONTROLS: Storage,"A Medtronic ""Urgent Medical Device Recall Notice"" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.",Contact the recalling firm for information,10,10,"Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.",Open,N/A,N/A,15,Not_Computer,N/A,N/A,N/A
Z-1324-2009,51777,"appliance, fixation, nail/blade/plate combination, multiple component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a a rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique.",Square Nut MR Safe,2,"May 29, 2009", 2009,Synthes Spine,Numbers are etched incorrectly on the product.,PRODUCTION CONTROLS: Process Control,"An ""Urgent: Medical Device Recall"" letter dated February 6, 2009 was sent to all affected Synthes Trauma Sales Consultants via USPS certified mail on February 09, 2009 and affected In House employees were notified via return receipt email on February 09, 2009. All affected hospitals were notified of the recall through a notification letter mailed via USPS certified mail on February 09, 2009. The notification letter described the affected product, issue and actions for recipients. Direct questions about the recall to Synthes Spine by calling 800-620-7025, Extension 5455 or 610-719-5455.",Contact the recalling firm for information,1137,"1,137 units","Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and UT) and country of Switzerland.",Terminated,"December 15, 2009",200,1137,Not_Computer,N/A,N/A,N/A
Z-1227-2009,51166,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.,ApexPro ,2,"June 01, 2009", 2009,GE Healthcare,Intermittent or continuous loss of patient monitoring.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent on 2/20/09 a GE Healthcare ""Urgent Medical Device Correction"" letter dated 2/12/09. The letter was addressed to Risk Manger/Chief of Nursing/Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.",N/A,291,291,Nationwide distribution and Canada.,Open,N/A,N/A,291,Not_Computer,N/A,N/A,N/A
Z-1249-2009,51422,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.",InSitu Bender Cutter Kit Narrow Sterile,2,"June 01, 2009", 2009,Synthes Spine,"The bender is heating prior to activation of the power button, requiring disassembly to stop heating.",PRODUCTION CONTROLS: Process Control,All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail.,Contact the recalling firm for information,40,40 units,"Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT",Terminated,"December 15, 2009",197,66,Not_Computer,N/A,N/A,N/A
Z-1318-2009,51449,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system",Mammo Test,2,"June 01, 2009", 2009,"Siemens Medical Solutions USA, Inc",Table may unintentionally lift during procedure,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.",N/A,4,4 units,"USA distribution to IL, NY, SC, and WA",Terminated,"June 01, 2009",0,4,Not_Computer,N/A,N/A,N/A
Z-1351-2009,51409,"nail, fixation, bone",JDS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.",Gamma3,2,"June 01, 2009", 2009,Stryker Howmedica Osteonics Corp.,Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.,DESIGN: Labeling Design,"Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.",N/A,18232,18232,Nationwide.,Open,N/A,N/A,19482,Not_Computer,N/A,N/A,N/A
Z-1352-2009,51693,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.","Biomet Dual Offset Broach Handle, Clamping Style",2,"June 01, 2009", 2009,"Biomet, Inc.",The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.,DESIGN: Device Design,"Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.",N/A,178,178 of all products.,"Nationwide, Canada and Finland.",Terminated,"December 23, 2009",205,178,Not_Computer,N/A,N/A,N/A
Z-1264-2009,51438,cadriovascular catheter sheath introducer kit,OEX,Catheter introducer.,Cardiovascular,Cardiovascular,N/A,"Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.",SLS II Laser sheath kit.,2,"June 01, 2009", 2009,Spectranetics Corporation,Catheter outer jacket may split during use.,PRODUCTION CONTROLS: Process Control,Spectranetics notified the 8 recipients of the catheters by letter on 3/17/2009. They were told that a Spectranetics sales rep would contact them to coordinate the return of the suspect devices. Questions were referred to 719-447-2462 or 719-447-2539.,N/A,17,17 units,"Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.",Open,N/A,N/A,17,Not_Computer,N/A,N/A,N/A
Z-1228-2009,51495,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.",MEDRAD Sterile Disposable Syringe Kit,2,"June 01, 2009", 2009,Medrad Inc,Possible compromised sterility due to holes in styrene tray,PRODUCTION CONTROLS: Packaging Process Control,"On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09.",N/A,2958,2958 kits,"Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.",Terminated,"June 04, 2009",3,2958,Not_Computer,N/A,N/A,N/A
Z-1390-2009,51673,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.",HeartStart MRx Defibrillator/Monitor,2,"June 02, 2009", 2009,Philips Healthcare Inc.,"Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. There is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.",DESIGN: Component Design/Selection,"Philips notified customers via Urgent Medical Device Recall Letter & Notice dated March 2009. Customers are asked to follow the ""Actions to be taken by customer/user section of theUrgent Medical Device Recall Notice. In this section, customers are given the following instructions:""During the interim period, as you await the upgrade for your device, you may continue to use the Heartstart MRx. However, to reduce the risk that a spontaneous turn-on could deplete the battery, it is advised that you keep:a charged spare battery with the Heartstart MRx AC power applied, if possible, when the device is not in useYou should also consider identifying a readily available backup defibrillator to use in the unlikely event that the device fails to turn on. Devices that exhibit a spontaneous turn-on or failure to respond to user initiated turn on should beremoved from service as soon as possible."" Philips will replace the therapy switch in affected units free of charge per Mandatory Field Change OrderFC086100077. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the therapy switch in the affected devices.",N/A,22176,"12,385 units US; 9,791 units OUS","Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Oman, Panama, Papua, New Guinea, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.",Open,N/A,N/A,22176,Other,Device Operation,Replace,Remove or Replace
Z-1435-2009,52049,"stimulator, neuromuscular, external functional",GZI,External functional neuromuscular stimulator.,Neurology,Neurology,510(k),"WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746.The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.",WalkAide Stimulator System,2,"June 03, 2009", 2009,"Innovative Neurotronics, Inc.",Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Innovative Neurotronics Inc notified the consignee via e-mail on August 6, 2008 of the affected product. The Consignee was asked to place a stop shipment on the WalkAides and to return inventory for replacement.Further questions can be directed to Innovative Neurotronics Inc at 1-512-721-1906.",Contact the recalling firm for information,137,137 units,Nationwide Distribution to the state of GA.,Terminated,"July 28, 2009",55,137,Not_Computer,N/A,N/A,N/A
Z-1430-2009,51869,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Injection Sites and Spin-Lock Connector, Catalog #470007.For use with Secondary Container.","Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Inject",2,"June 05, 2009", 2009,"B. Braun Medical, Inc.",Device defect is occlusion/no flow.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached ""Product Removal Acknowledgement"" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.",Contact the recalling firm for information,50,50 units,Worldwide Distribution -- USA and Canada.,Terminated,"December 15, 2009",193,397191,Not_Computer,N/A,N/A,N/A
Z-1325-2009,51701,microspheres radionuclide,NAW,N/A,N/A,Radiology,PMA,TheraSphere Administration Set (Part Number K125914-034).TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.,TheraSphere ,3,"June 05, 2009", 2009,MDS Canada Inc. DBA MDS Nordion,Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.,PRODUCTION CONTROLS: Error in Labeling,"A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions.For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.com.",Contact the recalling firm for information,26,26,"Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.",Terminated,"June 08, 2009",3,26,Not_Computer,N/A,N/A,N/A
Z-1348-2009,51781,"intervertebral fusion device with bone graft, cervical",ODP,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),"Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.",ZeroP StarDrive Screwdriver Shaft,2,"June 10, 2009", 2009,Synthes Spine,"Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.",DESIGN: Labeling Design,"All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.",N/A,1766,1766 units,Distributed Nationwide and Canada.,Terminated,"October 05, 2009",117,1766,Not_Computer,N/A,N/A,N/A
Z-1403-2009,51877,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095.To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.",Prelude Short Sheath Introducer,2,"June 10, 2009", 2009,"Merit Medical Systems, Inc.","External tubing may separate during use, allowing blood loss.",N/A,"All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.",Contact the recalling firm for information,6,6 units,"Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.",Open,N/A,N/A,18972,Not_Computer,N/A,N/A,N/A
Z-1510-2009,52076,implantable pacemaker pulse-generator,DXY,Implantable pacemaker pulse generator.,Cardiovascular,Cardiovascular,N/A,"Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303.",Medtronic SIGMA 100/200/300 Series IPGs,1,"June 11, 2009", 2009,Medtronic Inc. Cardiac Rhythm Disease Managment,"One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.",DESIGN: Device Design,"Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.",Contact the recalling firm for information,9434,9434,"Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.",Open,N/A,N/A,85378,Not_Computer,N/A,N/A,N/A
Z-1422-2009,51681,"generator, pulse, pacemaker, external programmable",JOQ,External programmable pacemaker pulse generator.,Cardiovascular,Cardiovascular,510(k),"EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002;EP MedSystems, Inc.575 Route 73 North, Units D, West Berlin, NJ 08091.Indicated for use during clinical electrophysiology procedures.",EP4 Stimulator,3,"June 12, 2009", 2009,St. Jude Medical,Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.,DESIGN: Device Design,"All foreign customers were sent Urgent Product Safety Information letters on March 23, 2009. Letters described units affected, the reason for action, and the actions to take to eliminate risk. It is recommended that the information in the letter be circulated to all users, risk managers and the biomedical engineering department responsible for maintaining and inspecting electrical equipment located within their institution. The letter also stated that a SJM representative will be in touch to perform the EP-4 Stimulator fuse modification. Customers are to complete and return the attachment.",N/A,694,"694 total (US, Canada, and OUS)",Worldwide distribution.,Terminated,"January 20, 2010",222,694,Not_Computer,N/A,N/A,N/A
Z-1420-2009,51413,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),STERRAD NX Sterilization System Product Code 10033The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.,STERRAD NX,2,"June 15, 2009", 2009,Advanced Sterilization Products,"ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.",DESIGN: Component Design/Selection,"Firm mailed out Urgent Device Correction letters dated March 9, 2009, advising customers/users that on April 23, 2008, Advanced Sterilization Products (ASP) initiated a device correction notification related to certain models of STERRAD Sterilization Systems that have the potential to emit oil mist due to a premature mechanical failure in the oil mist filter and/or filter assemblies. All affected STERRAD Systems have been corrected since the notification was issued.Recently, a secondary, lower-occurring cause of oil mist has been identified within the STERRAD NX System and STERRAD 50 System oil fill plugs. STERRAD NX System and/or STERRAD 50 System may potentially have defective oil fill plugs. Less than 1% of the installed STERRAD NX Systems have been affected. ASP has received 18 complaints in 10 months related to this failure for the STERRAD NX System. No complaints related to this issue for the STERRAD 50 System have been received. As of December 22, 2008, ASP has been actively replacing the plugs in these systems with stainless steel plugs during service calls and will continue to replace the oil fill plugs untilall affected units are corrected. The letter advises that there is a risk of symptoms, such as nausea, shortness of breath, dry throat, burning, watery and blurry eyes, and headache occurring if customers inhale oil mist. If you see mist, haze or smoke in the room or detect an oil odor, personnel should complete the following: - Cancel the cycle if the sterilizer is running and as always, do not use instruments from an incomplete cycle- Leave the room- Avoid working in the room until the mist has cleared- Discontinue use of the STERRAD System until the system is repaired.Any additional questions can be directed to the Clinical and Technical Support staff at 1-888-4613.",N/A,2013,"2,209 units installed in US; 2013 units OUS","Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.",Open,N/A,N/A,2013,Not_Computer,N/A,N/A,N/A
Z-1437-2009,51947,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7721165 Upper Body radiation shield, fixed.",Mavig Portegra 2,2,"June 16, 2009", 2009,"Siemens Medical Solutions USA, Inc","Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.",OTHER/UNDETERMINED: Pending,"The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.",N/A,427,427 units,Nationwide Distribution.,Terminated,"September 01, 2009",77,427,Not_Computer,N/A,N/A,N/A
Z-1416-2009,52008,"brush, endometrial",HFE,Endometrial brush.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL.Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.",Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush),2,"June 16, 2009", 2009,"Cook OB/Gyn, Inc.",There is an ink on the brush which has not been tested for use with the Tao Brush.,PRODUCTION CONTROLS: Process Control,"The consignee was notified by an Urgent: Recall Notice letter dated 4/2/09. The customer is to forward the notice to all personnel that need to be aware of it; pull from their stock and isolate any affected product; and complete the form. Upon receipt of the form, Cook Women's Health will issue a Return Goods Authorization number and the customer should return the affected products via FedEx using the Return Goods Authorization number.",N/A,15396,"15,396",Nationwide Distribution.,Terminated,"December 03, 2009",170,15396,Not_Computer,N/A,N/A,N/A
Z-1453-2009,50745,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.",BARD E LUMINEXX BILIARY STENT,2,"June 17, 2009", 2009,Bard Peripheral Vascular Inc,"This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated ""Now Approved for Vascular Use"".",TRAINING: Employee Error,"Bard Peripheral Vascular, Inc. (BVP) sent an ""Urgent - Product Recall Notice"" letter to consignees dated December 22, 2008 outlining the reason for the recall. In the letter, customers were informed to check all inventory locations, stop any further distribution of and return affected product to BPV. Consignees were to complete the enclosed Recall and Effectiveness Check Form and fax to 1-800-440-5376 or send information by phone at 1-800-321-4254 extension 2727 or e-mail at silvia.carillo@crbard.com.",N/A,94,94 units total for all product codes,"Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.",Open,N/A,N/A,94,Not_Computer,N/A,N/A,N/A
Z-1260-2009,51699,"ventilator, non-continuous (respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(k),Remstar Pro M-Series Heated Humidifier System.,REMStar Mseries Heated Humidifier System,2,"June 17, 2009", 2009,Respironics,Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices. The communication described the affected device and actions required.Further questions may be addressed by phone at 1-800-345-6443, and by email at service@respironics.com or clinical@respironics.com.",N/A,449585,"449,585 units","Worldwide Distribution -- US including states of OR, OH, KY, TX, MO, AZ, IN and NV and countries of United Arab Emirates, Bosnia, Belgium, Bulgaria, Bahrain, Canada, Czech Republic, Denmark, Egypt, Spain, Finland, Greece, Croatia, Hungary, Ireland, Israel, Jordan, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa.",Open,N/A,N/A,449585,Hardware,Physical Safety Hazards,Notification,Safety Notice/Insructions
Z-1540-2009,51211,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct.Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300.Abbott Point of Care inc., Abbott Park, IL 60064 USAIntended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.",iSTAT EG7 Cartridge,3,"June 18, 2009", 2009,Abbott Point of Care Inc.,"Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.",PRODUCTION CONTROLS: Packaging Process Control,"Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.",N/A,1048,1048 boxes of 25 cartridges each.,"Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.",Terminated,"July 29, 2009",41,2184,Not_Computer,N/A,N/A,N/A
Z-1447-2009,52027,surgeon's gloves,KGO,Surgeon's glove.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB65 - size 6-1/2; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand.To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.","Esteem Blue with Neu Thera Surgeons Glove, size 61/2",2,"June 18, 2009", 2009,Cardinal Health,Increase in the number of customer complaints due to cuff tears.,DESIGN: Device Design,"Urgent: Product Recall letters dated 4/24/09 were sent to the direct accounts on 4/24/09 via UPS 2-day mail, to the attention of the Director of Materials Management. The accounts were informed of the increased complaints of cuff tears, and were instructed to stop using them and destroy them. The letter included a list of gloves that could be substituted for the recalled gloves. The accounts were requested to call the appropriate customer service group to arrange for credit for the destroyed product, and to complete and return by fax the enclosed acknowledgement form, indicating the number of gloves destroyed.",N/A,29697,"29,697 cases total","Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.",Terminated,"May 11, 2010",327,29697,Not_Computer,N/A,N/A,N/A
Z-1470-2009,51865,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Wiseguide Guide Catheter, Sterilized.Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced.",Wiseguide Guide Catheter,2,"June 18, 2009", 2009,Boston Scientific Corporation,"Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as",PRODUCTION CONTROLS: Process Control,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall"" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form.Further questions can be addressed to Boston Scientific at 763-494-1634.",N/A,34036,"U.S. and U.S. territories: 22,728; OUS: 11,308","Worldwide Distribution -- USA, United Arab Emirates, Dutch Antilles, Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Egypt, Spain, Finland, France, Great Britain, India, Indonesia, Ireland, Iraq, Italy, Jamaica, Japan, Kuwait, Sri Lanka, Libya, Netherlands, Norway, Poland, Puerto Rico, Qatar, Saudi Arabia, Sweden, Singapore, Syria, Turkey and South Africa.",Open,N/A,N/A,34036,Not_Computer,N/A,N/A,N/A
Z-1474-2009,49524,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188.The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.",Digital Fluoroscopic Imaging System,2,"June 19, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during X-Ray imaging, the acquisition fails and the user has to rest the system. To date, one patient death has been reported related to this issue.",PRODUCTION CONTROLS: Process Control,"GE Healthcare sent a ""GE Urgent Medical Device Correction"" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system. Further questions may be addressed by calling 1-800-437-1171.",N/A,514,514,"Worldwide Distribution - US including Puerto Rico and states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV and WI and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GEORGIA, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SPAIN, SUDAN, SOUTH AFRICA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, VENEZUELA and SOUTH AFRICA.",Open,N/A,N/A,15816,Not_Computer,N/A,N/A,N/A
Z-1507-2009,50706,"tong, skull for traction",HAX,Skull tongs for traction.,Neurology,Neurology,510(k),"ReSolve Halo - Open Back Halo Ring, Model Number: 505300DThe ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.",ReSolve Halo Open Back Halo Ring,2,"June 19, 2009", 2009,"Ossur Engineering, Inc",Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Ossur contacted direct consignees and sub-accounts beginning on November 10 , 2008 via a phone call informing them of the recall, and the reason as stated in the public reason for recall. Consignees were asked to check their inventory for any of the identified products and contact them with this information. The firm developed a telephone script for the customer service representatives to use.Ossur then forwarded a notification letter to the affected customers beginning on November 12, 2008 via US Postal Service. In the event that any of these parts have already been applied to a patient, Ossur advised customers to follow their normal follow-up protocols, ensuring that the ceramic pins are properly fixed in the skull.At the time of the phone calls Ossur did not have sterilized open back replacement rings available; however, they offered their ReSolve Closed Back Halo ring as an alternative. The firm estimated that the normal product offering should be available once again in approximately four to six weeks from the date of the phone call.",N/A,1,1 piece,"Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.",Terminated,"April 22, 2010",307,92,Not_Computer,N/A,N/A,N/A
Z-1425-2009,51202,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.", Aisys ,2,"June 23, 2009", 2009,GE Healthcare,"Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h",DESIGN: Component Design/Selection,"GE Healthcare contacted consignees via two ""Urgent Medical device Correction"" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.",Contact the recalling firm for information,3082,3082,"Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.",Open,N/A,N/A,9325,Not_Computer,N/A,N/A,N/A
Z-1389-2009,51496,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively ""AED 10"")",AED 10,2,"June 23, 2009", 2009,"Welch Allyn Protocol, Inc","Issue #1: AED 10 displayed a ""Do Not Use"" symbol as a result of a blown F1 fuse.Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.",DESIGN: Component Design/Selection,"Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.",N/A,4568,Issue #1: 4568 units; Issue#2: 5186 units,Worldwide distribution.,Open,N/A,N/A,9754,Hardware,Display/Image,Replace,Remove or Replace
Z-1423-2009,51716,"massager, therapeutic, electric",ISA,Therapeutic massager.,Physical Medicine,Physical Medicine,510(K) Exempt,"Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.",SlimLine,2,"June 23, 2009", 2009,"Sybaritic, Inc",Misbranded and sale without pre-market notification.,PREMARKET APPROVAL: No Marketing Application,"Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.",N/A,1,1,UT,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-1424-2009,51952,"tubing, pump, cardiopulmonary bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(k),"Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits",Transfer Spike (Blood processing accessory),2,"June 23, 2009", 2009,Medtronic Cardiovascular Revascularization & Surgical Therap,"Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.",DESIGN: Device Design,"Consignees were sent a Medtronic ""Urgent Medical Device Recall Notice"" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.",N/A,20,20 units,Distribution to one medical facility in MN.,Open,N/A,N/A,20,Not_Computer,N/A,N/A,N/A
Z-1489-2009,51887,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits.",Arrow 4 way HiFlo Stopcock with male luer lock latex free,2,"June 24, 2009", 2009,Arrow International Inc,"Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.",DESIGN: Device Design,"Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.",N/A,900000,"900,000 total, all products","Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.",Terminated,"July 22, 2010",393,900000,Not_Computer,N/A,N/A,N/A
Z-1486-2009,52098,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Fort¶_¶_ Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.",Boston Scientific Fort,2,"June 24, 2009", 2009,Boston Scientific Corporation,"Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the",PRODUCTION CONTROLS: Process Control,"Consignees were sent a ""Boston Scientific Urgent Medical Device Recall"" letter dated may 19, 2009. The letter was addressed to ""Dear Risk Manger/ Field Action Contact"". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form.",Contact the recalling firm for information,5,"Total of 5 boxes (5 units /box) ,","USA distribution: AR, MO, CA, FL, and NV.",Open,N/A,N/A,9,Not_Computer,N/A,N/A,N/A
Z-1504-2009,51817,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16"" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2",AccuSure,2,"June 24, 2009", 2009,Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals,Needles separate from the barrel of the syringes.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).",N/A,559500,"559,500 syringes",Nationwide.,Terminated,"November 01, 2010",495,559500,Not_Computer,N/A,N/A,N/A
Z-1506-2009,51871,"antisera, all groups, streptococcus spp.",GTZ,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.",Inverness Medical BioStar Strep A OIA MAX,2,"June 24, 2009", 2009,"Binax, Inc. dba IMPD",Potential for false positive Strep A results.,OTHER/UNDETERMINED: Pending,"Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.",N/A,1729,"1,729 kits",Nationwide.,Terminated,"January 06, 2010",196,1729,Not_Computer,N/A,N/A,N/A
Z-1505-2009,50773,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).,E.CAM PHS Field of View Indicator Bars ,2,"June 24, 2009", 2009,"Siemens Medical Solutions USA, Inc.",Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up FOV indicator bars.,DESIGN: Device Design,"Siemens sent Urgent Field Correction Recall letters dated 12/18/08 to all users of the E.cam Systems. The accounts were informed of the potential risk to patients when they attempt to pull themselves up from the patient handling system (PHS) without any assistance and grabbing the field of view (FOV) indicator bar (aka flip-up armrests). The customers were advised to always assist the patient when getting on/off of the PHS. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective upgrade to the PHS with a modified FOV guide to mitigate the risk for patient injury free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance.",N/A,1107,"1,107 units","Worldwide distribution: USA, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates.",Open,N/A,N/A,1107,Not_Computer,N/A,N/A,N/A
Z-1488-2009,52023,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 20 ml SyringeLuer-Lok TipSterile, Do not reuse; Catalog Number 309661.",BD,2,"June 24, 2009", 2009,Becton Dickinson & Company,Potential for compromised sterility: Insufficient packaging seals.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762.Letters to customers of distributors went out on May 12, 2009.",N/A,201600,"201,600 units",Nationwide Distribution.,Terminated,"September 28, 2009",96,201600,Not_Computer,N/A,N/A,N/A
Z-1520-2009,52003,"prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing",NJL,N/A,N/A,Orthopedic,N/A,"Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left , sterile, Zimmer, Warsaw, IN; REF 00-5960-014-51.",Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPSFlex Femoral Component,2,"June 25, 2009", 2009,Zimmer Inc.,"The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.",TRAINING: Employee Error,"Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.",N/A,5,5,"Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.",Terminated,"November 12, 2009",140,37,Not_Computer,N/A,N/A,N/A
Z-1473-2009,51960,"catheter, embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(k),"Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605.The arterial embolectomy catheter is intended for use in removing arterial emboli.",Arrow Embolectomy Catheters,2,"June 25, 2009", 2009,Arrow International Inc,The inflation arm tubing may separate from the stopcock adapter.,PRODUCTION CONTROLS: Process Control,"Arrow International issued an ""Urgent Medical Device Recall"" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935.Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.",N/A,6910,6910 units (total all three products),Worldwide Distribution - USA and Panama.,Terminated,"February 01, 2010",221,6910,Not_Computer,N/A,N/A,N/A
Z-1524-2009,52031,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754.Orthopedic manual surgical screwdriver.",TX 8 Driver,2,"June 26, 2009", 2009,"Ascension Orthopedics, Inc","Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.",OTHER/UNDETERMINED: Pending,Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.,"Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",9,9 units.,"Nationwide Distribution -- including states of CO, OR, and TX.",Terminated,"September 24, 2010",455,9,Not_Computer,N/A,N/A,N/A
Z-1477-2009,52004,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01.Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.","Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component",2,"June 26, 2009", 2009,Zimmer Inc.,"The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.",TRAINING: Employee Error,"Zimmer, Inc. issued an ""Urgent: Device Recall"" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.",N/A,14,14,"Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.",Terminated,"October 21, 2009",117,14,Not_Computer,N/A,N/A,N/A
Z-1481-2009,52005,"pin, fixation, smooth",HTY,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69.Steinmann Pins are utilized in skeletal traction for alignment and reduction of long bone fractures as guide wires in hip pinning and for fracture alignment in certain other types of fractures.",Zimmer Steinmann Pins,2,"June 26, 2009", 2009,Zimmer Inc.,The package contains pins with an incorrect diameter.,PRODUCTION CONTROLS: Packaging Process Control,"Zimmer, Inc. issued an ""Urgent: Device Recall"" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265.For further questions, contact Zimmer, Inc. at 1-800-613-6131.",N/A,37,37,"Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.",Terminated,"November 12, 2009",139,37,Not_Computer,N/A,N/A,N/A
Z-1479-2009,52026,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),Philips Avalon Fetal Monitor FM30; Model Number: M2703A.,Philips Avalon Fetal Monitor,2,"June 26, 2009", 2009,Philips Healthcare Inc.,Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Philips Healthcare issued an ""Urgent-Medical Device Correction"" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade.Questions can be made to Philips response center at 1-800-722-9377.",N/A,4788,"4,788 units",Worldwide Distribution,Open,N/A,N/A,10451,Computer,N/A,N/A,N/A
Z-1525-2009,52093,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Stryker Xia Dual Anterior Staple;Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France;Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion.",Xia Dual Anterior Staple,2,"June 26, 2009", 2009,Stryker Spine,"Labeling Issue: The large Xia Anterior Staple was laser marked with an ""S"", indicating small.",PRODUCTION CONTROLS: Error in Labeling,"Market Withdrawal letters were sent to Stryker branches who received product on April 13, 2007 by Federal Express. The letters asked that they examine their inventory and hospital locations to identify the implant; reconcile these implants on the attached Product Accountability Form and fax a copy to (201) 760-8456; retrieve and return the affected implants; and contact their Stryker Customer Service rep to re-order the product that they are returning as part of the regulatory action.",Contact the recalling firm for information,38,38 in US,Nationwide Distribution.,Terminated,"June 29, 2009",3,38,Not_Computer,N/A,N/A,N/A
Z-1559-2009,52041,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap StyleCatalog #: 6480-25.The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.",MODEL 520A NOVAMETRIX PULSE OXIMETER,2,"June 28, 2009", 2009,"Dixtal Medical, Inc.",Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Urgent Product Recall Notification was issued to affected accounts by email/facsmile on May 8, 2009 requesting to cease distribution, quarantine and return recalled product. Contact Dixtal Medical with questions; to inquire about your on-hand inventory; or to arrange to receive replacement product at Customer Service: sales@dixtal.com, Phone Number 1-203-269-1112, Fax Number 1-203-269-1760.",N/A,27,27 Boxes (Packaged 25 sensors/box),"Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.",Open,N/A,N/A,27,Not_Computer,N/A,N/A,N/A
Z-1582-2009,52214,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner.The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",BRILLIANCE VOLUME,2,"June 29, 2009", 2009,Philips Medical Systems (Cleveland) Inc,"Software anomaly. An artifact may appear in brain scans and brain perfusion studies, when using 80kV and a UA, UB, or UC filter with this CT scanning device.",N/A,"An ""URGENT - Field Safety Notice"" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an ""URGENT -Medical Device Correction"" report dated January 29, 2009 which contained information noted in the ""URGENT - Field Safety Notice"". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",44,44,"Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.",Open,N/A,N/A,44,Software,Display/Image,Software update,Software Update
Z-1539-2009,52046,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.",StatLock Intravenous (IV) Catheter Stabilization Kit,2,"June 29, 2009", 2009,"C.R. Bard, Inc., Urological Division",The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.,PRODUCTION CONTROLS: Process Control,"All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard.",N/A,16100,"16,100 units","Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.",Terminated,"December 04, 2009",158,16100,Not_Computer,N/A,N/A,N/A
Z-1530-2009,51980,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124.A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.",OSS Elliptical Proximal Femoral Trial 7 cm,2,"June 29, 2009", 2009,"Biomet, Inc.",The retaining ring may fall out of the instrument during surgery.,N/A,"Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the ""FAX Back Response Form,"" and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed ""Dear Biomet Customer"" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.",Contact the recalling firm for information,387,387 of all products,"Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.",Terminated,"October 08, 2010",466,387,Not_Computer,N/A,N/A,N/A
Z-1247-2009,50841,"tube mount, x-ray, diagnostic",IYB,Diagnostic x-ray tube mount.,Radiology,Radiology,510(K) Exempt,"Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330.The device is used for X-Ray tube positioning.",Del CTM and DCTM Ceiling Tube Mount,2,"June 30, 2009", 2009,Del Medical Systems Group,There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator.,DESIGN: Component Design/Selection,"Del Medical sent a ""Field Correction Recall"" letter with an acknowledgement form to the direct account dealers/assemblers on January 12, 2009 - February 4, 2009, informing them that required maintenance inspection of a retaining ring inside the column assembly may not be performed as required. If the retaining ring is not regularly inspected and replaced when worn or loose, there is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. The accounts were requested to locate the affected systems and immediately take them out of service until correction by installing a Cable Mount Retention Retrofit Kit to eliminate the potential for the cable to become detached. Affected accounts were instructed to complete the enclosed acknowledgement form and return it via fax (847-288-7911) or mail to Del Medical. If there are any questions, please contact Del Medical Technical Support at 800-800-6006 or 847-288-7000.",N/A,213,213 devices,"Worldwide Distribution -- US, Canada, Scotland and Pakistan.",Terminated,"June 17, 2010",352,213,Not_Computer,N/A,N/A,N/A
Z-1485-2009,51406,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200.The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.",Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate,2,"June 30, 2009", 2009,Zimmer Inc.,"The tibial spacer will not affix to the distal surface of the baseplate, as intended.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Zimmer, Inc. issued an ""Urgent-Device Recall"" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265.Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131.",N/A,834,834 of all products,"Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.",Terminated,"October 23, 2009",115,834,Not_Computer,N/A,N/A,N/A
Z-1533-2009,51924,"appliance, fixation, nail/blade/plate combination, multiple component, metal composite",LXT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.",TransFx External Fixation System Drill Bit,2,"June 30, 2009", 2009,Zimmer Inc.,"Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.",PRODUCTION CONTROLS: Process Control,"Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.",N/A,1391,1391,"Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.",Terminated,"November 03, 2010",491,6085,Not_Computer,N/A,N/A,N/A
Z-1557-2009,52015,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE Signa OpenSpeed 0.7T MR System.The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.",GE Signa OpenSpeed 0.7T MR System,2,"June 30, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit",DESIGN: Device Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated April 16, 2009 addressed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A GE Healthcare Field Engineer will schedule a field visit to correct the device.Further questions or concerns may be addressed to GE Healthcare at 1-262-521-6681.",N/A,171,171,"Worldwide Distribution -- US including PR and states of AL, AZ, AR, CA, CO,CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MN, MS, MO,MT, NV, NH, NE, NJ, NY, NC, OH, OK,OR, PA, SC, SD, TN, TX, VA, WA, WV, WI and countries of BRAZIL CHINA, DENMARK, EGYPT, ENGLAND, GERMANY, GUATEMALA, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, OMAN, MEXICO, OMAN, PHILIPPINES, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES and VENEZUELA.",Open,N/A,N/A,374,Not_Computer,N/A,N/A,N/A
Z-1480-2009,52009,"mixer, cement, for clinical use",JDZ,Cement mixer for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000.Vacuum mixing and vacuum collection system and application system for bone cement.",Biomet Optivac Total Hip Kit,3,"June 30, 2009", 2009,"Biomet, Inc.",The package may contain two short mixing rods instead of one long and one short rod.,PRODUCTION CONTROLS: Packaging Process Control,"Biomet Orthopedics issued an ""Urgent Medical Device Recall Notice"" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product.Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.",Contact the recalling firm for information,250,250,"Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.",Terminated,"October 06, 2010",463,250,Not_Computer,N/A,N/A,N/A
Z-1570-2009,52124,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"Sterrad 50 Sterilizer, Product Code 10050.Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.",Ethylene oxide gas sterilizer,2,"June 30, 2009", 2009,Advanced Sterilization Products,"The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.",DESIGN: Component Design/Selection,"Advanced Sterilization Products (ASP) sent an ""Urgent: Product Correction"" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within thenext sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.",Contact the recalling firm for information,1151,"1,151 units.","Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland.",Open,N/A,N/A,1151,Hardware,Physical Safety Hazards,Replace component,Remove or Replace
Z-1549-2009,51501,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.",GE Centricity PACS software,2,"July 01, 2009", 2009,GE Healthcare Integrated IT Solutions,There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.,DESIGN: Software Design,"GE Healthcare Integrated IT Solutions sent an ""Urgent Medical Device Correction"" letter dated April 2, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers with attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the patient safety issue associated with the affected device and provided safety instructions to follow until the software is updated. User were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479.Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issue and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported.Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.",N/A,1188,"1,188 units","Worldwide Distribution - United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.",Open,N/A,N/A,1188,Software,Display/Image,Software update,Software Update
Z-1956-2009,50739,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.",Genicon,2,"July 02, 2009", 2009,"Genico, Inc., dba Genicon","Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).",N/A,2790,"2,790","Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.",Terminated,"October 01, 2009",91,3260,Not_Computer,N/A,N/A,N/A
Z-1547-2009,51484,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany.The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.",BrainLab m3 MicroMultileafCollimator for Elekta/Philips Type III with MLC,2,"July 02, 2009", 2009,Brainlab AG,The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.,OTHER/UNDETERMINED: Pending,"BrainLAB AG issued an ""Urgent Field Safety Notice/Product Notification"" letter dated March 19, 2009 informing all customers of the affected device. Consignees were instructed on proper steps to take to avoid further issues. In addition, the most current m3 mMLC user guide, version 7.4, was scheduled to be sent to users in April 2009.For further questions, contact BrainLAB AG by phone at 1-800-597-5911).",N/A,1,1 unit,"Nationwide Distribution - AL, CA, CO, FL, GA, IL, KS, KY, LA, MD, MI, MN, MS, ME, NJ, NY, OR, TN, TX, UT, VA, WV, WA and WI.",Terminated,"August 19, 2010",413,50,Not_Computer,N/A,N/A,N/A
Z-1578-2009,52176,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration.Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.","""PHILIPS PLUS"" COMPUTED TOMOGRAPHY SYSTEM",2,"July 06, 2009", 2009,Philips Medical Systems (Cleveland) Inc,"A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.",PRODUCTION CONTROLS: Packaging Process Control,"An ""URGENT - Field Safety Notice"" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.",N/A,13,13 units,"Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.",Open,N/A,N/A,27,Software,Device Operation,Software update,Software Update
Z-1568-2009,52047,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM).The ""Extended Brilliance Workspace (EBW)"" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.",MX8000 IDT CT SYSTEM,2,"July 06, 2009", 2009,Philips Medical Systems (Cleveland) Inc,Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.,DESIGN: Software Design,"An ""URGENT - Field Safety Notice"" dated April 27, 2009 was sent to all consignees via certified mail. The letter described the affected products, issue, and actions for the customer/user. The notification letter provides a work around until the new software is available. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.",N/A,417,417 units,"Worldwide Distribution -- US including DC (states of AL, AR, AZ, CO, DC, FL, IL, KY, LA, MA. ME, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, and WI) and countries of Africa, Albania, Austria, Australia, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Holland, India, Iraq, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden, Switzerland, Syria, Tahiti, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Venezuela.",Open,N/A,N/A,417,Software,Display/Image,Software update,Software Update
Z-1615-2009,52128,"prosthesis, hip, semi-constrained, metal/polymer, uncemented",LWJ,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18.Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics.",Zimmer Femoral Stem,2,"July 06, 2009", 2009,Zimmer Inc.,The threads on the screw are incomplete/non-functional.,PRODUCTION CONTROLS: Process Control,"Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified ""Urgent: Device Recall"" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265.For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131.",N/A,10,10,"Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.",Terminated,"November 12, 2009",129,10,Not_Computer,N/A,N/A,N/A
Z-1656-2009,51923,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively ""AED 10"")",AED 10 and MRL Jumpstart,2,"July 06, 2009", 2009,"Welch Allyn Protocol, Inc","Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to",DESIGN: Labeling Design,"The firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.",N/A,46740,46740 units,"Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.",Open,N/A,N/A,46740,Not_Computer,N/A,N/A,N/A
Z-1657-2009,52077,"device, hemostasis, vascular",MGB,N/A,N/A,Cardiovascular,N/A,"Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.",StarClose,2,"July 06, 2009", 2009,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,"Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.",DESIGN: Process Design,"Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.",Contact the recalling firm for information,240,240 units,Nationwide distribution.,Open,N/A,N/A,240,Not_Computer,N/A,N/A,N/A
Z-1655-2009,52051,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Blackstone Medical:ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.",ICON,2,"July 06, 2009", 2009,"Blackstone Medical, Inc.",Product marketed without an approved 510(k),DESIGN: Software Design (Manufacturing Process),"Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009.",N/A,63,"63 implant kits, 80 instrument kits",Nationwide,Open,N/A,N/A,63,Not_Computer,N/A,N/A,N/A
Z-1601-2009,50093,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Duracon Total Knee, A-P Lipped Tibial Insert; 11MMSterile; Howmedica Osteonics Corp.Stryker, Ireland. Product No. 6642-1-611.The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.",DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS,2,"July 07, 2009", 2009,Stryker Howmedica Osteonics Corp.,A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.,PRODUCTION CONTROLS: Labeling Mix-Ups,"A notification letter and product accountability form were sent via Federal Express on May 5, 2006 with return receipt to branch accounts that had received the affected product. For questions about the recall contact Stryker Howmedica Osteonics Corp. by calling 1-201-831-5000.",N/A,8,8,"Nationwide Distribution (AL, OH, MN, NM, and CA).",Terminated,"July 07, 2009",0,8,Not_Computer,N/A,N/A,N/A
Z-1648-2009,51483,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.",Symbia S Series SPECT System,2,"July 07, 2009", 2009,"Siemens Medical Solutions USA, Inc.","Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.",DESIGN: Software Design (Manufacturing Process),"Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.",N/A,152,152 units,"Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.",Terminated,"September 11, 2010",431,300,Software,N/A,N/A,Other
Z-1246-2009,51675,broach,HTQ,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery.The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.,Zimmer TM400 Broach Handle,2,"July 07, 2009", 2009,Zimmer Inc.,"The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.",DESIGN: Device Design,"Distributors and user accounts were notified by ""Urgent: Medical Device Recall"" letter dated April 29, 2009. The letter described the affected product, reason for recall, health risks, and action for consignees. Distributors were instructed to retrieve the devices and to return them to Zimmer no later than May 13, 2009. This instrument recall will result in an inability to implant the associated devices until a new instrument becomes available.For questions or assistance about the recall please contact Zimmer Spine by calling 800-777-7505.",N/A,435,435,"Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.",Terminated,"October 08, 2010",458,435,Not_Computer,N/A,N/A,N/A
Z-1597-2009,51953,"table, operating-room, electrical",GDC,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.,ASC2000 Ambulatory Surgical Table,2,"July 07, 2009", 2009,Steris Corp,"Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.",DESIGN: Device Design,"A Field Correction Notice dated April 17, 2009 was issued to customers. The letter described the potential problem of the unit. The letter also notified customers of the corrective actions to be taken by the firm. A Steris technician will visit affected accounts to inspect the hydraulic hoses and replace any that show abrasion and will make other preventive corrections. For further information or if you have questions regarding the servicing of your unit, please contact the STERIS Field Service Dispatch at 1-800-288-2805.",Contact the recalling firm for information,412,412 units,"Worldwide Distribution -- US (states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA and WV), AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ECUADOR, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, KOREA, MEXICO, PHILIPPINES, PORTUGAL, SINGAPORE, SPAIN, SRI LANKA and THAILAND.",Open,N/A,N/A,412,Not_Computer,N/A,N/A,N/A
Z-1612-2009,52090,"orthosis, spondylolisthesis spinal fixation",MNH,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677.The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.",Stryker Mantis Rod Inserter Inner Shaft,2,"July 07, 2009", 2009,Stryker Spine,"The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.",DESIGN: Device Design,"Stryker Spine issued an ""Urgent Product Recall"" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product. For further information, contact Stryker Spine at 201-760-8206.",N/A,387,387 in US,Nationwide Distribution.,Open,N/A,N/A,562,Not_Computer,N/A,N/A,N/A
Z-1582-2009,52223,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.",CardiAssist,2,"July 07, 2009", 2009,Cardiomedics Incorporated,"Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.",N/A,Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.,N/A,1,1,Florida,Open,N/A,N/A,1,Software,Display/Image,Software update,Software Update
Z-1654-2009,51979,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"Philips IntelliVue Clinical Information PortfolioSoftware Version D.0, for patient data collection, storage, and management.",IntelliVue,2,"July 07, 2009", 2009,Philips Healthcare Inc.,"Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.",DESIGN: Software Design,"Philips notified customers by Urgent Medical Device Correction Notification letter on May 6, 2009. The Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography.Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software corrections. The corrections will be in the form of software upgrades and will be performed by Philips service personnel.On May 27, 2009, Philips issued the second Urgent Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions:Clinicians should not rely solely on the worklist within lCIP to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist.",N/A,105,105 units,"Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK.",Open,N/A,N/A,105,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1553-2009,51951,"electrode, depth",GZL,Depth electrode.,Neurology,Neurology,510(k),"Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.",Cyberkinetics Inserter Wand & V2 Trigger Assembly,2,"July 07, 2009", 2009,"Cyberkinetics Neurotechnology Systems, Inc.",Sterility of product cannot be assured,PRODUCTION CONTROLS: Packaging Process Control,"Cyberkinetics Neurology Systems (CKI) notified the Distributor, Blackrock Microsystem, of the affected device. Blackrock notified the final user by email on February 4, 2009.",N/A,2,2 units,Nationwide Distribution - State of MA.,Terminated,"August 20, 2009",44,2,Not_Computer,N/A,N/A,N/A
Z-1606-2009,52016,"ventilator, continuous, non-life-supporting",MNS,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Respironics BiPAP Focus Noninvasive Ventilator System.The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.",Respironics BiPAP Focus Noninvasive Ventilator System,1,"July 07, 2009", 2009,Respironics California Inc,"Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau",DESIGN: Component Design/Selection,"Respironics California, Inc. issued an ""Attention - Medical Device Field Correction"" letter addressed to the Customer/Distributor dated September 22, 2008. The letter informed consignees of the affected device and instructions for removal, device replacement and return of the Business Response form by fax to 1-760-918-0169.Further question may be addressed to Respironics US Customer Service at 1-9800-345-6443 extension 5 or Respironics International Customer Service at 1-724-387-4000.",N/A,2270,"2,270 Power Cords","Worldwide to Argentina, Australia, Belgium, Brazil, Cambodia, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States and Venezuela.",Terminated,"July 06, 2010",364,2270,Not_Computer,N/A,N/A,N/A
Z-1573-2009,52130,port introducer kit,OKE,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,Enforcement Discretion,"Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.",TriState Centurion Port Access Tray,2,"July 07, 2009", 2009,Tri-State Hospital Supply Corporation,"The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.,N/A,100,100 trays,"Indiana, Mississippi, Ohio and Tennessee.",Terminated,"November 19, 2009",135,910,Not_Computer,N/A,N/A,N/A
Z-1653-2009,52388,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip¶_ Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.",Arrow,2,"July 07, 2009", 2009,Arrow International Inc,"The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.",DESIGN: Device Design,Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.,N/A,3019,3019 units,"Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.",Terminated,"December 03, 2009",149,3019,Not_Computer,N/A,N/A,N/A
Z-1650-2009,52436,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.",Syngo Imaging Version V31,2,"July 07, 2009", 2009,"Siemens Medical Solutions USA, Inc",Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.,DESIGN: Software Design,"syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.",N/A,16,16 units,Nationwide.,Open,N/A,N/A,16,Software,Output/Calculation,Software update,Software Update
Z-1651-2009,52430,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.",CXR4 Computed Tomography XRay System,2,"July 07, 2009", 2009,Hitachi Medical Systems America Inc,Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.,DESIGN: Software Design,"HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.",N/A,47,47 units,"Nationwide distribution, including Puerto Rico (PR).",Open,N/A,N/A,51,Software,Display/Image,Software update,Software Update
Z-1577-2009,52171,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device.",XORANCONNECT,2,"July 09, 2009", 2009,"Xoran Technologies, Inc.",An incorrect patient name label may appear on the screen displaying the selected patient's scan.,DESIGN: Software Design,"The firm released software version 4.1.0.7 by uploading it through a remote software upgrade on February 3, 2009. User accounts were notified by letter dated February 9, 2009. Direct questions to Xoran Technologies at 1-800-709-6726.",N/A,14,14,"Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).",Terminated,"November 19, 2009",133,14,Software,Display/Image,Software update,Software Update
Z-1542-2009,50824,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc).The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.",Tumor Localization (Tumor LOC) software application,2,"July 13, 2009", 2009,Philips Medical Systems (Cleveland) Inc,"A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.",DESIGN: Software Design,"Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.",N/A,356,356 units,"Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela.",Open,N/A,N/A,356,Software,Device Operation,Software update,Software Update
Z-1543-2009,51252,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.",GE Centricity PACS RA1000 Workstation,2,"July 13, 2009", 2009,GE Healthcare Integrated IT Solutions,"Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation Software Versions 2.1.x and 3.0.x customers via an Urgent Medical Device Correction notice dated March 2, 2009 of the affected device resulting in patient safety issues. The letter provided users with safety instructions until the software is updated. Consignees are requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 1-847-939-1479.Centricity PACS RA1000 Workstation Software Versions PathSpeed 7.x, 8.x, Centricity 1.X and 2.0.X customers were sent separate letters explaining the recall including instructions. There will be no software updates since those software versions are no longer being supported.For questions, call the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.",N/A,984,984 units,"Worldwide Distribution - US including Puerto Rico and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey.",Terminated,"September 06, 2010",420,984,Software,Display/Image,Software update,Software Update
Z-1551-2009,51785,cardiopulmonary bypass catheter kit,OEU,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,Enforcement Discretion,"Medtronic One Source Pack Magellan, Catalog Number: COS310.Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System",Medtronic Custom Kits,2,"July 13, 2009", 2009,Medtronic Cardiovascular Revascularization & Surgical Therap,"Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com",PRODUCTION CONTROLS: Packaging Process Control,"An ""Urgent Medical Device Recall Notice"" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.For further questions, contact Medtronic at 1-763-514-9605.",N/A,1363,"1363 kits total (1215 US, 148 OUS)","Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.",Open,N/A,N/A,1363,Not_Computer,N/A,N/A,N/A
Z-1576-2009,52170,"respirator,surgical",MSH,Surgical apparel.,General & Plastic Surgery,General Hospital,510(k),"Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.",INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR ,3,"July 13, 2009", 2009,Inovel LLC,"Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.",DESIGN: Component Design/Selection,"The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835.",N/A,80,80 cases,US (Illinois only).,Terminated,"July 17, 2009",4,80,Not_Computer,N/A,N/A,N/A
Z-1569-2009,52099,"cabinet, table and tray, anesthesia",BRY,"Anesthetic cabinet, table, or tray.",Anesthesiology,Anesthesiology,510(K) Exempt,"Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028.Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.",Amico ECylinder Canister Holder,2,"July 13, 2009", 2009,Stryker Communications Corp,"Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.",DESIGN: Device Design,"An ""Urgent: Device Recall"" letter dated May 19, 2009 was issued to customers. Customers were advised to discontinue use of all affected E-cylinder holders. Consignees were asked to return the ""Product Accountability Form"" included with the recall letter, after which consignees will be provided with an improved cylinder holder at no cost. Direct questions to Stryker Communications at 1-972-410-7100.",N/A,66,66 units.,Nationwide and Canada.,Terminated,"April 26, 2010",287,66,Not_Computer,N/A,N/A,N/A
Z-1605-2009,52036,"cabinet, moist steam",IMB,Moist steam cabinet.,Physical Medicine,Physical Medicine,510(k),"DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.",Hydrospa Capsules,2,"July 13, 2009", 2009,"Sybaritic, Inc","A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.",DESIGN: Device Design,"Sybaritic, Inc. issued a ""Safety Alert"" dated April 15, 2008 informing ""All Owners/Users of DermaLife 2G Equipment"" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered. For further questions, contact Sybaritic, Inc. at 1-800-445-8418.",N/A,10,10,"Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.",Open,N/A,N/A,363,Not_Computer,N/A,N/A,N/A
Z-1564-2009,52042,"accessories,arthroscopic",NBH,Arthroscope.,Orthopedic,Orthopedic,510(K) Exempt,"Smith & Nephew Endoscopic Disposable Blades:DISPOSABLE BL,4.5MM FR ELITEPart #: 7210499.DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.",Smith & Nephew Endoscopic Disposable Blades,2,"July 14, 2009", 2009,"Smith & Nephew, Inc. Endoscopy Division",Product sterility is compromised due to breach in the sterile packaging.,N/A,"Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.",Contact the recalling firm for information,906,906 units,"Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan,Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.",Open,N/A,N/A,13638,Not_Computer,N/A,N/A,N/A
Z-1614-2009,52092,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112.A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.",Biomet Modular TTPA Ceramic Head,2,"July 14, 2009", 2009,"Biomet, Inc.","The firm has received reports of fractured heads, requiring revision surgery.",PRODUCTION CONTROLS: Process Control,"Biomet Orthopedics issued an ""Urgent Medical Device Recall Notice"" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached ""Fax-Back Response Form"" to Biomet at 1-574-372-1683.Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.",N/A,161,161,"Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales.",Terminated,"October 06, 2010",449,335,Not_Computer,N/A,N/A,N/A
Z-1679-2009,51713,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.",Boston Scientific TELIGEN,2,"July 14, 2009", 2009,Boston Scientific CRM Corp,"Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.",DESIGN: Device Design,"Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.",Contact the recalling firm for information,49148,"49,148 total","Worldwide distribution: USA, Guam, Puerto Rico, Aruba, Austria, Belgium, Brazil, Canada, Cayman Islands, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Netherlands, New Caledonia, Norway, Philippines, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.",Open,N/A,N/A,49148,Not_Computer,N/A,N/A,N/A
Z-1673-2009,52461,"lens, guide, intraocular",KYB,Intraocular lens guide.,Ophthalmic,Ophthalmic,510(K) Exempt,"Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.",lens positioning Unit,2,"July 14, 2009", 2009,Volk Optical Inc,"Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.",DESIGN: Process Design,Volk Optical sent a 'MEDICAL DEVICE RECALL' letter to their sole customer on 1/23/2009. The letter requests the return of the remaining two (2) units in the customer's possession (this firm experienced the device failure and reported the consumer complaint which prompted the recall; and had already returned the affected unit to the Volk for refund or replacement). The letter provides Volk's Fedex and UPS numbers for the customer to use to return the recalled units and also provides the E-mail address for the firm's contact person concerning this recall should additional assistance be required.,N/A,3,3 units,USA distribution to a single customer located in MO.,Open,N/A,N/A,3,Not_Computer,N/A,N/A,N/A
Z-1622-2009,51903,"prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer",HSX,Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010.For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.,ConforMIs iUni,2,"July 15, 2009", 2009,Conformis Inc,Microscopic cracks potential for pre-mature revisions in patients implanted with the system.,PRODUCTION CONTROLS: Process Control,"ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted.Contact ConforMIS for further questions at 1-781-345-9164.",N/A,10,10 Units,"Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.",Terminated,"October 14, 2009",91,17,Not_Computer,N/A,N/A,N/A
Z-1619-2009,52191,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile;Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.",36 TCG Upper Tray,2,"July 15, 2009", 2009,Stryker Howmedica Osteonics Corp.,The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.,PRODUCTION CONTROLS: Error in Labeling,"Stryker Orthopaedics issued an ""Urgent Product Correction"" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069.Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.",N/A,26,26,Worldwide Distribution -- US and Canada.,Terminated,"April 05, 2010",264,53,Not_Computer,N/A,N/A,N/A
Z-1245-2009,51934,"cabinet, moist steam",IMB,Moist steam cabinet.,Physical Medicine,Physical Medicine,510(k),"Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.",Hydration Station with Pedestal,2,"July 15, 2009", 2009,"Sybaritic, Inc","Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns.There were 18 injuries and 8 malfunctions reported.",DESIGN: Device Design,"Sybaritic, Inc. issued a letter dated May 15, 2007 addressed to ""Hydration Station Customer"". The letter informed the customer of the new 2007 Hydration Station Upgrade Improvement Kits including instructions and advised the customer to coordinate the installation of the components with their Technical Service Department.Further questions can be addressed to Sybaritic, Inc. Technical Administration at 1-800-445-8418 extension 373.",Contact the recalling firm for information,370,370,"Worldwide Distribution - US including states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV and WI and CANADA.",Open,N/A,N/A,370,Not_Computer,N/A,N/A,N/A
Z-1554-2009,51986,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.,Disposable Waste Container,2,"July 15, 2009", 2009,Radiometer America Inc,When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.,PRODUCTION CONTROLS: Process Control,"Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers.For further questions, contact Radiometer America Inc. at 1-800-736-0600.",N/A,83958,"905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles",Worldwide Distribution to US and Canada.,Open,N/A,N/A,80756,Not_Computer,N/A,N/A,N/A
Z-1705-2009,52521,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399.The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control.",PARADIGM QUICKSET INFUSION SET ,1,"July 16, 2009", 2009,Medtronic MiniMed,"Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.",PRODUCTION CONTROLS: Process Control,"Medtronic issued an ""URGENT MEDICAL DEVICE RECALL"" notification letter dated July 6, 2009 to health care professionals, followed by notification letters dated July 7, 2009 to distributors, inactive and active customers. Letters to healthcare professionals and distributors were sent via UPS 2-Day Air with signature confirmation of delivery required. On July 8, 2009 and July 9, 2009, a notification letter, along with replacements sets, were mailed via UPS to active patients or customers (who have ordered since January 2009). The notification letter to patients (inactive customers) who last ordered prior to January 1, 2009 were issued via First Class U.S. Mail. All letters to patients include a preaddressed, postage paid card to confirm that the patient has received the recall notice and to identify whether or not they have unused sets to return. As described in the patient letters, patients have the option to confirm receipt of the notification and to order replacement infusion sets online or via an automated telephone voice response system.Distributors who purchased affected Paradigm Quick-set infusion sets must either notify all patients to whom they have provided infusion sets or provide patient names and addresses to Medtronic MiniMed so that the firm can carry out the notification.The firm's website, www.medtronicdiabetes.com/lot8, is available for customer concerns and questions not addressed in the recall letter. The website is also the most efficient way to exchange Lot 8 Quick-set infusion sets and/or place new supply orders.In the event the above website is not accessible or for additional questions, please call 1-800-345-8139 at Medtronic Diabetes 24- hours a day. Doctors who would like to speak with a Medtronic Diabetes medical officer may call 1-818-576-4211, 24-hours a day. Report product problems by calling 1-800-345-8139 at any time.Medtronic issued a press release on July 10, 2009.",N/A,28007256,"28,007,256 units","Worldwide Distribution -- US, Canada, Mexico, Bermuda, Brazil, United Kingdom, Ecuador, Paraguay, Kuwait, Germany, El Salvador and Turkey.",Terminated,"November 08, 2010",480,28007256,Not_Computer,N/A,N/A,N/A
Z-1620-2009,51345,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Guidant Contak¶_ Renewal¶_ 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798.Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.",Cardiac Resynchronization Therapy Defrillator,2,"July 17, 2009", 2009,Boston Scientific CRM Corp,"In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrenc",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Boston Scientific CRM notified Doctors via sales representatives of an ""Urgent Medical Device Information"" letter dated March 4, 2009. The letter described the problem and included Description of Issue, Rate of Occurrence, Patient Management Recommendations, Devices Affected, Warranty Program & Further Information. A Boston Scientific "" Product Advisory"" letter dated March 4, 2009, was also made available to physicians to distribute to patients. The letter informed the patient that their defibrillator was included in a group of devices that might experience a performance issue. For further questions, Contact Boston Scientific CRM at 1-800-227-3422.",N/A,112,112,"Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.",Open,N/A,N/A,1383,Not_Computer,N/A,N/A,N/A
Z-1548-2009,51485,"system,x-ray,extraoral source,digital",MUH,Extraoral source x-ray system.,Dental,Radiology,510(k),"Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018.Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.",Gendex VixWin Platinum Imaging Software,2,"July 17, 2009", 2009,Gendex Dental Systems,"There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients.",DESIGN: Software Design (Manufacturing Process),"Gendex issued an ""Urgent Medical Device Report"" dated March 6, 2009 to the direct account dealers of the affected device via first class mail. The noticed described the issue and provided a software update directed to fixing the problem. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-847-718-0601.Further questions should be directed to the Gendex Technical Support team at 1-888-275-5286.",N/A,1256,"1,256 units",Nationwide Distribution.,Open,N/A,N/A,1256,Software,Output/Calculation,Software update,Software Update
Z-1674-2009,52129,"walker, mechanical",ITJ,Mechanical walker.,Physical Medicine,Physical Medicine,510(K) Exempt,"Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator",Mechanical Walker/Rollator,2,"July 20, 2009", 2009,"Essential Medical Supply, Inc.",The caster may separate from the frame completely causing injury to the user.,DESIGN: Device Design,"Essential Medical Supply Inc issued a Notice of Quarantine Letter to all customers on 04/30/09, identifying affected products as W1700B & W1700R Essential Rollators, Serial #'s KLD-E07090001 through KLD-E08020570, received after 11/05/2007. Firm issued a Device Recall Letter to all direct customers on 05/08/09 instructing them to do the following: (1) segregate and quarantine any affected product; (2) identify and notify any customers that may received the affected products, instructing them to return the product to their dealer; and (3) either return the affected products to Essential Medical Supply or destroy the products and send proof of destruction.",N/A,2265,2265,Nationwide distribution.,Terminated,"September 15, 2010",422,2265,Not_Computer,N/A,N/A,N/A
Z-1599-2009,52172,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Cmax 110v Surgical Table Hand Control.The Cmax Surgical Table is a mobile, electro-hydraulically operatedsurgical table designed to support all general surgical procedures, with theaddition of STERIS table accessories. Tabletop positioning andarticulations are controlled via the hand control.",Cmax 110v Surgical Table Hand Control,2,"July 21, 2009", 2009,Steris Corp,"A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out c",PRODUCTION CONTROLS: Process Control,"Steris Corp. issued an ""Urgent Product Correction"" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805.For further questions, contact Steris at 1-800-548-4873 extension 27318.",N/A,217,217 Units,"Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.",Open,N/A,N/A,217,Not_Computer,N/A,N/A,N/A
Z-1711-2009,52431,"cystometer, electrical recording",EXQ,Urodynamics measurement system.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.",Urodynamic Catheters,3,"July 21, 2009", 2009,Laborie Medical Technologies Cor,Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages.,PRODUCTION CONTROLS: Packaging Process Control,"Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product.For further questions, contact Laborie Medical Technologies at 1-800-522-6743.",N/A,28,28 boxes (10's),"Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.",Terminated,"August 20, 2009",30,28,Not_Computer,N/A,N/A,N/A
Z-1710-2009,52453,"prism, gonioscopic",HKS,Gonioscopic prism.,Ophthalmic,Ophthalmic,510(K) Exempt,"G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.",Standard Gonio Lens,3,"July 21, 2009", 2009,Volk Optical Inc,"The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'",N/A,"Volk Optical Inc. contacted their customers and notified them of affected device via E-mail, letter, and Fax transmittals starting June 30, 2008. The recall notification(s) describes the engraving error and instructs the users on steps to replace the affected product.For further questions, contact Volk Optical Inc. at 1-800-345-8655 extension 443 .",N/A,15,15,"Worldwide Distribution -- Great Britain, China and the U.S.",Open,N/A,N/A,15,Not_Computer,N/A,N/A,N/A
Z-1598-2009,52283,"unit, electrosurgical, endoscopic (with or without accessories)",KNS,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.",Fusion OmniTome,3,"July 21, 2009", 2009,Cook Endoscopy,The wire control port of these devices may be missing due to omission of a manufacturing activity.,PRODUCTION CONTROLS: Process Control,The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed.Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at cws.complaints@cookmedical.com or 1-336-744-0157.,Contact the recalling firm for information,20,20 units,"International Distribution - Italy, Netherlands, Germany and Spain.",Terminated,"April 06, 2010",259,20,Not_Computer,N/A,N/A,N/A
Z-1354-2009,50901,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle.Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.",ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM,2,"July 22, 2009", 2009,Stryker Howmedica Osteonics Corp.,Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.,PRODUCTION CONTROLS: Process Control,"An ""Urgent Product Recall"" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.",No consumer action necessary,1628,"1,628 total stems, all varieties.",Nationwide Distribution.,Open,N/A,N/A,1628,Not_Computer,N/A,N/A,N/A
Z-1607-2009,52072,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.Indications for use include disabling joint disease of the knee.",Offset Adaptor Trial,2,"July 23, 2009", 2009,Stryker Howmedica Osteonics Corp.,Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.,PRODUCTION CONTROLS: Process Control,"""Urgent Product Correction"" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form.For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.",N/A,2498,"2498 units total, all sizes.",Worldwide Distribution.,Terminated,"April 05, 2010",256,2498,Not_Computer,N/A,N/A,N/A
Z-1699-2009,52227,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catatog Number: 00801102001.Total joint arthroplasty to control, restrict, or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plugged.",Zimmer Allen medullary cement plugs,2,"July 23, 2009", 2009,Zimmer Inc.,"The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.",PRODUCTION CONTROLS: Packaging Process Control,"Zimmer Orthopedic Surgical Products issued an ""Urgent: Medical Device Recall"" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.",N/A,133,133,"Worldwide Distribution -- United States, Canada and Japan.",Terminated,"December 15, 2009",145,258,Not_Computer,N/A,N/A,N/A
Z-1637-2009,51273,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings.The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.",Flite Clip Slings,2,"July 24, 2009", 2009,ArjoHuntleigh,"If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.",MISBRANDING: Labeling False and Misleading,"An ""Urgent Field Safety Notification"" letter dated January 30, 2009 to all customers with ARJO/BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars via UPS 2nd day on the February 26, 2009. The notification letter informed the accounts of the potential for clip detachments if the sling clips are not applied to the hanger bar attachment lugs. The accounts were instructed to do the following: 1) Apply the stickers provided to the passive patient lift and/or ceiling lift hanger bars as shown in the enclosed Sticker Application Instructions sheet; 2) Retrain lift operators in accordance with the enclosed instructional DVD, the revised Passive Clip Sling Operating and Product Care Instructions manual and the revised Flites Clip Operating and Product Care Instructions manual; and 3) Make lift operators aware of the Clip Sling/ Flites Clip Application Instructional poster and its location within their facility. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, acknowledging receipt and understanding of the Field Safety Notice.If you have any questions or require any additional information, contact the ARJO, Inc. Quality, Customer Support, or Technical Support Departments via e-mail at quality@arjousa.com, via phone at 1-800-323-1245, or via fax at 1-888-594-2756.",N/A,103108,"103,108 total slings",Nationwide.,Open,N/A,N/A,103108,Not_Computer,N/A,N/A,N/A
Z-1596-2009,52159,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.","Stat (TM) SuperFine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles ",2,"July 24, 2009", 2009,"Stat Medical Devices, Inc.",Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.,PREMARKET APPROVAL: No Marketing Application,"An ""Urgent: Medical Device Recall Notification"" letter dated June 18, 2009 was issued to direct customers requesting return of affected product and requesting they send notification to any customers which may have received the affected product from them. Direct questions about the recall to Stat Medical Devices by calling 1-978-774-1469.",N/A,6424100,"6,424,100 total pen needles","Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia.",Terminated,"September 07, 2010",410,6424100,Not_Computer,N/A,N/A,N/A
Z-1800-2009,52125,"intervertebral fusion device with bone graft, lumbar",MAX,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),"Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R.The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.",Medtronic INTREPID Spinal System SPACER,2,"July 24, 2009", 2009,Medtronic Sofamor Danek USA Inc,"The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.",DESIGN: Device Design,"Medtronic Sofamor Danek USA, Inc. instructed Sales Representative on starting February 6, 2009 by phone to immediately return product from the field.The firm further issued a ""Subject: Medtronic Intrepid Intervertebral Body Fusion Device Recall"" notice dated April 2009. The recall notices were mailed directly to Risk Managers and Surgeons, with Recall Questionnaires and Surgeon Confirmation forms included respectively.For further questions, contact your Medtronic Sales Representative or the Medtronic Global Quality Department at 1-800-876-3133 extension 6333.",N/A,390,390 units,"Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.",Terminated,"April 19, 2010",269,9087,Not_Computer,N/A,N/A,N/A
Z-1583-2009,52038,surgeon's gloves,KGO,Surgeon's glove.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka.The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.",DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE),2,"July 24, 2009", 2009,Ansell Healthcare Products LLC,Premature degradation which could result in tearing during use.,PRODUCTION CONTROLS: Process Control,"The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC representative.",N/A,560000,"560,000 total units--all lots.",Nationwide Distribution and Canada.,Terminated,"April 12, 2010",262,560000,Not_Computer,N/A,N/A,N/A
Z-1795-2009,52575,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only.The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).",Phiips Healthcare HeartStart MRx/MRxE Defibrillator/Monitor ,2,"July 24, 2009", 2009,Philips Healthcare Inc.,"External transport use environments, the mechanical/electrical connection between the padstherapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the device from sensing that the padstherapy cable is connected, or, cause the device to inappropriately identify external paddles or internalpaddles when the pads therapy cable is connected",DESIGN: Device Design,"Philips Healthcare issued an ""Urgent - Voluntary Medical Device Correction"" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service.Contact Philips Healthcare for further questions at 1-800-722-9377.",N/A,11579,"11,579 units","Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libyan Arab Jamaica, Lithuania, Netherlands, New Caldonia, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.",Open,N/A,N/A,11579,Not_Computer,N/A,N/A,N/A
Z-1616-2009,52169,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,N/A,"Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02.Orthopedic implant used in total hip arthroplasty.",Zimmer Alumina Ceramic Femoral Head,2,"July 27, 2009", 2009,Zimmer Inc.,"The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.",PRODUCTION CONTROLS: Packaging Process Control,"Zimmer, Inc. issued ""Urgent: Device Recall"" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265.For further questions, contact Zimmer, Inc. at 1-800-613-6131.",N/A,147,147 of both products,"Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.",Terminated,"December 22, 2009",148,147,Not_Computer,N/A,N/A,N/A
Z-1692-2009,52715,"system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy",MEQ,N/A,N/A,Gastroenterology/Urology,N/A,"Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.",Prolieve Thermodilatation System ; Prolieve Thermodilatation System Kit with Disposable RTM,2,"July 28, 2009", 2009,Boston Scientific Corporation,Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.,DESIGN: Process Design,"Boston Scientific sent Customer notification letters via Federal Express Priority mail on July 20, 2009. A total of 812 US consignees were notified and a total of 26 consignees in Puerto Rico. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.",N/A,26935,"26,935 kits","Nationwide distribution, including Puerto Rico.",Terminated,"March 04, 2010",219,26935,Not_Computer,N/A,N/A,N/A
Z-1805-2009,52705,"stent, coronary",MAF,N/A,N/A,Cardiovascular,N/A,POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE)Part #1005726-08,POWERSAIL,1,"July 29, 2009", 2009,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.,PRODUCTION CONTROLS: Process Control,"Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.",N/A,557,557 total devices,"Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.",Terminated,"July 06, 2010",342,557,Not_Computer,N/A,N/A,N/A
Z-1635-2009,50800,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Datex-Ohmeda S/5 Anesthesia Delivery UnitIntended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.",DatexOhmeda S/5 Anesthesia Delivery Unit,2,"July 30, 2009", 2009,GE Healthcare,"GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.",OTHER/UNDETERMINED: Pending,"A GE Healthcare ""Urgent Medical Device Correction"" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.",Contact the recalling firm for information,6621,"6,621","USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.",Open,N/A,N/A,9633,Not_Computer,N/A,N/A,N/A
Z-1873-2009,52721,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300).The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.",Welch Allyn Vital Sign Monitor,2,"July 30, 2009", 2009,"Welch Allyn Protocol, Inc",The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.,DESIGN: Device Design,"An ""Urgent: Correction"" letter dated July 28, 2009 was sent to customers describing the risk associated with loss of audible alarms and recommend that the users mitigate the risk by checking for proper audible alarm function each time they power on the device. (Current labeling describes the variety of beeps and tones that should be present). Users were instructed: 1) if the audio fails, do not use the device, 2) Remove it from service and 3) contact Welch Allyn Protocol, Inc. at the following telephone number (1-800-289-2501) to arrange the return and repair of your device to Technical Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.",N/A,68123,"68,123","Worldwide Distribution -- US, United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Bulgaria, Bahrain, Botswana, Canada, Switzerland, China, Cyprus, Germany, Denmark, Egypt, Spain, Figi, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Iceland, Italy, Jordan, Kenya, Kyrgyzstan, South Korea, Kuwait, Lebanon, Sri Lanka, Malaysia, Nigeria, The Netherlands, Norway, New Zealand, Oman, Phillipines, Pakistan, Poland, Puerto Rico, Panama, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Thailand, Taiwan and South Africa.",Open,N/A,N/A,68123,Not_Computer,N/A,N/A,N/A
Z-1675-2009,52435,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Somatom Definition Model AS/AS+, Model number 8098027.Intended use: Computed Tomography X-ray system",Somatom Definition,2,"July 30, 2009", 2009,"Siemens Medical Solutions USA, Inc",Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.,PRODUCTION CONTROLS: Equipment Maintenance,The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.,Contact the recalling firm for information,93,93 units,"Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.",Terminated,"September 01, 2009",33,93,Not_Computer,N/A,N/A,N/A
Z-1790-2009,52119,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above.",ALARIS PC UNIT,1,"August 03, 2009", 2009,Cardinal Health 303 dba Cardinal Health,"There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, an",DESIGN: Device Design,"The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process.The Recall Notification informed the consignees of:(A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included ""Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at customerfeedback@cardinalhealth.com 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific).The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio.",Contact the recalling firm for information,186000,"186,000 units","Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.",Open,N/A,N/A,1016000,Not_Computer,N/A,N/A,N/A
Z-1875-2009,52032,"bed, flotation therapy, powered",IOQ,Powered flotation therapy bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"Flexicair¶_ MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.",Flexicair MC3,2,"August 03, 2009", 2009,"Hill-Rom Manufacturing, Inc.",The devices may emit smoke from the blower box assembly.,PRODUCTION CONTROLS: Equipment Maintenance,"Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¶_ II and Flexicair¶_ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¶_ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.",N/A,889,889 units,Nationwide and Canada,Open,N/A,N/A,946,Not_Computer,N/A,N/A,N/A
Z-2046-2009,46722,"sucker, cardiotomy return, cardiopulmonary bypass",DTS,Cardiopulmonary bypass cardiotomy return sucker.,Cardiovascular,Cardiovascular,510(k),"Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.",Terumo Weighted Flexible Sucker,2,"August 04, 2009", 2009,Terumo Cardiovascular Systems Corporation,A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.,DESIGN: Component Design/Selection,Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818.,N/A,7079,7079,"Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.",Terminated,"November 01, 2009",89,7079,Not_Computer,N/A,N/A,N/A
Z-1676-2009,52091,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.",Symbia S Series SPECT System ,2,"August 04, 2009", 2009,"Siemens Medical Solutions USA, Inc.",The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.",N/A,37,37 units,"Worldwide Distribution -- USA, Australia, Austria, Brazil, Bulgaria, Canada, China, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Russia, Spain, Taiwan, and Turkey.",Terminated,"June 21, 2010",321,75,Not_Computer,N/A,N/A,N/A
Z-1702-2009,52226,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).",Zimmer ITST ,2,"August 04, 2009", 2009,Zimmer Inc.,"Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.",PRODUCTION CONTROLS: Process Control,Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.,N/A,120,120 of both products,"Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.",Terminated,"December 22, 2009",140,120,Not_Computer,N/A,N/A,N/A
Z-1704-2009,52177,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.",IMHS CP,2,"August 04, 2009", 2009,Smith & Nephew Inc,Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.,DESIGN: Process Design,"Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.",Contact the recalling firm for information,99,99 units,"Distribution to USA, Switzerland and Australia.",Open,N/A,N/A,99,Not_Computer,N/A,N/A,N/A
Z-1695-2009,52228,"stimulator, ultrasound and muscle, for use other than applying therapeutic deep",LPQ,N/A,N/A,Physical Medicine,N/A,"Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116.The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.",Exogen 4000Ultrasound Bone Healing System,2,"August 04, 2009", 2009,Smith & Nephew Inc,Problems with transducer may result in a reduced ultrasound output.,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.",N/A,4139,4139 units,"Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.",Terminated,"November 18, 2010",471,5030,Not_Computer,N/A,N/A,N/A
Z-1703-2009,52289,"prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented",MRA,N/A,N/A,Orthopedic,N/A,Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.,Trident,2,"August 04, 2009", 2009,Stryker Howmedica Osteonics Corp.,"The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident¶_ PSL Shell (LSP68) and one for the Trident¶_ Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.",DESIGN: Labeling Design,"Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees.",N/A,2376,"2376 in USA, 1326 internationally",Worldwide distribution.,Open,N/A,N/A,2376,Not_Computer,N/A,N/A,N/A
Z-1697-2009,49148,"lamp, infrared, therapeutic heating",ILY,Infrared lamp.,Physical Medicine,Physical Medicine,510(k),"Foot Choice Therapeutic Foot Massager, Model Number YS-322.The device is a heated foot massager intended for over the counter use.",Foot Choice Therapeutic Foot Massager,2,"August 07, 2009", 2009,Suarez Corporation Industries,Complaints of product causing burns to consumers.,DESIGN: Process Design,"On August 9- August 14, 2006, the firm sent a letter to all customers which included an ""Important Customer Reminder."" The Reminder now listed additional warnings about serious burns occurring regardless of the control settings. Direct questions to Suarez Corporation Industries by calling 1-330-494-5504.",Contact the recalling firm for information,71512,"71,512 units",Nationwide and Canada.,Terminated,"October 13, 2010",432,71512,Not_Computer,N/A,N/A,N/A
Z-1671-2009,52376,"catheter,intravascular,therapeutic,short-term less than 30 days",FOZ,Intravascular catheter.,General Hospital,General Hospital,510(k),"12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123.The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.",Large Bore Central Venous Catheters,2,"August 10, 2009", 2009,Arrow International Inc,Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.",Contact the recalling firm for information,46610,"46,610 total","Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.",Terminated,"July 29, 2010",353,46610,Not_Computer,N/A,N/A,N/A
Z-1593-2009,51963,"glucose dehydrogenase, glucose",LFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets).The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.",Roche ACCUChek Aviva Meter Kit,2,"August 11, 2009", 2009,Roche Diagnostics Corp.,"The lancet cap may be missing, which could result in an unintended lancet stick to the user.",OTHER/UNDETERMINED: Pending,"An ""Urgent Medical Device Correction"" letter dated May 13, 2009 was sent to all affected customers, distributors and consumer consignees who have either registered their blood glucose meter, contacted the firm about the lancets since 10/1/08, or have been shipped lancets by Roche since 10/1/08 were notified of the problem. Distributors were requested to notify each patient self-tester to whom a meter kit was distributed since October 1, 2008. The firm issued a press release on May 18, 2009. Diabetes Care customers: If you have questions regarding the recall, please contact the ACCU-CHEK¶_ Softclix Lancet Hotline at 1-800-778-7057.CoaguChek meter customers: If you have questions regarding the recall, please contact the ACCU-CHEK¶_ Softclix Lancet Hotline at 1-800-778-7505.",N/A,449533,"449,533 packages of lancets",Nationwide.,Open,N/A,N/A,449533,Not_Computer,N/A,N/A,N/A
Z-1813-2009,52439,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.",Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics,2,"August 11, 2009", 2009,Respironics California Inc,"The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and",DESIGN: Device Design,"Respironics California, Inc. issued an ""Urgent - Medical Device Field Correction"" notice dated April 22, 2009. Customers were informed of the affected device including corrective actions taken by the firm. A Respironics representative will contact customers to schedule service of the device.Further questions can be addressed by contacting Respironics US Customer Service at 1-800-345-6443.",Contact the recalling firm for information,508,508,"Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.",Open,N/A,N/A,508,Battery,Device Operation,Repair,Repair
Z-1815-2009,52523,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.","Hospira Phoenix Infusion System with MedNet Software, One Channel Infusion System",2,"August 11, 2009", 2009,Hospira Inc,Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.,N/A,"Hospira, Inc. issued an ""Urgent: Device Field Correction"" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades.For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100.",N/A,N/A,N/A,Product was distributed to 59 consignees to all 50 States.,Open,N/A,N/A,N/A,Other,Treatment/Delivery/Therapy,Upgrade,Repair
Z-1731-2009,51998,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),Dimension Cardiac Troponin I Flex reagent cartridge (CTNI).The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.,Dimension Cardiac Troponin I Flex reagent cartridge,2,"August 12, 2009", 2009,"Siemens Healthcare Diagnostics, Inc.",possibility of falsely elevated results,PRODUCTION CONTROLS: Process Control,"Siemens Healthcare Diagnostics issued a letter to their customers starting April 8, 2008 informing them of the problem and to discontinue use of the product. Further questions should be addressed to Siemens Healthcare Diagnostics, Inc. at 1-800-441-9250.",N/A,4574,"4,574 cartons","Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.",Terminated,"August 13, 2009",1,4574,Not_Computer,N/A,N/A,N/A
Z-1811-2009,52601,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.",BD 60ml Syringe LuerLok tip,2,"August 12, 2009", 2009,Becton Dickinson & Company,Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes.,PRODUCTION CONTROLS: Packaging Process Control,"Becton Dickinson issued an ""Urgent: Product Recall"" notice via UPS tracking dated July 7, 2009 to all distributors informing them of the affected product. The firm asked all distributors to identify end customers in an attempt to notify all customers. The firms asks that all affected product be returned.Further questions should be directed to BD Customer Service representatives at 1-888-237-2762.",N/A,133600,"133,600 units","Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.",Terminated,"October 02, 2009",51,133600,Not_Computer,N/A,N/A,N/A
Z-1878-2009,52708,"ring, teething, fluid-filled",KKO,Teething ring.,Dental,Dental,510(k),"Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool.This product is intended for use by infants for medical purposes to soothe gums during the teething process.",Luv N' Care Ltd Gel Filled Teethers,1,"August 12, 2009", 2009,Luv N' Care Ltd,Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.,PREMARKET APPROVAL: No Marketing Application,"The firm initiated their recall by telephone and email, and followed with letters to their consignees directing a recall to the consumer level. Consumers are urged to stop using the affected product and discard or return to the place of purchase. Consumers with questions about the recall may contact Luv N' Care, LTD by calling 1-800-256-2399. The firm issued a Press Release on July 17, 2009.Press Release about this recall is located on the website address: http://www.fda.gov/Safety/Recalls/ucm172689.htm.",Contact the recalling firm for information,546320,"546,320 units","Worldwide Distribution -- US (states of NY, IA, WI, IL, FL, NE, OH, MI, TX, NY, RI, and VA), Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay.",Open,N/A,N/A,546320,Not_Computer,N/A,N/A,N/A
Z-1685-2009,50097,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France.Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.",Trident Hemispherical Acetabular Shell,2,"August 13, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301",PRODUCTION CONTROLS: Error in Labeling,"Stryker Orthopaedics issued an ""Important Market Withdrawal"" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069.For further questions, contact Stryker Orthopaedics at 1-201-831-5825.",N/A,2,2 units,Distributed to 2 Stryker branches.,Terminated,"August 17, 2009",4,2,Not_Computer,N/A,N/A,N/A
Z-1734-2009,52079,"apparatus, automated blood cell diluting",GKH,Automated blood cell diluting apparatus.,Hematology,Hematology,510(K) Exempt,"CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.",CellTracks AutoPrep System,2,"August 13, 2009", 2009,"Veridex, LLC",Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.,DESIGN: Device Design,"Veridex, LLC issued a recall notice to consignees dated March 12, 2009 detailing the affected product. The firm will provide replacement bottles to all customers in the near future.For further questions, contact Veridex Customer Technical Services at 1-877-837-4339.",N/A,196,196 instruments,Worldwide Distribution,Terminated,"October 05, 2010",418,196,Not_Computer,N/A,N/A,N/A
Z-1720-2009,52022,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles.Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.","CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles",2,"August 13, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety.The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th",DESIGN: Software Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated April 23, 2009. The letter was addressed to Hospital Administrators / Risk managers and Radiology department mangers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information instructing the user to follow the enclosed User Guide Addendum to mitigate further problems.For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan); for other countries, contact your local GE Healthcare field service representative.",N/A,444,444,"Worldwide Distribution -- Including states of AZ, CA, CT, DC, FL, HI, IL, IA, MA, MI, NJ, NY, NC, OK, PA, PR, TX, WA, WV and WI and countries of ARGENTINA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PAKISTAN, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM and VENEZUELA.",Open,N/A,N/A,444,Software,N/A,N/A,Other
Z-1735-2009,52602,"accessories, soft lens products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"Bausch & Lomb, Boston¶_ Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.",Bausch & Lomb Boston Conditioning Solution Original Formula,2,"August 13, 2009", 2009,Bausch & Lomb Inc,The product failed to meet one of the shelf life specifications at the end of the expiry period.,EXPIRATION DATING: Incorrect or No Expiration Date,"Bausch & Lomb issued an ""Urgent Voluntary Medical Device Recall"" notice dated June 26, 2009. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, Indianapolis, IN. A Business Reply Card was included to be returned to Bausch & Lomb via US mail. A prepaid UPS Packing Slip was also provided to return the affected product.For further questions, contact Bausch & Lomb Customer Resource Center at 1-800-828-9030.",N/A,56000,"56,000 bottles",Nationwide Distribution.,Open,N/A,N/A,56000,Not_Computer,N/A,N/A,N/A
Z-1719-2009,51120,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1.The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients.",GE Healthcare MUSE Cardiology Information Systems,2,"August 14, 2009", 2009,"GE Healthcare, LLC","GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been confirmed with an invalid (default) patient identifier (PID), MUSE will accept future records with the same default PID as correct. If subsequent records don not contain a name, MUSE will pre-popu",DESIGN: Software Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated October 13, 2008, addressed to Healthcare Administrator/Risk Manager, Cardiology Administrators and Head of Cardiology. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Background Information and Contact Information.For further questions, contact GE Healthcare at 1-800-558-7044. Outside the US, please contact your local GE Healthcare Service Representative.",N/A,327,327,"Worldwide Distribution -- Including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WI, WY and DC and countries of UNITED KINGDOM , TAIWAN, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, QATAR, NEW ZEALAND, NETHERLANDS, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, FINLAND, ESTONIA, DENMARK, CANADA, BELGIUM, AUSTRIA and AUSTRALIA.",Open,N/A,N/A,327,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1670-2009,51138,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300.Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.","DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft,",2,"August 14, 2009", 2009,"DePuy Spine, Inc.",Tip of Driver may break during use,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"DePuy Spine notified direct accounts by visit and distributors by letter titled ""Urgent - Voluntary Product Recall Notification"". Accounts are requested to return the notification fax form and all affected product.For further questions, contact Depuy Spine at 1-800-227-6633.",N/A,117,117 units,"Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.",Open,N/A,N/A,117,Not_Computer,N/A,N/A,N/A
Z-1730-2009,51722,"cover, barrier, protective",MMP,Surgical drape and drape accessories.,General & Plastic Surgery,General Hospital,510(k),"GE Healthcare, Drapes and Sterile CoversPART NUMBER DESCRIPTION00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-; C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430.The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.","GEHealthcare, Drapes and Sterile Covers",2,"August 14, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Consignees were sent 8/29/08 a GE Healthcare ""Urgent Recall Notice"" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.",Contact the recalling firm for information,137689,"137,689 (123,373 US; 14,316 OUS)","Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.",Open,N/A,N/A,137689,Not_Computer,N/A,N/A,N/A
Z-1733-2009,52111,"kit, identification, mycobacteria",JSY,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS.Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.",Remel Middlebrook 7H10 Agar,3,"August 14, 2009", 2009,"Remel, Inc","The plate labeling is incorrect, but the outer box labeling is correct",PRODUCTION CONTROLS: Error in Labeling,The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.,Contact the recalling firm for information,118,118 packages,"Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.",Terminated,"October 15, 2009",62,118,Not_Computer,N/A,N/A,N/A
Z-1718-2009,51322,"system, simulation, radiation therapy",KPQ,Radiation therapy simulation system.,Radiology,Radiology,510(k),"AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.",AdvantageSim MD,2,"August 17, 2009", 2009,"GE Medical Systems, LLC","It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.",DESIGN: Software Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated March 11, 2009. The letter was addressed to AdvantageSim Customers, Hospital Administrators/ Risk Mangers and Oncology Department Mangers. The letter addressed the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information.For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan) and for other countries, contact your local GE Healthcare sales or field service representative.",N/A,687,687 units (351 US / 336 OUS),"Worldwide Distribution -- Including states of AL, AZ, CA, CO, CT, FL, GA, DC, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS,MO, MT,NE, NH, NJ, NM, NY, NC, ND, OH, OK PR, PA, SC, SD, TN, TX, UT, VA, WA and WI and AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TOKELAU, TURKEY, UNITED ARAB EMIRATES and the UNITED KINGDOM.",Open,N/A,N/A,687,Not_Computer,N/A,N/A,N/A
Z-1714-2009,52457,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038"" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only.Intended for use for the introduction of catheters into a vessel.",SJM Peel Away Introducer,2,"August 17, 2009", 2009,St. Jude Medical,"St. Jude Medical has initiated a voluntary recall of two lots of Peel Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product.",PRODUCTION CONTROLS: Error in Labeling,"The Consignee was provided with a St. Jude Medical ""Urgent Product Information"" letter and a doctor Acknowledgement form, via e-mail on June 2009. The letter described the problem and the product involved and advised to isolate and discontinue use of the product involved.The Consignee will notify the end user and remove any remaining affected units and will notify St Jude Medical of the results.",Contact the recalling firm for information,200,200,OUS only: Belgium.,Open,N/A,N/A,200,Not_Computer,N/A,N/A,N/A
Z-1812-2009,52160,"device, specimen collection",LIO,Microbiological specimen collection and transport device.,Microbiology,Microbiology,510(k),"Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS.Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.",Remel BactiSwab NPG ,3,"August 18, 2009", 2009,"Remel, Inc",Incorrect expiration date on the product,EXPIRATION DATING: Incorrect or No Expiration Date,"The recalling firm issued Important Medical Device Product Recall Notice letters dated 5/7/09 via regular mail to their direct accounts explaining the reason for recall and requesting they discard all remaining units of the affected lot number in their inventory. A Product Inventory Checklist was enclosed to be returned in the enclosed self-addressed, stamped envelope to report the amount of product that was discarded. The Technical Services Department should be contacted at 800-447-3641 if there are any inquiries concerning the letter.",N/A,103,103 packages,Nationwide Distribution,Terminated,"January 15, 2010",150,103,Not_Computer,N/A,N/A,N/A
Z-1821-2009,52525,"appliance, fixation, nail/blade/plate combination, multiple component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland.The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.,Dall Miles Cable Grip System,2,"August 18, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.",PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.",N/A,13,"13 total, (both products)",Nationwide Distribution,Open,N/A,N/A,13,Not_Computer,N/A,N/A,N/A
Z-1818-2009,52379,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker OrthopaedicsThe Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail.",T2 Ankle Arthrodesis Nail Surgical Protocol,3,"August 18, 2009", 2009,Stryker Howmedica Osteonics Corp.,Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Important Product Correction Letters, dated November 17, 2006, were sent to all Stryker Branches/agencies via Federal Express. The letter stated the issue and asked consignees to examine their inventory and contact their sales reps. It also told them to destroy the affected Operative Techniques by cutting them in half and discarding them, complete the attached Acknowledgment Form, and fax a signed copy of that form to 201-831-6069. The letter stated that Stryker Orthopaedics Customer Service reps would place consignees' re-orders for the product being destroyed. Also, the letter stated that in the interim a correct revision of the Operative Technique could be found online. Customers are to contact Dave O'Dell at 201-831-5277 or Rita Intorrella at 201-831-5825 with any questions.",N/A,1270,1270,Nationwide Distribution,Terminated,"August 20, 2009",2,1270,Not_Computer,N/A,N/A,N/A
Z-1933-2009,52809,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA.The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.",Boston Scientific Teligen,2,"August 18, 2009", 2009,Boston Scientific CRM Corp,"Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.",DESIGN: Device Design,"Boston Scientific Corporation field personnel began retrieving devices containing the original set screw system on Friday, July 17, 2009. If needed a letter, dated 07/17/2009 was left with the hospital administrator letting them know that product has been collected for return to Boston Scientific Corporation. Replacement devices will be provided at no charge. If the field personnel was unable to contact the hospital in the time provided, a notification letter dated July 22, 2009 was sent via Federal Express to the hospital. This letter was directed to the EP Catheter Lab Manager with a cc to the Hospital Risk Manager, Hospital Administrator and Purchasing and Central Supply. The letter asked that the affected devices not be implanted and to contact their local representative for pick-up and return. The firm will replace the affected devices. Please direct questions to your local Sales representative or Boston Scientific Corporation CRM Technical Services by calling 1-800-227-3422.",No consumer action necessary,104,104,"U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.",Open,N/A,N/A,149,Hardware,Output/Calculation,Return,Remove or Replace
Z-1954-2009,52853,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,PMA,"Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.",Medtronic Virtuoso,2,"August 18, 2009", 2009,Medtronic Inc. Cardiac Rhythm Managment,"Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.",PRODUCTION CONTROLS: Process Control,"Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.",N/A,1,1,Nationwide Distribution-- (states of IA and NJ).,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-1694-2009,51956,"orthosis, spondylolisthesis spinal fixation",MNH,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile.The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.",Capless Li Pedicle Screw System,2,"August 19, 2009", 2009,X Spine Systems Inc,"A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).",PRODUCTION CONTROLS: Process Control,"X Spine Systems Inc. issued advisory notices in March 2009 to Consignees notifying them of the problem and requesting all affected product be returned to the firm. The firm also conducted telephone calls and emails for the return of the product.For further information, contact X Spine Systems Inc. at 1-937-847-8400 extension 115.",N/A,9613,"9,613 units","Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom.",Open,N/A,N/A,9613,Not_Computer,N/A,N/A,N/A
Z-1736-2009,52452,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23.",Stryker PainPump catheter and split introducer needle,2,"August 19, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.",N/A,"Stryker Instruments issued a recall letter dated June 16, 2009 and instructed Consignees to cease using and destroy the product and to return a business reply form for credit via fax to Stryker Instruments Regulatory Department, 1-866-521-2762.For further questions, contact Stryker Instruments at 1-800-800-4236 extension 3808.",N/A,268,268,"Worldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan.",Terminated,"October 27, 2010",434,47091,Not_Computer,N/A,N/A,N/A
Z-1958-2009,50783,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Stryker Reflex Hybrid Level Anterior Cervical Plate;Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.",Stryker Reflex Hybrid Level Anterior Cervical Plate,2,"August 20, 2009", 2009,Stryker Spine,"Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.",DESIGN: Device Design,"Stryker Spine issued an ""Important Market Withdrawal"" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped.For further questions, contact Stryker Spine at 1-201-831-5825.",N/A,38987,38987 plates,"Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.",Terminated,"August 20, 2009",0,38987,Not_Computer,N/A,N/A,N/A
Z-1721-2009,51317,"table, radiographic, stationary top",IXQ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.",Foot Lok Cushion,3,"August 20, 2009", 2009,Med Tec Inc,The silkscreened indexing scale was reversed.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a ""Recall Notification"" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable.Foreign customers were notified by e-mail or phone beginning March 16, 2009.For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.",N/A,231,231 units,"Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.",Terminated,"November 05, 2009",77,231,Not_Computer,N/A,N/A,N/A
Z-1686-2009,52088,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005.The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.","DePuy P.F.C. Sigma Knee System, NonPorous Cruciate Retaining Femoral Component",2,"August 21, 2009", 2009,"Depuy Orthopaedics, Inc.",There may be a crack on the lateral side of the condyle in the posterior chamfer region.The device is used as a Orthopedic knee implant.,PRODUCTION CONTROLS: Process Control,"The firm's sales staff was notified by email on May 7, 2009, and the recall was expanded to include additional lots on May 29, 2009, instructing them to remove the affected lots from their inventory and the inventory of any consignees, to provide the consignees with a copy of the recall letter, and to return the product to the firm. Hospital consignees were notified by letter dated May 7, 2009, as well as by updated letter on May 29, 2009. A dear doctor letter dated May 29, 2009 was issued to implanting surgeons advising them of the issue. Direct questions to Depuy Customer Service by calling 1-800-366-8143.",Contact the recalling firm for information,260,260,Nationwide.,Terminated,"October 25, 2010",430,260,Not_Computer,N/A,N/A,N/A
Z-1724-2009,52057,"flowmeter, nonback-pressure compensated, bourdon gauge",CCN,Bourdon gauge flowmeter.,Anesthesiology,Anesthesiology,510(K) Exempt,"Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI.The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.",Amvex Integrated Flowmeter,2,"August 21, 2009", 2009,Amvex Corporation,The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully.,TRAINING: Employee Error,"An ""Urgent: Medical Device Recall"" letter dated May 29, 2009 was issued to the affected direct accounts on the same date, informing them that the Integrated Flowmeters shipped between April 12, 2007 and August 31, 2007 may experience damage to the o-ring which helps to control the flow of gas from the flowmeter portion of the outlet. Units with a damaged o-ring might deliver higher amounts of gas and/or not be able to shut off fully. The letter provided a list of the affected serial numbers, and asked the accounts to confirm that they have flowmeters from the recall time period. The accounts were provided with interim instructions to use the flowmeters during the replacement period, and were instructed to call an Amvex Corporation Representative at 1-866-462-6839 with at least one of the affected serial numbers and provide the number of units that need replacement. The Amvex Corporation will send new flowmeters for replacement, with instructions on how to replace, record the serial numbers and return the recalled units. If the accounts distributed the units, they were requested to forward the recall letter to the end users. The accounts were also requested to complete the enclosed reply sheet acknowledging receipt of the letter and fax it back to the Amvex Corporation at 1-905-764-7743. Direct questions to the Amvex Corporation by calling 1-866-462-6839.",N/A,1424,"1,424 units","Worldwide Distribution -- US (including Puerto Rico), Canada, Iran, Peru, Taiwan and Thailand.",Open,N/A,N/A,1424,Not_Computer,N/A,N/A,N/A
Z-1732-2009,52018,activated whole blood clotting time,JBP,Activated whole blood clotting time tests.,Hematology,Hematology,510(k),"Hemochron Jr. ACT- LR Assay (JACT- LR);ITC Catalogue/Code Number: JACTLR45 Cuvettes;For Performance on the HEMOCHROM Whole Blood Microagulation Systems;International Technidyne Corp., Edison, NJ 08820.The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.",HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT,2,"August 21, 2009", 2009,International Technidyne Corp.,One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.,TRAINING: Employee Error,"An ""Urgent - Medical Device Recall"" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases.If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at JACTLR@itcmed.com.",N/A,173,173 boxes of 45 cuvettes,Nationwide.,Terminated,"September 30, 2009",40,173,Not_Computer,N/A,N/A,N/A
Z-1027-2011,52903,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA.The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.",MOSAIQ,2,"August 21, 2009", 2009,Impac Medical Systems Inc,"Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).",DESIGN: Software Design,"Impac Medical Systems Inc sent an Important Safety Notice letter to all affected consginees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Impact Software support as soon as possible if they have the affected configurations identified in the letter. Customers were asked to complete the form included with the letter and and fax to:European customers: +44 1293 654401 American & rest of world customers 702-992-5002 or e-mail to support@impac.com Customers were asked to distribute the Safety Notice to any and all users of IMPAC software at their organization who are potentially affected by this issue. For questions e-mail support@impac.com or callEuropean customers: 44 1293 654320American & rest of world customers: 800-488-4672.",N/A,N/A,N/A,"Worldwide Distribution - USA including AL, CA, CT, FL, GA, IA, IL, KY, MI, MN, MS, ND, NJ, OH, OR, PA,TN, TX, VA, WA, WI, and WV and the country of Canada.",Terminated,"November 25, 2011",826,N/A,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-1712-2009,52633,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Twin-Pass¶_ Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.",TwinPass Dual Access Catheter,2,"August 21, 2009", 2009,"Vascular Solutions, Inc.",Three occurrences of Twin-Pass¶_ catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging,PRODUCTION CONTROLS: Process Control,"Vascular Solutions, Inc. issued an ""Urgent: Medical Device Recall - Lot Specific"" notice dated July 6, 2009. The letter described the problem and product involved and asked Consignees to immediately check their Twin-Pass¶_ catheter inventory, remove any affected units and complete the Product Recall Inventory Form and return to Customer Service Department.For further questions, contact Vascular Solutions, Inc. at 1-763-656-4300.",Contact the recalling firm for information,5885,5885,"Worldwide Distribution -- Including Puerto Rico and states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and DC and countries of CANADA, SPAIN, GREECE, IRELAND, NORWAY, SWITZERLAND, ENGLAND, TURKEY, ISRAEL, GERMANY, AUSTRIA, TAIWAN, FINLAND, SWEDEN, FRANCE, IRELAND and PORTUGAL.",Open,N/A,N/A,5885,Not_Computer,N/A,N/A,N/A
Z-1367-2011,53012,coronary drug-eluting stent,NIQ,N/A,N/A,Cardiovascular,PMA,"Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part ""Use immediately"". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part ""RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter",Endeavor Resolute ZotarolimusEluting Coronary Stent System with Rapid Exchange Delivery System,2,"August 21, 2009", 2009,Medtronic Vascular Galway Limited,"The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use.",PRODUCTION CONTROLS: Packaging Process Control,"The firm, Medtronic, sent their initial ""Urgent Medical Device Recall Notice"" to customers with affected product via e-mail on August 7, 2009. An additional ""Urgent Medical Device Recall Notice"" was sent to all customers on August 12-13, 2009 via FedEX and UPS. The notice described the product, problem and action to be taken by the customers. The customers were instructed to remove the affected units from their inventory and isolate the units in a secure location to prevent additional use. A Medtronic CardioVascular Clinical Customer Service (CCS) representative will contact their site to arrange for return of the units. This will be followed by a shipment of replacement units to their sites. If there were any questions regarding the return process, customers were to contact CCS at 800-556-4247.If you have any further questions or concerns regarding this notice, please contact the Sr. Clinical Research Manager at 707-543-2284 or ann.depaoli@medtronic.com.",N/A,49,49 units,"Nationwide distribution: AL, AR, CA, FL, IN, MD, MI, NY, OH, PA, RI, TX, VA, and VT.",Terminated,"February 17, 2011",545,49,Not_Computer,N/A,N/A,N/A
Z-1819-2009,52582,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116.The device is used for Orthopedic Knee Implants.",LEGION Pressfit Stem,2,"August 23, 2009", 2009,Smith & Nephew Inc,Products were mispackaged.,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.",Contact the recalling firm for information,16,16 units,"Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.",Open,N/A,N/A,35,Not_Computer,N/A,N/A,N/A
Z-1723-2009,51314,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)",Nuclear Magnetic Resonance Imaging System,2,"August 25, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. Two injuries and four complaints filed. 2/20/09: Recall being expanded to incl",DESIGN: Device Design,"GE Healthcare issued a ""Product Safety Notification"" letter dated October 23, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems.A second GE Healthcare ""Urgent Medical Device Correction"" letter dated March 5, 2009 was sent 3/9/09 to consignees which addressed the expanded recall to the Signa OpenSpeed0.7T MR Systems.For further questions, contact your local GE Healthcare sales or service representative.",Contact the recalling firm for information,14,170(156 US / 14 OUS),"Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.",Open,N/A,N/A,322,Not_Computer,N/A,N/A,N/A
Z-1726-2009,51692,"densitometer, bone",KGI,Bone densitometer.,Radiology,Radiology,510(k),"Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4.Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.",Hologic Explorer ,2,"August 25, 2009", 2009,"Hologic, Inc.",System may not turn off at the end of the x-ray and cause additional x-ray exposure,DESIGN: Component Design/Selection,"Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem.With the notification letter, customers will receive the following:-Software version Apex 12.6.2, 2.3.2, or 2.4.2-Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded.-New Operator's Manual for installations where the operatingcharacteristics of the system have changed due to the software upgrade.For Customers with systems with software versions other than 12.6, 2.3, or 2.4:Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.",N/A,1914,1914 units total,"Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.",Open,N/A,N/A,1914,Computer,N/A,N/A,N/A
Z-1906-2009,51336,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310.The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.",Perkin Elmer Specimen Gate Systems,2,"August 25, 2009", 2009,Perkin Elmer,"If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in theSpecimen History screen to open another assay, and then returns back to the original assay",N/A,"Perkin Elmer began notifying US customers January 15, 2009. Notification included instructions for how to avoid the situation and instructions for how to obtain a correction. The firm requested consignees to send in a Response Form by fax (358-2-2678-357) or by email (TurkuQMresponse@perkinelmer.com).For further information, please contact your closest Specimen Gate support center at specimen.gate.support@perkinelmer.com for North America and specimengatesupportfi@perkinelmer.com for outside of North America.",N/A,13,13 units,"Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.",Open,N/A,N/A,39,Not_Computer,N/A,N/A,N/A
Z-1913-2009,52629,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only.Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.",INTROFLEX VALVE INTRODUCER,2,"August 25, 2009", 2009,"Edwards Lifesciences, Llc","Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.",N/A,67357,"67,357 Units","Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.",Open,N/A,N/A,67357,Not_Computer,N/A,N/A,N/A
Z-1903-2009,52524,"bed, air fluidized",INX,Air-fluidized bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"CLINITRON¶_ UP-LIFT"" Air Fluidized Therapy Units.Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.",CLINITRON UPLIFT,2,"August 25, 2009", 2009,"Hill-Rom Manufacturing, Inc.",Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Hill-Rom issued an ""Urgent Field Safety Notice"" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken.For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.",Contact the recalling firm for information,625,625 units (total both units),"Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.",Open,N/A,N/A,625,Not_Computer,N/A,N/A,N/A
Z-1955-2009,52718,"warmer, infant radiant",FMT,Infant radiant warmer.,General Hospital,General Hospital,510(k),"Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.",Stabliet Infant Warming System,1,"August 25, 2009", 2009,"Draeger Medical Systems, Inc.",Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.,PRODUCTION CONTROLS: Equipment Maintenance,"On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible.",N/A,6489,6489 units,"Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,6489,Not_Computer,N/A,N/A,N/A
Z-1934-2009,52802,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Edwards Lifesciences ""VAMP Jr"" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)",VAMP Jr,2,"August 25, 2009", 2009,Edwards Lifesciences AG,"Edwards Lifescience initiated a recall of on Edwards ""VAMP Jr"" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the ""VAMP Jr"" to become disconnected.",PRODUCTION CONTROLS: Equipment Maintenance,"Edwards initiated the recall in the U.S. via a Urgent Customer lNotification letter with attached response confirmation fax-back attachment dated March 10, 2008 and was sent by Federal Express on March 12, 2008 requesting that customers cease using all ""VAMP Jr"" products and that they return all unused product.Customers were instructed to fax-back the confirmation attachment to 800-422-9329 and contact Edwards Customer service at 888-570-4012 to arrange for return of any unused product and obtain information about replacement product.Edwards Lifesciences requested that the customer provide written verification of stock and identify and unused product to be returned. This will enable a 100% effectiveness check for this recall. For product that was shipped to distributors, contact was made directly from Edwards Lifesciences Corporate Office in Irvine, CA. All product that was distributed internationally will be handled regionally. (i.e. US, Canada, Europe/EMEA, Japan, Intercontinental-including Latin America and Asia Pacific).",N/A,61199,"61,199 units","Worldwide Distribution including USA and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United Kingdom.",Open,N/A,N/A,61199,Not_Computer,N/A,N/A,N/A
Z-1899-2009,52712,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table",Vertier Surgical Table,2,"August 26, 2009", 2009,Stryker Communications Corp,Surgical tables were produced using an unapproved tilt frame bushing.,N/A,"Stryker Communications issued an ""Urgent: Medical Device Recall"" notice dated November 13, 2008 informing Consignees of the affected product. The firm intends to contact each facility to coordinate service by a trained representative.For further information, contact Stryker at 1-972-410-7100.",Contact the recalling firm for information,31,31,"Worldwide Distribution -- United States (OR, IL, WA, CA, AR, TX, UT, SC and GA) and Canada.",Open,N/A,N/A,31,Not_Computer,N/A,N/A,N/A
Z-1915-2009,52676,"device, prosthesis alignment",IQO,Prosthetic and orthotic accessory.,Physical Medicine,Physical Medicine,510(K) Exempt,"Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430.Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.",Stryker Orthopaedics PAL Pelvic Alignment Level,2,"August 26, 2009", 2009,Stryker Howmedica Osteonics Corp.,"The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking",DESIGN: Device Design,"Stryker Orthopaedics issued an ""Important Product Removal"" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax.For further information, contact Stryker Orthopaedics at 1-201-831-5825.",N/A,615,615,Nationwide Distribution,Terminated,"October 15, 2009",50,615,Not_Computer,N/A,N/A,N/A
Z-1916-2009,52641,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Triathlon AR 4:1 Cutting Blocks - Size 1-8;Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708;Triathlon MIS Instruments;Non SterileStryker Orthopaedics325 Corporate DriveMahwah, NJ 07430The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.",Triathlon AR 4:1 Cutting Blocks ,2,"August 26, 2009", 2009,Stryker Howmedica Osteonics Corp.,Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.,PRODUCTION CONTROLS: Process Control,"Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.",N/A,690,690 total units - both varieties,Worldwide Distribution,Terminated,"October 15, 2009",50,690,Not_Computer,N/A,N/A,N/A
Z-1693-2009,52835,"warmer, infant radiant",FMT,Infant radiant warmer.,General Hospital,General Hospital,510(k),"Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.",Heater Elements for Resuscitaire Infant Radiant Warmers,2,"August 26, 2009", 2009,"Draeger Medical Systems, Inc.","Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.",PRODUCTION CONTROLS: Process Control,"Draeger Medical issued an Urgent Medical Device Recall letter via certified mail on 8/7/09. The letter explained the problem, the need to conduct an inspection of the infant warmer (instructions included), and request replacement elements.",N/A,2915,2915 elements,"Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.",Terminated,"October 13, 2010",413,2915,Not_Computer,N/A,N/A,N/A
Z-1881-2009,52455,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),MR Coaxial 10g x 140mm (VC10140MR).,Vacora Plastic Radiolucent Coaxial,2,"August 26, 2009", 2009,Bard Peripheral Vas,Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.,PRODUCTION CONTROLS: Process Control,"Bard Peripheral Vascular, Inc. issued an ""Urgent Medical Device Recall Notification"" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax.For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.",Contact the recalling firm for information,695,695,Worldwide Distribution.,Open,N/A,N/A,10425,Not_Computer,N/A,N/A,N/A
Z-1891-2009,52782,"tube, tracheal (w/wo connector)",BTR,Tracheal tube.,Anesthesiology,Anesthesiology,510(k),"Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709Used for oral or nasal intubation for airway management.",Sheridan Preformed Cuffed Tracheal Tube,2,"August 26, 2009", 2009,Teleflex Medical,The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.,PRODUCTION CONTROLS: Process Control,Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.,N/A,1160,1160 total,"Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.",Terminated,"August 24, 2010",363,1160,Not_Computer,N/A,N/A,N/A
Z-1809-2009,52654,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CAThe Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions.","Varis, Aria Radiation Oncology Version 8.1.15, 8.5.11, and 8.6.07",2,"August 27, 2009", 2009,Varian Medical Systems Oncology Systems,"Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.",DESIGN: Software Design (Manufacturing Process),"An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager.",Contact the recalling firm for information,1587,"1,587 units",Worldwide Distribution,Open,N/A,N/A,1587,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1928-2009,52118,clinical sample concentrator,JJH,Clinical sample concentrator.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001.Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.","AMPLILINK Software, version 3.1.0 to 3.2.2 ",2,"August 27, 2009", 2009,"Roche Molecular Systems, Inc.","Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and",DESIGN: Software Design,"Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.",N/A,282,282,Nationwide Distribution,Terminated,"August 13, 2010",351,282,Software,Output/Calculation,Software update,Software Update
Z-1901-2009,52717,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080.The catheter is designed for external and internal percutaneous drainage of the biliary system.",Flexima Biliary Catheter System ,2,"August 27, 2009", 2009,Boston Scientific Corporation,"Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the",PRODUCTION CONTROLS: Error in Labeling,"Boston Scientific issued an ""Urgent Medical Device Recall -Immediate Action Required"" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned.For further information, contact Boston Scientific at 1-508-683-6036.",Contact the recalling firm for information,79,79 units (1 box = 1 unit),"Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands.",Open,N/A,N/A,79,Not_Computer,N/A,N/A,N/A
Z-1817-2009,52375,impactor,HWA,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide.Catalog No. 1440-1370Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.Authorized Representative in Europe: Stryker France, Cedex France.The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.",Lateral Decubitus Alignment Guide,2,"August 27, 2009", 2009,Stryker Howmedica Osteonics Corp.,"The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be referred to Rita Intorella at 201-831-5825.",N/A,61,61 units,Nationwide Distribution,Terminated,"October 15, 2009",49,61,Not_Computer,N/A,N/A,N/A
Z-1885-2009,52761,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.",IntelePACS Picture Archiving Communications System ,2,"August 27, 2009", 2009,Intelerad Medical Systems Inc.,Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.,DESIGN: Software Design,"Intelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice"" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to quality@intelerad.com.For further information, contact Intelerad Medical Systems at 1-514-931-6222.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",17,17 (including 11 free trials),"Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.",Terminated,"September 24, 2010",393,18,Software,Device Operation,Software Update,Software Update
Z-1904-2009,52725,"lubricant, personal",NUC,Condom.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.",ConceivEase,2,"August 27, 2009", 2009,Memphis Fertility Laboratory Inc,Product was marketed without a 510(k).,PREMARKET APPROVAL: No Marketing Application,The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.,No consumer action necessary,800,800 units,"Nationwide Distribution -- USA, including the state of MA.",Terminated,"October 05, 2009",39,800,Not_Computer,N/A,N/A,N/A
Z-1729-2009,52636,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA.Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.",Clinac with Version 7.x Software,2,"August 27, 2009", 2009,Varian Medical Systems Oncology Systems,"Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.",DESIGN: Device Design,"Varian Medical Systems issued an ""Urgent Medical Device Correction"" dated May 29, 2009 distributed to all affected users, as well as Varian Sales, Marketing and Service organizations, informing them of the issue. Consignees were informed that a Varian Service representative will be in contact to schedule the proper correction.For further questions, contact your local Varian Customer Support District Manager.",N/A,1933,"1,933 units",Worldwide Distribution.,Open,N/A,N/A,1933,Other,Physical Safety Hazards,Correction,Repair
Z-1945-2009,52126,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610.The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.",Maxilift ,2,"August 27, 2009", 2009,ArjoHuntleigh,The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.,PRODUCTION CONTROLS: Equipment Maintenance,"ArjoHuntleigh sent a Field Safety Notice DCHU-UK/0209/001FSN to all affected end users via UPS Ground on 4/27/09. The notice informed the accounts of the potential for the roll pin to break due to a combination of severe corrosion and fatigue, leading to the detachment of the hanger bar from the jib of the lift. The accounts were advised to identify if they have any Arjo Maxilift patient lifters in their facility, identify which version of Arjo Maxilift hanger bar they have using the photographs in Figures 1,2 and 3 in the letter. Any lifters found with a hanger bar attachment as shown in Figure 1 must be immediately and permanently taken out of use, as the replacement hanger bar assembly is no longer available. Any lifters with a hanger bar attachment as shown in Figure 2 must be taken out of use until a correction has been performed by ArjoHuntleigh. Any lifters with a hanger bar attachment design as shown in Figure 3 are not affected and can continue being used. The accounts were provided with a product upgrade offer and a MaxiLift Preventative Maintenance Schedule. The accounts were requested to complete and fax, e-mail or mail the enclosed Customer Response Form to Arjo at 630-925-7974 or quality@arjousa.com, indicating the number of Maxilifts in each category that they have and that the products have been taken out of service for replacement or correction, listing the model numbers and serial numbers of their lifts. Questions were directed to the ArjoHuntleigh Customer Support or Quality Department at 1-800-323-1245.",N/A,8015,"8,015 lifts",Worldwide Distribution -- Countries of USA and Mexico.,Open,N/A,N/A,8015,Not_Computer,N/A,N/A,N/A
Z-1897-2009,52640,"pump, blood, extra-luminal",FIR,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.",Owner Manual for PlasmaPro Plasma Pump,2,"August 27, 2009", 2009,"Apheresis Technologies, Inc.","Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.",DESIGN: Labeling Design,PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.,Contact the recalling firm for information,7,7 Owner's Manuals,"Nationwide Distribution -- Florida, Colorado and Utah.",Terminated,"July 06, 2010",313,7,Not_Computer,N/A,N/A,N/A
Z-1872-2009,52199,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344.The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use.",ACIST Automated Manifold Kit,2,"August 30, 2009", 2009,Acist Medical Systems,ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent on 5/11/09 a ACIST Medical Systems ""Urgent: Medical Device Recall"" letter dated May 11, 2009. The letter described the problem and the product. It advised consignees to discontinue the use or further distribution of the recall product and to return the inventory and the enclosed ""Medical Device Recall Form"". Please use the enclosed form with firms address: 7905 Fuller Rd, Eden Prairie, MD 55344. Additional questions please contact the firm at 1-877-272-2269, option 1.",No consumer action necessary,280,"62, 280 (57,110 US, 5130 Canada, 40 Hong Kong)","Worldwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, ID, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE,NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT VA, WA, and WI.The countries ofCANADA and HONG KONG",Open,N/A,N/A,62280,Not_Computer,N/A,N/A,N/A
Z-1929-2009,52055,"stainer, tissue, automated",KEY,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"VP 2000 Processor; an automated tissue stainer100 volt - part 30-144100 or list 2J11-60;117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only;230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only.Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements.",VP 2000 Processor,3,"August 30, 2009", 2009,Abbott Molecular,"Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor.",DESIGN: Device Design,"Abbott sent Device Recall/Urgent Field Safety Notice letters dated 9/15/08 to the VP2000 customers on 9/12/08, informing them that thermal runaway conditions may occur within the heated slide basins of the VP2000 Slide Processor. The customers were given actions to take to prevent this condition: a) VP2000 should be powered down when not in use and when the controlling computer is not in use; b) Liquid level in all heated basins should be checked periodically to ensure that there is adequate reagent present for slide processing and to keep the sensor probe immersed for accurate temperature sensing; and c) If large, rapid and random fluctuations in indicated basin temperature occurs the unit should be shut down and a Field Service Representative be contacted. Any questions were directed to their local Abbott Technical Service Representative.",N/A,261,261 units,"Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Columbia, Czech Republic, Egypt, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Malaysia, Norway, Russia, Saudi Arabia, Singapore, Switzerland and the United Kingdom.",Terminated,"January 07, 2010",130,261,Not_Computer,N/A,N/A,N/A
Z-1900-2009,52722,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA",ArthroWand Saber 30 with Integrated Cable wand,2,"August 30, 2009", 2009,ArthroCare Corporation,"Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.",N/A,"Firm initiated this recall on August 5, 2008. Consignees were notified via letter asking them to contact consignees and delivered via courier. Distribution discontinued on July 9, 2008.",N/A,23443,"23,443 units (includes distribution of previously returned product)","Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, Kuwait, China, Bahrain, Denmark, Norway, Sweden, Australia, Germany, Austria, UK, New Zealand, Mexico and Canada.",Open,N/A,N/A,23443,Not_Computer,N/A,N/A,N/A
Z-1990-2009,51999,"lift, patient, ac-powered",FNG,AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs;Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs;Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs;Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs;Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs.Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga, Ontario, Canada L5T 1X7, made in Canada. The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.",BHM/MediMan Combi Sling,2,"August 31, 2009", 2009,"B.H.M. Medical, Inc.",Premature failure of the stitching at the junction of the shoulder strap and sling body of the BHM/Medi-Man Combi Sling used with patient lifts.,DESIGN: Device Design,"Arjo sent ""Urgent Device Recall Customer Notification"" cover letters dated April 15, 2009 to the end user accounts who received the affected BHM/Medi-Man Combi Slings, to the attention of the Administrator/Risk Manager, advising them of the potential for possible stitching failure that could lead to a hazardous situation. Enclosed with the letter was a copy of the BHM Medical Field Safety Notice, FSN 10/2009/ca, dated April 3, 2009 which was sent to their BHM customers in the U.S. on April 7, 2009. The FSN identified the part numbers of the BHM/Medi-Man Combi Slings, described the potential health hazard, and listed the actions to take. The accounts were instructed to inspect and assess their slings' suitability for use per the Slings Maintenance Instructions. If the sling is showing this kind of breakage, the account was instructed to remove it from use and discard it immediately. If the inspection reveals no deterioration of the stitching, the sling is safe to use. The accounts were requested to complete and return the enclosed FSN receipt form within 10 days, acknowledging the receipt and understanding of the letter, and indicating the number of slings in use prior to inspection, the number of slings in use after the inspection, and the number of slings rejected. The accounts will be contacted for the replacement of their eligible old slings (in use up to two years).",N/A,1396,"1,396 slings",Nationwide,Open,N/A,N/A,1396,Not_Computer,N/A,N/A,N/A
Z-1894-2009,52560,"set, administration, for peritoneal dialysis, disposable",KDJ,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Baxter Minicap Extended Life PD Transfer Set Extra Short (4"") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.","Baxter Minicap Extended Life PD Transfer Set Extra SHort (4"") with Twist Clamp",2,"August 31, 2009", 2009,Baxter Healthcare Corp.,"The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Baxter Healthcare Corporation telephoned the accounts receiving the affected lots and then faxed or e-mailed ""Urgent Product Recall"" letters dated July 2, 2009, to them, to the attention of the Peritoneal Dialysis Nurse, to inform them of the defective white sleeve twist clamp, which may result in leakage and possible peritonitis. The accounts were asked to immediately discontinue the use of the affected lot numbers and examine their inventory for the affected lots. If any affected product was found, they were requested to quarantine it and contact Baxter Center for Service at 1-888-229-0001 to arrange for its return to Baxter. The accounts were also requested to review their patient records to determine if any of their patients had received the affected product. If so, they were advised to contact the patients to see if they had experienced any leaking. If so, the patients should return to the facility to have the set changed per the facility's transfer set change procedure. Any questions were directed to the Center for One Baxter at 1-800-422-9837, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Standard Time (CST). The accounts were requested to complete the enclosed reply form acknowledging receipt of the letter and that they followed the instructions and disseminated the information to their staff.",N/A,2436,"2,436 sets","US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.",Terminated,"July 08, 2010",311,3150,Not_Computer,N/A,N/A,N/A
Z-1869-2009,52663,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.",Maquet Coronary Perfusion Cannulae with Balloon Tip,2,"August 31, 2009", 2009,Maquet Cardiovascular,Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.,PRODUCTION CONTROLS: Process Control,"Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.",N/A,2226,"2,226 devices",Nationwide distribution.,Open,N/A,N/A,2226,Not_Computer,N/A,N/A,N/A
Z-1994-2009,51278,"monitor, st segment with alarm",MLD,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCMIndicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.",DatexOhmeda S/5 Critical Care Monitor,2,"September 01, 2009", 2009,GE Medical Systems Information Tecnology,"GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result i",DESIGN: Software Design,"GE Healthcare Technologies issued a Marketing Bulletin ""Ref: MB MS HKI 06007"" dated February 6, 2006 to explain a software update.",N/A,873,873,"ITALY, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, ISRAEL JORDAN, LITHUANIA, ITALY, MACEDONIA, MALAYSIA, MEXICO, NETHERLAND, NICARAGUA, NORWAY, POLAND, PORTUGAL PUERTO RICO, RUSSIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SWEDEN, SYRIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA.",Open,N/A,N/A,1380,Software,Alarm/Message,Software update,Software Update
Z-1936-2009,52427,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA.The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.",FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM,2,"September 01, 2009", 2009,"Abbott Diabetes Care, Inc.",Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.,PRODUCTION CONTROLS: Process Control,"An ""Important: Medical Device Notification"" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400.",N/A,9252,"9,252 vials","US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI).",Open,N/A,N/A,9252,Not_Computer,N/A,N/A,N/A
Z-1914-2009,52168,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,Abiomed AB5000 Portable DriverCatalog number: 0025-0000The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.,AB5000 Portable Driver,2,"September 01, 2009", 2009,"Abiomed, Inc.",The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.",N/A,18,18 units,"Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.",Open,N/A,N/A,18,Not_Computer,N/A,N/A,N/A
Z-1910-2009,52758,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Jejunal Feeding Set, Product Order number FLOWJ-9-20.This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.",Jejunal Feeding Set,2,"September 01, 2009", 2009,Cook Endoscopy,The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.,PRODUCTION CONTROLS: Process Control,"The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.",N/A,4,4 units,International Only Distribution -- Country of Italy.,Terminated,"April 06, 2010",217,4,Not_Computer,N/A,N/A,N/A
Z-1898-2009,52762,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),"SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics IncorporatedThe SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.",AngioDynamics SmartPort ,2,"September 01, 2009", 2009,"Angiodynamics, INC",The product may contain an incorrect size catheter and introducer.,PRODUCTION CONTROLS: Packaging Process Control,"Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of the devices. All devices will be inspected for damage to the devices and any damaged devices destroyed (scrapped) via the AngioDynamics procedure for Disposition of Nonconformances, procedure. Non-damaged product may be reworked to remove the incorrect catheter and introducer and replaced with the correct catheter and introducer, repackaged and re-sterilized in accordance with the AngioDynamics procedure for Rework. If necessary, follow-up letters, phone calls or visits by the AngioDynamics sales representatives may be used to complete the effective checks. Level A (100%) of consignees to be contacted).Please contact your local representative or Recall Coordinator at 1-706-846-3126, for assistance. You may e-mail your questions to customerservice@angiodynamics.com.",N/A,150,150 kits,"AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX.",Terminated,"October 27, 2010",421,150,Not_Computer,N/A,N/A,N/A
Z-1706-2009,52561,"cover, barrier, protective",MMP,Surgical drape and drape accessories.,General & Plastic Surgery,General Hospital,510(k),"GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150"" long x 87"" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.",GE sterile drape,2,"September 01, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.",PRODUCTION CONTROLS: Packaging Process Control,"GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.",Contact the recalling firm for information,2760,2760,"Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.",Open,N/A,N/A,2910,Not_Computer,N/A,N/A,N/A
Z-1947-2009,52604,"drill, dental, intraoral",DZA,Intraoral dental drill.,Dental,Dental,510(K) Exempt,"ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland.Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.",ACT3020 Twist Drill,2,"September 01, 2009", 2009,"Biomet 3i, LLC","Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Consignees were notified of recall by telephone and by faxed an Urgent: Medical Device Recall letter, dated June 30, 2009. The letter stated the problem. The letter also asked customers to check their surgical kits and confirm the drill is placed in the correct space within the kit. Customers are to verify that the shank of the drill is marked as ACT3020 on one side and as 3.0 x 20mm on the opposite side. The letter also stated the clinical implications. Customers are to respond with the attached response fax and then return the drills to BIOMET 3i. Once the returned product is received, replacement drills will be sent to the customers. Questions or concerns should be directed to Kelly Taylor at 561-776-6906.",Contact the recalling firm for information,29,29 units,"Worldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA.",Terminated,"January 05, 2010",126,29,Not_Computer,N/A,N/A,N/A
Z-1895-2009,52565,"ligator, hemorrhoidal",FHN,Hemorrhoidal ligator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips).The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.","Boston Scientific Clipping Device, Resolution Clip",2,"September 02, 2009", 2009,Boston Scientific Corporation,"The clip may not deploy or, if deployed, the clip may not release from the tissue.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by an ""Urgent Recall Letter "" dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance.",Contact the recalling firm for information,217,217,"Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.",Terminated,"October 08, 2010",401,4486,Not_Computer,N/A,N/A,N/A
Z-1889-2009,52679,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),NX 2008 Central Monitoring System (CMS). Product code: E2FB6Agfa's Computed Radiography Systems with NX Workstations are intended for use inproviding diagnostic quality images to aid the physician with diagnosis.,Agfa Healthcare Corp. NX 2008 Central Monitoring System,2,"September 02, 2009", 2009,AGFA Corp.,"After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.",DESIGN: Software Design,"An ""Urgent Safety Notice"" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.",Contact the recalling firm for information,97,97 units,"Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America",Terminated,"July 22, 2010",323,97,Software,Display/Image,Software update,Software Update
Z-1444-2009,51704,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Sybaritic, NannoLight MP50.Model Numbers and Description:1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included);2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration.The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.",NANNOLIGHT INTENSE PULSED LIGHT SYSTEM,2,"September 03, 2009", 2009,"Sybaritic, Inc",Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.,DESIGN: Device Design,"A ""Sybaritic"" notification letter dated April 15, 2008 was issued to consignees. The letter described the modifications to the protocols for the NannoLight MP50 and the temporary replacement of 585 Filter for the 560 Filter for Vascular Lesions until further notice. They requested the immediate use of the protocols replacing all other versions.A follow-up letter dated June 3, 2008 was issued to customers. The letter included an attachment "" Product Notice Nannolight MP50 585 nm ""special"" filter from Sybaritic, Inc. The letter described the new 585 nm ""bandwidth filter"". Also the notification advised consignees to discontinue the use of the old 585 filter and to use 560nm filter until they receive the new 585 nm bandwidth filter.Please direct any questions to your Account Manager or to Sybaritic, Inc. by calling 1-800-445-8418 or 1-952-888-8282.",Contact the recalling firm for information,59,59,"Worldwide Distribution -- US (states of WA, CA, MN, FL and AR), POLAND, THAILAND, CHILE, CANADA, KOREA, AZERBAIJAN, INDIA, SPAIN, ARGENTINA, RUSSIA, GREECE, PHILIPPINES, POLAND, INDIA, JORDAN, TURKEY, MEXICO, URUGUAY,BELGIUM, LEBANON, BULGARIA and SINGAPORE.",Open,N/A,N/A,59,Not_Computer,N/A,N/A,N/A
Z-1918-2009,52115,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.",Malibu Polyaxial Screw,2,"September 03, 2009", 2009,"SeaSpine, Inc",SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"In an Urgent Voluntary Product Recall Notification letter dated March 5th, 2009, SeaSpine informed consignees about the reason for recall and asked them to immediately check the products in their possession and hospital inventories to determine if they have any of the affected product. Alternatively, there were told if they would prefer to return to SeaSpine all Malibu Screw inventory that is in their possession, SeaSpine will sort out the affected product upon receipt and will replace their inventory with Malibu Screws that conform to all SeaSpine specifications. The part number and lot are laser marked on the outside of the seat assembly of each screw.SeaSpine asked their consignees to return affected product to them immediately. Attached was a verification form, that they were told to complete and return even if they did not have any product to return. Furthermore their local Sales Manager could assist them in completing the form. They were also encouraged to contact their Sales Manager or Steve Rybka at (760) 727-8399 x202 if they had any questions regarding the recall, any of their products, or would like assistance with the recall.",N/A,1116,"1,116 Screws in total","Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.",Open,N/A,N/A,1116,Not_Computer,N/A,N/A,N/A
Z-2050-2009,52695,"catheter, conduction, anesthetic",BSO,Anesthesia conduction catheter.,Anesthesiology,Anesthesiology,510(k),"Portex Continuous Epidural Tray, Reference 4037-20An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia.",Portex Continuous Epidural Tray,3,"September 03, 2009", 2009,"Smiths Medical ASD, Inc.","Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Smiths Medical notified consignees by an Urgent Device Recall letter dated July 15, 2009, to locate and quarantine the affected product, stop distribution, and complete and fax back the attached Distributor Reply Letter to Smiths Medical. Credit or replacement will be arranged as requested for the return of any affected product. All distributors will be required to return any affected product in stock. All of the distributors will be required to send their customer list to Smiths Medical who will notify their customers of this recall.",N/A,190,190 kits (19 cases),"Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.",Open,N/A,N/A,190,Not_Computer,N/A,N/A,N/A
Z-2002-2009,52724,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.",Roche Coaguchek XS,2,"September 03, 2009", 2009,"Roche Diagnostics Operations, inc.",The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.,DESIGN: Device Design,"Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures.For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194.",N/A,37215,"37,215 in US",Worldwide Distribution,Open,N/A,N/A,66326,Not_Computer,N/A,N/A,N/A
Z-1998-2009,52817,"retractor, fiberoptic",FDG,Gastroenterology-urology fiberoptic retractor.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box.The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.",UltraThin LightMat Surgical Illuminator,2,"September 03, 2009", 2009,Lumitex Inc,"Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Lumitex, Inc. issued a recall letter dated July 2, 2009 to their Customers describing the affected device and requesting its return.For further information, contact Lumitex, Inc. at 1-440-243-8401.",N/A,59,59 packs/5 individual units,"Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.",Open,N/A,N/A,59,Not_Computer,N/A,N/A,N/A
Z-2010-2009,52898,"tube, tracheostomy (w/wo connector)",BTO,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened.The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.",Transtracheal (Jet Ventilation) Catheter ACU 1060.1,2,"September 03, 2009", 2009,Instrumentation Industries Inc,user instructions not updated to correspond with product change,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Instrumentation Industries, Inc. issued a notification letter dated July 9, 2009 to their customers explaining the problem and the need to replace current inventory user instructions with the revised user instructions accompanying the letter.For further questions, contact Instrumentation Industries, Inc. at 1-800-633-8577.",N/A,396,396 units,"Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC, SD, TX, VA and WA.",Terminated,"October 15, 2009",42,396,Not_Computer,N/A,N/A,N/A
Z-1961-2009,52611,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),Celsite Access Port Model ST305P.The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.,Celsite Access Port,2,"September 03, 2009", 2009,B. Braun Interventional Systems,"B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite¶_ ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"B. Braun Interventional Systems, Inc. issued an ""Urgent: Medical Device Recall"" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted.For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.",No consumer action necessary,40,40 in US,Nationwide Distribution -- NY.,Open,N/A,N/A,40,Not_Computer,N/A,N/A,N/A
Z-1965-2009,52798,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.",iLink Bone Void Filler,2,"September 03, 2009", 2009,Theken Spine LLC,"Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.",N/A,"Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm.For further questions, contact Theken Spine, LLC at 1-330-475-8662.",N/A,22,22 units,Nationwide Distribution -- TX.,Open,N/A,N/A,22,Not_Computer,N/A,N/A,N/A
Z-2048-2009,52993,"ophthalmoscope, ac-powered",HLI,Ophthalmoscope.,Ophthalmic,Ophthalmic,510(k),"Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164.The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma.","Carl Zeisss Meditec, Inc. Stratus OCT",2,"September 03, 2009", 2009,Carl Zeiss Meditec Inc,Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.,DESIGN: Software Design,"Firm initiated notification to customers on July 2, 2009, by sending a letter via FedEx to US customers, and via e-mail and FedEx to outside US consignees. Customers were informed of the issue and steps needed to correct it. A revised software version will be provided to the customers. Any questions should be directed to Carl Zeiss Meditec, Inc. Customer Care at 1-800-341-6968.",N/A,244,244 units,"Worldwide - US, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China.",Terminated,"April 19, 2010",228,244,Software,Display/Image,Software update,Software Update
Z-2029-2009,50785,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous(endotracheal or tracheostomy [ET] tube) or non-continuous(mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).",Newport e360 Ventilator,2,"September 04, 2009", 2009,Newport Medical Instruments Inc,"In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu",DESIGN: Software Design,"Newport Medical initally sent out a Field Correction Notice to a limited number consignees dated December 17, 2008 and then the notice was expanded to include all e360 consignees dated June 15, 2009. The firm notified consignees that they have revised the e360 software to version 3.8. A customer verification form was attached to verify upgrade completion. For further questions, contact Newport Customer Technical Support Department at 1-800-451-3111 or +1-714-427-5811 Extension 500.",Contact the recalling firm for information,4117,"4,117 units (214 Domestically; 3,903 Internationally)","Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, England, Finland, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Japan, Jordan, Kazahkstan, Kenya, Korea, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nambia, Nepal, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, AUE, Ukraine, United Kingdom, Yemen Republic and Zimbabwe.",Open,N/A,N/A,4117,Software,Alarm/Message,Software update,Software Update
Z-1558-2009,52019,"system,network and communication,physiological monitors",MSX,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02.The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.","DATEXOHMEDA S/5 DEVICE INTERFACING SOLUTION, NDISXXXX..01 WITH NDISVENT..02",2,"September 04, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an",DESIGN: Software Design (Manufacturing Process),"An ""Urgent Medical Device Correction"" letter was issued to consignees on or about April 9, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A representative from GE Healthcare will contact customers to schedule implementation of the correction when it is available for installation at the customer's facility. Direct questions regarding this notice to GE Healthcare Technical Support or your local GE Distributor and refer to FMI 36042.",No consumer action necessary,2638,"2,638","Worldwide Distribution -- US (including DC and states of AL, AK, AZ, AR, CA, CO, FL, IL, IN, IA, KS, KY, LA, ME, MD, MI,MN, MO,MT, NE, NH, NJ, NY, NC, OH, OK OR, PA, SC, TX, UT,VT, VA, WA, WV and WI) and countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, CYPRUS, DENMARK, ESTONIA, FRANCE, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, PORTUGAL SAUDI ARABIA, SERBIA, SOUTH AFRICA, SWEDEN SWITZERLAND, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES and UNITED KINGDOM.",Open,N/A,N/A,2638,Not_Computer,N/A,N/A,N/A
Z-2016-2009,51966,dialyzer reprocessing system,LIF,N/A,N/A,Gastroenterology/Urology,510(k),"HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA.SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.",HACH SteriChek Residual Peroxide Reagent Strips,2,"September 04, 2009", 2009,Hach Co,Some of the reagent strip bottles contain the incorrect strips,PRODUCTION CONTROLS: Error in Labeling,"Hach Company issued an ""Urgent Medical Device Recall"" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned.Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter.For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.",N/A,275,275 kits,"Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.",Terminated,"October 07, 2009",33,275,Not_Computer,N/A,N/A,N/A
Z-2008-2009,52209,"warmer, thermal, infusion fluid",LGZ,N/A,N/A,General Hospital,510(k),"Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.",enFlow Fluid/Blood Warmer,2,"September 04, 2009", 2009,Enginivity LLC,"1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).",DESIGN: Device Design,"Vital Signs, Inc. issued Product Safety Notification on March 23, 2009 informing users of potential EMI and fluid ingress issues. All warmers in the field will be replaced beginning in May 2009.",N/A,3052,3052 units,"Worldwide Distribution -- USA, Philippines, Saudi Arabia, India, Israel, Australia, Mexico, Germany, Republic of Singapore, China, Guatemala, Switzerland, Dubai United Arab Emirates, New Zealand, Malaysia, India, Ecuador, & United Kingdom.",Open,N/A,N/A,3052,Hardware,Device Operation,Replace component,Remove or Replace
Z-1827-2009,52163,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF 0531-200-200.",Stryker 100 mL AutoFuser PainPump,2,"September 04, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.",PRODUCTION CONTROLS: Process Control,Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.,Contact the recalling firm for information,28755,"28,755 of all pumps",Nationwide and Canada.,Terminated,"January 20, 2010",138,28755,Not_Computer,N/A,N/A,N/A
Z-1808-2009,52697,"unit, phacofragmentation",HQC,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.",Horizon,2,"September 04, 2009", 2009,American Optisurgical Inc,Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.",N/A,12,12 units,"Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.",Terminated,"September 04, 2009",0,12,Software,Device Operation,Remove,Remove or Replace
Z-1600-2009,52002,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware).The CIC Pro"" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.",Central Station Monitoring System ,2,"September 04, 2009", 2009,GE Medical Systems Information Tecnology,GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"A GE Healthcare ""Urgent Medical Device Correction"" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units byGE Field Service team members.For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.",Contact the recalling firm for information,352,352,"Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH REPUBLIC, GERMANY, EGYPT, SPAIN, FRANCE, GREAT BRITAIN, ITALY, POLAND and SWEDEN.",Open,N/A,N/A,352,Hardware,Physical Safety Hazards,Replace,Remove or Replace
Z-1992-2009,52701,"prosthesis, shoulder, semi-constrained, metal/polymer, uncemented",MBF,Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.,Turon,2,"September 04, 2009", 2009,"Encore Medical, Lp",Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.",No consumer action necessary,60,60 units,"Nationwide Distribution -- Including states of TX, FL, and GA.",Terminated,"January 07, 2010",125,60,Not_Computer,N/A,N/A,N/A
Z-2026-2009,52773,"valve, prosthesis",ISP,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,Icelock Expulsion Valve 551 Model L-551000The valve has a push button for suction release to release a lower limb prosthesis.,Icelock Expulsion Valve 551 ,2,"September 04, 2009", 2009,"Ossur Engineering, Inc",The plastic caps have come off or become loose when the user stepped into their prosthesis.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Customers were sent a Safety Notice Voluntary Product Recall, dated June 23, 2009, that advised them to return any unused valves to Ossur for a free replacement. Those using valves in combination with a cushion liner and suspension sleeve should replace immediately if problems are experienced, otherwise replace at next routine service. Customers using valve in combination with an Iceross Seal-In liner should replace ASAP and return used valves to Ossur for free replacement. Customers with questions can call Darlyne Roa 1-800-233-6263 ext 1023743.",N/A,4647,"4,647",Worldwide Distribution,Open,N/A,N/A,4647,Not_Computer,N/A,N/A,N/A
Z-1989-2009,52775,"pack, hot or cold, water circulating",ILO,Water circulating hot or cold pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"Power Supply Accessory (model AD-0660G)Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low voltage power to the Kodiak unit. The power supply is not used with other Polar Care models such as PC300 and PC500.",Polar Care Kodiak,2,"September 04, 2009", 2009,"Breg Inc, An Orthofix Company","Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.",N/A,"An Urgent: Medical Device Recall Notification was sent to customers on June 18, 2009. FOR USERS: Customers are advised to immediately open all unused Kodiak cold therapy units and inspect the lot code of the Power Supply included with the Kodiak unit. If the lot code is 3508, 3908, 4308, or 4808, then remove the power supply, cut the cord using scissors and discard. Call Breg Customer Service for a replacement: 1-800-321-0607. Complete and return the response form ASAP.FOR DISTRIBUTORS: Send Breg your distribution information, including contact and quantities. Breg will notify your customers of the recall directly.",N/A,20439,"20,439",Worldwide Distribution,Open,N/A,N/A,20439,Battery,Device Operation,Remove,Remove or Replace
Z-1996-2009,52801,"fiber, medical, absorbent",FRL,Medical absorbent fiber.,General Hospital,General Hospital,510(K) Exempt,"Coloplast, InterDry Ag 10"" x 144"" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. InterDry"" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry"" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry"" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.",InterDry Ag ,3,"September 04, 2009", 2009,Coloplast Corp Skin Care Div,"Coloplast determined that a portion of one lot of InterDry"" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrobial properties of the product could be compromised although the absorption and transportation of moisture would be as expected.",PRODUCTION CONTROLS: Process Control,"Consignees were faxed on 7/27/09 a Coloplast ""Product Recall"" letter dated July 2009. The letter addressed the problem and requested consignees to contact Coloplast Customer Service at 1-800-533-0464 to communicate the status of the product. Replacement product will be provided upon receipt of returned product. It also advised distributors to contact their customers immediately and advise them of the recall and to return the product them. Questions or concerns should be directed to the customer's customer care rep at 1-800-533-0464.",N/A,876,"USA, 876 cases (10 rolls/case) ; Canada 53.9 cases (10 rolls/case)","Worldwide Distribution -- USA, including states of AL, AZ, CA, CT, FL, GA, IL, IN, IA, KY. LA, MI, MA,MO, MN, MS, MD, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and country of CANADA.",Open,N/A,N/A,930,Not_Computer,N/A,N/A,N/A
Z-2013-2009,52826,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX.Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in cerebral vasculature.",Wiseguide Guide Catheter,2,"September 04, 2009", 2009,Boston Scientific Corporation,"Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and the top seal approximately 3/8 in len",PRODUCTION CONTROLS: Packaging Process Control,"Boston Scientific issued an ""Urgent Medical Device Recall Removal"" letter dated August 5, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and product involved. The Firm recommended to segregate affected product immediately and return to Boston Scientific and requested return of the ""The Reply Verification Tracking Form"" enclosed with the letter.For further questions, contact your local Boston Scientific Sales Representative or call 1-763-494-1634.",N/A,27892,"27,892 (US 19,257; OUS 8,635)","Worldwide Distribution -- US (including DC and Puerto Rico), Japan, United Arab Emirates, Albania, Austria, Belgium, Bulgaria, Bahrain, Switzerland, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, Finland, France, Great Britain, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Jordan, Kuwait, Lebanon, Lithuania, Libya, Morocco, Netherlands, Norway, Pakistan, Poland, West Bank Gaza Strip/ Palestine, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Slovakia, Syria, Turkey, Ukraine, South Africa, Argentina, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Guatemala, Indonesia, India, South Korea, Mexico, Malaysia, Nicaragua, New Zealand, Panama, Philippines, Puerto Rico, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, American Virgin Islands and Vietnam.",Open,N/A,N/A,787578,Not_Computer,N/A,N/A,N/A
Z-1948-2009,52768,"holder, needle, gastroenterologic",FHQ,Manual gastroenterology-urology surgical instrument and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"BARD¶_ Simpulse"" SOLO System with Soft Splash Shield Tip Product Code: 0067590.The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.",SIMPULSE SOLO SUCTION IRRIGATOR,2,"September 06, 2009", 2009,"Davol, Inc., Sub. C. R. Bard, Inc.",Product sterility may be compromised due to lack of package integrity.,PRODUCTION CONTROLS: Process Control,"Davol issued a Recall Letter dated July 30, 2009 requesting user facilities examine inventory and immediately discontinue use of any product from the affected lot and return it to Davol. Direct questions about the recall to Davol, Inc., Sub. C. R. Bard, Inc. by calling 1-401-463-7000.",N/A,1140,"1,140 units",Nationwide.,Open,N/A,N/A,1140,Not_Computer,N/A,N/A,N/A
Z-1883-2009,52767,"cabinet, table and tray, anesthesia",BRY,"Anesthetic cabinet, table, or tray.",Anesthesiology,Anesthesiology,510(K) Exempt,"Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA.The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization.",Pyxis Anesthesia System 3500,2,"September 06, 2009", 2009,Cardinal Health Manufacturing LLC,"Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system ""non-responsiveness"" (lock ups) during the use of the product since its release in September 2008.",DESIGN: Software Design,"The ""Safety Alert Notification"" letter was mailed to all Pyxis Anesthesia System 3500 customers on December 17, 2008 by registered return receipt mail. The letter was addressed to the Director of Pharmacy at each facility. The mailing packages contain the ""Safety Alert Notification"" letter and the revised pages of the Pyxis Anesthesia System 3500 User Guide and Safety Manual. The ""Safety Alert Notification"" letter reinforced to customers how to maintain back-up processes to allow quick access if a system lock-up condition is experienced.The letter informed customers the situation will be corrected and a solution will be implemented. If you experience any system unresponsiveness during the use of the product, please report the issue to the Cardinal Health Technical Support Center at 1-800-727-4102. If you have any questions regarding this issue, please contact your local field support representative or the Customer Advocacy Department at Customer.Advocacy@cardinalhealth.com.",N/A,250,250,Nationwide and Germany.,Open,N/A,N/A,250,Software,Device Operation,Software update,Software Update
Z-2053-2009,51674,"shunt, central nervous system and components",JXG,Central nervous system fluid shunt and components.,Neurology,Neurology,510(k),Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC.This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.,Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit ,2,"September 08, 2009", 2009,Integra Neuro Sciences,"Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.",DESIGN: Process Design,"An ""Urgent-Product Recall Notification"" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product.Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorization number, and return the product as directed.Direct questions about the recall to Integra NeuroSciences by calling 1-858-455-1115, extension185.",N/A,274,274 kits,"Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.",Open,N/A,N/A,274,Not_Computer,N/A,N/A,N/A
Z-1946-2009,52232,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden.The equipment is intended for hygiene care, showering, and toileting ofhospital or nursing home residents under the supervision of trainednursing staff and in accordance with the instructions outlined in theOperating and Product Care Instructions.",ARJO Carendo MultiPurpose Hygiene Chair,2,"September 08, 2009", 2009,ArjoHuntleigh,Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.,DESIGN: Device Design,"ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245.",N/A,1987,"1,987 hygiene chairs",Nationwide Distribution,Terminated,"August 19, 2010",345,1987,Not_Computer,N/A,N/A,N/A
Z-1930-2009,52000,"system, test, c-reactive protein",DCN,C-reactive protein immunological test system.,Immunology,Immunology,510(k),"Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP).In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.",Dimension Flex Reagent Cartridge CReactive Protein Extended Range (RCRP),3,"September 08, 2009", 2009,"Siemens Healthcare Diagnostics, Inc.",falsely elevated results in EDTA plasma samples,MISBRANDING: Labeling False and Misleading,"Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded. Current lots in the firm's inventory have been put on hold and reworked with an Alert Card rescinding the EDTA plasma claim. Subsequent lots use a revised instruction for use stating ""Do not use EDTA plasma"" in the Specimen Collection and Handling Section.For further questions, contact Siemens Healthcare Diagnostics at 1-302-631-6564.",N/A,25760,"25,760 cartons","Worldwide Distribution -- US, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan.",Terminated,"September 09, 2009",1,25760,Not_Computer,N/A,N/A,N/A
Z-1949-2009,52672,"bur, dental",EJL,Dental bur.,Dental,Dental,510(K) Exempt,"BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.",BIOMET MICROFIXATION Trauma One SYSTEM ,2,"September 08, 2009", 2009,"Biomet Microfixation, Inc.","Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe",PRODUCTION CONTROLS: Process Control,"Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425.For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400.",N/A,79,79,"Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri.",Terminated,"November 05, 2009",58,79,Not_Computer,N/A,N/A,N/A
Z-1887-2009,52757,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Agfa Impax R6.3 DB Server.Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.",Agfa Impax System,2,"September 08, 2009", 2009,AGFA Corp.,Measurements are inaccurate on multiple workstations.,DESIGN: Software Design,"Agfa Healthcare issued an ""URGENT FIELD SAFETY NOTICE"" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm.For further information, contact Agfa Healthcare at 1-773-592-4769.",N/A,1,One unit,Nationwide Distribution -- IL,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-1912-2009,52694,"needle, aspiration and injection, disposable",GAA,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Broselow/Hinkle Pediatric Emergency System;Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use,INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ.The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.",Broselow/Hinkle Pediatric Emergency System,2,"September 08, 2009", 2009,Vital Signs Inc,Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module.,N/A,"Vital Signs, Inc. issued an ""Urgent Medical Device Correction"" letter dated June 30, 2009 to all direct and indirect accounts by first class mail. Consignees were informed of the affected device, asked to complete a Confirmation form for return and to return unused product for replacement.For further questions, contact Vital Signs, Inc. at 1-973-790-1330 extension 404.",N/A,23429,"23,429 kits","Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.",Open,N/A,N/A,23429,Not_Computer,N/A,N/A,N/A
Z-2024-2009,52642,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120.In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.",Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System ,2,"September 08, 2009", 2009,"Ev3, Inc.",ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were emailed a letter with a subject heading of ""Medical Device Recall"". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the ""Device Recall Field Action Reconciliation Form"".",N/A,2,2,"International Distribution Only -- Brazil, Uruguay, & Malaysia.",Open,N/A,N/A,13,Not_Computer,N/A,N/A,N/A
Z-2047-2009,52927,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap).Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.",PediCap CO2 Detector,1,"September 08, 2009", 2009,Covidien Limited,CO2 detector may increase resistance to air flow in an intubated patient.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Covidien issued an Urgent Medical Device Recall letter dated August 14, 2009 informing Consignees of the affected devices. Users were told to stop use and arrange for return of all affected product. For further information, contact Covidien at 1-800-635-5267.",No consumer action necessary,276390,"276,390 units","Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.",Open,N/A,N/A,276390,Not_Computer,N/A,N/A,N/A
Z-2042-2009,52885,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.",Biomet 8.0MM cannulated reamer for the Aimer system,2,"September 08, 2009", 2009,"Biomet, Inc.",These surgical instruments are etched with incorrect measurement markings.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.",Contact the recalling firm for information,2,2,Nationwide Distribution -- Including the state of Texas.,Terminated,"October 06, 2010",393,2,Not_Computer,N/A,N/A,N/A
Z-2041-2009,52804,"burr, orthopedic",HTT,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA.ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA.ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA.Single use devices.CONMED LINVATEC11311 Concept BlvdLargo, FL 33773-4908Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.",ULTRAPOWER DIAMOND WHEEL Burs,2,"September 08, 2009", 2009,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.",DESIGN: Packaging Design/Selection,"Firm notified international and domestic consignees by an Urgent Medical Device Recall letter on July 31, 2009. Customers were asked to check their inventory; complete, sign, and return the enclosed Reply Form; and return the devices for credit. Questions should be directed to Customer Service at 1-800-237-0169.",N/A,2502,2502,Worldwide Distribution,Terminated,"May 11, 2010",245,2502,Not_Computer,N/A,N/A,N/A
Z-2049-2009,52963,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA.Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.",Penumbra Neuron Select Catheter,1,"September 08, 2009", 2009,Penumbra Inc.,"Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.",PRODUCTION CONTROLS: Process Control,"Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra.For further information, contact Penumbra, Inc. at 1-510-748-3223.",N/A,9,9 units,"Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.",Open,N/A,N/A,9,Not_Computer,N/A,N/A,N/A
Z-1877-2009,52659,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.",LeVeen Needle Electrode,2,"September 09, 2009", 2009,Boston Scientific Corp,"The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.",PRODUCTION CONTROLS: Process Control,"Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.",Contact the recalling firm for information,347,347,Nationwide.,Terminated,"October 08, 2010",394,3121,Not_Computer,N/A,N/A,N/A
Z-1999-2009,52667,"device, microtiter diluting/dispensing",JTC,Microtiter diluting and dispensing device.,Microbiology,Microbiology,510(K) Exempt,"300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV.Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices.",Microliter CORE Tips,3,"September 09, 2009", 2009,Hamilton Co,Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.,PRODUCTION CONTROLS: Process Control,"The firm initiated the recall on April 10, 2009, and issued notification to consignees via certified mail and e-mail. Customers were instructed to return the affected product to the Hamilton Company. A fax-back form was supplied with each notification. Direct questions about the recall to the Hamilton Company by calling 1-775-858-3000, extension 236.",N/A,20,20 cases of Part 235950 and 27 cases of Part 235902.,"Worldwide Distribution -- US (states of DE, NJ, PA, MA and CA), New Zealand and Japan.",Terminated,"January 04, 2010",117,20,Not_Computer,N/A,N/A,N/A
Z-1911-2009,52652,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,N/A,"Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.",Akreos Advance Optics Aspheric Lens,2,"September 09, 2009", 2009,Bausch & Lomb Inc,Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612.",N/A,158,158,"Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel,Italy, Mexico, Portugal,Spain, Thailand andUnited Kingdom.",Terminated,"November 05, 2009",57,158,Not_Computer,N/A,N/A,N/A
Z-2052-2009,52668,intracranial neurovascular stent,NJE,N/A,N/A,Neurology,HDE - Humanitarian Device Exemption,"Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.",Neuroform 3 Microdelivery Stent System,2,"September 09, 2009", 2009,Boston Scientific Corporation,"Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.",TRAINING: Employee Error,"The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.",N/A,8,8 units,"International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.",Terminated,"October 21, 2009",42,8,Not_Computer,N/A,N/A,N/A
Z-1993-2009,52423,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020.The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.",ORTHO DEVELOPMENT BALANCED KNEE SYSTEM,3,"September 09, 2009", 2009,Ortho Development Corporation,Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).,PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450.",N/A,13,13 units,Worldwide -- US (states of FL and TX) and Japan.,Terminated,"May 11, 2010",244,13,Not_Computer,N/A,N/A,N/A
Z-2054-2009,52434,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.",Hi Vision ultrasound diagnostic scanners,2,"September 09, 2009", 2009,Hitachi Medical Systems America Inc,"The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.",DESIGN: Process Design,"HMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.",N/A,10,10 units,"The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.",Open,N/A,N/A,16,Software,Output/Calculation,Software update,Software Update
Z-1870-2009,52605,"circuit, breathing (w connector, adaptor, y piece)",CAI,Anesthesia breathing circuit.,Anesthesiology,Anesthesiology,510(K) Exempt,"GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780,M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662,M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628,M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.","UniCircuit (W Connector, Adaptor, Y piece)",2,"September 09, 2009", 2009,"GE Medical Systems, LLC","Breathing circuit inner tube may separate from the rigid connectors under certain conditions. A separation of the inner tube from the connector may prevent adequate gas flow (O2, N2O and anesthetic agents) to the patient. A separation can also cause CO2 re-breathing. This could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.",PRODUCTION CONTROLS: Process Control,"GE Healthcare sent consignees 6/5/09 an ""Urgent Medical Device Correction"" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included ""Recall Confirmation"" form fax to 973-790-4150), Product Correction and Contact Information.",N/A,85097,85097,"Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.",Open,N/A,N/A,85097,Hardware,Treatment/Delivery/Therapy,Correction,Repair
Z-2045-2009,52814,negative pressure wound therapy powered suction pump,OMP,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553;Advanced Negative Pressure Wound Therapy System;Sterile, box contains 15 units;Boehringer Wound Systems, LLC, Norristown, PA 19404Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.","Engenex BioDome Easy Release Dressing Kit, XL",3,"September 09, 2009", 2009,ConvaTec,Labeling: The expiration date does not appear on the product label.,DESIGN: Labeling Design,"Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.",N/A,152,152 units,Nationwide Distribution,Terminated,"October 02, 2009",23,456,Not_Computer,N/A,N/A,N/A
Z-2051-2009,52811,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA.CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908.ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.",LIGHTWAVE SUCTION ABLATOR,2,"September 09, 2009", 2009,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.",DESIGN: Device Design,"ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169.",N/A,28074,"28,074 units",Worldwide Distribution,Open,N/A,N/A,28074,Not_Computer,N/A,N/A,N/A
Z-2000-2009,51896,"calibrators, drug mixture",DKB,Clinical toxicology calibrator.,Toxicology,Toxicology,510(k),"Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.",Roche/Hitachi Preciset TDM I,2,"September 10, 2009", 2009,Roche Diagnostics Corp.,"The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.",PRODUCTION CONTROLS: Packaging Process Control,"Roche Diagnostics Corp. notified Consignees via letter dated April 22, 2009 and instructed to not use excessive force when opening bottles and contact the firm for product replacement instead. A Fax Back Form was included for customers to return via fax to 1-888-345-0480.For further information, contact your Roche Diagnostics representative or call 1-800-428-5074.",N/A,3970,"3,970 bottles of both products",Nationwide Distribution,Terminated,"December 07, 2009",88,3970,Not_Computer,N/A,N/A,N/A
Z-1963-2009,52107,"system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen",NQX,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit).For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.",BD GeneOhm MRSA Assay,2,"September 10, 2009", 2009,"BD Diagnostics (GeneOhm Sciences, Inc)",BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.,PRODUCTION CONTROLS: Process Control,"BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form.To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.",Contact the recalling firm for information,114,114 kits,"Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.",Open,N/A,N/A,114,Not_Computer,N/A,N/A,N/A
Z-1979-2009,52662,"prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm ODProduct Code: H3-82851.Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.",APEX Hip System Bipolar Head,2,"September 10, 2009", 2009,Omni Life Science,The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.,N/A,"Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the ""Quantity Returned"" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.",N/A,17,17 units,"Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.",Open,N/A,N/A,278,Not_Computer,N/A,N/A,N/A
Z-2040-2009,52114,"chair, adjustable, mechanical",INN,Mechanical chair.,Physical Medicine,Physical Medicine,510(K) Exempt,"Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs:a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193",Leckey 4Point Pelvic Harness Belts,2,"September 10, 2009", 2009,"Patterson Medical Holdings, Inc.",The plastic buckles on the hip belts of the 4-Point Pelvic Harness may break.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.",No consumer action necessary,226,226 belts,Nationwide and Canada,Open,N/A,N/A,226,Not_Computer,N/A,N/A,N/A
Z-2037-2009,52383,"cylinder, compressed gas, and valve",ECX,N/A,N/A,Anesthesiology,510(k),"Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #65261-E, Desc D PORTABLE W STRAIGHT POS, Catalog #65261-E. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.",Chemetron,2,"September 10, 2009", 2009,Allied Healthcare Products Inc,Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.,DESIGN: Component Design/Selection,"The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall. A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.",Contact the recalling firm for information,3,3 cylinders,"Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.",Open,N/A,N/A,360,Not_Computer,N/A,N/A,N/A
Z-1997-2009,52614,"ring, teething, fluid-filled",KKO,Teething ring.,Dental,Dental,510(k),"MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant.The product is used as a endosseous dental implant.","MDI Hybrid Implant, OBall Abutment",2,"September 10, 2009", 2009,IMTEC Corporation,Size printed on product packaging does not match size of enclosed product.,N/A,"A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.",N/A,605,605 units,"Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.",Terminated,"December 02, 2009",83,605,Not_Computer,N/A,N/A,N/A
Z-1937-2009,52352,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.",EASYMax N SelfMonitoring Blood Glucose System,2,"September 10, 2009", 2009,"Oak Tree International Holdings, LLC, Inc.","Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.",PRODUCTION CONTROLS: Process Control,"EPS Technology issued a certified notification letter to the sole distributor/customer: GEMCO, Coconut Creek, FL dated May 26, 2009. The letter describes the potential preset error and its possible consequences to the user/customer. The letter goes on to inform the distributor that EPS Technology Corp. will be sending out letters to all affected user/customers during a direct mailing. If the error is found, the user/customer can either: 1) have the firm's Customer Service Dept. instruct them as to how to fix the unit, or 2) request that a replacement meter be sent to them.For further information, contact EPS Technology Customer Service at 1-866-994-3345.",N/A,5396,"5,396 units","Nationwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VA, WA, WY and HI.",Open,N/A,N/A,5396,Not_Computer,N/A,N/A,N/A
Z-2028-2009,52810,"catheter, peripheral, atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(k),"Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA.The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.",Diamondback 360 Orbital Atherectomy Device,2,"September 10, 2009", 2009,"Cardiovascular Systems, Inc.","CSI is correcting (8) packages of Diamondback 360 due to a missing ""Use By Date"" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s",PRODUCTION CONTROLS: Error in Labeling,"Cardiovascular System, Inc. issued an ""URGENT: Medical Device Correction"" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the ""Device"" re-labeling would be performed by company representatives. Devices will not be returned.For further information, contact Cardiovascular System, Inc. 1-877-274-0901.",Contact the recalling firm for information,8,8,"Nationwide Distribution -- CA, GA, MI, NY, NY and TN.",Open,N/A,N/A,8,Not_Computer,N/A,N/A,N/A
Z-2076-2009,53129,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve.This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.",Medtronic Sutureless Pump Connector Revision Kit,1,"September 10, 2009", 2009,Medtronic Neuromodulation,Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters ) incorrectly states that SC catheters are compatible with Medtronic IsoMed¶_ constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed¶_ II and SynchroMed EL pumps. Medtronic has determined that SC catheters are not compatible with IsoMed pumps.,DESIGN: Device Design,"A ""Medical Device Correction Notification"" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card.Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, ""Advisories"".",Contact the recalling firm for information,20000,"20,000 of all products","Worldwide Distribution -- US (including Washington D.C. and Puerto Rico), Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Poland, Portugal, Reunion, Romania, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.",Open,N/A,N/A,20000,Not_Computer,N/A,N/A,N/A
Z-1938-2009,51281,"coil, magnetic resonance, specialty",MOS,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143.The indications for use are routine MR imaging.",Mirror assembly to 1.5T Atlas SPEEDER HeadNeck Coil,2,"September 10, 2009", 2009,Quality Electrodynamics Llc,The firm received a complaint indicating that the mirror is high risk and could drop on a patient.,N/A,"Quality Electrodynamics, LLC notified Customers via email beginning December 29, 2008 requesting the affected device be returned to the firm for improvement.For further information, contact Quality Electrodynamics, LLC at 1-440-484-2228.",N/A,5,5 units,Nationwide Distribution: IL and OH.,Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-2011-2009,51726,"cylinder, compressed gas, and valve",ECX,N/A,N/A,Anesthesiology,510(k),"Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.",Post Medical Valves,2,"September 11, 2009", 2009,Intermed Gas Products Corporation,Firm received reports from customers that valves malfunctioned when installation and/or filling process. Customers forwarded pictures of the defect where the top portion of the packing nut broke off from the threaded portion of the net; which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.,DESIGN: Component Design/Selection,"Intermed Gas Products Corporation notified customers of the affected product by phone beginning March 27, 2009 and followed up with a formal ""Product Recall Notice"" letter dated March 31, 2009. All affected product should be located and returned to the firm for replacement.For further information, contact Intermed Gas Products at 1-561-483-1364.",N/A,8767,"8,767","Nationwide Distribution -- FL, SC, TX, MO, TN, NC, NY, GA, MN, AZ.",Open,N/A,N/A,8767,Not_Computer,N/A,N/A,N/A
Z-2039-2009,52700,"implant, cochlear",MCM,N/A,N/A,Ear Nose & Throat,PMA,"Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case.Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.",Harmony HiResolution Bionic Ear system,2,"September 11, 2009", 2009,Advanced Bionics LLC,"The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas",PRODUCTION CONTROLS: Process Control,"Advanced Bionics, LLC issued an ""Important Notification"" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621.For further information, contact Advanced Bionics at 1-877-829-0026.",N/A,18,18,"Worldwide Distribution -- US, Canada, France and South Korea.",Open,N/A,N/A,18,Not_Computer,N/A,N/A,N/A
Z-2211-2009,53124,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25.The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.",Spacelabs Medical Integrated ECG Cable ,2,"September 11, 2009", 2009,"Spacelabs Healthcare, Incorporated","The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.",PRODUCTION CONTROLS: Process Control,"Spacelabs Healthcare issued an ""Urgent: Medical Device Recall"" dated July 20, 2009. Consignees are being sent replacement ECG cables for each item ordered and are requested to replace the affected cables. Also, they are instructed to destroy and dispose of the recalled cables according to their own protocol or local regulations.For further information, contact Spacelabs Healthcare Technical Support at 1-800-522-7025, option 2 (US) or +86-512-87171888, extension 304 (outside US).",Contact the recalling firm for information,1395,"1,395","International Distribution -- Bangladesh, Turkey, Trinidad and Tobago, Romania, Guatemala, Algeria, Netherlands, Egypt, Chile, Venezuela, Spain, Colombia, India, the United Kingdom, Singapore, France and Ecuador.",Open,N/A,N/A,1395,Not_Computer,N/A,N/A,N/A
Z-2117-2009,52713,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Stryker Orthopaedics Cancellous Bone Screw;Dia 6.5 mm; Lnth: 16 mm; Sterile:Made in the USA;Stryker Osteonics Corp.325 Corporate DriveMahwah, NJ 07430.The bone screws are optional fixtures that may be used during knee and hip replacement procedures.",Stryker Orthopaedics Cancellous Bone Screw,3,"September 14, 2009", 2009,Stryker Howmedica Osteonics Corp.,Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Stryker Orthopaedics issued ""Urgent Product Recall"" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069.For further information, contact Stryker Orthopaedics at 1-201-831-5970.",N/A,51113,"51,113 total - all sizes.",Worldwide Distribution,Terminated,"July 27, 2010",316,51137,Not_Computer,N/A,N/A,N/A
Z-1810-2009,52643,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA.Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",CyberKnife Robotic Radiosurgery System,2,"September 14, 2009", 2009,Accuray Inc,"Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.",DESIGN: Software Design,"Accuray, Inc. issued an ""Urgent Device Correction"" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue.For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.",N/A,61,61 units,"Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.",Open,N/A,N/A,61,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2111-2009,50802,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico.The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.",Easy Pump LT 6024,2,"September 14, 2009", 2009,I-Flow Corporation,"I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t",PRODUCTION CONTROLS: Error in Labeling,"I-Flow Corp. issued an ""Important Recall Information"" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot.For further information, contact I-Flow Corp. at 1-949-206-2653.",Contact the recalling firm for information,4450,"4,450 Distributed","Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.",Terminated,"February 04, 2010",143,4450,Not_Computer,N/A,N/A,N/A
Z-2030-2009,53035,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor.Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.,LIFEPAK CR Plus Defibrillator/Monitor,1,"September 14, 2009", 2009,"Physio Control, Inc.",The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Physio-Control, Inc. notified Customers by phone beginning August 18, 2009. In addition, the recalling firm Issued an ""Urgent Medical Device Recall"" letter dated August 2009 informing Customers of the affected product and informing them that a Physio-Control representative will call and arrange for immediate device replacement.For further information, contact Physio-Control Customer Care at 1-800-442-1142.",N/A,34,34 devices (2 domestically & 32 internationally),Worldwide Distribution -- US (DC and MN) and Japan.,Open,N/A,N/A,34,Hardware,Output/Calculation,Replace device,Remove or Replace
Z-2179-2009,50678,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky ""Pull"" Placement Technique REF 000373, 20F, STERILE.",Gauderer Genie II PEG ,2,"September 15, 2009", 2009,"C.R. Bard Access Systems, Inc","Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.",N/A,177614,"177,614 units","Worldwide, including USA, Belgium, Canada, Australia, and Japan.",Open,N/A,N/A,177614,Not_Computer,N/A,N/A,N/A
Z-2027-2009,52617,"pin, fixation, threaded",JDW,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.",PIP FIXATION HINGE,2,"September 15, 2009", 2009,Smith & Nephew Inc,Hinge failure: The product is cracking or breaking during use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118.",N/A,7089,"7,089 units","Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.",Open,N/A,N/A,7089,Not_Computer,N/A,N/A,N/A
Z-2109-2009,53179,"agents,embolic,for treatment of uterine fibroids",NAJ,Vascular embolization device.,Cardiovascular,Obstetrics/Gynecology,510(k),"Boston Scientific, Contour SE Microspheres, for tumor treatment.UPN Codes:Description:M001761101Contour SE/100-300/1mL/2vialsM001761122Contour SE/100-300/1mL/5vialsM001761141Contour SE/100-300/2mL/2vialsM001761162Contour SE/100-300/2mL/5vialsM001761201Contour SE/300-500/1mL/2vialsM001761222Contour SE/300-500/1mL/5vialsM001761241Contour SE/300-500/2mL/2vialsM001761262Contour SE/300-500/2mL/5vialsM001761301Contour SE/500-700/1mL/2vialsM001761322Contour SE/500-700/1mL/5vialsM001761341Contour SE/500-700/2mL/2vialsM001761362Contour SE/500-700/2mL/5vialsM001761401Contour SE/700-900/1mL/2vialsM001761422Contour SE/700-900/1mL/5vialsM001761441Contour SE/700-900/2mL/2vialsM001761462Contour SE/700-900/2mL/5vialsM001761501Contour SE/900-1200/1mL/2vialsM001761522Contour SE/900-1200/1mL/5vialsM001761541Contour SE/900-1200/2mL/2vialsM001761562Contour SE/900-1200/2mL/5vials",Contour SE Microspheres,2,"September 15, 2009", 2009,Boston Scientific Corporation,"Compromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached. The breach of sterility could l",DESIGN: Process Design,"Boston Scientific sent consignees an ""Urgent Medical Device Recall Removal"" letter dated August 28, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and the product and advised the consignee to cease immediately the distribution and use of the product. Requested consignees to return affected product to Boston Scientific. The letter enclosed the Recall Instructions, Reply Verification Tracking Form and Field Action Return Shipping Label.",N/A,45724,"45,724 (13,048 US, 45,724 OUS)","Worldwide distribution: USA, United Arab Emir., Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Latvia, Libya, Mexico, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Poland, Puerto Rico, Portugal, Russian Fed., Saudi Arabia, Sweden, Slovakia, Tunisia, Turkey, Taiwan, Ukraine, and South Africa.",Open,N/A,N/A,45724,Not_Computer,N/A,N/A,N/A
Z-2220-2009,48960,"test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions",MTG,N/A,N/A,Immunology,N/A,"Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215.The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.",Access Immunoassay Systems Hybritech free PSA Calibrator,2,"September 16, 2009", 2009,Beckman Coulter Inc,Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.,PREMARKET APPROVAL: No Marketing Application,"Beckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately.For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.",N/A,22,22 Kits,"Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.",Open,N/A,N/A,22,Not_Computer,N/A,N/A,N/A
Z-1931-2009,52200,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,"iPulse Circulatory Support SystemCatalog number: 0036-0010The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.",iPulse Circulatory Support System,2,"September 16, 2009", 2009,"Abiomed, Inc.","iPulse Console SC1035 displayed a ""Low Pressure / Low Flow"" alarm and stopped pumping during patient transport in battery operation.",DESIGN: Device Design,"An ""Urgent Voluntary Medical Device Field Correction Notice"" was issued April 8, 2009 to affected customers. The customers were notified that the iPulse Console SC1032 displayed a ""Low Pressure/ Low Flow"" alarm and stopped pumping during patient transport in battery operation. Instructions were provided to users in case they encounter this failure mode. ABIOMED Field Service Engineers will contact customers to schedule a time to visit site and correct affected consoles. Please contact ABIOMED's Field Service at 1.800.554.8666, if you have any questions.",N/A,79,79,"Domestic: MA, MI, SC, NY, NJ, OH, CA, PA, AR, MI, MD, CT, IL, WI, TX, NJ, TN, IN, MI, DE, FL, IA, WA, KY, and WVForeign: Germany, Greece, Italy, Latvia, Spain, and Turkey",Open,N/A,N/A,79,Other,Device Operation,Instructions,Safety Notice/Insructions
Z-1886-2009,52658,"orthosis, spondylolisthesis spinal fixation",MNH,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Stryker Trio Connector Hex Socket for Torque Wrench 3.5MMNot Sterile:Manufactured by: Stryker Spine SAS, Cestas, France;Distributed in the USA by: Stryker Spine, Allendale, NJ 07401The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine.",Stryker Trio 3.5.MM Hex Socket,2,"September 16, 2009", 2009,Stryker Spine,The Trio 3.5MM Hex socket has been reported to break under high stresses.,OTHER/UNDETERMINED: Pending,"Product Correction letters were sent on July 1, 2009 to all Branches/Agencies, Surgeons and Hospital Risk Management OR Supervisor by Federal Express. The letter indicates the potential hazards associated with the breakage and it reinforces the appropriate surgical technique in using the hex socket. Customers are requested to complete an acknowledgement form and return it via FAX to Aminah Crawford at 201.760.8370 within five (5) days of receipt of the notice. If you have questions, please contact Tiffani Rogers, Regulatory Compliance Manager at 201.760.8206.",N/A,143,143,"Nationwide - OR, AR, CA, MA, KY, MD, GA, FL, NY, NM, UT, FL, OK, KS, MI, MN, IN, MT, TX, WI, and TN.",Terminated,"October 20, 2009",34,143,Not_Computer,N/A,N/A,N/A
Z-2005-2009,52449,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.",Roche ACCUCHEK Performa blood glucose test strips,2,"September 16, 2009", 2009,Roche Diagnostics Corp.,There may be a significant negative bias when testing neonate samples.,PRODUCTION CONTROLS: Process Control,"Roche Diagnostics notified consignees in the affected countries of the problem by ""Urgent Field Safety Notice"" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative.",N/A,1518,"1,518 of total products","International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.",Terminated,"October 29, 2010",408,1518,Not_Computer,N/A,N/A,N/A
Z-1892-2009,52704,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8"" tilt, model number 4535604 34811, 3/4""tilt, model number 4535674 34801, and 3/8"" fixed, model number 4535604 34781, all catalog number 882480Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.",BrightView Gamma Camera Radius Drive,2,"September 16, 2009", 2009,Phillips Nuclear Medicine,"Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.",PRODUCTION CONTROLS: Process Control,"Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.",N/A,288,288 units,Worldwide,Terminated,"April 12, 2010",208,288,Not_Computer,N/A,N/A,N/A
Z-2009-2009,52766,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),"Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.",Advanced Medical Oxygen Generating Systems (AMOGS) Concentrator,2,"September 16, 2009", 2009,Carleton Life Support Systems Inc,The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.,DESIGN: Device Design,"Cobham Life Support Systems, Inc. issued letters to their two customers via e-mail. One customer letter was dated July 24, 2009 and the other was dated July 28, 2009. Both letters notified the customer of the reason for the recall and that the usage of the concentrator must be restricted to exclude actual use with a patient until corrected. The letter informs customers they are redesigning the backup supply control valve and will coordinate the retrofit in the future. For further information, contact Cobham Life Support at 1-563-383-6421.",N/A,23,23 units,Nationwide Distribution -- CT and AL.,Open,N/A,N/A,23,Not_Computer,N/A,N/A,N/A
Z-1940-2009,52823,"connector, airway (extension)",BZA,Airway connector.,Anesthesiology,Anesthesiology,510(K) Exempt,"Hudson RICA¶_ Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709.Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.",Endobronchial Tubes,2,"September 16, 2009", 2009,Teleflex Medical,"The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.",PRODUCTION CONTROLS: Process Control,"Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.",N/A,569465,"569,465 (total for all types)","U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).",Open,N/A,N/A,569465,Not_Computer,N/A,N/A,N/A
Z-2212-2009,53135,"lamp, surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),Drager Surgical Lights Sola 500 and Sola 700.,Drager Surgical Lights Sola 500 and Sola 700,2,"September 16, 2009", 2009,"Draeger Medical, Inc.",welded seam may fail,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Draeger Medical, Inc. issued a ""Medical Device Recall"" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement.For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.",Contact the recalling firm for information,20,20 units,"Nationwide Distribution -- IL, KY, and PA.",Terminated,"March 08, 2010",173,20,Not_Computer,N/A,N/A,N/A
Z-2219-2009,51309,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"GE Healthcare Ventri, GE Healthcare, Waukesha, WI.Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT.The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.",GE Healthcare Ventri,2,"September 17, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.",PRODUCTION CONTROLS: Process Control,"GE Healthcare issued a ""Product Safety Notification"" dated January 2009 to consignees. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Field Engineer will visit each site and implement the correction.For further information, contact your local GE Healthcare service representative at 1-800-437-1171 (US or Canada) or 1-262-896-2890 (outside the US).",Contact the recalling firm for information,308,"308 (252 US, 57 OUS)","Worldwide Distribution -- US (AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MS, MO, NE, NV, NH, NJ, NY, NC, OH,OK PA, RI,SC, TN, TX, UT, VA, WA, WI and WV), AUSTRALIA, BRAZIL CANADA, DENMARK, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY,SWEDEN, SWITZERLAND, TURKEY and UNITED KINGDOM.",Open,N/A,N/A,308,Not_Computer,N/A,N/A,N/A
Z-1939-2009,52769,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.",Verathon BladderScan BVI 9400,2,"September 17, 2009", 2009,"Verathon, Inc.","Three specific issues are being addressed:1. Calculation and use of an incorrect year in dates after 12/31/2009.2. Double scans, continuous scans, and double printing.3. Calibration sensitivity.",DESIGN: Software Design,"U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading.Canadian customers were phoned by Verathon.For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia.Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.",N/A,1978,"1,978","Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.",Terminated,"October 07, 2010",385,1978,Software,Output/Calculation,Software update,Software Update
Z-2019-2009,52862,"tube, gastro-enterostomy",KGC,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.",BUTTON REPLACEMENT GASTROSTOMY DEVICE,2,"September 17, 2009", 2009,C R Bard Inc,Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.,PRODUCTION CONTROLS: Equipment Maintenance,Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.,N/A,337,"13, 337 total of all products","Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.",Terminated,"December 09, 2009",83,13337,Not_Computer,N/A,N/A,N/A
Z-2225-2009,50528,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families.The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.",CT/e and HiSpeed X/i computed Tomography systems,2,"September 18, 2009", 2009,"GE Medical Systems, LLC","During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE Healthcare issued an ""Important - Electronic Product Radiation Warning"" to affected customers. GE Healthcare field service representative will perform a field corrective action on all affected units. All potential users of the device should be made aware of the notification and the information contained.For further information, contact GE Healthcare at 1-800-437-1171 (US) or by contacting your local GE Healthcare service manager.",N/A,643,643 units ( 136 US; 507 OUS),"Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BRAZIL BULGARIA, BYELORUSSIAN, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK , DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COST, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, , MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITANIA, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGER, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIAN F=FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND , SYRIA ARAB REPUBLIC, TAIWAN, THAILAND, TRINIDAD & TOBAGO TUNISIA, TURKEY,, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN and YUGOSLAVIA.",Open,N/A,N/A,7648,Not_Computer,N/A,N/A,N/A
Z-2223-2009,52218,"colorimeter, photometer, spectrophotometer for clinical use",JJQ,"Colorimeter, photometer, or spectrophotometer for clinical use.",Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"BioTek Gen5CL Microplate Data Collection and Analysis Software.Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.",BioTek Gen5CL Microplate Data Collection and Analysis Software,2,"September 18, 2009", 2009,"BioTek Instruments, Inc.",Software design allowed false negatives to be read when wells are dark.,DESIGN: Software Design,"BioTek Instruments, Inc. issued a ""Product Recall Notification"" dated March 13, 2009 information customers of the affected product. Follow-up letters with software installation instructions were sent March 25, 2009.For further information, contact BioTek Instruments, Inc. at 1-888-451-5171 extension 405.",N/A,13,13,"Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.",Open,N/A,N/A,13,Software,Output/Calculation,Software update,Software Update
Z-2222-2009,51275,"kit, test,alpha-fetoprotein for testicular cancer",LOJ,Tumor-associated antigen immunological test system.,Immunology,Immunology,N/A,"Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05.AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).",Abbott AxSYM Cancer Assay Disk Version 5.0,2,"September 18, 2009", 2009,Abbott Laboratories,The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.,DESIGN: Device Design,"Abbott sent ""Product Correction Immediate Action Required"" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.",N/A,8205,"8,205 disks","Worldwide Distribution -- United States (including Puerto Rico), Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Curacao (Neth Ant), Dominican Republic, Germany, Guatemala, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Trinidad and Tobago, Turks and Caicos and Venezuela.",Terminated,"August 23, 2010",339,8205,Computer,N/A,N/A,N/A
Z-2221-2009,50488,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.",ACCELERATOR Automated Processing System ,2,"September 18, 2009", 2009,"Abbott Laboratories, Inc","When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR APS System may not generate an error warning when a Sample Presentation/Sample Queue error occurs, which could result in contamination of subsequent samples.",DESIGN: Software Design,"Abbott Laboratories notified Customers of the affected device via a ""Product Correction"" letter dated October 27, 2008. Consignees provided with a temporary work around until a service representative upgrades the system software.For further information, contact your local Abbott Laboratories, Inc. service representative.",N/A,15,15 units,"International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.",Terminated,"December 02, 2009",75,15,Software,Alarm/Message,Software update,Software Update
Z-2226-2009,52774,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile.Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.",Applied Medical Kii Optical Access System,2,"September 18, 2009", 2009,Applied Medical Resources Corp,"Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.",DESIGN: Component Design/Selection,"Applied Medical Resources Corp. notified Customers via an overnight ""Voluntary Recall Notification"" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).",N/A,934,934 units,"Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.",Open,N/A,N/A,934,Not_Computer,N/A,N/A,N/A
Z-2218-2009,52230,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Stryker MedSurg bed, 115v, Stryker Medical, Portage, MI; Model 3002 S3.Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.",Stryker MedSurg bed,2,"September 18, 2009", 2009,Stryker Medical Div. of Stryker Corporation,The backrest of the bed may not stay in an upright position (may drift down when left raised).,DESIGN: Device Design,"Stryker Medical issued an ""Urgent - Medical Device Correction"" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly.For further information, contact Stryker Medical at 1-269-324-6527.",N/A,12599,"12,599 total products","Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.",Open,N/A,N/A,12599,Not_Computer,N/A,N/A,N/A
Z-2110-2009,53087,"system, measurement, blood-pressure, non-invasive",DXN,Noninvasive blood pressure measurement system.,Cardiovascular,Cardiovascular,510(k),"Biphasic LIFEPAK 15 Monitor/Defibrillator.The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.",LIFEPAK 15 MONITOR/DEFIBRILLATOR,2,"September 18, 2009", 2009,"Physio Control, Inc.","Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing thecuff. In some instances this may result in a screen display",OTHER/UNDETERMINED: Pending,"The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time)..",N/A,445,445 devices worldwide,"Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.",Open,N/A,N/A,445,Not_Computer,N/A,N/A,N/A
Z-2228-2009,53121,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038"", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO.Used for the introduction of catheters into a vessel.",St. Jude Medical FASTCATH Hemostasis Introducer,2,"September 18, 2009", 2009,St. Jude Medical,"St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another",PRODUCTION CONTROLS: Error in Labeling,"Field Representatives were sent a ""St Jude Medical Urgent Product Information"" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm.Contact your local St Jude Medical representative for further information.",N/A,2000,"2,000","Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.",Open,N/A,N/A,2490,Not_Computer,N/A,N/A,N/A
Z-2012-2009,52828,"lenses, soft contact, daily wear",LPL,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,510(k),Acuvue Advance for Astigmatism Diagnostic Product.Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07.Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12.Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.,N/A,3,"September 18, 2009", 2009,Vistakon,Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.",N/A,73,73,Nationwide.,Terminated,"October 01, 2009",13,73,Not_Computer,N/A,N/A,N/A
Z-2056-2009,53075,"tube, tracheal (w/wo connector)",BTR,Tracheal tube.,Anesthesiology,Anesthesiology,510(k),"Portex¶_ Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm, Product Code: 100/105/025.Intended for oral and/or nasal intubation for airway management.",Portex Uncuffed Paediatric Sized Tracheal Tube,1,"September 18, 2009", 2009,Smiths Medical,Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway,PRODUCTION CONTROLS: Process Control,"Smiths Medical issued an ""Urgent Field Safety Notice"" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.",N/A,95263,"7,233 (US) 88,030 (International)","Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¶_¶_te d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.",Open,N/A,N/A,4151604,Not_Computer,N/A,N/A,N/A
Z-2251-2009,52988,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0Catalog number 20620 - Radiosurgery 3.5 andCatalog number 20630 - Circular ARC SRS/SRT Planning.The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.",BrainSCAN and iPlan RT Dose,2,"September 20, 2009", 2009,Brainlab AG,"Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.",OTHER/UNDETERMINED: Pending,"BrainLAB AG issued an ""Urgent Field Safety Notice"" letter dated August 12, 2009 informing all customers of the BrainLab radiotherapy planning software using conical collimators of the important safety checks to avoid the failure to apply and verify an adequate jaw-shaped field size and field position at the LINAC for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator. Consignees were instructed on proper steps to take to avoid further issues. For further questions, contact BrainLAB AG by phone at 1-800-597-5911.*** On February 1, 2010, BrainLab sent supplemental letters to 50 of the accounts who received the August 12, 2009 letter and have Novalis Dose Delivery Systems (excluding all Novalis Tx systems). The accounts were informed that in addition to the safety checks listed in the August letter, BrainLab will be installing a mandatory software modification on their systems that limits the field size to a maximum of 4x4 cm2 when the conical collimators are inserted. The accounts would be contacted by a service representative within the next six weeks to schedule the update. Any questions were directed to BrainLab at 1-800-597-5911. ***.",N/A,230,230 units,Nationwide.,Open,N/A,N/A,230,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1935-2009,52781,N/A,N/A,N/A,N/A,N/A,N/A,"Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005.General purpose aspiration Cytology Biopsy Needle",Chiba Needle Marked ,2,"September 20, 2009", 2009,Remington Medical Inc.,"Two unsealed pouches were identified after product release, compromising product sterility.",TRAINING: Employee Error,"Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.",N/A,50,50 units,US - CA and WI.,Terminated,"October 23, 2009",33,50,Not_Computer,N/A,N/A,N/A
Z-2112-2009,50687,"pump, infusion, enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(k),"EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.",EnteraLite Infinity Enteral Feeding Pump,2,"September 21, 2009", 2009,"Zevex International, Inc.","Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.",DESIGN: Software Design (Manufacturing Process),"All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or sales@zevex.com. Distributors were to contact their customers and notify them of the letter.",No consumer action necessary,32545,"32,545","Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.",Open,N/A,N/A,32863,Not_Computer,N/A,N/A,N/A
Z-2078-2009,52211,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006,DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction ,2,"September 21, 2009", 2009,"Smith & Nephew, Inc. Endoscopy Division",The sterility of the device cannot be assured,DESIGN: Packaging Design/Selection,"Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.",Contact the recalling firm for information,67697,"67,697 units","Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.",Open,N/A,N/A,67697,Not_Computer,N/A,N/A,N/A
Z-2116-2009,51725,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Uniflex Ti Buttress Thread Screw;TI Screw Buttress ThreadTrauma Fixation Systems, Rx onlyBiomet, 100 Interpace Parkway, Parsippany, NJ 07054Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.",Uniflex Ti Buttress Thread Screw,3,"September 21, 2009", 2009,"EBI, L.P.",Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.",N/A,5,5,Worldwide Distribution -- USA and Spain.,Terminated,"September 23, 2009",2,56,Not_Computer,N/A,N/A,N/A
Z-2085-2009,52683,anesthesia conduction kit,CAZ,Anesthesia conduction kit.,Anesthesiology,Anesthesiology,Enforcement Discretion,"Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.",GENERAL PROCEDURE KIT,2,"September 21, 2009", 2009,Integra Life Sciences Corporation,Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.,PRODUCTION CONTROLS: Packaging Process Control,"Consignees were notified by telephone on July 09, 2009 and by ""Urgent Medical Device Recall"" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.",N/A,350,350 units,"Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.",Terminated,"October 23, 2009",32,3594,Not_Computer,N/A,N/A,N/A
Z-2232-2009,52959,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.",Capnostream20,2,"September 21, 2009", 2009,Oridion Medical 1987 Ltd.,1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze.2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices,DESIGN: Device Design,"Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.",N/A,326,326 units,Nationwide.,Terminated,"October 01, 2010",375,326,Other,Display/Image,Upgrade,Repair
Z-2252-2009,53207,"pump, infusion, enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(k),"Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322.The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care.",FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP,2,"September 21, 2009", 2009,"Abbott Nutrition, Abbott Laboratories","The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps, have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.",N/A,"An ""Urgent Device Recall"" letter dated September 4, 2009 was issued via FedEx overnight delivery to all direct consignees. The letter described the affected product, issue and immediate actions for customers. Direct consignees were further instructed to immediately contact affected customers and notify them about the Urgent Device Recall. Abbott Nutrition (AN) Device Call Center (DCC) will telephone those customers who do not responded promptly to the ""Urgent Device Recall"" letter with the completed AN Account Summary of the Flexiflo Quantum Enteral Pump Shipments. AN Device Call Center will make arrangements for the service or replacement of the recalled pumps. Please contact the AN Device Call Center at 1-877-457-0249, Monday through Friday between the hours of 8:30 am and 5:00 pm Eastern Standard Time (EST). An AN representative will work with you to arrange service or replacement of the recalled enteral pumps.",Contact the recalling firm for information,5173,"5,173 pumps","Nationwide Distribution (states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY).",Open,N/A,N/A,5173,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-2243-2009,52729,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy Hi-Art System¶_, Version 3.XThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717.The TomoTherapy HI-ART System¶_¶_ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.",HIART SYSTEM,2,"September 21, 2009", 2009,TomoTherapy Incorporated,"TomoTherapy received one customer report indicating that after starting a patient procedure from the StatusConsole, the radiation on light and the audible indicator on the Status Console came on as expected,however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta",DESIGN: Software Design,"Consignees were sent a TomoTherapy ""Urgent Medical Device Correction Field Safety Notice"" letter dated August 10, 2009. The letter addressed the Issue, Product Affected, Investigation, Recommended Actions and Resolution.Customers were recommended to perform the following actions (in the event that the dose rate, procedure timer, and couch position updates are not present on the OS, after pressing Start on the status console and the radiation on light and audible indicators are active):1) Immediately press the Stop button on the Status Console and 2) contact your authorized TomoTherapy Service Representative for further direction. The affected issue will be corrected in the next software version, which is scheduled for release in early 2010. The TomoTherapy Customer Contact Center can be reached 24 hours a day, 7 days a week, by e-mail atsupport@tomotherapy.com or by phone at 1-866-368-4807 (North America).",Contact the recalling firm for information,259,259 (169 US; 91 OUS),"Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN,MO, NE,NV,NJ, NM, NY, OH, OK OR, PA, PR, SC, SC, TN, TX, UT, VA, WA, WI and WY) andBelgiumCanadaSwitzerlandChinaGermany Spain FranceEnglandHong KongIndiaItaly Japan KoreaNetherlandsPolandSaudi ArabiaSwedenSingaporeTurkey andTaiwan.",Open,N/A,N/A,259,Software,Display/Image,Software update,Software Update
Z-2312-2009,51730,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar;Biomet Spine, Parsippany, NJ 07054The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.",MultiAxial Screw ,3,"September 22, 2009", 2009,"EBI, L.P.","Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.",N/A,"The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.",N/A,1,1,"Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.",Open,N/A,N/A,708,Not_Computer,N/A,N/A,N/A
Z-2209-2009,52780,"device, thermal ablation, endometrial",MNB,N/A,N/A,Obstetrics/Gynecology,PMA,Boston Scientific HydroThermAblator Endometrial Ablation System-HTA¶_ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx)Material/UPN/Catalog Number: M006560201System-HTA¶_ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea)Material/UPN/Catalog Number: M006560200Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.,HydroThermAblator Endometrial Ablation System,2,"September 22, 2009", 2009,Boston Scientific Corporation,"Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.",DESIGN: Process Design,"Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.",Contact the recalling firm for information,22744,"22,744 eaches","Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.",Open,N/A,N/A,24299,Not_Computer,N/A,N/A,N/A
Z-2227-2009,52631,"helmet, cranial, for protective use",NDA,Prosthetic and orthotic accessory.,Physical Medicine,Physical Medicine,510(K) Exempt,"3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410.Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.",3i Custom ,2,"September 22, 2009", 2009,"Biomet 3i, LLC","Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.",N/A,24,24,USA and Italy,Terminated,"October 01, 2009",9,24,Not_Computer,N/A,N/A,N/A
Z-0003-2009,53158,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.Intended for use in generating Tomographic images of human anatomy.",Revolution XR/d,2,"September 22, 2009", 2009,"GE Medical Systems, LLC",GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/dconfigured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.,DESIGN: Software Design,"Consignees were sent a GE Healthcare ""Product Safety Notification"" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.",Contact the recalling firm for information,83,"83 (63 USA, 20 OUS)","Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.",Open,N/A,N/A,83,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-2256-2009,52711,"restraint, protective",FMQ,Protective restraint.,General Hospital,General Hospital,510(k),"Posey Connecting Strap/Belt, Cotton, 36"" (232036).Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.",Posey Connecting Strap/Belt,2,"September 22, 2009", 2009,J T Posey Company,"Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.",PRODUCTION CONTROLS: Process Control,"JT Posey Company issued an ""Urgent Medical Device Recall (Removal)"" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form.For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111.",Contact the recalling firm for information,47,47,"Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.",Open,N/A,N/A,3136,Not_Computer,N/A,N/A,N/A
Z-2230-2009,52824,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.",Maxi Move Scoop Stretcher,2,"September 22, 2009", 2009,ArjoHuntleigh,"A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning.",PRODUCTION CONTROLS: Manufacturing Material Removal,"ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher:* Place the stretcher on its side on a non-scratch surface.* Try to pull the two sides apart with the safety latch engaged.* Test both the head and foot ends of the stretcher.* If the stretcher pulls apart, remove it from use immediately.It is important to note that all affected stretchers will be upgraded, whether they fail the test or not.",N/A,214,214 units,Worldwide Distribution,Terminated,"January 07, 2010",107,214,Not_Computer,N/A,N/A,N/A
Z-2239-2009,53132,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"ILUMAVision Software, version 2.1.0 Picture Archiving and Communication systemProduct used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.",ILUMAVision ,2,"September 22, 2009", 2009,IMTEC IMAGING L.L.C.,"Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.",DESIGN: Software Design,"Firm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.",N/A,223,223,"Worldwide - US - Foreign: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Egypt, France, Germany, Hong Kong, Italy, Korea, Malaysia, Mexico, The Netherlands, Poland, Saudi Arabia, Spain, Turkey, and United Kingdom",Terminated,"January 27, 2010",127,223,Software,Output/Calculation,Software update,Software Update
Z-2231-2009,53045,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.","Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48",2,"September 22, 2009", 2009,Varian Medical Systems Oncology Systems,"Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.",DESIGN: Software Design,"Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.",N/A,1,1,Product was distributed to one user in Texas,Open,N/A,N/A,1,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2236-2009,53041,"system, therapeutic, x-ray",JAD,X-ray radiation therapy system.,Radiology,Radiology,510(k),"Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.",BolXII,2,"September 22, 2009", 2009,Action Products Incorporated,"Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.",PRODUCTION CONTROLS: Process Control,Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.,N/A,1,1 carton,Nationwide distribution.,Terminated,"September 29, 2009",7,1,Not_Computer,N/A,N/A,N/A
Z-2235-2009,50473,"pulse generator, permanent, implantable",NVZ,N/A,N/A,Cardiovascular,N/A,"Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber.",Reply DR ,2,"September 24, 2009", 2009,ela Medical Llc,"Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.",TRAINING: Employee Error,"A Reply Technical Note, dated September 2008, titled Additional Instructions for use at Implant for REPLY pacemakers, was issued to physicians on September 24, 2008. The Technical Note describes the background for an increased incidence of complaints relating to the screwdriver and setscrew. The letter provided a reminder for inserting the screwdriver, and additional instructions for insertion of the screwdriver.",Contact the recalling firm for information,233,233,"Nationwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, FL, GA, KS, KY, LA, MA, MI, NC, NJ, OH, OK, SC, TN, and TX.",Open,N/A,N/A,233,Not_Computer,N/A,N/A,N/A
Z-0345-2009,50742,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Integris H5000F,Integris H5000F,2,"September 24, 2009", 2009,Philips Medical Systems North America Co. Phillips,Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377.Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C.",N/A,929,929 units,Worldwide Distribution,Open,N/A,N/A,3361,Not_Computer,N/A,N/A,N/A
Z-1155-2009,51856,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System,Fluorostar 7900 Mobile Fluoroscopy System,2,"September 24, 2009", 2009,Ge Healthcare,The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.",N/A,554,554 units,Worldwide Distribution,Open,N/A,N/A,554,Software,Alarm/Message,Software update,Software Update
Z-2241-2009,52703,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova¶_ 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).The Innova¶_ systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.",Innova 3100,2,"September 24, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently became aware of a potential power supply failure with the Innova¶_ 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.",DESIGN: Component Design/Selection,"Consignees were sent a GE Healthcare ""Urgent Medical Device Correction"" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.",Contact the recalling firm for information,6,6,"Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV),TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.",Open,N/A,N/A,508,Not_Computer,N/A,N/A,N/A
Z-1888-2009,52723,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA.Medical charged-particle radiation therapy system.",ARTISTE MV Systems,2,"September 24, 2009", 2009,"Siemens Medical Solutions USA, Inc",Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment,DESIGN: Software Design,"Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009.For further information, contact Siemens Medical Solutions at 1-925-602-8157.",N/A,53,53 units,"Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.",Open,N/A,N/A,53,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-2250-2009,53080,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr",B. Braun Blistered Omnifix L.L. Syringe ,2,"September 24, 2009", 2009,I-Flow Corporation,I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.Used to provide an optional filling device for the Easypump.,PRODUCTION CONTROLS: Packaging Process Control,"I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately. They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt.The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.",N/A,1608,"1,608 units",France,Terminated,"October 07, 2009",13,2177,Not_Computer,N/A,N/A,N/A
Z-2314-2009,52616,"prosthesis, hip, hemi-, femoral, metal ball",LZY,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116Designed for use with femoral stems and acetabularcomponents distributed by Smith & Nephew.",Tandem Unipolar,2,"September 24, 2009", 2009,Smith & Nephew Inc,46 mm Femoral head was mismarked and packaged as being 45 mm,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health.Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.",Contact the recalling firm for information,10,10 units,"CA, FL, MI, and Canada",Open,N/A,N/A,10,Not_Computer,N/A,N/A,N/A
Z-1036-2009,53176,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.",Digital Fluoroscopic Imaging System,2,"September 24, 2009", 2009,"GE Medical Systems, LLC",One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators.,N/A,166,166,"Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico.",Open,N/A,N/A,166,Not_Computer,N/A,N/A,N/A
Z-2244-2009,53143,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Renegade"" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20M001182840 18-284 11294909 RENEGADE HI FLO 105/10M001182850 18-285 12703162 RENEGADE HI FLO 105/20M001182860 18-286 11339895 RENEGADE HI FLO 115/10M001182870 18-287 12669789 RENEGADE HI FLO 115/20M001182880 18-288 11295844 RENEGADE HI FLO 135/10M001182890 18-289 12703088 RENEGADE HI FLO 135/20M001182900 18-290 11295637 RENEGADE HI FLO 150/10M001182910 18-291 12684437 RENEGADE HI FLO 150/20M001182980 18-298 11320970 RENEGADE HI FLO 105/10 KITM001182990 18-299 12721456 RENEGADE HI FLO 105/20 KITM001183000 18-300 11319972 RENEGADE HI FLO 115/10 KITM001183010 18-301 12703082 RENEGADE HI FLO 115/20 KITM001183020 18-302 11279134 RENEGADE HI FLO 135/10 KITM001183030 18-303 11296276 RENEGADE HI FLO 135/20 KIT",Renegade HiFlo Microcatheter,2,"September 24, 2009", 2009,Boston Scientific Corporation,Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.,PRODUCTION CONTROLS: Packaging,"Consignees were sent a Boston Scientific Urgent Medical Device Recall Removal - Immediate Action Required letter Dated August 26,2009. The letter was addressed to Risk Manager / Field Action Contact. The letter described the problem and product involved. Advised consignees to segregate the affected product and return it to Boston Scientific. Requested the return and completion of The Account Reply Verification Tracking form enclosed. Replacements will be issued for all recalled product that is properly returned to Boston Scientific.",N/A,80885,"80,885 (51,491 US; 29,394 OUS)","Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Libya, Luxembourg, Macau, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Romania, Saudia Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, and Vietnam.",Open,N/A,N/A,118920,Not_Computer,N/A,N/A,N/A
Z-2316-2009,52858,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images.",Centricity Enterprise Archive,2,"September 24, 2009", 2009,GE Healthcare Integrated IT Solutions,Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.,DESIGN: Software Design,"GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated August 7, 2009 to the attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the potential safety issue and provided safety instructions to follow until the software is updated. Users were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Any questions should be directed to the Remote Online Center or the GE Customer Care Center at 1-800-437-1171.",N/A,212,212 units,"Worldwide Distribution -- United States, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey.",Open,N/A,N/A,212,Software,Device Operation,Software update,Software Update
Z-1690-2009,53260,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.",GE Innova 4100,2,"September 24, 2009", 2009,Ge Healthcare,"GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equival",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Consignees were sent a GE Healthcare ""Important electronic Product Radiation Warning"" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information.For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.",Contact the recalling firm for information,929,929 units total,Nationwide Distribution -- United States including Puerto Rico and Guam.,Open,N/A,N/A,929,Not_Computer,N/A,N/A,N/A
Z-0002-2009,53157,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434,Revolution XR/d,2,"September 24, 2009", 2009,"GE Medical Systems, LLC",GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure onRevolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety.It was reported that images acquired with off-center collimation for extremities with theposition selected as Digits to front or Digits to back are displayed as blank. Investigation intoth,DESIGN: Software Design,"Consignees were sent a GE Healthcare ""Product Safety Notification"" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information.",N/A,129,129,"Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV.",Open,N/A,N/A,129,Software,Display/Image,Notification,Safety Notice/Insructions
Z-2313-2009,52989,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CAPercutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.",Penumbra Neuron Delivery Catheter 053,2,"September 24, 2009", 2009,Penumbra Inc.,Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery',COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.",N/A,37,37 units,"CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.",Open,N/A,N/A,37,Not_Computer,N/A,N/A,N/A
Z-2234-2009,52794,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"S&W; Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604The device is non-sterile and single use.For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.",Multifunctional electrode/defibrillation electrode,2,"September 24, 2009", 2009,Leonhard Lang Gmbh,"A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.",Contact the recalling firm for information,3044,3044,"Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon",Open,N/A,N/A,4477,Not_Computer,N/A,N/A,N/A
Z-2248-2009,52849,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16"" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton",AccuSure,2,"September 24, 2009", 2009,Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals,Needles separate from the barrels of the syringes,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm initiated the recall via a press release on 08/21/2009. They began notifying their consignees of the problem and the recall by letter on 08/21/2009. email: recallresponse@qualitestrx.com.,N/A,100,"16,520 boxes of 100 units",Nationwide,Open,N/A,N/A,16520,Not_Computer,N/A,N/A,N/A
Z-1666-2009,53034,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),Diagnost 96/97 DSI,Diagnost 96/97 DSI,2,"September 24, 2009", 2009,Philips Medical Systems North America Co. Phillips,The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.",Contact the recalling firm for information,17,17 units distributed in US.,Worldwide Distribution,Open,N/A,N/A,401,Not_Computer,N/A,N/A,N/A
Z-0623-2009,50748,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higherUsed for general R/F, fluoroscopy, radiography, and angiography examinations.",MultiDiagnost Eleva with Flat Detector (MDE FD),2,"September 25, 2009", 2009,Philips Medical Systems North America Co. Phillips,"System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer.",N/A,30,30 systems,"Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.",Terminated,"September 28, 2010",368,30,Other,N/A,Software update,Software Update
Z-0937-2009,51488,ranging (geodimeter) laser products,REQ,N/A,N/A,N/A,N/A,MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).,MilCAM Recon III,2,"September 25, 2009", 2009,"Flir Systems, Inc.","LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Customers will be notified by a letter instructing them to stop using the LRF, contact a Customer Service Representative, and to detach and return the Laser Range Finder. For each returned LRF, FLIR will provide a certified Class I LRF.",N/A,120,120,Nationwide Distribution,Open,N/A,N/A,120,Not_Computer,N/A,N/A,N/A
Z-1223-2009,51867,ranging (geodimeter) laser products,REQ,N/A,N/A,N/A,N/A,"MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer",MilCAM Recon III,2,"September 25, 2009", 2009,"Flir Systems, Inc.",MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,FLIR Systems notified direct account by letter of the Corrective Action Plan and updated certification label that references CDRH issued variance and instructions on how to install it.,N/A,58,58,"Nationwide Distribution -- Washington, D.C.",Open,N/A,N/A,58,Not_Computer,N/A,N/A,N/A
Z-1118-2009,51490,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Definium 5000 X-ray System, model number 5220493 and 5220393-2",Definium 5000 Xray System,2,"September 25, 2009", 2009,"GE Healthcare, LLC",A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.",N/A,85,85,Nationwide Distribution,Open,N/A,N/A,85,Hardware,Device Operation,Instructions,Safety Notice/Insructions
Z-1259-2009,51879,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.,GE Healthcare CT Systems Table Model Number 2269165,2,"September 25, 2009", 2009,"GE Medical Systems, LLC",Failure to provide the certification label required by 21 CFR 1010.2.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.,Contact the recalling firm for information,1179,1179 total of all units,Nationwide Distribution,Open,N/A,N/A,1179,Not_Computer,N/A,N/A,N/A
Z-0005-2009,53451,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.,Infinix,2,"September 28, 2009", 2009,Toshiba American Medical Systems Inc,"Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.",DESIGN: Device Design,"Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.",N/A,129,129,Nationwide,Open,N/A,N/A,129,Not_Computer,N/A,N/A,N/A
Z-1658-2009,52173,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Celex/GE Precision MPi, REF no.: 02980000Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F;, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.",Celex/GE Precision MPi,2,"September 29, 2009", 2009,NRT - Nordisk Rontgen Teknik A/S,The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Advisory Notice concerning GE Precision MPi, dated May 1, 2009, was issued to Healthcare Professionals. The notice discussed the problem, risk, recommended immediate action, future actio, and affected system and serial numbers. A GE Field Service Representative will visit each affected U.S. customer site and introduce a speaker connected to the generator touch screen (to which the audible tone is delivered) in the operator's room, to be placed on the wall in the x-ray room. For further information, customers were to contact their local GE field engineer.",N/A,38,38 units (US),"Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.",Terminated,"October 20, 2009",21,38,Not_Computer,N/A,N/A,N/A
Z-2276-2009,52730,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic SynchroMed¶_ II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed¶_ II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3).The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids.",SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM,2,"September 29, 2009", 2009,Medtronic Neuromodulation,"This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed¶_ II pumps with batteries manufactured during two distinct time periods prior to April 2005.Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent on July 7, 2009 a Medtronic "" Urgent: Medical Device Correction"" letter dated July 2009. The letter was addressed to Healthcare Professionals. The letter described the nature of the Device Issue, Scope, Potential Severity of the Issue, Recommendations, Ongoing patient Management Recommendations and Additional Information. Important patient management information is also available at http://www.professional.medtronic.com under the heading Product Advisories.Direct questions to your Medtronic Field Representative or Medtronic Neuromodulation Technical Services by calling at 1-800-707-0933.",No consumer action necessary,18572,"18,572","US (including DC and Puerto Rico), Australia, India, canada, Hong Kong, Japan, Austria, Belgium Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Saudi Arabi, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.",Open,N/A,N/A,18572,Battery,Device Operation,Notification,Safety Notice/Insructions
Z-2315-2009,53162,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),ZOLL R Series Defibrillator/Pacemaker/MonitorUsed by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.,ZOLL R Series Defibrillator/Pacemaker/Monitor,2,"September 29, 2009", 2009,"ZOLL Medical Corporation, World Wide Headquarters",Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Zoll notified domestic consignees on August 31, 2009 and international consignees on September 1, 2009 by an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily tests per the recommendations provided in the R Series Operator's Guide. In the event of a failure, customers are to remove the device from service and contact biomedical or clinical engineering department per their facility's protocol. Units that operate as expected can remain in service and back-up monitor should be available in the event of a failure. Zoll's technical support department should be contacted at 1-800-348-9011 or +1-978-421-9460 to schedule the return of affected devices with the defect for replacement of the suspect component.",N/A,247,247 units,"Worldwide Distribution -- USA, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia.",Open,N/A,N/A,247,Other,Display/Image,Replace component,Remove or Replace
Z-1991-2009,52861,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"EasyLink Informatics System included with the Dimension Vista System.The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.",EasyLink Informatics System included with the Dimension Vista System,2,"September 29, 2009", 2009,"Siemens Healthcare Diagnostics, Inc.",incorrect results may be transmitted to LIS,DESIGN: Software Design,"Siemens issued an ""Urgent Device Correction"" letter dated July 2009. The letter informed the user of the affected product including instructions for avoiding the problem.For further information, contact Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.",Contact the recalling firm for information,359,359 units,"Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.",Terminated,"January 05, 2010",98,359,Not_Computer,N/A,N/A,N/A
Z-1814-2009,52680,negative pressure wound therapy powered suction pump,OMP,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm)Rx only, Latex Free; SterileHealth Industry Bar Code: H984BWS4464509A.Packaged in boxes of 15 units per box.",Engenex,3,"September 29, 2009", 2009,ConvaTec,Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.",N/A,764,764,Nationwide distribution and ConvaTec sales rep in the UK and France.,Terminated,"October 02, 2009",3,764,Not_Computer,N/A,N/A,N/A
Z-2238-2009,48191,"colorimetry, salicylate",DKJ,Salicylate test system.,Toxicology,Toxicology,510(k),"SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194.SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.",SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR,2,"September 30, 2009", 2009,Beckman Coulter Inc,The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Urgent: Product Corrective Action"" letter dated October 22, 2007 was issued to customers. Customers were instructed to do the following: 1) Discontinue use and discard appropriately the affected lots of Salicylate Reagent., 2) Contact your Customer Service Representatives at 1-800-526-3821 in the United States or local Beckman Coulter Representative to discuss replacement options and 3) Complete and return the enclosed response form within 10 days. Contact your Customer Service Representative at 1-800-526-3821 in the United States or 1-800-463-7828 in Canada or, if you are outside the United States or Canada, please contact your local Beckman Coulter Representative to discuss replacement options.Direct any questions regarding this Product Corrective Action letter to the Customer Support Center (Hotline) at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, please contact your local Beckman Coulter Representative.",N/A,7842,"7,842 total",Nationwide and Canada.,Open,N/A,N/A,7842,Not_Computer,N/A,N/A,N/A
Z-2326-2009,51156,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30.In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.",Diagnostic Chemicals Limited ,2,"September 30, 2009", 2009,"Diagnostic Chemicals, Ltd.",Labeled with extended expiration date (24 months instead of 18 months),CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Genzyme Corp. notified consignees by Letter dated February 12, 2009 via Federal Express. Accounts are requested to discontinue use and discard units. Customers were also asked to complete and sign the Confirmation of Notification the fax to 1-902-628-6504.For further information, contact Genzyme Technical Support at 1-800-565-0265.",N/A,82,82 kits,"Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.",Open,N/A,N/A,107,Not_Computer,N/A,N/A,N/A
Z-2317-2009,51258,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09.To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.",AxSYM System Tubing Decontamination Solution ,3,"September 30, 2009", 2009,Abbott Laboratories,"Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.",PRODUCTION CONTROLS: Process Control,"Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.",N/A,1965,"1,965 kits","Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.",Terminated,"July 08, 2010",281,1965,Not_Computer,N/A,N/A,N/A
Z-2328-2009,51872,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack.Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.",Martel Printer Accessory to iSTAT Portable Clinical Analyzer,2,"September 30, 2009", 2009,Abbott Point of Care Inc.,It appears that the rechargeable battery pack is overheating with or without the presence of smoke.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.",Contact the recalling firm for information,2552,2552,Worldwide Distribution,Terminated,"February 25, 2010",148,2552,Battery,Physical Safety Hazards,Return,Remove or Replace
Z-2325-2009,51928,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower.The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.",ARCHITECT i System Assay CD ROM,3,"September 30, 2009", 2009,Abbott Laboratories,"There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).",DESIGN: Software Design,"Abbott issued a ""Product Correction-Immediate Action Required"" letter dated April 24, 2009. The letter provided users with the steps to take to determine what version of the ARCHITECT LH Assay is on their instrument and instructions for installing the assay file provided with the letter if needed. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.",N/A,5713,"1,037CD-ROMs - US, 4,676 CD-ROMs - WW","Worldwide Distribution -- United States including Puerto Rico and Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay and Venezuela.",Terminated,"November 30, 2009",61,5713,Other,Device Operation,Update file,Software Update
Z-1871-2009,52089,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),Whatman Body Fluid Collection Paper 903The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.,Whatman Body Fluid Collection Paper 903,2,"September 30, 2009", 2009,"Whatman, Inc.",The two portions of the card are coming apart prematurely.,PRODUCTION CONTROLS: Process Control,"Whatman issued an Urgent Medical Device Correction letter to to the direct account on 5/6/09 requesting this notice is distributed to users. The notice states the safety issue; requests users to inspect 903 cards prior to use, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card, discard the card obtain a new card and inspect. On May 26, 2009 the firm expanded the notification to additional users of the 903 cards to inspect cards prior to use.",N/A,2853410,"2,853,410 cards","Nationwide Distribution -- AZ, FL, GA, NC, IL, IN, LA, KS, KY, MI, MO, NE, NY, OH, OK, PA, SC, OR, TX, TN,UT VA, WI, WI, & PR.",Open,N/A,N/A,2853410,Not_Computer,N/A,N/A,N/A
Z-2324-2009,52813,"culture media, antimicrobial susceptibility test, mueller hinton agar/broth",JTZ,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"Sensititre¶_ Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA.In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.",Sensititre MuellerHinton Broth w/Lysed Horse Blood ,3,"September 30, 2009", 2009,Trek Diagnostic Systems,"Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.",TRAINING: Employee Error,On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.,N/A,31,31 boxes/10/11 ml tubes,"Nationwide Distribution -- PA, VA & WA.",Terminated,"February 26, 2010",149,31,Not_Computer,N/A,N/A,N/A
Z-2253-2009,52961,"apparatus, vestibular analysis",LXV,N/A,N/A,Ear Nose & Throat,510(k),VEST 6.6 or earlier software for use with Neuro Kinetics products.The device is used for vestibular testing.,VEST 6.6 or earlier software,2,"September 30, 2009", 2009,Neuro Kinetics,Marketed without a 510k or PMA submission to include the normative data display.,PREMARKET APPROVAL: No Marketing Application,"A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance.Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.",N/A,72,72 units,"Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain.",Terminated,"January 13, 2010",105,72,Software,N/A,Notification,Safety Notice/Insructions
Z-1950-2009,52803,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro Battery Reciprocator Handpiece. Speed Range: 0-14,500 cpm+/- 500 cpm.CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.",PowerPro ,1,"October 01, 2009", 2009,Linvatec Corp. dba ConMed Linvatec,"There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.",PRODUCTION CONTROLS: Process Control,"Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169.Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.",N/A,4772,"4,772",Worldwide Distribution including United States.,Open,N/A,N/A,11713,Not_Computer,N/A,N/A,N/A
Z-2007-2009,52812,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only.ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773.The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode.","MC5057 Universal Cable, 12 ft (3.6 meters)",1,"October 01, 2009", 2009,Linvatec Corp. dba ConMed Linvatec,"Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.",DESIGN: Component Design/Selection,"ConMed Linvatec notified customers via letter, cautioning the users to inspect cords for signs of excessive wear or damage and urging them to discontinue use and return cables when appropriate. Direct questions to Linvatec Corporation by calling 1-800-237-0169.",N/A,12205,"12,205 units",Worldwide Distribution including United States.,Open,N/A,N/A,12205,Not_Computer,N/A,N/A,N/A
Z-0001-2010,53426,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA.Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.",Penumbra Neuron Delivery Catheter 070,1,"October 05, 2009", 2009,Penumbra Inc.,"Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.",DESIGN: Device Design,"The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form.",N/A,2246,2246 units,"Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.",Terminated,"November 24, 2010",415,2246,Not_Computer,N/A,N/A,N/A
Z-0010-2010,52202,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG",MultiDrug iCup Drug Screen Test Cup,2,"October 06, 2009", 2009,Biosite Inc,"The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.",PRODUCTION CONTROLS: Process Control,"Biosite, Inc. issued a ""Notice of Correction"" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.For further information, contact Biosite, Inc. using the following information:Biosite Incorporated, an Inverness Medical Company9975 Summers Ridge RoadSan Diego, CA 92121Phone: 1-877-441-7440, option 2Fax: 1-858-695-7100Email: productadvisory@invmed.com.",N/A,113575,"113,575 cups distributed in total",Nationwide Distribution,Terminated,"April 02, 2012",909,113575,Not_Computer,N/A,N/A,N/A
Z-0018-2010,52866,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.",LifeCare PCA with Hospira Mednet,2,"October 06, 2009", 2009,Hospira Inc,Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.,DESIGN: Component Design/Selection,"Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.",Contact the recalling firm for information,204999,"204,999 total",Worldwide Distribution,Terminated,"November 30, 2010",420,204999,Not_Computer,N/A,N/A,N/A
Z-0036-2010,52760,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ROC Lumbar bolt caddy, Part Number: 81997-01-05.Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.",ROC Lumbar bolt caddy,2,"October 08, 2009", 2009,"Alphatec Spine, Inc.",Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.,TRAINING: Employee Error,"Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up.Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.)If they have any follow up questions, they were told to call 1-800-922-1356.",N/A,7,7 Screws,"Nationwide Distribution -- Including states of TX, FL, & NJ.",Terminated,"November 13, 2009",36,7,Not_Computer,N/A,N/A,N/A
Z-0038-2010,53081,"regulator, pressure, gas cylinder",CAN,Pressure regulator.,Anesthesiology,Anesthesiology,510(K) Exempt,"AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.",AGI2238 Portable 4 Cylinder Manifold Cart,2,"October 14, 2009", 2009,Airgas Puritan Medical,"Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.",DESIGN: Component Design/Selection,Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.,N/A,208,208,Nationwide distribution.,Terminated,"January 26, 2010",104,208,Not_Computer,N/A,N/A,N/A
Z-0059-2010,52847,"regulator, pressure, gas cylinder",CAN,Pressure regulator.,Anesthesiology,Anesthesiology,510(K) Exempt,Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070.The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.,Medical Gas Yoke Assembly,2,"October 15, 2009", 2009,Western - a Scott Fetzer Company,The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.,DESIGN: Component Design/Selection,"Western Enterprises issued an ""Urgent-Device Recall"" notification dated August 20, 2009 informing Consignees of the affected product. Consignees are to contact the firm to request backup plates and installation instructions or request an RGA and shipping instructions for return of the manifold block assembly for modification.For further information, contact Western at 1-800-783-7890.",N/A,18,18 cart assemblies containing 72 yoke assemblies (36 Oxygen yokes and 36 Nitrous Oxide yokes),"Nationwide Distribution -- AL, AR, CA, CO, FL, GA, HI, IL, IN, MA, OH, OR, PA, TX, WA and WI.",Terminated,"April 25, 2012",923,363,Not_Computer,N/A,N/A,N/A
Z-0064-2010,53033,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module,200998 Cable Assembly, Hybrid, UI PanelSubcomponents for the 203000 RIO STANDARD SYSTEMManufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL.All three cables are integral components and are not purchased separately.However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible .The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.",Cable Assembly for the RIO STANDARD SYSTEM,2,"October 19, 2009", 2009,Mako Surgical Corporation,"Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System.",DESIGN: Device Design,"A Recall Notice, dated July 15, 2009, was sent to owners of the RIO system (hospital OR staff) with a signed acknowledgement returned to MAKO. Surgeons using the RIO system during the recall time period, regardless of whether their system has already been upgraded, are given the notification letter and asked to sign and return the acknowledgement memo. The letter stated that customers' RIO will be upgraded to replace the potentially faulty cable with a new cable. Their MAKOplasty Specialist (MPS) will notify them when their system was scheduled to have their fiber optic cable upgrade. The upgrade will be installed by a Field Service Engineer (FSE) free of charge and the RIO will be completely tested prior to being returned to service. Customers should direct questions or concerns to their MPS, FSE, or Jim Pomeroy, who can be reached at 954-927-2044.",Contact the recalling firm for information,23,23,Nationwide Distribution,Terminated,"May 12, 2010",205,23,Not_Computer,N/A,N/A,N/A
Z-0065-2010,52964,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA.Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.",CELLDYN Emerald Hematology Analyzer,2,"October 19, 2009", 2009,Abbott Laboratories,Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.,DESIGN: Software Design,"Abbott Diagnostics issued a ""Product Correction"" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions.For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should contact your local hematology customer support representative.",N/A,411,411 units,"Worldwide Distribution -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.",Terminated,"December 06, 2010",413,411,Software,Alarm/Message,Software update,Software Update
Z-0066-2010,52632,"indicator, biological sterilization process",FRC,Sterilization process indicator.,General Hospital,General Hospital,510(k),"Sterrad CycleSure Biological Indicator, Product Code 14324.The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.",Sterrad CycleSure Biological Indicator,2,"October 20, 2009", 2009,Advanced Sterilization Products,Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.,DESIGN: Device Design,"An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.",N/A,N/A,N/A,Worldwide Distribution.,Terminated,"November 29, 2011",770,N/A,Not_Computer,N/A,N/A,N/A
Z-0067-2010,52808,"apparatus, traction, non-powered",HST,Nonpowered orthopedic traction apparatus and accessories.,Orthopedic,Orthopedic,510(K) Exempt,"Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517.The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheathed blade. These knives are supplied sterile, single-use. Each knife assembly contains a color coded sliding retractor that coincides with a specific blade type. The blade can be extended and locked to a half extended position or fully extended position.",ArthroKnife,2,"October 21, 2009", 2009,Linvatec Corp. dba ConMed Linvatec,ConMed has determined there is a possibility that the device may not fully retract once it is deployed.,PRODUCTION CONTROLS: Process Control,"ConvaMed Linvatec USA issued an ""Urgent Medical Device Recall"" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax.For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at Custserv1@linvatec.com.",N/A,66144,"Approximately 66,144 products.",Worldwide Distribution,Terminated,"February 25, 2011",492,66144,Not_Computer,N/A,N/A,N/A
Z-0069-2010,53498,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Extended PTFE Coated Blade electrosurgical electrodes, 6.5"" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.",Medline Extended PTFE Coated Blade electrosurgical electrodes,2,"October 21, 2009", 2009,"Unimed Surgical Products, Inc.","Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.",PRODUCTION CONTROLS: Process Control,"Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall.For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.",Contact the recalling firm for information,1920,1920 units,Nationwide Distribution -- MI,Terminated,"May 12, 2010",203,1920,Not_Computer,N/A,N/A,N/A
Z-0068-2010,53435,"stent, coronary",MAF,N/A,N/A,Cardiovascular,N/A,"Boston Scientific Liberte¶_¶_ Monorail¶_ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX"".The Liberte¶_¶_ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¶_ Monorail¶_ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¶_ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.",Liberte Monorail and OvertheWire Coronary Stent Systems,2,"October 21, 2009", 2009,Boston Scientific Corporation,"Boston Scientific initiated a field correction for the Liberte¶_ Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS¶_ Libert¶_¶_ Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte¶_ Bare-Metal stent, and Libert¶_¶_ Bare-Metal stents have been ina",DESIGN: Labeling Design,"Boston Scientific issued an ""Urgent Medical Device Field Correction"" letter dated September 18, 2009. The letter was addressed to Risk Manger/Field Action Contact. The letter described the product, problem and actions which included renaming the Liberte¶_¶_ Bare-Metal stent as VeriFlex"" Bare-Metal stent. Enclosed with the letter included the Direction for Field Correction and a Reply Verification Tracking Form.For further information, contact you local Boston Scientific Sales Representative or call 1-800-811-3211.",Contact the recalling firm for information,391769,"391,769",Nationwide Distribution -- United States including Puerto Rico.,Terminated,"June 28, 2012",981,391769,Not_Computer,N/A,N/A,N/A
Z-0073-2010,53163,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124.The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.",Biotrak Resorbable Fixation System,2,"October 23, 2009", 2009,Acumed LLC,"Labeling may contain 2 lot numbers and 2 model numbers.It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385).",N/A,"Urgent Notice: Device Recall Letters dated August 21, 2009 were sent to all consignees advising of the issue and and required action. Customers are to identify and quarantine the product having the affected lot code(s). Customers are to also return all product from the specified lot(s) to Acumed immediately. If product was further distributed, then those consignees should be notified of the recall and return of the product(s) should be requested. Questions should be directed to Acumed Customer Service at 1-888-627-9957.",N/A,125,125,Worldwide Distribution -- USA and South Africa.,Terminated,"November 06, 2010",379,125,Not_Computer,N/A,N/A,N/A
Z-0074-2010,53296,"cement, dental",EMA,Dental cement.,Dental,Dental,510(k),"Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.",Kerr TempBond Clear,3,"October 23, 2009", 2009,Kerr Corp,"The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Kerr Corporation issued an ""Urgent Medical Device Recall"" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.",Contact the recalling firm for information,13518,"13,518 units","Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.",Terminated,"December 12, 2011",780,13518,Not_Computer,N/A,N/A,N/A
Z-0080-2010,53327,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005.Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.",SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM,2,"October 26, 2009", 2009,"Synthes USA (HQ), Inc.",The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.,PREMARKET APPROVAL: No Marketing Application,"The customer account was notified by an Urgent: Medical Device Removal letter via USPS certified mail on 9/4/2009. The letter stated that the products did not have clearance for the hospital's intended use and that if the customer has any of the identified devices, they should call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Also, the customer should complete the Verification Section, and return the letter along with any remaining product. For questions the hospital could call 610-719-5865.",Contact the recalling firm for information,15,15,Nationwide Distribution -- State of CA.,Terminated,"March 08, 2010",133,136,Not_Computer,N/A,N/A,N/A
Z-0086-2010,52048,"prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.",Pivot BiPolar Head,2,"October 28, 2009", 2009,Ortho Development Corporation,"A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.",DESIGN: Device Design,"Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.",N/A,23,23,"AZ, CA, FL, MA, MI. No military, government or foreign distribution.",Terminated,"May 25, 2010",209,23,Not_Computer,N/A,N/A,N/A
Z-0083-2010,53073,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP.Indicated to cut and shape bone including bones of the spine and cranium.",Foot Pedal,2,"October 28, 2009", 2009,"The Anspach Effort, Inc.","The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal",DESIGN: Device Design,"Anspach issued an ""Urgent Product Removal"" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm.For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.",No consumer action necessary,14,14,"Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).",Terminated,"January 05, 2010",69,14,Hardware,Device Operation,Return,Remove or Replace
Z-0035-2010,51228,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warmingpatients before, during and after surgery, and other specialty procedures.",WarmAir 135,2,"October 29, 2009", 2009,Cincinnati Sub-Zero Products Inc,The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.,DESIGN: Process Design,"The firm sent an ""URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.",Contact the recalling firm for information,2674,"2,674 units","Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.",Terminated,"September 19, 2012",1056,2674,Hardware,Physical Safety Hazards,Repair,Repair
Z-0090-2010,53192,"bottle, collection, vacuum",KDQ,Vacuum-powered body fluid suction apparatus.,General Hospital,General Hospital,510(K) Exempt,"Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float;6700-0018-800 - Bottle with V Wall Bracket, Cap & Float;6700-0370-800 - Bottle with Floor Bracket, Cap & Float.The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.",Vacuum Collection Bottle,2,"October 29, 2009", 2009,Ohio Medical Corporation,"The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.",PRODUCTION CONTROLS: Process Control,"Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.",N/A,823,823 bottles,"Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.",Terminated,"June 22, 2011",601,6715,Not_Computer,N/A,N/A,N/A
Z-0088-2010,53086,intestinal stimulator,LNQ,N/A,N/A,Gastroenterology/Urology,HDE - Humanitarian Device Exemption,"Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.",Enterra Gastric Electrical Stimulation System,2,"October 29, 2009", 2009,Medtronic Neuromodulation,"Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical intervention (all patients recovered withou",DESIGN: Device Design,"Medtronic Neuromodulation issued a ""Medical Device Correction"" letter beginning August 25, 2009 addressed to Healthcare Professionals. The letter described the Nature of the Issue, Scope, Potential Severity of the Issue, Enterra Therapy System labeling updating information warnings, Recommendations and other Additional Information.For further information, contact Medronic Neuromodulation Technical Services at 1-800-707-0933.",Contact the recalling firm for information,1909,"1909 (1095 US, 814 OUS)",Worldwide Distribution.,Terminated,"May 22, 2012",936,1909,Not_Computer,N/A,N/A,N/A
Z-0094-2010,53436,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010.,Cryosurgical Freezer,2,"October 29, 2009", 2009,"Cooper Surgical, Inc.","CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.",DESIGN: Device Design,"Cooper Surgical notified customers by letter titled ""Notice of Recall - Urgent"" dated September 29, 2009 advising them of the problem and requesting return of the device. International accounts were notified by letter Beginning October 1, 2009.For further information, contact Cooper Surgical by fax at 1-203-799-2002 or phone at 1-203-799-2000.",Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.",Terminated,"April 17, 2012",901,N/A,Not_Computer,N/A,N/A,N/A
Z-0119-2010,53492,"implant, cochlear",MCM,N/A,N/A,Ear Nose & Throat,N/A,"Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.",NUCLEUS COCHLEAR IMPLANT SYSTEM,2,"November 02, 2009", 2009,Cochlear Americas Inc.,Cochlear implant device component was mis-labeled.,PRODUCTION CONTROLS: Labeling Mix-Ups,"On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.",N/A,10,10 units,"Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.",Terminated,"December 22, 2009",50,10,Not_Computer,N/A,N/A,N/A
Z-0039-2010,53489,"ventilator, emergency, manual (resuscitator)",BTM,Manual emergency ventilator.,Anesthesiology,Anesthesiology,510(k),"Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206.Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.","Dynarex, Evergreen, Mada and Hospitak.",1,"November 04, 2009", 2009,Unomedical,"In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.",DESIGN: Device Design,"Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.",N/A,200,over 200 total lots,"Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.",Terminated,"August 10, 2010",279,200,Not_Computer,N/A,N/A,N/A
Z-0104-2010,53583,"hexokinase, glucose",CFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry)Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.",Pointe Scientific Liquid Glucose (HEXO) Reagent Set,1,"November 04, 2009", 2009,"Pointe Scientific, Inc.",There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.,DESIGN: Process Design,"The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.",Contact the recalling firm for information,474,400 kits plus 59 liters and 15 vials.,"Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.",Terminated,"September 27, 2010",327,474,Not_Computer,N/A,N/A,N/A
Z-0121-2010,53329,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA",ARTISTE syngo RT Therapist ,2,"November 05, 2009", 2009,"Siemens Medical Solutions USA, Inc","A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.",DESIGN: Software Design,"The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.",Contact the recalling firm for information,97,97 units,"Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.",Terminated,"December 06, 2010",396,97,Software,Device Operation,Software update,Software Update
Z-0087-2010,53574,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA.Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USAVital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK.The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.",CROSSOVER Sheath Introducer,1,"November 05, 2009", 2009,Cordis Corporation,Cordis has received complaints of stretching or fracture of the sheath shaft during use.,DESIGN: Component Design/Selection,"A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers.A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460).In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.",N/A,2362,"2,362 units","Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.",Terminated,"August 12, 2013",1376,2362,Not_Computer,N/A,N/A,N/A
Z-0124-2010,53142,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA.Intended to be used for patient fixation.",CIVCO MTAPSID2932 TypeS Thermoplastic,3,"November 06, 2009", 2009,Med Tec Inc,Some of the packages contain the incorrect mask style.,PRODUCTION CONTROLS: Process Control,"The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it.",N/A,12,12 boxes,"Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.",Terminated,"March 07, 2012",852,12,Not_Computer,N/A,N/A,N/A
Z-0085-2010,53576,"clamp, vascular",DXC,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"EndoClamp aortic catheter label reading in part: ""CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, EdwardsLifesciences LLC Irvine, CA 92614-5686"" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta.Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allowsdelivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.",CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 65 cm,1,"November 06, 2009", 2009,"Edwards Lifesciences Research Medical, Inc.",Spontaneous balloon rupture during use of the product.,PRODUCTION CONTROLS: Process Control,"Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions.",N/A,2737,"2,737 total","Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.",Terminated,"April 25, 2012",901,2737,Not_Computer,N/A,N/A,N/A
Z-0151-2010,50763,"excavator, dental, operative",EKC,Dental hand instrument.,Dental,Dental,510(K) Exempt,Neos Vanadium Excavator Part Number 591/0,Neos Vanadium Excavator,2,"November 09, 2009", 2009,Sybron Dental Specialties,"The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled ""URGENTMEDICAL DEVICE RECALL,"" informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account.The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address:KerrHawe SAVia Strecce 4CH-6934 BioggioSwitzerlandPLEASE LABEL RETURNED PRODUCT ""RECALLED PRODUCT RETURN"". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14.",N/A,135,135,"Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.",Terminated,"August 09, 2012",1004,355,Not_Computer,N/A,N/A,N/A
Z-0145-2010,53257,"computer, diagnostic, pre-programmed, single-function",DXG,"Single-function, preprogrammed diagnostic computer.",Cardiovascular,Cardiovascular,510(k),"Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.",Q2 Continuous Cardiac Output (CCO)/SO2 Computer,2,"November 09, 2009", 2009,Hospira Inc,Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.,DESIGN: Component Design/Selection,"Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.",N/A,204999,"204,999 power cords distributed for all devices",Worldwide distribution.,Terminated,"April 04, 2012",877,204999,Not_Computer,N/A,N/A,N/A
Z-0149-2010,53251,"stretcher, hand-carried",FPP,Hand-carried stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.",Stryker Medical StairPRO Stair Chair,2,"November 09, 2009", 2009,Stryker Medical Div. of Stryker Corporation,"The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.",DESIGN: Device Design,"Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.",N/A,165,165,"Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.",Terminated,"February 16, 2011",464,230,Not_Computer,N/A,N/A,N/A
Z-0139-2010,53301,"tube, tracheostomy (w/wo connector)",BTO,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.,John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube,2,"November 09, 2009", 2009,"Gf Health Products, Inc.","Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end user names; however it plans to reach end-users by financially supporting a mailing from dealers to their individual customers notifying them of this recall. A follow up 60 day certified mailing will be performed for non-responders. The dealers will receive financial support for this second mailing. A secure third company will be contracted to hold for destruction all products affected by this recall. The method of destruction will be to cut the products into pieces, make them not usable. The FDA will be notified prior to the destruction of product and detailed logs and records will be maintained. Periodic effectiveness status report will be maintained for this recall.",N/A,396,396 units,Nationwide distribution.,Terminated,"December 30, 2010",416,396,Not_Computer,N/A,N/A,N/A
Z-0135-2010,52056,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)",Innova 3100 / 3100 IQ,2,"November 09, 2009", 2009,"GE Medical Systems, LLC","Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra",DESIGN: Device Design,"Consignees were sent on May 1, 2009 a GE Healthcare "" Urgent Medical Device Correction"" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.",Contact the recalling firm for information,78,78,"Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.",Open,N/A,N/A,234,Not_Computer,N/A,N/A,N/A
Z-0134-2010,53177,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power).Intended use is to act as a medical data backup and disaster recovery plan.",Guardian Services,2,"November 09, 2009", 2009,Stryker Imaging,Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.,OTHER/UNDETERMINED: Pending,"Stryker Imaging issued an ""Urgent: Device Correction"" notice dated August 18, 2009. Customers were notified of the defective product and informed that Stryker will be in contact shortly to coordinate the product correction. Actions to be taken during the interim were also detailed.For further information, contact Stryker Imaging at 1-972-410-7100.",No consumer action necessary,12,12 devices affected,"Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.",Terminated,"April 14, 2010",156,12,Software,Device Operation,Prodcut correction,Repair
Z-0003-2010,52990,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor.The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.","HEARTSTART MRX, MODEL M3535A",2,"November 09, 2009", 2009,Philips Healthcare Inc.,"incorrect default configuration settings, insufficientbattery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the ""Action to be taken by customer/user"" section of the UrgentVoluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.",Contact the recalling firm for information,1523,"1,523 units","NationwideCanadaAustralia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar,Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK",Open,N/A,N/A,1523,Other,Alarm/Message,Instructions,Safety Notice/Insructions
Z-0132-2010,52833,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit.ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.,ARCHITECT i2000 System and ARCHITECT i2000 SR ,2,"November 09, 2009", 2009,"Abbott Laboratories, Inc","Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.",OTHER/UNDETERMINED: Pending,"A product correction notice was issued to consignees on July 17, 2009. Field representatives were instructed to visit consignees, inspect cables and replace them.",No consumer action necessary,4526,"4,526",Worldwide Distribution,Terminated,"January 26, 2010",78,4526,Not_Computer,N/A,N/A,N/A
Z-0141-2010,53137,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8"" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000",V. Mueller,2,"November 09, 2009", 2009,Cardinal Health,"The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.",N/A,"Cardinal Health sent Urgent Product Recall letters dated 8/28/09 to all customers who received the product during the recalled period on the same day via UPS Next Day Air. The accounts were informed of the problem with the cannula, and were instructed to functionally test the cannula by passing the toothed cutter within it to ensure the cutter advances freely into the cannula. If any restriction is noticed, the product should be segregated and returned to Cardinal Health. The accounts were requested to complete and return by fax the enclosed acknowledgement form, indicating the number of affected cannulas being returned. Any questions were directed to V. Mueller Customer Service at 800-323-9088.",N/A,19,19 units,Nationwide distribution.,Terminated,"May 12, 2010",184,19,Not_Computer,N/A,N/A,N/A
Z-0130-2010,53294,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,PMA,"This device is not approved in the United States.Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA.",Medtronic Virtuoso DR,2,"November 09, 2009", 2009,Medtronic Inc. Cardiac Rhythm Disease Managment,"A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Important Medical Device Information"" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09.For additional information: Doctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636;Device tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; andPatients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.",Contact the recalling firm for information,439,439,"Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.",Terminated,"May 29, 2012",932,6294,Not_Computer,N/A,N/A,N/A
Z-0133-2010,53461,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA.","VARiS 6.2, 6.1 and 6.0",2,"November 09, 2009", 2009,Varian Medical Systems Oncology Systems,"Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.",DESIGN: Software Design,"Recall initiated September 15, 2009. An ""Urgent - Field Safety Notice"" letter was distributed to all affected users, with a description of the problem and corrective action steps. The letter was also distributed to Varian sales, marketing, and service organizations, informing them of the issue. For further information in the USA and Canada, contact Varian at 1-650-424-5731 or 1-888-VARIAN5 (888- 827-4265). In Europe, contact +41 41 749 8844.",N/A,100,100 units,"Worldwide distribution to 100 consignees throughout the US in IL, NY, MI, NJ, AL, TN, MD, OH, FL, and TX, and to Brazil, Chile, China, Czech Republic, Egypt, Germany, Hungary, Israel, Italy, Japan, Malaysia, the Netherlands, Romania, Slovakia, Slovenia, South Korea, Spain, Taiwan, Thailand and the United Kingdom.",Terminated,"July 29, 2011",627,100,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-0108-2010,53509,spinal vertebral body replacement device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001.Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.",TI Synex (TM) II Central Body 14mm 19mm,1,"November 09, 2009", 2009,"Synthes USA (HQ), Inc.",loss of device height,DESIGN: Device Design,"Synthes USA issued an ""Urgent: Medical Device Recall"" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm.For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453.",N/A,267,267 units,Worldwide Distribution -- Including the United States and Canada.,Open,N/A,N/A,2275,Not_Computer,N/A,N/A,N/A
Z-0125-2010,53532,"lens, contact, (disposable)",MVN,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,510(k),"ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight"" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.",ClearSight 1Day Toric ,3,"November 09, 2009", 2009,CooperVision Inc.,Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA.,OTHER/UNDETERMINED: Pending,"Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.",N/A,1440,1440 cartons,Nationwide Distribution,Terminated,"June 12, 2012",946,1440,Not_Computer,N/A,N/A,N/A
Z-0140-2010,53482,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Olsen Medical, MIDAS TOUCH ¶_ NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.",MIDAS TOUCH NEEDLE ELECTRODE,2,"November 10, 2009", 2009,Kentucky Packaging Service LP,THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS,PRODUCTION CONTROLS: Process Control,"Olsen Medical issued an ""Urgent: Device Recall"" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall.For further information, contact Olsen Medical at 1-502-772-4272.",N/A,3617,"3,617 pieces","Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.",Terminated,"October 05, 2010",329,3617,Not_Computer,N/A,N/A,N/A
Z-0169-2010,52639,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Byrd Screw, 2.0X6MM SD, Model Number: 01-0264Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4 ) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1, BIOMET MICROFIXATION, INC., 150 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USAInstrument used to pull up the broken bone, so it is flush and can be plated fixated. The Byrd screw is then removed.",Byrd Screw,2,"November 10, 2009", 2009,"Biomet Microfixation, Inc.","Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Biomet plans to send letters to customers on February 19, 2009. Customers are told to discontinue use of the item and return it to Biomet Microfixation. The firm plans to follow up with an e-mail to their customers. Questions pertaining to this issue, should be directed to Christy Cain at 1.800.874.7711 or 904.741.4400.",Contact the recalling firm for information,22,22,"AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada.",Terminated,"May 03, 2012",905,22,Not_Computer,N/A,N/A,N/A
Z-0170-2010,53128,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,Eon Rechargeable Implantable Pulse Generator (IPG) System,Eon IPG,2,"November 10, 2009", 2009,"Advanced Neuromodulation Systems, Inc",Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.,DESIGN: Device Design,"12/22/2006, Marketing Update 5015 was issued to field sales representatives providing information on improving communication between the Internal Pulse Generator and its charger. May 15, 2007, Marketing Update 5022 was issued to field sales representatives to reiterate avoiding contact between the charger antenna and conductive materials and place the preferred side of the charging antenna face-down over the implant. Troubleshooting Guide was created in January 2008 for field sales representatives and technical services departments regarding isolation of the communication issue to the external devices instead of the implanted component. March 25, 2008, the Clinician's Manual was updated adding a recommendation for a minimum depth of pocket for device implantation.",Contact the recalling firm for information,24750,"24,750 units total",Worldwide,Terminated,"July 23, 2010",255,24750,Not_Computer,N/A,N/A,N/A
Z-0166-2010,53353,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Koodinat M/MP Patient Table used with Angiostar Model 5294009.The device is used as an Angiographic X-Ray System.,Koodinat M/MP Patient Table used with Angiostar ,2,"November 10, 2009", 2009,"Siemens Medical Solutions USA, Inc",The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.,MISBRANDING: Labeling False and Misleading,"The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.",Contact the recalling firm for information,107,107 units,Nationwide Distribution.,Terminated,"January 12, 2010",63,469,Not_Computer,N/A,N/A,N/A
Z-0168-2010,53133,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice).The intended us of Guardian is to act as a medical data backup and disaster recovery plan.",Guardian Services,2,"November 10, 2009", 2009,Stryker Imaging,Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis.,OTHER/UNDETERMINED: Pending,"Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.",N/A,55,55 devices affected,Nationwide Distribution,Terminated,"January 08, 2010",59,55,Software,Device Operation,Backup instructions/Upgrade infrastructure,Repair
Z-0159-2010,52987,"accessories, soft lens products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,N/A,"Bausch & Lomb ReNu¶_ Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609.Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses.",Bausch & Lomb ReNu,2,"November 10, 2009", 2009,Bausch & Lomb Inc,During routine testing the product failed to meet shelf life specifications.,OTHER/UNDETERMINED: Pending,"Consignees were notified by letter on/about August 17, 2009. All consignees were asked to review their inventory and return any of the affected product to Stericycle Pharmaceutical Services.For questions about the recall process or need additional shipping labels, please contact Stericycle Inc. at 1-888-345-83 16. For questions regarding this recall, please contact Bausch & Lomb's Customer Resource Center at 1-800-828-6974.",Contact the recalling firm for information,5000,"5,000 bottles","Distribution: Nationwide, Trinidad, St. Croix, St. Thomas, Aruba and Bermuda.",Terminated,"May 10, 2012",912,5000,Not_Computer,N/A,N/A,N/A
Z-0002-2010,52834,N/A,N/A,N/A,N/A,N/A,N/A,Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F.The product is intended for use in Temporary Vessel Occlusion.,Fogaty Occlusion Catheter ,2,"November 10, 2009", 2009,"Edwards Lifesciences, Llc",Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Edwards initiated a worldwide recall via customer letter dated June 29, 2009, sent via Federal express on same day, requesting that customers cease using Fogarty Occlusion Catheter, Model No. 62080822F products from the indicated lots and that they return all unused products. Edwards requested that the customers provide written verification of stock and identify any unused products to be returned to Edwards Lifesciences LLC, Att: Field Action Coordinator, ODW Logistics, Inc., 13725 Pipeline Ave., Chino, CA 91710. Additionally provided Customer Service Tel # 800.424.3278.",Contact the recalling firm for information,9548,9548,"AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MO NC ND NE NH NJ NM NV NK OH OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico Australia, Belgium, Brazil, Bulgaria, Canada, Canary Island, China, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Ireland, Italy, Japan, Luxembourg, Netherland, New Zealand, Poland, Portugal, Rumania, Russia, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and Turkey.",Terminated,"February 23, 2012",835,9548,Not_Computer,N/A,N/A,N/A
Z-0150-2010,52791,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPIThe ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.",ABL 80 COOX SYSTEM,2,"November 10, 2009", 2009,Sendx Medical Inc,Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the,OTHER/UNDETERMINED: Pending,"Radiometer sent out a letter to consignees informing them of public reason for recall, and telling them that they have provided a copy of the upgrade software and instructions to correct this potential problem immediately. Software upgrade instructions were included with the recall letter. Consignees were informed that if they preferred that their local service representative perform the upgrade, to follow the Instructions for disabling auto upload of patients records.SOFTWARE UPGRADE INSTRUCTIONS:The upgrade software must be installed via the Software Upgrade option under Menu",Contact the recalling firm for information,317,317,"Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and DenmarkDomestically to OH",Terminated,"July 16, 2012",979,317,Software,Output/Calculation,Software update,Software Update
Z-0161-2010,53136,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box.Hemodialysis catheter insertion kits.",10F Bioflex Tesio Kit,2,"November 10, 2009", 2009,"Medical Components, Inc dba MedComp",mislabeled as right are actually left,TRAINING: Employee Error,"Medcomp issued a ""Product Alert"" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.",N/A,100,100 trays,"Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.",Terminated,"April 16, 2010",157,100,Not_Computer,N/A,N/A,N/A
Z-0160-2010,53134,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.",Guardian Services,2,"November 10, 2009", 2009,Stryker Imaging,Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.,OTHER/UNDETERMINED: Pending,"Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.",No consumer action necessary,85,85,Nationwide Distribution,Terminated,"January 26, 2010",77,85,Software,Device Operation,Upgrade infrastructure,Repair
Z-0164-2010,53453,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Siemens Biograph mCT-S 64, model number 10248672.Medical Imaging Equipment.",Biograph mCTS 64,2,"November 10, 2009", 2009,Siemens Medical Solutions USA Inc.,"In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.",DESIGN: Device Design,"Siemens Medical Solutions USA, Inc. issued an ""Urgent Field Correction - Recall"" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product.For further information, contact Siemens at 1-800-888-7436.",N/A,2,2 units,"Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.",Terminated,"December 22, 2009",42,3,Not_Computer,N/A,N/A,N/A
Z-0171-2010,53531,"device, impotence, mechanical/hydraulic",FHW,Penile inflatable implant.,Gastroenterology/Urology,Gastroenterology/Urology,N/A,"Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA.Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.",Titan OTR Inflatable Penile Prosthesis,2,"November 10, 2009", 2009,"Coloplast Manufacturing US, LLC",Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the prod,N/A,"Coloplast issued a customer notification letter dated October 2009 describing the affected product.For further information, contact Coloplast at 1-800-533-0464.",N/A,3,3,"Nationwide Distribution -- FL, GA, NC.",Terminated,"December 12, 2011",762,3,Not_Computer,N/A,N/A,N/A
Z-0173-2010,53535,"laparoscope, gynecologic (and accessories)",HET,Gynecologic laparoscope and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Gynecare Morcellex Tissue Morcellator;Manufactured by: Ethicon Women's Health & Urology;A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876",Gynecare Morcellex Tissue Morcellator,2,"November 10, 2009", 2009,"Ethicon, Inc.",There is the potential for the duckbill seal to become dislodged.,DESIGN: Device Design,"Recall notification letters titled ""URGENT VOLUNTARY PRODUCT RECALL"" were sent on 10/8/2009 via UPS next day. The letters describe the lots within expiration that are recalled. The motor drive unit is not included in the recall. Letters have photos and illustrations of the product which clearly show the location of the product code and expiration date. Recalled product is to be returned to Stericyle using an enclosed pre-paid authorized shipping label. Ethicon will notify customers when the product is available.Questions are to be directed to Ethicon at 1-888-276-5901.",N/A,60930,"60,930 in US.","Worldwide distribution - US and United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Greece, Israel, Italy, Jordan, Republic of Korea, Mexico, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, Reunion, Russian Federation, Sweden, Slovina, Turkey, Saudi Arabia, Venezuela and S. Africa.",Terminated,"August 02, 2010",265,60930,Not_Computer,N/A,N/A,N/A
Z-0174-2010,53564,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license,Syngo Imaging XS,2,"November 10, 2009", 2009,"Siemens Medical Solutions USA, Inc","Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.",DESIGN: Software Design,"The recalling firm issued a ""Customer Safety Advisory Notice"" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center.",N/A,2,2 units,The product was shipped to medical facilities in NY and OH,Terminated,"July 05, 2012",968,2,Software,Output/Calculation,Update,Other
Z-0165-2010,53545,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"* (Box label) SUCTION COAGULATOR 10FR QTY 25 ****** (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE *****LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UTICA, NY USA 13502""",ConMed Suction Coagulator,2,"November 10, 2009", 2009,ConMed Electrosurgery,One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.,PRODUCTION CONTROLS: Process Control,"Recalling firm notified all distributors by phone from 9/30 - 10/1/09. All customers were notified by letter titled ""URGENT: DEVICE RECALL"" dated 09/30/2009 on 10/2/2009. Customers were instructed to check their inventory for the affected product, complete the reply form and return affected product. For questions, please contact Damaris Velez or Jeff Dickinson of ConMed Electrosurgery at 800-552-0138, ext 5225 or email succoagrecall AT conmed.com.",N/A,2700,2700 units,"US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA",Terminated,"March 16, 2010",126,2700,Not_Computer,N/A,N/A,N/A
Z-0176-2010,53676,"ventilator, continuous, minimal ventilatory support,facility use",MNT,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),RESPIRONICS V60 VENTILATOR,RESPIRONICS V60 VENTILATOR,2,"November 11, 2009", 2009,Respironics California Inc,"The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo",DESIGN: Device Design,"The recall notification was initiated October 26, 2009 with the firm mailing a Urgent Medical Device Field Correction letter to the affected customers. The letter informed the customers of the reason for the notice and how Respironics Field Service Technicians were going to correct this issue. The letter also gave the customers instructions to follow pending the completion of the field inspection/replacement.For questions or additional information contact Respironics US Customer Service at 1.800.345.6443, Option #5 then Option #1.",N/A,524,524,"Nationwide and Internationally to :Libya, Hong Kong, France, Italy, India, Spain, United Kingdom,Germany, Netherlands and Saudi Arabia",Terminated,"October 13, 2011",701,524,Hardware,Device Operation,Replace,Remove or Replace
Z-0175-2010,53582,"lithotriptor, electro-hydraulic",FFK,Electrohydraulic lithotriptor.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.",Boston Scientific 1.0mm x 570 mm rigid pneumatic probe,2,"November 11, 2009", 2009,Boston Scientific Corp,"The label incorrectly reads ""compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)"" instead of bearing the correct statement ""compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170.""",OTHER/UNDETERMINED: Pending,"Consignees were notified by letter titled ""Urgent Medical Device Recall-Immediate Action Required"" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.",N/A,173,173,Nationwide.,Terminated,"October 08, 2010",331,173,Not_Computer,N/A,N/A,N/A
Z-0177-2010,53536,"prosthesis, shoulder, hemi-, humeral, metallic uncemented",HSD,Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13.Shoulder replacement surgery.","Zimmer Trabecular Metal Shoulder, humeral stem",2,"November 12, 2009", 2009,Zimmer Inc.,"Some of the devices may possess a taper which will not mate with the humeral head, as intended.",OTHER/UNDETERMINED: Pending,Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.,N/A,12,12,Nationwide.,Terminated,"December 22, 2009",40,12,Not_Computer,N/A,N/A,N/A
Z-0190-2010,52759,"intervertebral fusion device with bone graft, lumbar",MAX,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),"Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124.Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.",Novel Spinal Spacer System,2,"November 12, 2009", 2009,"Alphatec Spine, Inc.","Due to a deficiency in the process validation related to the machine that manufacturedthese parts, Alphatec would like to have the parts returned to them so that they may perform anadditional inspection of each implant.",PRODUCTION CONTROLS: Process Control,"Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.",N/A,37,37 devices,"Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.",Terminated,"November 13, 2009",1,37,Not_Computer,N/A,N/A,N/A
Z-0179-2010,53139,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.","System 1000, TINA, AURORA and AltraTouch",2,"November 12, 2009", 2009,Baxter Healthcare Renal Div,"When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manual.",DESIGN: Software Design,"Baxter sent an Urgent Device Correction letter dated August 31, 2009 to all System 1000 Series of Hemodialysis Instruments customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that a software anomaly in software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 was discovered when the main power was lost temporarily during a simulated treatment. The anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's Manual. The accounts were informed that instruments with software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 will be upgraded to version 4.B.1.4 software, provided the instruments have a 486 Motherboard or Single Board Computer, and that instruments containing versions of 4.A software are not affected. The accounts were requested to complete the enclosed Customer Reply form, indicating the instrument serial number and software version for each machine at the site, and if they would be requesting Baxter Technical Services to upgrade their instruments or have the software sent to them to make the upgrades, and fax the sheet to 1-847-270-5457. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 4, option 1.",N/A,8258,"8,258 units","Worldwide Distribution -- United States (including Puerto Rico and the Virgin Islands), Algeria, Argentina, Austria, Bahrain, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, India, Indonesia, Ireland, Italy, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mauritania, Mexico, Morocco, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, Saipan, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay and Venezuela.",Terminated,"November 15, 2010",368,8258,Software,Output/Calculation,Software update,Software Update
Z-0180-2010,53083,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Guidant LATITUDE¶_ Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE¶_ Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE¶_ Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.",LATITUDE Communicator,2,"November 12, 2009", 2009,Boston Scientific CRM Corp,"The L ATITUDE¶_ communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It",DESIGN: Software Design,"Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling1-651-582-4000.",N/A,97,97,"Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.",Terminated,"December 04, 2012",1118,97,I/O,N/A,N/A,Other
Z-0189-2010,53494,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033.Indended use: X-Ray, Fluoroscopic, Image-intensified.",Siregraph CF XRay System,2,"November 12, 2009", 2009,"Siemens Medical Solutions USA, Inc",possible injury to hand/fingers,DESIGN: Device Design,"Siemens Medical Solutions USA, Inc. issued a ""Customer Safety Advisory Notice"" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system.For further information, contact Siemens at 1-610-448-4500.",Contact the recalling firm for information,14,14 units,"Nationwide Distribution -- FL, IL, MI, PA and TX.",Terminated,"January 12, 2010",61,14,Not_Computer,N/A,N/A,N/A
Z-0181-2010,53458,"dressing, wound and burn, interactive",MGR,N/A,N/A,General & Plastic Surgery,N/A,"Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.",Organognesis Apligraf,2,"November 12, 2009", 2009,"Organogenesis, Inc.",Unit contaminated with Staphylococcus epidermidis,PRODUCTION CONTROLS: Packaging Process Control,"Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm.For further information, contact Organogenesis, Inc. at 1-888-432-5232.",N/A,60,60 units,Nationwide Distribution,Terminated,"March 31, 2010",139,60,Not_Computer,N/A,N/A,N/A
Z-0188-2010,53499,"light, surgical, ceiling mounted",FSY,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"XTEN LED DF cupola, P/N: 567815999.Intended to provide visible illumination for the surgical field or for the examination of the patient.",XTEN LED DF cupola,2,"November 12, 2009", 2009,MAQUET Inc.,Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.,N/A,"Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.",No consumer action necessary,346,346,Nationwide Distribution.,Terminated,"June 04, 2012",935,940,Not_Computer,N/A,N/A,N/A
Z-0191-2010,53581,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P.Intended to be implanted for fixation of bone fractures and for bone reconstructions.","Biomet 5.5mm peek allthread, knotless,",2,"November 12, 2009", 2009,"Biomet, Inc.","These anchors may be difficult to remove, or may not detach from the inserter shaft.",DESIGN: Device Design,"Biomet issued an ""Urgent Medical Device Recall Notice"" dated September 9, 2009 informing consignees of the affected product and requesting return of the device. Distributors were instructed to notify their customers copy of the recall letter and to locate and return the products from user facilities.For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.",N/A,894,894,Worldwide Distribution -- United States and Belgium.,Terminated,"January 19, 2011",433,894,Not_Computer,N/A,N/A,N/A
Z-0105-2010,53550,"tube, tracheal (w/wo connector)",BTR,Tracheal tube.,Anesthesiology,Anesthesiology,510(k),"Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.",Premie Pack,1,"November 12, 2009", 2009,Centurion Medical Products,"The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.",PRODUCTION CONTROLS: Process Control,"The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.",N/A,650,650,Illinois.,Terminated,"August 03, 2010",264,1400,Not_Computer,N/A,N/A,N/A
Z-0198-2010,52836,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02.Intended for mating femoral stems equipped with tapered necks.",VerSys Hip System Femoral Head,2,"November 13, 2009", 2009,Zimmer Inc.,Manufacturing material may be present on the surface of the implant.,PRODUCTION CONTROLS: Manufacturing Material Removal,"An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A ""Dear Surgeon"" letter will be issued to any hospitals where the devices have been implanted.",N/A,104,104,"Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.",Terminated,"December 15, 2009",32,104,Not_Computer,N/A,N/A,N/A
Z-0197-2010,53471,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.",Boston Scientific Equalizer Balloon Catheter,2,"November 13, 2009", 2009,Boston Scientific Corporation,"Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.",OTHER/UNDETERMINED: Pending,"An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.",Contact the recalling firm for information,9800,9800 total (2373 US and 7427 OUS),"Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.",Terminated,"December 17, 2011",764,9800,Not_Computer,N/A,N/A,N/A
Z-0260-2010,53517,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.",GEMINI PET/CT diagnostic imaging systems,2,"November 13, 2009", 2009,Philips Medical Systems (Cleveland) Inc,"Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required, which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm notified customers with an ""URGENT - Field Safety Notice"" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.",N/A,2,2 units,"The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.",Terminated,"November 24, 2009",11,11,Not_Computer,N/A,N/A,N/A
Z-0262-2010,53578,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, and F12-345-425NS.",Intramedullary Skeletal Kinetic Distractor (ISKD),2,"November 13, 2009", 2009,"Orthofix, Inc","ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.",OTHER/UNDETERMINED: Pending,Firm notified consignees by letter sent via certified mail on 10/9/2009. Follow up is planned for nonresponders. Questions are directed to the firm at (800) 527-0404.,"Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",539,539 units,"Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.",Terminated,"September 24, 2010",315,539,Not_Computer,N/A,N/A,N/A
Z-0199-2010,53399,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-09The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.","Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,",2,"November 13, 2009", 2009,Zimmer Inc.,"The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.",OTHER/UNDETERMINED: Pending,"An ""Urgent: Field Correction"" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative ifyou have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.",N/A,26404,"26,404 of all products","Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.",Terminated,"May 16, 2011",549,26404,Not_Computer,N/A,N/A,N/A
Z-0192-2010,53543,"pump, blood, cardiopulmonary bypass, non-roller type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Revolution Blood Pump, ""revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599""Intended for use in cardiopulmonary bypass procedures.",Revolution Blood Pump,2,"November 13, 2009", 2009,"Sorin Group USA, Inc.",A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact Sorin Group Customer Service at 1-800-650-2623.",Contact the recalling firm for information,808,808 units,"Worldwide Distribution -- US, Canada, Japan, and Europe.",Terminated,"December 14, 2009",31,1064,Not_Computer,N/A,N/A,N/A
Z-0259-2010,53603,"drill, surgical, ent (electric or pneumatic) including handpiece",ERL,"Ear, nose, and throat electric or pneumatic surgical drill.",Ear Nose & Throat,Ear Nose & Throat,510(k),"Medtronic Integrated Power Console System, IP X1REF 1898001 or REF EC300Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA.Distributed by: Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137 USA.No difference between two referenced Consoles (REF numbers differ for internal sales tracking purposes).",Integrated Power Console System,2,"November 13, 2009", 2009,"Medtronic Xomed, Inc.",An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.,DESIGN: Software Design,"A Product Correction Notification was issued to each consignee on June 15, 2009. Medtronic sales representatives will visit each facility to advise consignees of the issue and to install a software upgrade that will correct the handpiece recognition issue on the console(s).",N/A,493,493,Worldwide Distribution,Terminated,"January 20, 2010",68,493,Software,Alarm/Message,Software update,Software Update
Z-0268-2010,52546,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18.Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.",suburethral sling,3,"November 16, 2009", 2009,Generic Medical Devices,Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.,TRAINING: Employee Error,"On June 17, 2009 the recalling firm called the consignees and arranged for the unused product to be returned. On July 13, 2009 the firm sent a notification letter to the consignee that had implanted 1 of the devices.",Contact the recalling firm for information,15,15 devices,"USA - NJ, and PA",Terminated,"March 14, 2012",849,15,Not_Computer,N/A,N/A,N/A
Z-0264-2010,53131,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,PMA,"Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.",Cyberonics VNS Therapy Programming M250 System,2,"November 16, 2009", 2009,"Cyberonics, Inc","Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report ""Lead Impedance: OK"" when a short-circuit condition exists.",DESIGN: Device Design,"Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives.",N/A,9500,"9,500 programming devices","Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.",Terminated,"September 26, 2012",1045,9500,Software,Output/Calculation,Labeling update,Other
Z-0266-2010,53497,"applicator (laryngo-tracheal), topical anesthesia",CCT,Laryngotracheal topical anesthesia applicator.,Anesthesiology,Anesthesiology,510(k),"Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: mailbox@sharn.comThe device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.",Nasal Mucosal Atomizer Device with syringe,2,"November 16, 2009", 2009,"Sharn, Inc.","Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.",DESIGN: Device Design,Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.,N/A,550,550,Nationwide Distribution,Terminated,"July 13, 2012",970,3225,Not_Computer,N/A,N/A,N/A
Z-0269-2010,53496,methyl methacrylate for cranioplasty,GXP,Methyl methacrylate for cranioplasty.,Neurology,Neurology,510(k),Norian CRS Rotary Mixer Cement 10cc sterile,Norian CRS Rotary Mixer Cement 10cc sterile,2,"November 16, 2009", 2009,"Synthes USA (HQ), Inc.",Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product.Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Autho,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.,Contact the recalling firm for information,15,15 units,"The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.",Terminated,"March 08, 2010",112,15,Not_Computer,N/A,N/A,N/A
Z-0263-2010,53549,"drill, bone, powered",DZI,Bone cutting instrument and accessories.,Dental,Dental,510(k),"Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.",Stryker Instruments 2.1 mm CrossCut Fissure Bur,2,"November 16, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.,No consumer action necessary,93,93,"USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.",Terminated,"November 30, 2009",14,93,Not_Computer,N/A,N/A,N/A
Z-0270-2010,53563,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.,Syngo Imaging XS,2,"November 16, 2009", 2009,"Siemens Medical Solutions USA, Inc","Distorted image. The ""Distorted"" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.",DESIGN: Software Design,"The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage.The issue will be resolved in the release of version VA70B.For all potentially affected customers with ""JPEG Compression"" license an update instruction will be released which defines the necessary corrective actions in case of ""Distorted"" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.",N/A,28,28 units,"The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.",Terminated,"July 05, 2012",962,58,Not_Computer,N/A,N/A,N/A
Z-0286-2010,50135,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.",GEMINI GXL PET/CT Scanners,2,"November 17, 2009", 2009,Philips Medical Systems (Cleveland) Inc,A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.,DESIGN: Process Design,"Philips Medical Systems Nuclear Medicine division initiated this recall by sending a 'Customer Advisory Notification to their customer accounts on 11/24/2008. This notification informs the customer of the potential for the device equipped with the Pulmonary Gating Option to develop an air leak which could result in the device being unable to produce the desired respiratory correlated images. The notification provides field test instructions and recommends that the customer test the bellows on each day of use in order to assess that the unit is functioning properly. If the bellows device fails the test the recalling firm recommends that the unit not be used and that the recalling firm be contacted via telephone or E-mail. The firm intends to conduct a field correction of the affected units in which their Field Service Engineers will install upgrade kits on the affected devices tentatively scheduled to begin in September, 2009.",Contact the recalling firm for information,20,20 units,"Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.",Terminated,"September 24, 2010",311,71,Not_Computer,N/A,N/A,N/A
Z-0277-2010,52229,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 734. Wheeled hospital stretcher.",Stryker Medical transport stretcher,2,"November 17, 2009", 2009,Stryker Medical Div. of Stryker Corporation,"The brake/steer pedal may seize, resulting in the brakes not working.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by letter dated August 10, 2009 that Stryker will contact them to upgrade the stretchers within 6 months. The recall was expanded in scope to include additional serial numbers by a second letter dated September 17, 2009, which was issued to additional consignees who had not been previously notified of the recall, as well as the consignees who had been issued the August 10, 2009 letter.",N/A,241,241,"Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, Japan, Korea, Latin America, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, and United Kingdom,",Terminated,"October 29, 2010",346,17807,Not_Computer,N/A,N/A,N/A
Z-0308-2010,53605,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"32CM DECATHLON EXCHANGE KITModel: DX27SH32-XPDECATHLON MINI KIT15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis andapheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free.",Decathlon,2,"November 17, 2009", 2009,"Spire Biomedical, Inc.","There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira",PRODUCTION CONTROLS: Process Control,"Spire Medical issued an ""Urgent device Recall"" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.",N/A,70,70 units,"Worldwide distribution - Nationwide, Government. Foreign: Canada, France.",Terminated,"June 09, 2010",204,55183,Not_Computer,N/A,N/A,N/A
Z-0276-2010,53615,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620.Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.","Needle, Biopsy",2,"November 17, 2009", 2009,Bard Peripheral Vascular Inc,"The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was no injury to the patient or user. When us",DESIGN: Process Design,"The recall notification was initiated by the firm issuing an urgent medical device notification to it's consignees on October 08, 2009 via USPS requesting them to check all inventory locations for the affected products, remove and return affected products to Bard. The consignees were instructed to complete and return a recall effectiveness check form. Bard provided this 800 number 1-800-321-4254 for any questions consignees may have.",Discard product or return to place of purchase for a full refund or exchange,925,"77, 848 units",Nationwide and internationally to CanadaMexicoAlgeria Andorra Austria Bahrain Belarus Belgium Croatia Cyprus Czech Republic Denmark Finland France French Guiana Germany Gibraltar Greece Hungary Ireland Israel Italy Ivory Coast Kenya Kuwait Latvia Lebanon Luxembourg Malta Martinique Mauritius Morocco Netherlands New Caledonia Nigeria Norway Oman Poland Portugal Republic of Kosovo Republic of Macedonia Reunion Romania Russia Saudi Arabia Senegal Serbia Seychelles Slovenia South Africa Spain Sweden Switzerland Syria Tunisia Turkey Ukraine United Arab Emirates United Kingdom AustraliaNew ZealandCanadaJapanBangladeshChinaHong KongIndiaIndonesiaKoreaMalaysiaPakistanSingaporeSri LankaTaiwanThailandVietnamArgentinaBahamasBarbadosBrazilChileColombiaDominican RepublicMexicoPeru andSuriname,Terminated,"April 02, 2012",867,205830,Not_Computer,N/A,N/A,N/A
Z-0272-2010,53586,"clip, tubal occlusion",HGB,Contraceptive tubal occlusion device (TOD) and introducer.,Obstetrics/Gynecology,Obstetrics/Gynecology,N/A,"Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90.Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes",Hulka Clip,2,"November 17, 2009", 2009,Richard Wolf Medical Instruments Corp.,The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.,PRODUCTION CONTROLS: Packaging,"Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.",N/A,150,150 cartons,Nationwide,Terminated,"March 16, 2011",484,150,Not_Computer,N/A,N/A,N/A
Z-0338-2010,51389,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.",HillRom 100 Low Bed,2,"November 18, 2009", 2009,"Hill-Rom, Inc.","The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.",PRODUCTION CONTROLS: Process Control,"Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.",Contact the recalling firm for information,4017,4017 beds,"Worldwide distribution: USA, Canada, France, India, Singapore and Spain.",Terminated,"October 15, 2010",331,4017,Not_Computer,N/A,N/A,N/A
Z-0365-2010,51876,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,"PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.",PICIS,2,"November 18, 2009", 2009,Picis Inc.,"Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your ""HIS"" or ""CIS"") and certain Picis applications, if that interface is not configured properly.",DESIGN: Software Design,"On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.",N/A,325,325,"Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom",Open,N/A,N/A,325,Other,N/A,N/A,Other
Z-0366-2010,53604,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),AGFA IMPAX HeartStation ECG Management System.,Agfa IMPAX HeartStation ECG Management System,3,"November 18, 2009", 2009,AGFA Corp.,HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter.,OTHER/UNDETERMINED: Pending,"An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.",N/A,9,9 units,"CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore",Terminated,"July 27, 2010",251,9,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0370-2010,51933,"posterior metal/polymer spinal system, fusion",NQP,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.","Zimmer Dynesys toploading cutter, spacer",2,"November 19, 2009", 2009,Zimmer Inc.,"The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.",OTHER/UNDETERMINED: Pending,"Consignees were notified by letter dated 5/20/09 titled ""Urgent Medical Device Correction"" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.",N/A,177,177,"Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.",Terminated,"October 05, 2011",685,177,Not_Computer,N/A,N/A,N/A
Z-0369-2010,50784,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02,Biosense NaviStar RMT Catheters,2,"November 19, 2009", 2009,"BioSense Webster, Inc.","Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u",PRODUCTION CONTROLS: Process Control,"The firm sent an ""Urgent Medical Device Correction"" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay ""close attention to the location of the ablation catheter icon on the map viewer when applying RF energy.""If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement.Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.",Contact the recalling firm for information,2180,2180 Units,"CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI",Terminated,"November 23, 2009",4,4739,Not_Computer,N/A,N/A,N/A
Z-0367-2010,53580,"guide, surgical, instrument",FZX,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534.Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.",Biomet KWire/Trocar Point,2,"November 19, 2009", 2009,"Biomet, Inc.",Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.,PRODUCTION CONTROLS: Process Control,"An ""Urgent Medical Device Recall Notice"" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the ""FAX back Response Form"" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics.Direct questions related to the recall notification by calling at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.",Contact the recalling firm for information,19,19,United States (Florida and Pennsylvania).,Terminated,"October 06, 2010",321,19,Not_Computer,N/A,N/A,N/A
Z-0389-2010,52615,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116",Oxinium,2,"November 20, 2009", 2009,Smith & Nephew Inc,Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.,OTHER/UNDETERMINED: Pending,All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. Further questions are directed to the contacts at Smith and Nephew listed in the letter.,Contact the recalling firm for information,925,925 units,"Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France.",Terminated,"February 07, 2012",809,925,Not_Computer,N/A,N/A,N/A
Z-0371-2010,53772,"prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer",HSX,Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stelkast Unicondylar Knee Femoral Component SC2462-1.Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.",Stelkast Unicondylar Knee Femoral Component SC24621,2,"November 20, 2009", 2009,Stelkast Co,incorrect size markings on component,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.",N/A,20,20 units,Nationwide,Terminated,"November 20, 2009",0,20,Not_Computer,N/A,N/A,N/A
Z-0107-2010,53579,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA.The device is intended to facilitate placement of interventional devices into the neurovascular system.",Guider XF Softip Guide Catheter,2,"November 20, 2009", 2009,Boston Scientific Corporation,"Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.",PRODUCTION CONTROLS: Environmental Control,"The firm initiated its 'Safety Alert' on October 6, 2009. A notification letter was sent to each customer reminding them to follow storage and handling instructions. The firm has not ceased distribution. Direct questions about this notification to the Boston Scientific Corporation at 1-510-624-1734.",Contact the recalling firm for information,94296,"94,296 units","Worldwide Distribution -- United States, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, UAE, Uruguay, Venezuela, Vietnam and Yemen.",Terminated,"December 19, 2011",759,94296,Not_Computer,N/A,N/A,N/A
Z-0123-2010,53614,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201.The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions.",Stryker Instruments Navigation System II PC SPC1 Assembly,1,"November 20, 2009", 2009,Stryker Instruments Div. of Stryker Corporation,"Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.",DESIGN: Software Design,"The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.",N/A,2,2 replacement systems,"Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.",Terminated,"December 31, 2009",41,23,Computer,N/A,N/A,N/A
Z-0413-2010,53619,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical¶_ labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.",Merit Medical,2,"November 23, 2009", 2009,"Merit Medical Systems, Inc.",Surgical gloves in hospital convenience kits may be degraded and tear during use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Merit Medical Systems notified customers by phone, fax, or visit by sales representatives on 05/19/09. The notification advised of the convenience kit correction due to the recall of the Derma Prene Ultra Surgical Gloves, and that use of the product should cease immediately. Sales representatives were instructed to provide replacement gloves and ""warning"" stickers to be placed on identified kits in inventory. The warning stickers advise the customer to discard the surgical gloves in the kit and replace. Customers were requested to verify product disposition by signing a response form.",N/A,378,378 units,USA distribution: nine hospitals in Texas and Colorado.,Terminated,"December 03, 2009",10,378,Not_Computer,N/A,N/A,N/A
Z-0414-2010,53475,"lamp, surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm.Intended for local illumination of the operating and examination area of the patient in treatment rooms.",STERIS Harmony LL 500/700 Surgical Light,2,"November 23, 2009", 2009,Steris Corp,"Dr¶_ger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Dr¶_ger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Dr¶_ger SOLA 500/700 surgical light.",DESIGN: Device Design,"The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.",Contact the recalling firm for information,388,388 units,"Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.",Terminated,"March 01, 2012",829,388,Not_Computer,N/A,N/A,N/A
Z-0374-2010,53688,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and RecorderPart Number: 863067 and 453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.",Philips SureSigns Vital Signs Viewer ,2,"November 23, 2009", 2009,Philips Healthcare Inc.,Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker,DESIGN: Software Design,"Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377.On December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.",Contact the recalling firm for information,221,221 units,"Nationwide Foreign: CanadaAfghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates",Terminated,"February 20, 2013",1185,19678,Computer,N/A,N/A,N/A
Z-0398-2010,53694,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75G.",Power Linear Cutter,2,"November 23, 2009", 2009,Surgical Devices/Covidien,Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.",Contact the recalling firm for information,28303,"28,303 units","The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.",Terminated,"March 08, 2010",105,240432,Not_Computer,N/A,N/A,N/A
Z-0390-2010,53434,"prosthesis, hip, femoral component, cemented, metal",JDG,Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.",Stryker V40,2,"November 23, 2009", 2009,Stryker Howmedica Osteonics Corp.,Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.,PRODUCTION CONTROLS: Process Control,"Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.",N/A,7,7 units,Nationwide distribution.,Terminated,"June 26, 2013",1311,17,Not_Computer,N/A,N/A,N/A
Z-0388-2010,52806,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11.The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.","Zimmer Natural Nail System, Connecting Knob",2,"November 24, 2009", 2009,Zimmer Inc.,"The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.",OTHER/UNDETERMINED: Pending,"On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts.The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.",N/A,327,327 of total product,"Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.",Terminated,"October 05, 2011",680,327,Not_Computer,N/A,N/A,N/A
Z-0415-2010,53299,"accessories,arthroscopic",NBH,Arthroscope.,Orthopedic,Orthopedic,510(K) Exempt,AlMER ENDOFEMORAL 4MM OFFSET (PURPLE)Part Number 72201714.The product is an orthopedic device.,"Smith and Nephew, Endo Femoral Aimer",2,"November 24, 2009", 2009,"Smith & Nephew, Inc., Endoscopy Div.","Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.",DESIGN: Labeling Design,"A notification letter was issued via Fedex on September 3, 2009 to domestic consignees and international consignees were notified via e-mail. The letter described the issue as the affected device may have improper laser marking. The 4mm devices are marked as 6mm and the 6mm devices are marked at 4mm. Customers were instructed to return the completed response form and affected product in inventory to Smith & Nephew. Direct questions about the recall to your local Smith & Nephew Sales Representatives or call 1-508-261-3655.",Contact the recalling firm for information,134,134 individual units,"Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.",Terminated,"May 08, 2012",896,134,Not_Computer,N/A,N/A,N/A
Z-0455-2010,52886,"prosthesis, toe, constrained, polymer",KWH,Toe joint polymer constrained prosthesis.,Orthopedic,Orthopedic,510(k),"Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435.The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint.",LMP50 (Lesser Metatarsal Phalangeal Implant,2,"November 24, 2009", 2009,"Tornier, Inc.","Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).",PRODUCTION CONTROLS: Labeling Mix-Ups,"Consignees were sent on April 6, 2009 a Tornier ""Urgent-Product Recall"" letter dated April 3, 2009. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.",Contact the recalling firm for information,77,77,"Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France.",Terminated,"December 17, 2011",753,77,Not_Computer,N/A,N/A,N/A
Z-0120-2010,53672,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.",Crossover Reinforced Catheter Introducer System,1,"November 24, 2009", 2009,Thomas Medical Products Inc,Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.,DESIGN: Component Design/Selection,"An ""Urgent Medical Device Correction"" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc.Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30AM to 5:OOPM Eastern Standard Time, for questions about product return.",N/A,17236,"17,236 units",United States (FL and MN).,Terminated,"November 08, 2010",349,17236,Not_Computer,N/A,N/A,N/A
Z-0456-2010,53462,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.",GE Centricity PACS RA1000 Workstation Software,2,"November 24, 2009", 2009,GE Healthcare Integrated IT Solutions,"There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.",DESIGN: Software Design,"GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated September 23, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers, to the attention of the Hospital Risk Manager, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator, on 9/25/09. The letters advised the users of the patient safety issues associated with the use of GE Centricity PACS related to unintentionally adding new images to an approved exam; deletion of images from PACS if Cancel Checked or Cancel Selected is chosen in the CA Tool - Archive Queue; inadvertently getting two or more exams out of sync with the corresponding reports resulting in the RIS-IC reports being associated with the wrong patients exam; and when rejecting a duplicate image(s) from an unspecified exam that is still in the Arrived or Verified status, the duplicate image(s) is also rejected from the Dictated, Transcribed, or Completed status exam. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issues and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.",N/A,1188,"1,188 units","Worldwide Distribution -- United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.",Terminated,"May 25, 2012",913,1188,Software,Output/Calculation,Software update,Software Update
Z-0422-2010,53561,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,"HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems.The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.",HeartMate 12 volt sealed lead acid Battery Clips ,2,"November 24, 2009", 2009,Thoratec Corp,"Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled",OTHER/UNDETERMINED: Pending,"Firm has issued a notification letter to consignees, dated October 14, 2009 asking them to return proof of receipt, and to remove all affected unused devices from stock, and asking ongoing patients to return to hospitals for inspection, replacement if needed, and retraining on the process of switching power sources and safely switching to a back-up system controller. Contact Thoratec Customer Services at 1-800-456-1477 for any questions or concerns about this issue.",N/A,8194,"8,194 battery clips","Worldwide - USA- AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the District Columbia. Internationally to Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Lithuania, Luxembourg, Monaco, Netherlands, Singapore, South Africa, Sweden, Switzerland, Taiwan and the UK.",Terminated,"April 18, 2011",510,8194,Not_Computer,N/A,N/A,N/A
Z-0420-2010,53681,"unit, neonatal phototherapy",LBI,Neonatal phototherapy unit.,General Hospital,General Hospital,510(k),"The Natus Blue Light Phototherapy is also called the ""neoBLUE LED Phototherapy System"". The ""neoBLUE mini LED Phototherapy System""","Natus Blue Light, neoBLUE",2,"November 24, 2009", 2009,Natus Medical Incorporated,The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.,DESIGN: Device Design,"On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp. Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus.International distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees. Replacements will be sent to the distribution partner for their consignees.",N/A,2127,2127,"Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK",Terminated,"September 22, 2011",667,2127,Not_Computer,N/A,N/A,N/A
Z-0418-2010,53593,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02.Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.",Philips medical Systems,2,"November 24, 2009", 2009,Philips Healthcare Inc.,"A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.",DESIGN: Software Design,"Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.",N/A,53,53 units,"MD, RI, WV, and TXAustraliaBelgiumDenmarkFranceItalyMalaysiaSingaporeSpainSwitzerlandTaiwanUnited Arab EmiratesUnited KingdomandIreland",Open,N/A,N/A,53,Software,Device Operation,Software update,Software Update
Z-0429-2010,53606,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Stryker Thor Anterior Plating System;Non SterileThor Standard Long Screw 6.0 x 40MM, spinal implant component",THOR,2,"November 24, 2009", 2009,Stryker Spine,Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.,DESIGN: Device Design,"Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.",Contact the recalling firm for information,202,202,Nationwide,Terminated,"January 23, 2013",1156,9550,Not_Computer,N/A,N/A,N/A
Z-0421-2010,52445,"wheelchair, mechanical",IOR,Mechanical wheelchair.,Physical Medicine,Physical Medicine,510(k),Kuschall K Junior Manual wheelchair,Kuschall K Junior Manual wheelchair,2,"November 25, 2009", 2009,Invacare Corporation,"The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).",DESIGN: Device Design,The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: Recalls@Invacare.com or phone: 800-333-6900.,Contact the recalling firm for information,20,20 Wheelchairs,"Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to Canada.",Terminated,"November 21, 2011",726,20,Not_Computer,N/A,N/A,N/A
Z-0457-2010,52720,"table, radiographic, non-tilting, powered",IZZ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882.Intended to be used for general purpose radiography and tomography.",COMPAX 40E Xray Systems,2,"November 25, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently become aware that table lock safety features, which are provided with Compax40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movementthat may impact patient safety.",OTHER/UNDETERMINED: Pending,"Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare ""Urgent Medical device Correction"" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.",N/A,1046,1046,"Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.",Open,N/A,N/A,1046,Not_Computer,N/A,N/A,N/A
Z-0419-2010,53261,"system, communication, powered",ILQ,Powered communication system.,Physical Medicine,Physical Medicine,510(K) Exempt,Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.,Philips Lifeline,2,"November 25, 2009", 2009,Philips Lifeline Inc,Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.,N/A,"Philips Lifeline initiated Safety Notification letters on 9/21/09 to users and advised of the potential choking risk of the Pendant Personal Help Button The firm recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them. A postage-paid reply envelope had been provided. Questions should be addressed to Philips at 1-877-221-8756 (Monday Friday, 8 a.m. 8 p.m. EST). Firm issued Press on 9/11/09. FDA Press issued 9/22/09.",N/A,715000,"715,000",NationwideCanada,Terminated,"October 02, 2012",1042,715000,Not_Computer,N/A,N/A,N/A
Z-0458-2010,53801,"oximeter, tissue saturation",MUD,Oximeter.,Cardiovascular,Cardiovascular,510(k),"Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.",Nonin Cerebral Oximeter Pod,2,"November 25, 2009", 2009,"Nonin Medical, Inc","A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.",DESIGN: Device Design,An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166.,Contact the recalling firm for information,62,62,"Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.",Terminated,"March 29, 2012",855,62,Not_Computer,N/A,N/A,N/A
Z-0479-2010,52121,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064;",Cargille Modified KingsburyClark Albumin Standards ,3,"December 01, 2009", 2009,Cargille-Sacher Laboratories Inc.,The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.,PRODUCTION CONTROLS: Storage,"Cargill sent recall letters mailed July 7, 2006 by first class mail.",N/A,5,5 kits,"The product was distributed to 5 customers in OH, Washington, DC, PA, WI, and VA.",Terminated,"December 02, 2009",1,5,Not_Computer,N/A,N/A,N/A
Z-0459-2010,53161,"aid, transfer",IKX,Daily activity assist device.,Physical Medicine,Physical Medicine,510(K) Exempt,"Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001",Bath Safe Adjustable Shower Seat Without Back and Arms,2,"December 01, 2009", 2009,Nutech Manufacturing Corp,Safety chair used in shower/bath may not meet specifications for weight load.,DESIGN: Device Design,"The subsidiary distributor, Maddak, Inc. notified customers by A ""Voluntary Product Recall Notice"", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a ""storefront"" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.",N/A,3627,"3,627 total units",Worldwide Distribution -- USA and Canada.,Terminated,"May 29, 2013",1275,3627,Not_Computer,N/A,N/A,N/A
Z-0467-2010,53588,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Scorpio CR Waffle Femur Lfit with posts;Stryker Orthopaedics;325 Corporate Drive, Mahwah, NJ 07430.The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.",OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM,2,"December 01, 2009", 2009,Stryker Howmedica Osteonics Corp.,It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.,OTHER/UNDETERMINED: Pending,"An ""Urgent Product Recall"" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form (with spreadsheet) and faxing to 1-201-831-6069. Direct questions to Stryker Orthopaedics by calling 1-201-972-2100.",N/A,77,77 of total product,"Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.",Terminated,"April 05, 2010",125,77,Not_Computer,N/A,N/A,N/A
Z-0478-2010,53867,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Prot¶_g¶_ EverFlex"" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only.Prot¶_g¶_ EverFlex"" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only.In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.",PROTEGE EVERFLEX SELFEXPANDING BILIARY STENT SYSTEM,2,"December 01, 2009", 2009,"Ev3, Inc.",ev3 has determined that a lot of 150mm Prot¶_g¶_ EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Service at 1-800-716-6700.",N/A,6,6 (United States) and 6 (Outside United States),"Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.",Terminated,"March 08, 2012",828,6,Not_Computer,N/A,N/A,N/A
Z-0480-2010,53612,"accessories, operating-room, table (kit)",FWZ,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0.An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.",Connection Bracket,2,"December 02, 2009", 2009,Maquet Inc.,"Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.",DESIGN: Device Design,"Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.",Contact the recalling firm for information,9,9 units in US.,"Nationwide Distribution -- USA, including states of SC and PA.",Terminated,"May 18, 2010",167,9,Not_Computer,N/A,N/A,N/A
Z-0486-2010,53555,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"E-Z CLEAN Non Stick Cautery Tip. Label reads in part: ""MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***""The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.",EZ Clean Electrosurgical Electrodes,3,"December 03, 2009", 2009,"Megadyne Medical Products, Inc.",Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.,PRODUCTION CONTROLS: Error in Labeling,"A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.",N/A,324,324 units,"Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.",Terminated,"February 17, 2010",76,324,Not_Computer,N/A,N/A,N/A
Z-0482-2010,53673,"crown and bridge, temporary, resin",EBG,Temporary crown and bridge resin.,Dental,Dental,510(k),"TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.",FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL,2,"December 03, 2009", 2009,Jeneric/Pentron,Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting.Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.,TRAINING: Employee Error,"The recall customer notification was initiated on October 22, 2009 with the firm forwarding an urgent medical device letter with recall return form via USPS first class mail to the affected consignees. The letter informed the consignees of the reason for recall and instructed them to return any used or unused product of the affected lot. The firm provided an 800 number for the consignees to call to arrange for product return and replacement.",Contact the recalling firm for information,58,58 units,Nationwide,Terminated,"July 19, 2012",959,58,Not_Computer,N/A,N/A,N/A
Z-0481-2010,53748,"accessories, pump, infusion",MRZ,Infusion pump.,General Hospital,General Hospital,510(k),Animas ezManager Max Diabetes Management System version 2.0.9,ezManager Max Diabetes Management System version 2.0.9,2,"December 03, 2009", 2009,Animas Corporation,Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.,DESIGN: Software Design,Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.,N/A,20648,"20,648 units","Nationwide distribution, and Canada, Cayman Islands, and Denmark.",Terminated,"October 27, 2010",328,20648,Software,Output/Calculation,Software update,Software Update
Z-0483-2010,53844,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Axiom Artis MP, Model number 5904466 angiographic x-ray systems",Axiom Artis MP,2,"December 03, 2009", 2009,"Siemens Medical Solutions USA, Inc",c-arm may tilt,OTHER/UNDETERMINED: Pending,"The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.",N/A,70,70 units,Nationwide,Terminated,"January 26, 2010",54,113,Not_Computer,N/A,N/A,N/A
Z-0491-2010,50685,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.",Zodiac Polyaxial Spinal Fixation System,2,"December 07, 2009", 2009,"Alphatec Spine, Inc.","Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.",PRODUCTION CONTROLS: Error in Labeling,"Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information.The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.",N/A,56,56,"AZ, CA, FL, TX",Terminated,"December 08, 2009",1,56,Not_Computer,N/A,N/A,N/A
Z-0063-2010,53383,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label.,automated external defibrillator,2,"December 08, 2009", 2009,Philips Medical Systems,"A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool.For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.",N/A,5808,"5,808","Domestic and Worldwide distribution to:United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.",Terminated,"September 27, 2013",1389,5808,Not_Computer,N/A,N/A,N/A
Z-0492-2010,53538,"prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer",MBH,Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002",ADVANCE (R) CANAL FILLING STEM EXTENSION (11mm),3,"December 08, 2009", 2009,Wright Medical Technology Inc,"Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.",PRODUCTION CONTROLS: Process Control,"Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630.",N/A,37,37 units,"Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece",Terminated,"December 16, 2010",373,62,Not_Computer,N/A,N/A,N/A
Z-0488-2010,53812,gutta-percha,EKM,Gutta percha.,Dental,Dental,510(K) Exempt,"Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002",Elements Gutta Percha and Elements RealSeal Cartridges,2,"December 09, 2009", 2009,Sybronendo,"The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart",DESIGN: Component Design/Selection,"The recall communications was initiated on November 06, 2009 with the firm forwarding a Recall Letter to the affected consignees via US Postal Service 1st class mail. The recall letter informed the consignees of the reason for recall, the hazard and the affected products. Consignees were instructed to call SybronEndo Customer Care at 1-800-346-3636 directly to handle returns & replacements. In addition, consignees were asked to complete the enclosed Recall Return Form and return it by fax to 909-962-5605.The recall notice also instructed consignees that are an authorized SybronEndo distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.",N/A,5046,5046 units (3720 units in US),"Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela",Terminated,"March 22, 2012",834,5046,Not_Computer,N/A,N/A,N/A
Z-0487-2010,53751,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.",Baxter Clearlink System Buretrol Solution Set,2,"December 09, 2009", 2009,Baxter Healthcare Corp.,"The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.",TRAINING: Employee Error,"An ""Urgent Product Recall"" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement product by calling Baxter Healthcare Center for Service at 1-888-229-0001, Prompt 2, during hours of operation 7:00 a.m. to 6:00 p.m. Central Standard Time. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. If the accounts further distributed the Buretrol Sets, they were requested to forward the communication to those accounts. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter.",Contact the recalling firm for information,173,173 cases,"Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.",Terminated,"July 08, 2010",211,173,Not_Computer,N/A,N/A,N/A
Z-0499-2010,53813,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.","Zimmer Dental AdVent Implant System, Abutment, Tapered",2,"December 10, 2009", 2009,Zimmer Inc.,"The devices may not meet specifications, which may result in fracturing during tightening of the component.",PRODUCTION CONTROLS: Process Control,User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.,N/A,738,738,"Ohio, Canada and France.",Terminated,"October 08, 2010",302,738,Not_Computer,N/A,N/A,N/A
Z-0498-2010,51734,retractor,GAD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site.",ILLICO access retractor,2,"December 11, 2009", 2009,"Alphatec Spine, Inc.",The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.,DESIGN: Device Design,"On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.",N/A,14,14,"AZ, CA, OR, TX, and Tokyo, Japan.",Terminated,"December 22, 2009",11,14,Not_Computer,N/A,N/A,N/A
Z-0500-2010,53689,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Medtronic Accessory Kit , Titan¶_ Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604",Titan Anchor Accessory Kit,2,"December 11, 2009", 2009,Medtronic Neuromodulation,Medtronic is issuing a medical device correction for the Model 3550-39 Titan¶_ anchor due to the potential for lead migration as a result of insert separation within the anchor. The Medtronic Model 3550-39 Titan¶_ anchor accessory kit is designed for use with Medtronic percutaneous in-lineconnector spinal cord stimulation leads. Medtronic has received reports of separation of the titaniuminsert,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a Medtronic ""Urgent: Medical Device Correction"" letter on 10/27/09. The letter was addressed to ""Dear Healthcare Professional"" and was dated October 2009. The letter described the problem and the product as well as the Scope and Potential Severity and gave Recommendations. Enclosures with the letter included: Use By Date (UBD) location on the Titan anchor accessory kit product packaging, Titan anchor patient letter, Reply card and Return envelope. Questions are direct to Medtronic via email at rs.neuroqa1a@medtronic.com.",N/A,55600,"55,600","All states in the United States including Puerto Rico.Australia, New Zealand, Canada, Andurra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, Tukey, United Kingdom.",Terminated,"December 24, 2011",743,55600,Not_Computer,N/A,N/A,N/A
Z-0502-2010,53144,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12",Solanas,2,"December 14, 2009", 2009,"Alphatec Spine, Inc.",Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.,PRODUCTION CONTROLS: Process Control,"Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located.If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.",N/A,163,163 Units,Nationwide distribution.,Terminated,"June 07, 2010",175,321,Not_Computer,N/A,N/A,N/A
Z-0511-2010,53557,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12"" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag",Connection Tube,2,"December 14, 2009", 2009,"Merit Medical Systems, Inc.",Potential sterility breach caused by excessive shipment damage.,OTHER/UNDETERMINED: Pending,Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.,No consumer action necessary,1,1 connection tube,"US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.",Terminated,"December 15, 2009",1,352,Not_Computer,N/A,N/A,N/A
Z-0525-2010,53454,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States.The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.",Abbott Spine Thoracolumbar Common,3,"December 14, 2009", 2009,Zimmer Inc.,"The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.",Contact the recalling firm for information,13,13,"Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)",Terminated,"October 08, 2010",298,13,Not_Computer,N/A,N/A,N/A
Z-0501-2010,53860,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.","Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabilized, Gender Sol",2,"December 14, 2009", 2009,Zimmer Inc.,"The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.",PRODUCTION CONTROLS: Packaging Process Control,"Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.",Contact the recalling firm for information,22,22,"Nationwide, Korea and Switzerland.",Terminated,"October 15, 2010",305,22,Not_Computer,N/A,N/A,N/A
Z-0535-2010,52837,"device, anti-snoring",LRK,Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.,Dental,Dental,510(k),"Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.",Repose G2 Bone Screw System,2,"December 15, 2009", 2009,"Medtronic Xomed, Inc.","Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist.1. Fill-in the ""quantity on-hand ""column on the checklist.2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSEField Action Contact Person for help to arrange for returns and replacements or credit.3. Fax your Checklist to Medtronic ENT at the number provided.4. Return products clearly marked.",N/A,7,7,9 consignees in the continental United States.,Terminated,"March 15, 2010",90,20,Not_Computer,N/A,N/A,N/A
Z-0509-2010,53495,"catheter, angioplasty, peripheral, transluminal",LIT,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.",IMPACT,2,"December 15, 2009", 2009,Numed Inc,"The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like ""paint crackle."" The risk is that for continued sterility to be assured, the packaging must remain intact.",DESIGN: Labeling Design,"An informal e-mail was sent to B. Braun to give them notice not to distribute any Impact devices until further notice. This was followed up by a formal URGENT MEDICAL DEVICE RECALL letter (dated 9/24/09) to the sole consignee. The products are to be returned to the manufacturer, including any products further distributed. Customer questions should be directed to the recall contact (replace "" AT "" with @) nlaflesh ATnumedusa.com.",N/A,7367,"7,367 units domestically",One distributor in Pennsylvania,Terminated,"May 23, 2012",890,7367,Not_Computer,N/A,N/A,N/A
Z-0530-2010,53584,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.Component is found in:TMJ SYSTEM ARTHROSIMPLICITY KIT REF 922070, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.comKit contains individually packaged sterile products. Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.",TMJ SYSTEM ARTHROSIMPLICITY Kit,2,"December 15, 2009", 2009,"Biomet Microfixation, Inc.","Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ",DESIGN: Device Design,"Consignees were notified by a combination of telephone, fax, e-mail and certified mail. Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.",Contact the recalling firm for information,121,121 Kits,"Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.",Terminated,"March 17, 2010",92,235,Not_Computer,N/A,N/A,N/A
Z-0529-2010,53858,"knife, orthopedic",HTS,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter;Stainless Steel, Disposable;Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 0743033 mm size, One single unit to a package.Note: The 30 mm instruments were not distributed.The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.",Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter,2,"December 15, 2009", 2009,Stryker Howmedica Osteonics Corp.,"Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.",PRODUCTION CONTROLS: Labeling Mix-Ups,"An ""Urgent Product Recall"" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.",N/A,12,12,"Nationwide Distribution (MA, NJ, FL, TN, OR and NY).",Terminated,"August 30, 2010",258,12,Not_Computer,N/A,N/A,N/A
Z-0537-2010,50486,"joint, knee, external limb component",ISY,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany.Pediatric Prosthetic Device used by Lower Limb amputees.","Otto Bock Modular Knee Joint,",2,"December 16, 2009", 2009,"Bock,Otto,Orthopedic Ind,Inc","Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out of the joint and result in a risk of falling for the user.",TRAINING: Employee Error,"Consignees were sent on 10/28/08 a Otto Bock ""Urgent: Correction Notice"" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.",N/A,9,9,The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.,Terminated,"December 10, 2011",724,9,Not_Computer,N/A,N/A,N/A
Z-0526-2010,52010,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare Proteus XR/a. Model # 2259988.GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.The Silhouette FC is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. The device is not intended for mammographic applications.",SILHOUETTE FC,2,"December 16, 2009", 2009,"GE Medical Systems, LLC","Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A GE Healthcare ""Urgent Medical Device Correction"" letter dated April 9, 2009 was issued to customers. The letter was addressed to Hospital Administrators/Managers of Radiology and Radiologists. The letter described the Product Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Operators should verify that the tabletop is locked before the patient is loaded on or off the table. A Field Modification will be performed on the affected products. A GE Healthcare Field Engineer willschedule a field visit to make this modification. Direct questions or concerns regarding the recall to your local GE Healthcare service representative or by calling 1-262-853-7685.",Contact the recalling firm for information,5943,"5,943 of total product","Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL POLAND, PANAMA, PAKISTAN, NORWAY NEW ZEALAND, NETHERLANDS , MEXICO MARTINIQUE, MALTA, MALAYSIA, LITHUANIA, LABA NON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUAM, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE FINLAND , ECUADOR, DENMARK CZECH REPUBLIC, CROATIA, COLUMBIAN, CHINA, CHILE , CANDA, BULGARIA, BRAZIL, BOSNIA, BELGIUM AUSTRIA, AUSTRALIA, and ARGENTINA.",Terminated,"May 24, 2012",890,5943,Not_Computer,N/A,N/A,N/A
Z-0172-2010,53809,laser target designator,RET,N/A,N/A,N/A,N/A,"MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.",MX Series Products,2,"December 16, 2009", 2009,Wescam Inc,Products do not comply with 21 CFR 1040.11.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"L-3 Wescam has issued notification of the MX Series Products describing a non-compliance with 1040.11(b). The notice instructs customers to refrain from using the infrared laser illuminator, based on a serious eye hazard from viewing the direct or reflected laser emission. Products will be repaired or removed if they cannot be repaired and a refund will be implemented.",N/A,306,306 total,Nationwide Distribution,Terminated,"January 15, 2013",1126,306,Not_Computer,N/A,N/A,N/A
Z-0541-2010,53519,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems","GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems",2,"December 16, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety.When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow v",DESIGN: Software Design,"Consignees were sent on 10/23/09 a GE healthcare ""Urgent Medical Device Correction"" letter dated 10/22/09. The letter was addressed to Hospital Administration/Risk manger, Primary Physician and Biomedical Dept. Manger. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Questions and concerns regarding this issue are directed to the local GE Healthcare service representative or to 1-800-437-1171.GE also plans to update all of the affected GE Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems that were distributed.",Contact the recalling firm for information,715,715,"AL, AR, CA, CT, FL, GA, IL, KS, KY, LA ME, MD, MA, MI, MN,MS, MO, NE NJ, NY, NC, OH, OK PA, SC, TN,TX, VA,WI.AUSTRALIA, AUSTRIA , BELGIUM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ITALY, JAMAICA, JAPAN, KOREA, KUWAIT, LITHUANIA, MALAYSIA. NETHERLANDS, NE ZEALAND, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB, EMIRATES, UNITED KINGDOM, MEXICO, VENEZUELA.",Terminated,"December 17, 2011",731,715,Software,Display/Image,Software update,Software Update
Z-0540-2010,53596,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.",Innova 21211Q/31311Q Biplane Cardiovascular Imaging System.,2,"December 16, 2009", 2009,"GE Medical Systems, LLC","GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety.A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in",TRAINING: Employee Error,"GE Healthcare issued an ""Urgent Medical Device Correction"" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.",N/A,114,114,"Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHILE , CANADA and BAHRAIN.",Terminated,"February 04, 2012",780,114,Not_Computer,N/A,N/A,N/A
Z-0538-2010,53943,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141.DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.",Twist Drill with J Notch,2,"December 16, 2009", 2009,"Biomet Microfixation, Inc.","The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.",Contact the recalling firm for information,283,283 pieces,"Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.",Terminated,"March 02, 2010",76,283,Not_Computer,N/A,N/A,N/A
Z-0539-2010,52384,forceps,HTD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Holding Forceps for Trident Acetabular System; non Sterile;Catalog number 2105-0000;Howmedica Osteonics Corp, 325 Corporate Drive,Mahwah, NJ 07430;Authorized representative in Europe:Stryker France, Cedex. FranceThe Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.",Holding Forceps for Trident Acetabular System,3,"December 16, 2009", 2009,Stryker Howmedica Osteonics Corp.,The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.,N/A,"Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.",N/A,351,351 units,"Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.",Terminated,"December 21, 2009",5,351,Not_Computer,N/A,N/A,N/A
Z-0543-2010,53771,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA.To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.","iCat Classic, 3D Dental Imaging System",2,"December 17, 2009", 2009,"Imaging Sciences International, LLC",overhead carriage drops quickly,DESIGN: Device Design,"Imaging Sciences International issued an ""Urgent Medical Device Recall"" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit.For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.",No consumer action necessary,98,98 units,"Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.",Terminated,"September 30, 2010",287,98,Not_Computer,N/A,N/A,N/A
Z-0544-2010,53577,"pump, blood, cardiopulmonary bypass, non-roller type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units.Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.",Sarns Centrifugal Pump,2,"December 17, 2009", 2009,Terumo Cardiovascular Systems Corporation,The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.,DESIGN: Device Design,"Terumo Cardiovascular Systems Corporation notified consignees of an ""Urgent Medical Device Correction"" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form.For further information, contact Terumo CVS Customer Service at 1-800-521-2818.",N/A,20702,"20,702 units",Nationwide Distribution,Terminated,"November 09, 2011",692,34455,Not_Computer,N/A,N/A,N/A
Z-0546-2010,53996,"motor, drill, pneumatic",HBB,Pneumatic cranial drill motor.,Neurology,Neurology,510(k),"Medtronic Midas Rex Legend Footed Attachment, AF01.Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.",Medtronic Midas Rex Legend Footed Attachment,2,"December 17, 2009", 2009,"Medtronic Sofamor Danek Usa, Inc - Dallas Distribution",Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic issued an ""Urgent: Medical Device Recall"" letter dated November 30, 2009. Consignees were notified of the issued and asked to quarantine any affected product and return affected product to the firm for replacement.For further information, contact Medtronic Powered Surgical Solutions Customer Service at 1-800-433-7080 or 1-817-788-6400.",N/A,64,64,"Worldwide Distribution -- Including the United States (DC, TN, NC, KY, AL, FL, NJ, OH, MI, IN, NY, WA, CA, NV, NM, IA, MO, NE and UT), Great Britain, Brazil, Turkey, Singapore and the Netherlands.",Terminated,"May 12, 2010",146,64,Not_Computer,N/A,N/A,N/A
Z-0548-2010,53987,"table, obstetrical, ac-powered (and accessories)",HDD,Obstetric table and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B.Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.",HillRom Affinity Four Birthing Bed,2,"December 17, 2009", 2009,"Hill-Rom, Inc.",The brakes may not hold or lock.,DESIGN: Device Design,"Hill-Rom issued an ""Urgent Safety Notice"" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections.For further information, contact Hill-Rom Technical Support at 1-800-445-3720.",N/A,2551,"2551 (US), 4171 (OUS)","Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates.",Terminated,"July 02, 2012",928,2551,Not_Computer,N/A,N/A,N/A
Z-0549-2010,53889,"system, monitoring, perinatal",HGM,Perinatal monitoring system and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),Philips Avalon Fetal Monitor FM 20Catalog Number: M2702A.,Philips Avalon Fetal Monitor,2,"December 17, 2009", 2009,Philips Healthcare Inc.,"Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous generation Philips Series 50 fetal monitors. Clinical decisions bas",DESIGN: Process Design,"Philips notified customers with an Urgent Medical Device Recall notice and Instructions for Use Addendum on 11/23/09 via UPS. Philips is providing the Addendum to reinforce the Avalon Instructions for Use regarding:""Recognizing these phenomena as they relate to the Avalon Fetal monitor and fetal monitors in general; and""Understanding the differences between the Philips Avalon Fetal Monitors and their predecessors, the Philips Series 50 Fetal Monitors, as they relate to the display of ultrasound-derived FHR.Philips is providing access to application specialists who are on call 24 hours a day to assist users with questions related to device use by calling 1-800-722-9377, press",Contact the recalling firm for information,10128,"10,128 units","Nationwide (US and Puerto Rico).Foreign: AfghanistanAlgeriaArgentinaAustraliaAustriaBahrainBelgiumBoliviaBosnia and HerzegovinaBotswanaBrazilBulgariaCanadaChileChinaColombiaCosta RicaCroatiaCzech RepublicDenmarkDominican RepublicEcuadorEgyptEl SalvadorEstoniaFinlandFranceFrench GuianaGabonGermanyGreeceGuadeloupeGuatemalaHong KongHungaryIcelandIndiaIndonesiaIrelandIsraelItalyJapanJordanKazakhstanKenyaKorea, Republic ofKosovoKuwaitLatviaLebanonLibyan Arab JamahiriyaLithuaniaLuxembourgMacauMalaysiaMartiniqueMauritiusMexicoMoldovaMoroccoNamibiaNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNorwayOmanPakistanPanamaPeruPhilippinesPolandPortugalPuerto RicoQatarReunionRomaniaRussiaSaudi ArabiaSingaporeSlovakiaSloveniaSouth AfricaSpainSri LankaSwedenSwitzerlandSyrian Arab RepublicTaiwanThailandTunisiaTurkeyTurks and Caicos IslandsUkraineUnited Arab EmiratesUnited KingdomUzbekistanVenezuelaViet NamZambia",Open,N/A,N/A,18940,Not_Computer,N/A,N/A,N/A
Z-0547-2010,53938,"catheter, embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(k),"Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018"" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA.",ProntoShort Extraction Catheter,2,"December 17, 2009", 2009,"Vascular Solutions, Inc.","It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009.",PRODUCTION CONTROLS: Process Control,"Vascular Solutions issued an ""Urgent: Medical Device Recall - Lot Specific"" notification dated November 20, 2009, via USPS. The letter described the issue, identified affected product, asked for affected devices to be removed from inventory, quarantine, and call customer service for a Return Authorization number. Units will be replaced upon Vascular Solutions (VSI) receiving the returned devices. A Product Recall Inventory form was asked to be completed and faxed back to VSI.For further information, contact your local sales representative or Vascular Solutions Director of Marketing at 1-763-656-4300.",Contact the recalling firm for information,274,"274 (150 US, 124 OUS)","Worldwide Distribution -- United States (CA, CO, FL, GA, IA, IL, IN, KS, LA, MI, MO, NC, NE, NH, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA and WI), Canada, France, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Taiwan and Turkey.",Terminated,"April 05, 2012",840,274,Not_Computer,N/A,N/A,N/A
Z-0557-2010,51180,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile;Arc Deposited, V40 taperNot for use with 16mm heads.",Super SecurFit ,2,"December 22, 2009", 2009,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.,DESIGN: Device Design,"Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.",N/A,786,786 total stems,Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.,Terminated,"July 18, 2012",939,786,Not_Computer,N/A,N/A,N/A
Z-0555-2010,51219,"prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer",HSX,Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.","Insall/Burstein II Modular Knee System, Tibial Wedge ",2,"December 22, 2009", 2009,Zimmer Inc.,Smaller diameter screws than required were included in the package.,PRODUCTION CONTROLS: Process Control,Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.,N/A,13,13,"USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.",Terminated,"February 28, 2011",433,13,Not_Computer,N/A,N/A,N/A
Z-0554-2010,52805,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.",Abbott Spine Sequoia dorsal height & revision tool,2,"December 22, 2009", 2009,Zimmer Inc.,The tip of the instrument may fracture during use.,DESIGN: Device Design,Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).,N/A,215,215,"Nationwide, Belgium and New Zealand.",Terminated,"April 13, 2011",477,215,Not_Computer,N/A,N/A,N/A
Z-0558-2010,53687,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.","Zimmer/CAS Power Cord, Sesamoid Plasty, NA",2,"December 22, 2009", 2009,Zimmer Inc.,The power cord female receptacle is not recessed sufficiently and may present a shock hazard.,DESIGN: Device Design,Zimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.,Contact the recalling firm for information,71,71,Nationwide.,Terminated,"October 15, 2010",297,71,Not_Computer,N/A,N/A,N/A
Z-0560-2010,53878,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; REF 909857.A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.",Toggleloc System,2,"December 22, 2009", 2009,"Biomet, Inc.","Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed ""FAX Back Response Form"" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.",N/A,24,24 of both products.,"Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.",Terminated,"November 03, 2010",316,24,Not_Computer,N/A,N/A,N/A
Z-0542-2010,53946,sunglasses (non-prescription including photosensitive),HQY,Sunglasses (nonprescription).,Ophthalmic,Ophthalmic,510(K) Exempt,"Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106","Liberty Sport Slam, or MaxMorpheus",2,"December 22, 2009", 2009,Luxottica,The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus ) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact.,TRAINING: Employee Error,On 11/24/2009 the firm sent recall notification letters to their customers indicating the problem with the lenses. they instructed their customers return the product to the place of purchase for replacement or refund. Questions are directed to the firm at 1-877-488-2407 from 8:00 a.m. to 5:00 p.m. ET.,Contact the recalling firm for information,276,276 polycarbonate prescription lenses (138 pairs of lenses),"Product was distributed to the following states: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, & WV.",Terminated,"October 27, 2010",309,276,Not_Computer,N/A,N/A,N/A
Z-0553-2010,53873,"products, contact lens care, rigid gas permeable",MRC,Rigid gas permeable contact lens care products.,Ophthalmic,Ophthalmic,510(k),"Bausch & Lomb Boston¶_ Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.","Bausch & Lomb Boston Conditioning Solution, Original Formula",2,"December 22, 2009", 2009,Bausch & Lomb Inc,"The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.",OTHER/UNDETERMINED: Pending,"Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.",N/A,159672,"159,672 bottles","U.S. Nationwide, Canada and Hong Kong",Terminated,"August 29, 2012",981,159672,Not_Computer,N/A,N/A,N/A
Z-0561-2010,47370,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.",Xoran MiniCAT System for ENT ,2,"December 23, 2009", 2009,"Xoran Technologies, Inc.","The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.",DESIGN: Device Design,A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections.,N/A,82,82,Nationwide Distribution,Terminated,"December 23, 2009",0,82,Hardware,Device Operation,Repair,Repair
Z-0566-2010,53817,"table, cystometric, electric",MMZ,Urological table and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden.Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures.",Sonesta 6303,2,"December 23, 2009", 2009,Stille AB,"There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Stille sent Field Safety Notices dated 10/30/09 to the direct accounts, informing them that there is a potential hazard with the Sonesta tables if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. Stille developed a retrofit kit consisting of six side rail bolts and instructions for installing the bolts, which were sent to the end users with the safety notice. The accounts were requested to replace the side rail bolts with the new bolts provided, and to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 12/11/09. Contact Stille Surgical Inc. at 224-612-5404 for assistance.",N/A,68,68 units total,Worldwide Distribution -- Including countries of USA and Canada.,Terminated,"December 10, 2010",352,68,Not_Computer,N/A,N/A,N/A
Z-0562-2010,53820,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Module, Model M5529A.The HeartStart MRx portable external defibrillator has optional accessories which include a wall mount and a DC power module. The wall mount is intended for storage and transport of MRx devices in land based transport vehicles. The power module is an additional optional accessory intended to be connected to the wall mount as a means for charging MRx devices (batteries) when stored in the wall mount. The DC power Module is also intended for use with an extension power cable, which is exclusively intended to be used to connect the DC module directly to the MRx. Philips private labels and distributes these devices which are designed and manufactured by Laerdal Medical.",Philips Medical Systems ,2,"December 23, 2009", 2009,Philips Healthcare Inc.,HeartStart Vehicle Wall Mount (Model M5528A) with DC Power Module (Model M5529A)--Incorrect wiring during installation by user may result in a smoke or fire hazard.,OTHER/UNDETERMINED: Pending,"Philips Healthcare, Inc. notified customers by an ""URGENT - Voluntary Medical Device Correction"" letter, plus revised Instructions For Use (IFU) for the Vehicle Wall Mount accessory and the DC Power Module accessory of the HeartStart MRx which includes a revised description of correct installation and verification of performance. Customers were asked to follow the Actions in the customer/user section of the Urgent - Voluntary Medical Device Correction Notification. In this section, customers were given the instructions to correct their devices. Distribution of the Urgent - Voluntary Medical Device Correction Notification along with the IFU will be managed by Philips representatives in each affected geography. Direct questions or concerns about the recall to your local Philips representative.",N/A,3265,"3,265 units","Class II Recall -- Worldwide Distribution -- United States, Canada, Australia, Brazil, China, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Jordan, Kenya, Libyan Arab Jamahiriya, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Saudi Arabia, Spain, Sri Lanka, Switzerland, Trinidad, Tobago, United Arab Emirates, and United Kingdom.",Terminated,"January 25, 2012",763,3265,Not_Computer,N/A,N/A,N/A
Z-0563-2010,53837,"stimulator, caloric-water",ETP,Air or water caloric stimulator.,Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium.The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.",AquaStar,3,"December 23, 2009", 2009,"Micromedical Technologies, Inc",Some of the filters on both the display board and the main electronic board (PCB) become oxidized causing the LCD display to be garbled and the timer will not operate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Micromedical Technologies, Inc. sent letters dated November 16, 2009 via e-mail (with read receipt) to each customer and their representative. If they did not have the customer's e-mail address, the sales representative was requested to forward the letter to the customer and copy Micromedical. The letters advised the customers that one or more electronic components in the AquaStar caloric irrigator may fail due to contact corrosion. In the event of this failure, unheated tap water will continue to flow through the device back to the water drain, but the LCD display will be garbled and the timer will not operate. If this problem develops, the account should stop using the irrigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at mmtinfo@micromedical.com to report the problem for repair of the unit.",N/A,10,10 units,"Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.",Terminated,"April 18, 2011",481,10,Hardware,Display/Image,Repair,Repair
Z-0567-2010,53952,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),"SeQual Technologies Inc. Eclipse Oxygen System, Model 1000Indicated for the administration of supplemental oxygen.",Eclipse Oxygen System,2,"December 23, 2009", 2009,Sequal Technologies Inc,"Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.",N/A,"The recall notification was initiated on November 12, 2009 with the firm forwarding a ""Medical Device Correction"" letter to all of the affected consignees via US Postal Service for US Consignees and FedEx for Foreign Consignees. The Medical Device Correction Letter contained the following:(1) Medical Device Correction Letter; (2) List of Serial Number affected that were distributed to the Provider; (3) Reply Card that the Provider will be requested to send back regarding receipt notification of the Medical Device Correction Letter and confirming that they have the affected product; (4) Additional Medical Device Correction Letters for Providers to distribute to their patients.The Medical Device Correction Letter informed the consignees of the reason for recall, the hazard involved and the actions that were required. For further details or information, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 AM to 5:00 PM PST.",N/A,6588,"6,588 units","Worldwide Distribution -- Including countries of USA, ARGENTINA, AUSTRIA, BAHAMAS, BERMUDA, CANADA, CHILE, COLUMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, ITALY, ISRAEL,JAPAN, JORDAN, KUWAIT, MALTA, NETHERLANDS, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Terminated,"June 18, 2012",908,6588,Battery,Device Operation,Notification,Safety Notice/Insructions
Z-0497-2010,53879,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO.US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150.Intended to guide and support a guide wire during access of the vasculature.",TrailBlazer Support Catheter,1,"December 23, 2009", 2009,"Ev3, Inc.","Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization.",DESIGN: Component Design/Selection,"Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.",N/A,70,70,"Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI.",Terminated,"January 05, 2011",378,70,Not_Computer,N/A,N/A,N/A
Z-0568-2010,53339,"stretcher, hand-carried",FPP,Hand-carried stretcher.,General Hospital,General Hospital,510(K) Exempt,Paramed Polypropylene evacuation sled for non-ambulatory patients.Hand-carried stretcher. Product 11-778-01.,"ParaSlyde, Controlled descent device.",2,"December 28, 2009", 2009,Paramed Systems,Possible partial board disassembly due to inadequate webbing attachment.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices.,N/A,722,722 Units,"Nationwide Distribution -- Including states of AZ, CA, FL, GA, IL, IN, KS, KY, MA, MI, MT, NY, PA, SC, TN and UT.",Terminated,"January 28, 2010",31,722,Not_Computer,N/A,N/A,N/A
Z-0574-2010,53709,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16"" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21","AccuSure U100 30 Gauge, 1cc ",2,"December 28, 2009", 2009,Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals,Needles are becoming dislodged from the barrels.,OTHER/UNDETERMINED: Pending,"The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure ¶_¶_ Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.",N/A,100,"171,421 cartons of 100",Nationwide,Terminated,"November 24, 2010",331,171421,Not_Computer,N/A,N/A,N/A
Z-0580-2010,53777,permanent pacemaker electrode,DTB,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.",Enpath Lead Adapter,2,"December 29, 2009", 2009,Greatbatch Medical,"The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.",N/A,45,45 units,CA and MN,Terminated,"December 17, 2011",718,80,Not_Computer,N/A,N/A,N/A
Z-0586-2010,53901,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"BD 30 ml Syringe;Luer-Lok TipCatalog # 309650Becton Dickinson, Franklin Lakes, NJ.",BD 30ml Syringe Luer Lok Tip,2,"December 29, 2009", 2009,Becton Dickinson & Company,"Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised.",OTHER/UNDETERMINED: Pending,"Recall notification letters were sent to all distributors on 11/23/2009 by Federal Express. BD called all distributors to get customer lists and will start sending letter to customers commencing on December 8, 2009. Questions are directed to BD Customer Service at 1-888-237-2762, Monday Friday, 8:00 AM 5:00 PM Eastern Time.",Contact the recalling firm for information,166240,166240 units,Distributors nationwide.,Terminated,"April 06, 2010",98,166240,Not_Computer,N/A,N/A,N/A
Z-0582-2010,53875,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),Delta/Delta XL Monitors with Omega S Package,Delta/Delta XL Monitors with Omega S Package,2,"December 29, 2009", 2009,"Draeger Medical, Inc.",monitor is rebooting/resetting,DESIGN: Software Design,"Draeger Medical Systems, Inc. issued and Urgent Medical Device Recall letter dated November 2009 to their affected customers informing them of the problem and a work around until software can be validated. A Technical Service Bulletin has been generated and distributed globally that instructs the affected International Drager subsidiaries to inform customers in their countries.For further information, contact Draeger Medical Systems, Inc. at 1-800-543-5047, extension 1-2349.",N/A,4188,"4,188 units","The product was shipped to medical facilities in CA, CO, CT, ID, IN, KY, MS, NY, OK, and WI. The product was also shipped to United Arab Emirates, Argentina, Austria, Australia, Bosnia Herz, Belgium, Benin, Brunei Darussalam, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Croatia, Hungary, Ireland, India, Iran, Italy, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Lithuania, Latvia, Libya, Morocco, Mexico, Malaysia, Netherlands, Norway, Nepal, Oman, Poland, Portugal, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Thailand, Turkey, Taiwan, Ukraine, Venezuela, Vietnam, and South Africa.",Terminated,"August 23, 2011",602,4188,Software,Device Operation,Sofrware validation,Software Update
Z-0579-2010,53871,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),"Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD",Invacare Storm TDX SR Power Wheelchair with Stability Lock,2,"December 29, 2009", 2009,Invacare Corporation,"For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for",DESIGN: Device Design,"On 9/15/2009 the firm sent recall notification letter to their customers instructing them to immediately contact the dealer to have the stability lock inspected and/or adjusted. If the dealer is unavailable or the repair will take longer than 60 days, they are to contact the firm and arrange for an inspection and/or adjustment. Invacare requested contact names to whom it can send additional information. Invacare plans to mail, via FEDEX, information regarding the recall to each consignee. Initial consignees received a response card and instructions to forward cards to any customer to whom they have distributed the product. The products are to be inspected at the cylinder label and if the label does not have a long alpha-numeric string demonstrated in the label, the cylinders on the chair have to be replaced. Questions are directed to Recalls@Invacare.com or to 800-333-6900.",N/A,36,36,"Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.",Terminated,"February 26, 2013",1155,36,Not_Computer,N/A,N/A,N/A
Z-0585-2010,53937,"analyzer, gas, oxygen, gaseous-phase",CCL,Oxygen gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709",Oxygen Sensor ,2,"December 29, 2009", 2009,Teleflex Medical,Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"Consignees were notified via next day delivery on or about 11/25/2009. Each customer received a letter requesting acknowledgement of the recall and a request to return the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second and third mailing to non-responding customers on the consignee list will be made, or as an alternative, the third contact may be by phone, e-mail, or fax. Affected products received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. Records of contacts and of destruction or rework will be maintained. Questions are directed to the company at 1-866-246-6990.",N/A,51,51 eaches,"FL, KY, MI, OH, PA, SD, TN, Australia and Canada.",Terminated,"April 07, 2011",464,51,I/O,Alarm/Message,Replace,Remove or Replace
Z-0583-2010,53919,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061.Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.",Symbia S Series SPECT System ,2,"December 29, 2009", 2009,"Siemens Medical Solutions USA, Inc.","Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.",PRODUCTION CONTROLS: Process Control,"Siemens issued an Urgent Field Correction Recall letters dated November 18, 2009 and December 11, 2009 to the affected users of the Symbia S and Symbia T Systems, respectivley. The customers were advised of precautionary measures and that Siemens will replace the affected device. They also were advised that a Siemens Customer Service Representative would contact them within a few days to schedule a replacement of the device. For further information, contact Siemens Medical Solutions USA, Inc. at 1-800-888-7436 (USA).",N/A,135,135 units,"Worldwide Distribution -- United States, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Finland, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Mexico, Netherlands, Norway, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, Venezuela and Vietnam.",Terminated,"August 27, 2012",972,232,Hardware,Physical Safety Hazards,Replace,Remove or Replace
Z-0490-2010,53845,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone.",LACTOSORB SYSTEM 2.0MM ,2,"January 04, 2010", 2010,"Biomet Microfixation, Inc.","Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm.For further information, contact Biomet Microfixation at 1-904-741-9468.",No consumer action necessary,7,7 pieces,"USA - FL, MO, and KS; Foreign: Brazil and China.",Terminated,"January 23, 2010",19,22,Not_Computer,N/A,N/A,N/A
Z-0589-2010,53843,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Maquet Servo Ventilator SV900C/D/E (SV900)Siemens-Elema AB, Solna, Sweden",SV900C/D/E (SV900),2,"January 05, 2010", 2010,MAQUET Inc.,Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.,DESIGN: Device Design,Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.,N/A,29364,29364 (8438 of those in US),Worldwide distribution,Terminated,"June 04, 2012",881,50201,Not_Computer,N/A,N/A,N/A
Z-0590-2010,52207,"exerciser, powered",BXB,Powered exercise equipment.,Physical Medicine,Physical Medicine,510(K) Exempt,"Hocoma Lokomat-System with Pediatric ModuleSoftware Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x.Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients.",LokomatSystem,2,"January 07, 2010", 2010,Hocoma AG,"Changes to the stored ""sensitivity"" values may occur and leads to higher limits in the force and trajectory deviation",DESIGN: Software Design,"Hocoma issued a letter dated May 27, 2009 to Lokomat users informing them of the affected device. Instructions were provided to avoid further problems with the product and users were asked to complete and return the provided Declaration to Field Safety Notice.For further information, contact Hocoma at info@hocoma.com.",Contact the recalling firm for information,7,7,"Nationwide Distribution -- including IL, MA, MI, NY and OH.",Terminated,"February 22, 2010",46,7,Software,N/A,N/A,N/A
Z-0504-2010,53386,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),Accolade System Surgical Technique;Accolade C - Cemented Hip Stem;Accolade TMZF Cementless Hip System;Accolade HFx Cementless Hip System.Stryker Orthopaedics.Surgical protocols instruct surgeons on proper surgical technique.,Accolade System Surgical Technique,2,"January 11, 2010", 2010,Stryker Howmedica Osteonics Corp.,Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.,PRODUCTION CONTROLS: Error in Labeling,"""Urgent Product Correction - Surgical Protocol"" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).",N/A,5670,"5,670",Worldwide Distribution.,Terminated,"July 17, 2013",1283,14396,Not_Computer,N/A,N/A,N/A
Z-0592-2010,53957,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.)Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.",GE Healthcare MRI systems with Confirmas CADstream,2,"January 11, 2010", 2010,"GE Medical Systems, LLC","GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p",DESIGN: Software Design,"GE Healthcare issues an ""Important Product Information"" letter dated October 23, 2009. The letter was addressed to Hospital Administrators, Managers of Radiology and Radiologists. The letter listed the Issue, Affected Product Details, Instructions, Product correction and Contact Information.For further information, contact GE Healthcare at 1-262-548-2731.",N/A,5460,5460,"Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, ISLAMIC IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA REPUBLIC, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, UNITED KINGDOM, UZBEKISTAN, VENEZUELA and VIETNAM.",Terminated,"August 03, 2012",935,5460,Software,N/A,N/A,N/A
Z-0594-2010,53983,"catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",OAD,N/A,N/A,Cardiovascular,N/A,"Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.",Powerlink (R) System with IntuiTrak Delivery System,2,"January 11, 2010", 2010,Endologix Inc,"This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health",DESIGN: Process Design,The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.,N/A,14,14 UNITS DISTRIBUTED: 3 LOT W09-2967 AND 1 LOT W09-3000 STILL AT CONSIGNEES. 10 UNITS USED.,"Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.",Terminated,"May 07, 2010",116,17,Not_Computer,N/A,N/A,N/A
Z-0591-2010,53949,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,N/A,"Bausch & Lomb SoFlex SE Foldable Intraocular Lens.UPC 4001404, Rx Only, STERILE.Manufactured by:Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759.Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.",SoFlex SE Foldable Intraocular Lens,2,"January 11, 2010", 2010,Bausch & Lomb Inc,"Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens.",OTHER/UNDETERMINED: Pending,"Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009. Titled ""Urgent - Medical Device Recall"", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm.For further information, contact Bausch & Lomb at 1-585-338-6612.",N/A,85,85 lenses,"Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.",Terminated,"July 22, 2010",192,85,Not_Computer,N/A,N/A,N/A
Z-0595-2010,53982,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120.","Stryker MIS Bur, 2.0mm Neuro Diamond",2,"January 11, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,"The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.",DESIGN: Device Design,"Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.",No consumer action necessary,5438,5438 of all products,"Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.",Terminated,"October 25, 2010",287,5438,Not_Computer,N/A,N/A,N/A
Z-0605-2010,53781,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,N/A,AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00),AMO Tecnis 1Piece Intraocular Lens ,2,"January 12, 2010", 2010,Abbott Medical Optics Inc (AMO),Abbott Medical Optics (AMO) has received complaints of some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.,DESIGN: Process Design,"Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA.""THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY.""Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).",N/A,246000,246000 Lenses,"AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico.INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.",Terminated,"July 25, 2012",925,246000,Not_Computer,N/A,N/A,N/A
Z-0607-2010,54031,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON¶_ LEGACY"" Percutaneous Peek Spinal System",Medtronic Sofamor Danek Extended Length Trocar,2,"January 12, 2010", 2010,Medtronic Sofamor Danek USA Inc,The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.,DESIGN: Device Design,"On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.",N/A,266,266,"Nationwide distribution, and the Netherlands",Terminated,"January 14, 2011",367,465,Not_Computer,N/A,N/A,N/A
Z-0616-2010,53788,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.",AdvantxE,2,"January 13, 2010", 2010,"GE Medical Systems, LLC","Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems.Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient",DESIGN: Device Design,"Consignees were sent on 12/22/09 a GE Healthcare "" Urgent Medical Device Correction"" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.",N/A,1502,1502,"Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.",Open,N/A,N/A,3635,Not_Computer,N/A,N/A,N/A
Z-0611-2010,54114,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Sports Medicine, Warsaw, IN; REF 905456.Intended for use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee.",Biomet 2.9j Micromax L15 suture anchor,2,"January 13, 2010", 2010,"Biomet, Inc.","The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Biomet Sports Medicine notified the single consignee by letter dated December 11, 2009. The firm requested that users locate and return the affected product and return a business reply card.For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.",N/A,6,6,Nationwide Distribution -- Alabama.,Terminated,"October 18, 2010",278,6,Not_Computer,N/A,N/A,N/A
Z-0623-2010,53953,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035"" Tip Length Flexible 3 cm, Sterile.Contents 5 Hydrophilic guidewires and torquing devices.",Cordis Aquatrack ,2,"January 13, 2010", 2010,Cordis Corporation,Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).,PRODUCTION CONTROLS: Process Control,"Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition.Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",145,145 units,Nationwide distribution.,Terminated,"August 11, 2010",210,145,Not_Computer,N/A,N/A,N/A
Z-0631-2010,53980,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software),GE ApexPro Oximeter ,2,"January 13, 2010", 2010,General Electric Medical Systems Information Technology,"Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters:1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do",DESIGN: Labeling Design,"Consignees were sent on 10/27/09 a GE Healthcare ""Urgent Medical Device Correction"" letter dated September 25, 2009. The letter was addressed to Risk Manger, Chief of Nursing, director of Biomedical Engineering. The letter described the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. ""ApexPro Telemetry System Operator's Manual Supplement for SpO2 was enclosed with the letter.",Contact the recalling firm for information,8305,8305,"Worldwide distribution: USA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VENEZUELA.",Terminated,"May 24, 2012",862,8305,Not_Computer,Physical Safety Hazards,N/A,Other
Z-0622-2010,53981,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.",Foundation Baseplate,2,"January 13, 2010", 2010,"Encore Medical, Lp",Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.",N/A,17,17,"Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.",Terminated,"May 05, 2010",112,17,Not_Computer,N/A,N/A,N/A
Z-0609-2010,53994,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.",Boston Scientific COGNIS,2,"January 13, 2010", 2010,Boston Scientific CRM Corp,"BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise",DESIGN: Device Design,"Boston Scientific CRM issued an ""Urgent Medical Device Correction"" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available.For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422, or European Technical Services at +32-2-416-7222.",N/A,39873,"39,873","Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.",Terminated,"November 06, 2012",1028,100084,Not_Computer,N/A,N/A,N/A
Z-0637-2010,53890,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4"" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.",Gyrus ACMI PKS Seal Open Forceps.,2,"January 14, 2010", 2010,Gyrus ACMI Corporation,"Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product sh",PRODUCTION CONTROLS: Environmental Control,"An Urgent Medical Device Recall letter, dated 08/15/09 was sent to customers notifying them of the issue. The letter identified affected product, asked that they cease further use, remove affected devices from stockrooms, contact Gyrus ACMI customer service for a return goods authorization and return product to Gyrus ACMI at no charge. A reply form is also asked to be returned to Gyrus ACMI via fax.Questions and requests for a Return Goods Authorization are directed to Gyrus ACMI customer service at 1-888-524-7266.",Contact the recalling firm for information,93665,"93,665 total (63,418 US, 30,247 OUS)","US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.",Terminated,"March 06, 2012",782,93665,Not_Computer,N/A,N/A,N/A
Z-0642-2010,54020,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,PMA,"VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously.Indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures.",VNS Therapy Demipulse Generator and VNS Therapy Demipulse Duo Generator,2,"January 14, 2010", 2010,"Cyberonics, Inc","Under certain conditions, product's battery life can be reduced.",OTHER/UNDETERMINED: Pending,"Firm sent ""An Important Safety Notice"" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.",Contact the recalling firm for information,8667,"8,667 units","Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Panama, Portugal, Republic of Germany, Saudi Arabia, Sweden, Slovakia, Spain, Switzerland, Taiwan, UAE, United Kingdom, and Venezuela.",Terminated,"July 24, 2012",922,8667,Battery,N/A,Notification,Safety Notice/Insructions
Z-0630-2010,54000,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.",CLEARGLIDE PRECISION BIPOLAR DEVICE,2,"January 14, 2010", 2010,"Sorin Group USA, Inc.",Vessel clamping device may break during use.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Consignees were notified by ""Urgent Field Safety Notice"" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.",N/A,756,756 units,"Worldwide Distribution -- United States, Australia, Canada and Italy.",Terminated,"October 04, 2010",263,5817,Not_Computer,N/A,N/A,N/A
Z-0643-2010,53755,"culture media, enriched",KZI,Enriched culture medium.,Microbiology,Microbiology,510(K) Exempt,"BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (ID) tests.",BBL Brain Heart Infusion (BHI),3,"January 15, 2010", 2010,Becton Dickinson & Co.,In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.,PRODUCTION CONTROLS: Equipment Maintenance,"The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908.",N/A,144,144 boxes,"Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.",Terminated,"February 12, 2010",28,144,Not_Computer,N/A,N/A,N/A
Z-0646-2010,53945,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206.Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.",Biomet Vanguard Instruments LockOn Femoral Impactor,2,"January 15, 2010", 2010,"Biomet, Inc.",The locking hook tabs may fracture and fragments remain in the patient post-operatively.,DESIGN: Device Design,"Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the ""FAX Back Response Form"" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.",N/A,92,92,"Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.",Terminated,"October 18, 2010",276,92,Not_Computer,N/A,N/A,N/A
Z-0652-2010,53960,"connector, airway (extension)",BZA,Airway connector.,Anesthesiology,Anesthesiology,510(K) Exempt,"Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709",Hudson RCI One Way Valve,2,"January 15, 2010", 2010,Telefelx Medical,"Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. Each of these valves demonstrate the appropriate direction with a red arrow.The reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665.If the red arrows are not followed, the valve may be placed in the circuit in the wrong",PRODUCTION CONTROLS: Packaging,"Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained.Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990.",Contact the recalling firm for information,2450,2450 eaches,"CA, IL, NE, NJ, TX, VA, WI and Canada.",Terminated,"August 11, 2010",208,2450,Not_Computer,N/A,N/A,N/A
Z-0644-2010,54042,"culture media, antimicrobial susceptibility test, mueller hinton agar/broth",JTZ,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS.The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).",remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin,2,"January 15, 2010", 2010,"Remel, Inc",The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).",Contact the recalling firm for information,267,267 units,Nationwide.,Terminated,"July 12, 2011",543,267,Not_Computer,N/A,N/A,N/A
Z-0641-2010,53968,spinal vertebral body replacement device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case.Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470.The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.",BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE,2,"January 15, 2010", 2010,"Orthofix, Inc",The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A notification letter dated November 19, 2009 was sent to customers via Federal Express. The letter described the recalled product (PILLAR SA Implant Insertion Instrument, 49-1100) and problem and actions for customers to take. The affected product, PILLAR SA lmplant lnsertion lnstrument, 49-1100 is in the PILLAR SA set (set part number 49-0021) which was shipped to customers. An enclosed attachment provide instructions on product removal and return. Customers were instructed to complete the enclosed Tracking and Verification Form and fax to Orthofix Spinal Implants at 1-973-406-2912. A replacement instrument will be provided as available. In the interim, the Implant Inserter (Part Number 49-1000) included in the PILLAR SA UPE set (set number 49-0020) that was provided earlier this year may be used as an alternative to the affected product. For questions regarding the removal and return of the recalled product to Orthofix Spinal Implants, please contact your Account Services Representative.Direct other questions to the Regulatory Affairs Department at 1-973-406-2812. Direct product questions to Marketing at 1-862-221-1335 or Product Development at 1-973-406-2824.",Contact the recalling firm for information,29,29 instruments,"United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).",Terminated,"February 02, 2010",18,29,Not_Computer,N/A,N/A,N/A
Z-0651-2010,53940,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA)",Smiths Medical Medfusion infusion pump,2,"January 15, 2010", 2010,"Smiths Medical ASD, Inc.","Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion¶_ Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so",DESIGN: Device Design,"An Urgent Medical Device Recall letter, dated November 16, 2009, was sent to customers beginning November 16, 2009. The letter described the issue, identified affected devices, and asked that affected devices be returned to Smiths Medical to be inspected, repaired, if necessary, and returned back to medical facility. A Confirmation Form is also asked to be completed and returned to Smiths Medical.To return Pumps or for questions regarding this Urgent Recall Notice, please contact Smiths Medical Customer Service Department at 1~866-270-7060.Please report any issues with these Pumps please contact Smiths Medical Technical Customer Service Department at 1866-216-8806.",Contact the recalling firm for information,43,43,"AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates.",Terminated,"December 18, 2011",702,5436,Not_Computer,N/A,N/A,N/A
Z-0647-2010,53779,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"Spacelabs Model 91367 SL 2200 Compact MonitorSpacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.",Ultraview SL 2200 ,2,"January 19, 2010", 2010,"Spacelabs Healthcare, Incorporated",Potential for monitor to shut down and not being able to power on again.,DESIGN: Component Design/Selection,"On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.",Contact the recalling firm for information,422,422 units,Worldwide Distribution,Terminated,"July 21, 2011",548,3413,Not_Computer,N/A,N/A,N/A
Z-0656-2010,54036,"accessories,arthroscopic",NBH,Arthroscope.,Orthopedic,Orthopedic,510(K) Exempt,Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair.Catalog Number: SMB000101,Tournier Arthro Tunneler,2,"January 19, 2010", 2010,TAG Medical Corp.,Device failed to deploy the distal loop,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009.",N/A,60,60 UNITS,Nationwide,Open,N/A,N/A,60,Not_Computer,N/A,N/A,N/A
Z-0655-2010,53199,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.","Complete SE Biliary Stent System, SC680L (6 mm x 120 mm)",2,"January 19, 2010", 2010,Medtronic CardioVascular,Mislabeling-- A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Medtronic, Inc. issued an ""Urgent - Voluntary Medical Device Recall"" communication dated July 17, 2009 asking consignees to segregate labeled lot numbers until a representative from the firm arrived to retrieve the products.For further information, contact your local Medtronic representative or call Medtronic, Inc. at 1-707-525-0111.",N/A,20,20 units,"Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.",Terminated,"June 21, 2010",153,20,Not_Computer,N/A,N/A,N/A
Z-0004-2010,53491,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.,GE OEC 9900ESP Elite,2,"January 20, 2010", 2010,Ge Healthcare,A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.",N/A,1411,1411 units total,Nationwide and Canadian Distribution,Terminated,"April 23, 2012",824,1411,Software,Alarm/Message,Notification,Safety Notice/Insructions
Z-0577-2010,54019,"laser, ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(k),"Ellex Motorised Safety Filter, Zeiss; Model number 6339585.Intended for photocoagulation.",Ellex Motorised Safety Filter,2,"January 20, 2010", 2010,Ellex Medical Pty Ltd,Potential for two screws important in the design of the safety filter to come loose.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.,N/A,200,200 units total,Worldwide Distribution.,Terminated,"September 07, 2012",961,200,Not_Computer,N/A,N/A,N/A
Z-0645-2010,53164,electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(k),"GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM.The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to beused by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.",MAC 800 RESTING ECG ANALYSIS SYSTEM,2,"January 21, 2010", 2010,"GE Medical Systems, LLC","GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.",DESIGN: Software Design,"Consignees were sent a GE Healthcare ""Urgent Medical Device Correction"" letter dated December 10, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.GE Healthcare will provide a software upgrade to resolve the issue. A GE Healthcare representative will contact customers to schedule implementation of the correction when it is available for installation at the customer facility.Direct questions to the GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.",N/A,567,567,"Worldwide Distribution -- United States (CA, CO, CT, FL, IL,MD, NY, NC, OH, TN, TX, WA and WI), UNITED KINGDOM, UNITED ARAB EMIRATES, THAILAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, ROMANIA, QATAR, PORTUGAL NETHERLANDS, LITHUANIA, KOREA, JAPAN, ITALY, ISRAEL, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, CZECH REPUBLIC, CROATIA, CHINA, BAHRAIN, AUSTRIA and AUSTRALIA.",Terminated,"August 06, 2013",1293,567,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0336-2010,53704,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Imager"" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland:Material Number (OUTER CARTON LABEL OF 5pk) /Material Number (INNER-POUCH LAB LE FOR EACH SINGLE CATHETER)/ Catalog Number /Material Description:M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5;M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5;M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5;M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5;M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5;M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5;M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5;M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5;M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5;M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5;M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5;M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5;M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5;M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5;M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5;M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5;M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5;M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5;M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5;M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5;M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5;M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5;M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5;M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5;M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5;M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5;M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 andM001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5:M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5;M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5;M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5;M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5;M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5;M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5;M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5;M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5;M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5;M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5;M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5;M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5;M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035;M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035;M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035;M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035;M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035;M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035;M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035;M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 andM001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035.Imager "" II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with",IMAGER II ANGIOGRAPHIC CATHETER,2,"January 21, 2010", 2010,Boston Scientific Corporation,The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.,PRODUCTION CONTROLS: Packaging Process Control,"Two Boston Scientific ""Urgent Voluntary Medical Device Recall"" letters were sent to consignees on October 29, 2009. The letters described the problem and the affected product. Consignees were instructed to cease use and distribution of the product and to complete and return the Account Reply Verification Tracking Form. The first letter with the heading, ""Boston Scientific IMAGER II Angiographic Catheter (Peripheral Intervention)"", was addressed to the Risk Manager/Field Action Contact. The second letter with the heading, ""Imager II Urology Torque Catheters"" was addressed to the Risk/Materials Manager. Direct questions about the recall to your local Sales Representative or Boston Scientific Corporation by calling at 1-763-494-1700.",N/A,8845,8845 boxes (5/box) US ; 3202 boxes (5/box) OUS,"Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.",Terminated,"December 12, 2011",690,8919,Not_Computer,N/A,N/A,N/A
Z-0587-2010,54153,"laser, dental, soft tissue",NVK,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,Dental,510(k),"SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA.Intended use: Dentistry.",SoftLase Pro Family of Lasers,2,"January 21, 2010", 2010,Zap Lasers LLC,"The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Zap Lasers sent a letter to affectedcustomers stating that their SoftLase diode laser is eligible for a compliance maintenance upgrade. The upgrades will be free of charge and will enhance the safety of the laser. Customers are encouraged to call the firm's customer service line at 888-876-4547 to schedule their RMA number and shipping instructions. The letter also lists the upgrades that are needed.,No consumer action necessary,1375,1375 units,Worldwide Distribution to 1397 consignees,Terminated,"May 25, 2010",124,1375,Not_Computer,N/A,N/A,N/A
Z-0495-2010,53883,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118.Generating head and whole body CT images of human subjects",Infinia with Hawkeye 4 ,2,"January 21, 2010", 2010,"GE Medical Systems, LLC",Failure to provide the complete User Manualinformation.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.,N/A,343,343 total,Nationwide Distribution,Terminated,"February 04, 2012",744,343,Not_Computer,N/A,N/A,N/A
Z-0613-2010,53941,"centrifuge, hematocrit",GKG,Hematocrit measuring device.,Hematology,Hematology,510(K) Exempt,Haematokrit 24 Centrifuge with 2050 RotorTYP #2075 and TYP #2075-01.Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.,Hettich Centrifuge Rotor,1,"January 21, 2010", 2010,Hettich Instruments Management I,"Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.",DESIGN: Device Design,"Hettich Instruments notified Distributors by email on 11/21/09, to the Request For Urgent Action notifications, dated 11/23/2009. There is a description of how to identify a recalled rotor as well as a description of the replacement metal rotor that is to be used in place of the list of centrifuges affected by this recall. Customers are to cease using the setup described and contact their distributor or the firm. The firm will replace the plastic housing with a metal housing. Questions should be directed to 978-232-3957.",N/A,46,46 units total,"Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.",Terminated,"October 25, 2011",642,46,Not_Computer,N/A,N/A,N/A
Z-0638-2010,54203,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE).",Exel Huber Needle,1,"January 22, 2010", 2010,Exelint International Co.,"Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue",DESIGN: Device Design,Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: info@exelint.com.,N/A,849000,"849,000",US (VA TX NV KY OH NH MS NY OH NM DE WA AZ IL PA OR CO FL GA LA UT MI WI NV CA NJ MO IA) and Canada.,Terminated,"June 06, 2011",500,2010360,Not_Computer,N/A,N/A,N/A
Z-0662-2010,53802,"bed, flotation therapy, powered",IOQ,Powered flotation therapy bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.",AC Power Cords,2,"January 25, 2010", 2010,"KCI USA, Inc.",Power cords may crack and fail inside plug with potential for fire hazard.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Kinetics Concepts, Inc. (KCI) issued an ""Urgent Medical Device Correction"" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product. For further information, contact KCI's technical support team at 1-800-275-4524 option #3.",N/A,4637,"4,637 units",Nationwide and Canada,Terminated,"January 21, 2011",361,79267,Not_Computer,N/A,N/A,N/A
Z-0670-2010,53955,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F","Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve",2,"January 26, 2010", 2010,"B. Braun Medical, Inc.","System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers.Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920.International customers, please call (610) 691-5400.",Contact the recalling firm for information,3792,3792 units,"The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.",Terminated,"February 14, 2011",384,5435249,Not_Computer,N/A,N/A,N/A
Z-0653-2010,53554,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Edwards Lifesciences Aquarius System Model GEF09800.,EDWARDS AQUARIUS HEMOFILTRATION SYSTEM,1,"January 27, 2010", 2010,"Edwards Lifesciences, Llc","There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injuries or death.",TRAINING: Employee Error,"Edwards is continuing a field corrective action related to the possibility of fluid imbalance when using the Aquarius. In order to mitigate some of the risk associated with this problem, Edwards sent notifications to consignees advising of mitigation steps. Consignees were provided: a description of the affected product, problem, and potential hazard; advice on action to be taken; and revised device labeling. Additionally, consignees were notified of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Although Edwards does not believe there is a need to stop using the Aquarius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the use of the device Edwards first provided some of this information to consignees in a Field Safety Notice on March 16, 2009. On January 11, 2010, Edwards provided an Urgent Product Recall letter to consignees which updated and expanded the earlier communication. The FDA classified this as a Class I recall.",N/A,135,135 units,Nationwide Distribution.,Terminated,"January 18, 2012",721,135,Software,Physical Safety Hazards,Software update,Software Update
Z-0604-2010,53692,"densitometer, bone",KGI,Bone densitometer.,Radiology,Radiology,510(k),"DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.",DPXBravo/Duo,2,"January 27, 2010", 2010,Ge Healthcare,Failure to properly pre-indicate the technique factors to be used during a patient scan.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.",N/A,1764,"1,764 total",Nationwide Distribution,Terminated,"December 31, 2011",703,1764,Not_Computer,N/A,N/A,N/A
Z-0748-2010,51104,cardiovascular procedure kit,OEZ,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,Enforcement Discretion,"Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.Intended for fluid management convenience when catheterization is required.",Cath Procedure Tray,2,"January 29, 2010", 2010,"Merit Medical Systems, Inc.",A manufacturing defect may prevent adequate sterilization of the entire device.,PRODUCTION CONTROLS: Packaging Process Control,"Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm.For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.",N/A,157,157 units,Worldwide Distribution -- United States ( PA and TX) and Japan.,Terminated,"June 16, 2011",503,910,Not_Computer,N/A,N/A,N/A
Z-0749-2010,53607,"stent, carotid",NIM,N/A,N/A,Cardiovascular,N/A,"RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851.Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.",RX ACCULINK Carotid Stent System,2,"January 29, 2010", 2010,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,"The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.",PRODUCTION CONTROLS: Process Control,"Abbott Vascular's Sales Representatives initiated customer contact with the identified consignees beginning October 1, 2009 . They provided the consignees with a recall letter with attached fax-back effectiveness check form. The recall letter instructed the consignees to work with their local account representative to review their inventory, complete the attached recall effectiveness check form and return identified products to Abbott Vascular.For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.",N/A,22,22 units,Nationwide Distribution.,Terminated,"September 27, 2011",606,22,Not_Computer,N/A,N/A,N/A
Z-0725-2010,54149,"apparatus, autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(k),"Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar, sterile, Stryker Instruments, Kalamzoo, MI; REF 225-28-514.Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.","Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar,",2,"January 29, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,The product may not be sterile due to package not being intact.,PRODUCTION CONTROLS: Packaging Process Control,"Stryker issued a ""Medical Device Recall Notification"" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm.For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808.",Contact the recalling firm for information,79617,79617 all products,Worldwide Distribution.,Terminated,"October 25, 2010",269,79617,Not_Computer,N/A,N/A,N/A
Z-0761-2010,54138,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USAStryker Orthopaedics, Mahwah, NJ 07430.The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.",TRIATHLON TS KNEE SYSTEM,2,"February 01, 2010", 2010,Stryker Howmedica Osteonics Corp.,"Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Urgent Product Recall"" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.",N/A,9,9,"Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada.",Terminated,"August 28, 2012",939,45,Not_Computer,N/A,N/A,N/A
Z-0755-2010,53749,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151","MPS Acacia Extension Set, Luer access extension",1,"February 02, 2010", 2010,Becton Dickinson Medical Systems,"Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType;_ID=1&BusinessCode;=20001&d;=BD+Worldwide&s;=&dTitle;=&dc;=&dcTitle;=.",No consumer action necessary,45350,"45,350 units",Nationwide distribution.,Terminated,"October 19, 2010",259,3947780,Not_Computer,N/A,N/A,N/A
Z-0779-2010,54141,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.",Biomet bone mulch screw,2,"February 02, 2010", 2010,"Biomet, Inc.","The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.",TRAINING: Employee Error,"Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.",N/A,169,169,"Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.",Terminated,"October 22, 2010",262,169,Not_Computer,N/A,N/A,N/A
Z-0764-2010,54172,"dilator, vessel, for percutaneous catheterization",DRE,Vessel dilator for percutaneous catheterization.,Cardiovascular,Cardiovascular,510(k),"Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200.For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.",Percutanious Cathether Introducer Set,3,"February 02, 2010", 2010,"Argon Medical Devices, Inc",One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.,OTHER/UNDETERMINED: Pending,"Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or Sarah.Larson@argonmedical.com.",N/A,500,500 units,Nationwide Distribution -- State of CA.,Terminated,"July 14, 2010",162,500,Not_Computer,N/A,N/A,N/A
Z-0661-2010,54193,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.",Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port,1,"February 02, 2010", 2010,Thomas Medical Products Inc,Radiopaque sheath tip may fracture,DESIGN: Component Design/Selection,GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010.,Contact the recalling firm for information,60982,"60,982 units",Nationwide.,Terminated,"November 01, 2010",272,60982,Not_Computer,N/A,N/A,N/A
Z-0668-2010,54178,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4.For head, whole body, cardiac and vascular X-ray Computed Tomography applications.",Discovery CT 750 HD,2,"February 02, 2010", 2010,Ge Healthcare,Failure to properly document the CTDI in the Technical Reference or User Manual.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.",N/A,111,111 units total,"Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.",Terminated,"December 10, 2011",676,111,Not_Computer,N/A,N/A,N/A
Z-0782-2010,53947,"pack, hot or cold, water circulating",ILO,Water circulating hot or cold pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"TempPad¶_ Cold Therapy Pad.The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.",TempPad Cold Therapy Pad .,2,"February 04, 2010", 2010,Cincinnati Sub-Zero Products Inc,"Product is labeled as ""Sterile"". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.",OTHER/UNDETERMINED: Pending,"On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.",N/A,677,"8,872 cartons of ten + 677 each (89,397 total)","Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.",Terminated,"January 25, 2012",720,9967,Not_Computer,N/A,N/A,N/A
Z-0608-2010,54226,suntan lamp,REG,N/A,N/A,N/A,N/A,"Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc.Use: feet tanner.",Solafeet Foot Tanner Model ST400,2,"February 16, 2010", 2010,"Solafeet, Inc.",Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or info@solafeet.com.",N/A,72,72 units,Nationwide Distribution,Terminated,"August 21, 2012",917,72,Not_Computer,N/A,N/A,N/A
Z-0789-2010,54274,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ.Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.",Stryker Xia Precision System,2,"February 16, 2010", 2010,Stryker Spine,"Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.",DESIGN: Packaging Design/Selection,"Stryker Spine issued an ""Urgent Product Recall"" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product.For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.",N/A,2727,2727 total - all sizes.,Nationwide distribution.,Terminated,"September 06, 2012",933,2727,Not_Computer,N/A,N/A,N/A
Z-0794-2010,50099,reamer,HTO,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430.Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.",Reamer THandle,2,"February 17, 2010", 2010,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.,DESIGN: Device Design,"Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement.For further information, contact Stryker at (201) 831-5825.",N/A,22,22,"Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.",Terminated,"February 18, 2010",1,295,Not_Computer,N/A,N/A,N/A
Z-0795-2010,50101,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics.Intended for cemented application to replace the articulating surface of the distal femur.",Scorpio PS Femoral Waffle and LFIT,2,"February 19, 2010", 2010,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Stryker Orthopaedics issued an ""Important Product Removal"" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm.For further information, contact Stryker Orthopaedics at (201) 831-5825.",N/A,7,7,Worldwide Distribution -- United States and France.,Terminated,"February 19, 2010",0,7,Not_Computer,N/A,N/A,N/A
Z-0796-2010,54198,"gauge, depth",HTJ,Depth gauge for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Depth Gauge; Catalog Number: 703707;Stryker Trauma AG, CH 2545 Selzach;Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.This product is sold separately or as part of Kit # 990256.The depth gauge is an instrument in the VariAx Elbow System. Depth gauges are tools used intra-operatively, to aid in correct screw selection. They can be used with a plate, or directly on bone.",Depth Gauge,2,"February 19, 2010", 2010,Stryker Howmedica Osteonics Corp.,The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.,PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters, dated December 22, 2009, were sent to all Stryker Branches/Agencies. Letters were also sent to hospitals and surgeons that use the VariaAx Elbow System were also notified. All letters were sent by Federal Express. The letters identified the affected product, stated the issue, and the hazards involved. It also asked customers to examine their inventory and hospital locations to identify affected products. All affected products are to be retrieved and returned to their branch or agency warehouse for reconciliation. All products should be reconciled on the attached Product Accountability Form and a copy should be faxed to 201-831-6069 within 5 days of receipt of the notice. Follow the instructions for shipping the affected product back to the firm. Questions should be directed to 201-972-2100.",N/A,49,49,Nationwide Distribution,Terminated,"March 16, 2010",25,49,Not_Computer,N/A,N/A,N/A
Z-0780-2010,53989,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),MRI Eclipse 1.5T System Model #781230.The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.,"INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100",2,"February 19, 2010", 2010,Philips Medical Systems (Cleveland) Inc,Polymeric RF connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the RF trap assembly located below the connector and flame rating of the connector block material.,OTHER/UNDETERMINED: Pending,"An ""Urgent-Field Safety Notice"" dated December 4, 2009 was issued via certified mail to customers. The notification letter described the affected product, problem, hazard involved and action to be taken by customer. The customer will ensure to maintain frequent contact with patients during scanning and that the patient comfort kit is installed for all patient studies. The Customer will be visited by a Philips Service Representative to inspect their MRI System and install the newly remanufactured RF Connector Block. Additionally, step-by-step trap/cable installation instructions including pictures are being drafted to ensure correct installation of cabling. If you need any further information or support concerning this issue, please contact your local Philips representative or 1-800-722-9377.",N/A,290,290 units,"Worldwide distribution- United states: (AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, LA, MA, MD, ME, MN, MO, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA & WI), ARGENTINA, BRAZIL, CANADA, CHINA, CYPRUS, FRANCE, GERMANY, GREECE, ITALY, JAPAN, KOREA, NEW ZEALAND, PAKISTAN, POLAND, RUSSIA, SWITZERLAND, TAIWAN & UNITED KINGDOM.",Terminated,"September 19, 2012",943,290,Not_Computer,N/A,N/A,N/A
Z-0798-2010,54233,"stimulator, nerve",ETN,Surgical nerve stimulator/locator.,Ear Nose & Throat,Ear Nose & Throat,510(k),2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)For use as a Surgical stimulator/locator for recurrent laryngeal nerve.,Dragonfly 2Channel Laryngeal Surface Electrode,2,"February 22, 2010", 2010,Neurovision Medical Products Inc,"This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c",PRODUCTION CONTROLS: Process Control,"URGENT RECALL: Medical Device Letter dated 1/7/10.The letter identified the affected product and provided a list of necessary actions for customers to take.The customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter.This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor.Please complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.",N/A,4143,4143,Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI),Terminated,"April 21, 2011",423,4143,Hardware,Device Operation,Instructions,Safety Notice/Insructions
Z-0811-2010,54005,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Biphasic LIFEPAK 12 defibrillator / monitor.,LIFEPAK 12 DEFIBRILLATOR/MONITOR,2,"February 22, 2010", 2010,"Physio Control, Inc.",Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices.Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.,Contact the recalling firm for information,1718,1718,"Distributed domestically and internationally to hospitals, clinics, etc.Foreign distribution to the following countries:Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.",Terminated,"August 08, 2013",1263,1718,Hardware,Treatment/Delivery/Therapy,Repair,Repair
Z-0808-2010,54195,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28.",LifeShield Primary SYMBIQ Set,2,"February 22, 2010", 2010,Hospira Inc.,There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.,PRODUCTION CONTROLS: Process Control,"Hospira Medical issued an ""Urgent Device Recall"" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.",N/A,47904,"47,904 sets",Minnesota and Utah,Terminated,"July 20, 2011",513,49440,Not_Computer,N/A,N/A,N/A
Z-0810-2010,54074,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile.BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.",Locator Restorative Abutment,2,"February 22, 2010", 2010,"Biomet 3i, LLC",Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.,PRODUCTION CONTROLS: Process Control,"Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.",Contact the recalling firm for information,97,97,"Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.",Terminated,"December 15, 2010",296,97,Not_Computer,N/A,N/A,N/A
Z-0806-2010,54485,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.Intended for palliation of malignant neoplasms in the biliary tree.",Endotek AlimaxxB Uncovered Biliary Stent ,2,"February 22, 2010", 2010,"Merit Medical Systems, Inc.",Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm. For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228.",N/A,51,51 units,"Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.",Terminated,"April 27, 2010",64,165,Not_Computer,N/A,N/A,N/A
Z-0813-2010,52754,activated whole blood clotting time,JBP,Activated whole blood clotting time tests.,Hematology,Hematology,510(k),Abbott i-STAT ACT Celite Cartridges.In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.,iSTAT ACT Celite Cartridges,2,"February 23, 2010", 2010,Abbott Point of Care Inc.,Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.,MISBRANDING: Labeling False and Misleading,"Abbott Point of Care issued an ""Important Product Information"" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product.For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.",N/A,696675,"696,675 Cartridges",Worldwide distribution.,Terminated,"May 18, 2010",84,1807450,Not_Computer,N/A,N/A,N/A
Z-0819-2010,53025,"system, immunomagnetic, circulating cancer cell, enumeration",NQI,Immunomagnetic circulating cancer cell selection and enumeration system.,Immunology,Pathology,510(k),"CellSearch Circulating Tumor Cell Kit (Epithelial) IVDREF 7900001Veridex LLC, a Johnson & Johnson Company.",CellSearch Circulating Tumor Cell Kit (Epithelial) IVD,2,"February 23, 2010", 2010,"Veridex, LLC",Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.,OTHER/UNDETERMINED: Pending,"Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).",N/A,1641,"1641 in US, 380 internationally.","Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.",Terminated,"July 18, 2012",876,1641,Not_Computer,N/A,N/A,N/A
Z-0817-2010,53553,"kit, screening, staphylococcus aureus",JWX,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK.Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.",Oxoid dry Spot Staphytect Plus,2,"February 23, 2010", 2010,"Remel, Inc",The products may give false positive results with some non-Staphylococcus aureus strains,PRODUCTION CONTROLS: Process Control,"Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.",N/A,27,27 kits,"Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.",Terminated,"April 25, 2012",792,77,Not_Computer,N/A,N/A,N/A
Z-0812-2010,53335,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA.The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.","ISTAT PORTABLE CLINICAL ANALYZER, MODEL 300",3,"February 24, 2010", 2010,Abbott Point of Care Inc.,The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.,PRODUCTION CONTROLS: Labeling Mix-Ups,"An ""Urgent Recall Notice"" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.",Contact the recalling firm for information,3918,"3,918 analyzers",Worldwide Distribution (including the United States).,Terminated,"May 21, 2010",86,3918,Not_Computer,N/A,N/A,N/A
Z-0827-2010,54184,"culture media, antimicrobial susceptibility test, excluding mueller hinton agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.,RambaChrom KPC M/N 11500,2,"February 24, 2010", 2010,Gibson Laboratories Inc,Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.,TRAINING: Employee Error,"On 12/10/2009 the firm sent letters to their customers notifying them of the problem and instructing them to replace insert with a new one. They were also instructed to complete and return a ""Recall Response Form."".",N/A,3440,"3,440 units","Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.",Terminated,"September 21, 2012",940,18770,Not_Computer,N/A,N/A,N/A
Z-0823-2010,54271,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile;Manufactured by Stryker Spine, SA, Cestas, France.Distributed in the USA by Stryker Spine, Allendale, NJIntended for use in the noncervical spine.",XIA 3 Polyaxial Screw,2,"February 24, 2010", 2010,Stryker Spine,"The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.",PRODUCTION CONTROLS: Process Control,"Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.",N/A,21,21,"Nationwide Distribution -- IL, MO, DA, MA and CO.",Terminated,"September 06, 2012",925,21,Not_Computer,N/A,N/A,N/A
Z-0826-2010,54197,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left",Foundation Knee Revision Baseplate,2,"February 24, 2010", 2010,"Encore Medical, Lp",Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.,PRODUCTION CONTROLS: Process Control,Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.,"Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",17,17,"TX, FL, GA, CA, AZ, Japan",Terminated,"September 24, 2010",212,17,Not_Computer,N/A,N/A,N/A
Z-0825-2010,54238,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.,Synthes In Situ Bender Cutter Kit Sterile Wide,2,"February 24, 2010", 2010,"Synthes USA (HQ), Inc.",There is the potential for the bender/cutter attachment to continue heating after release of the powerbutton. There is potential for patient and/or staff injury if continuous heating is unrecognized.,OTHER/UNDETERMINED: Pending,"An ""Urgent: Medical Device Recall"" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.",No consumer action necessary,187,187 units,Nationwide Distribution.,Terminated,"October 06, 2010",224,187,Not_Computer,N/A,N/A,N/A
Z-0822-2010,53702,"cells, animal and human, cultured",KIR,Cultured animal and human cells.,Hematology,Pathology,510(K) Exempt,"Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each.Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents.",Rabbit Kidney Culture,3,"February 24, 2010", 2010,Diagnostic Hybrids Inc,"During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).",PRODUCTION CONTROLS: Process Control,"Diagnostic Hybrids issued a ""Product Notification"" letter dated January 23, 2009 in addition to verbal communication of the affected product beginning January 21, 2009. The firm requested that all affected product be discarded /destroyed and not use for diagnostic testing. Consignees were asked to complete and return a Fax-Back form.For further information, contact Diagnostic Hybrids Technical Services at 1-866-344-3477 or 1-740-589-3300.",N/A,1127,1127 units,"Worldwide Distribution -- United States (CA, FL, GA, MA, MO, NY, NJ, TN, TX and VA), Ontario Canada and Manitoba Canada.",Terminated,"September 21, 2010",209,1127,Not_Computer,N/A,N/A,N/A
Z-0846-2010,54249,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number: 18191230S;Sterile, TI Alloy;Stryker Trauma GmbH, Germany;Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.",T2 Ankle Arthrodesis Nail,2,"February 24, 2010", 2010,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.,PRODUCTION CONTROLS: Packaging,"Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.",N/A,702,"702 total, all sizes.",Nationwide Distribution.,Terminated,"August 06, 2012",894,702,Not_Computer,N/A,N/A,N/A
Z-0853-2010,53785,"transmitters and receivers, electrocardiograph, telephone",DXH,Telephone electrocardiograph transmitter and receiver.,Cardiovascular,Cardiovascular,510(k),"Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.",Cybernet Medical MedStar Telemedicine System,2,"February 25, 2010", 2010,Cybernet Systems Corp.,"A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.",DESIGN: Component Design/Selection,"The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.",N/A,24,24,"Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.",Terminated,"October 22, 2010",239,88,Computer,N/A,N/A,N/A
Z-0850-2010,48978,"slide stainer, automated",KPA,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series.",Coulter LH SlideMaker,2,"February 25, 2010", 2010,Beckman Coulter Inc,Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the barcode affixed to a slide made by the Coulter GEN*S and LH SlideMaker does not match the text.,N/A,"An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to: 1. Only use upper case alpha characters in the Sample Identifier2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code. Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.",N/A,843,843,Worldwide Distribution -- USA and Canada.,Terminated,"November 29, 2011",642,847,Not_Computer,N/A,N/A,N/A
Z-0858-2010,53026,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521.Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk or mortality.",Dimension Flex Reagent Cartridge Cardiac TropininI,2,"February 25, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Tests exhibit falsely elevated results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,The recalling firm issued a Field Correction letter dated 3/2/07 informing user of the problem and to contact the firm at 800-241-0420 for replacements. Customers are to follow the precautions provided in the letter. Questions should be directed to Dade Behring Technical Assistance Center at 800-441-9250. The notification should be forwarded to anyone to whom the product may have been further distributed to.,Contact the recalling firm for information,9767,9767 cartons,"Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.",Terminated,"February 25, 2010",0,9767,Not_Computer,N/A,N/A,N/A
Z-0856-2010,53679,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1.In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.",Access Immunoassay Systems,2,"February 25, 2010", 2010,Beckman Coulter Inc.,"This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument",DESIGN: Software Design,"Beckman Coulter issued an ""Urgent: Product Corrective Action"" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved.For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.",Contact the recalling firm for information,377,377 Instruments,Worldwide Distribution -- United States and Canada.,Terminated,"May 07, 2012",802,377,Software,Alarm/Message,Instructions,Safety Notice/Insructions
Z-0859-2010,53810,"ldl & vldl precipitation, hdl",LBR,Lipoprotein test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry).For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.",Liquid HDL (PEG) Cholesterol Reagent Set,2,"February 25, 2010", 2010,"Pointe Scientific, Inc.",The firm initiated the recall due to the presence of visible contamination of the product.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by an Urgent: Medical Device Recall letter (sent by email, fax or through the mails) dated 11/10/09. The letter identified the affected product and instructed customers to immediately examine their inventory. If the product was further distributed their customers should be identified and notified of the recall. Customers are instructed to dispose of any product in stock. Questions should be directed to the Technical Support Department at 800-757-5313 or 734-487-8300.",N/A,379,379 sets,"Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.",Terminated,"February 11, 2011",351,625,Not_Computer,N/A,N/A,N/A
Z-0857-2010,54364,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341.Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.",EnVe Ventilator ,2,"February 25, 2010", 2010,"CareFusion 203, Inc.",CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.,DESIGN: Component Design/Selection,"CareFusion issued an ""Urgent Medical Device Recall notification"" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction.For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1.",N/A,9,9,MN,Terminated,"December 17, 2011",660,9,Not_Computer,N/A,N/A,N/A
Z-0870-2010,53800,"kit, identification, yeast",JXB,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of the organisms addressed by the RapID Yeast Plus System is given in the RapID Yeast Plus Differential Chart.RapID"" YEAST PLUS System, Catalog No. R8311007. 4 hour identification of yeast based on enzyme technology. Database includes over 40 taxa. Requires Inoculation Fluid, REF R8325106. CE, 20 Panels/Kit The responsible firm name on the product labeling is Remel, 12076 Santa Fe Dr., Lenexa, KS 66215-3594",ERIC (Electronic RapID Compendium) Version 1.0.77 ,3,"February 26, 2010", 2010,"Remel, Inc",There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and Candida dubliniensis. When using the,DESIGN: Software Design,"The firm issued an ""IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE"" dated October 29, 2009. After completion of the firm's investigation and risk assessment, Remel decided to notify customers of this situation and quarantine any remaining units on hand. The notification provided the consignees with instructions for obtaining and downloading the software patch. A response form was included with the recall letter and the consignee was asked to complete the form and return it to Remel.The consignees should contact the Technical Services Department at 800-255-6730 (USA) or 913-888-0939 (International), if they have inquiries concerning this advisory.",Contact the recalling firm for information,143,143 units of software,"Worldwide Distribution: USA, Europe and Canada",Terminated,"March 03, 2010",5,143,Software,Output/Calculation,Software update,Software Update
Z-0864-2010,53323,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA),Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System","Dimension Vista System CHEM 1 CAL, Catalog Number KC110",2,"February 26, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.",OTHER/UNDETERMINED: Pending,"An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.",N/A,1474,1474 Cartons,"Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.",Terminated,"December 13, 2010",290,1474,Not_Computer,N/A,N/A,N/A
Z-0861-2010,53341,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116.Safety IV administration set used to access surgically implanted vascular ports.",Huber Plus NonCoring Needle Safety Infusion Set,2,"February 26, 2010", 2010,Bard Access Systems,"After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Bard Access Systems, Inc. issued and ""Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall"" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.",N/A,4975,"4,975 units","Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.",Terminated,"May 14, 2010",77,5750,Not_Computer,N/A,N/A,N/A
Z-0865-2010,53483,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,i-STAT HL7 InterfaceThe HL7 Interface product is an accessory to the analyzer,Electronic Data Interchange,2,"February 26, 2010", 2010,Abbott Point of Care Inc.,"Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.",DESIGN: Software Design,"Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.",N/A,36,36,"Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.",Terminated,"July 01, 2010",125,36,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0868-2010,54237,"accessory equipment, cardiopulmonary bypass",KRI,Cardiopulmonary bypass accessory equipment.,Cardiovascular,Cardiovascular,510(K) Exempt,"IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.",IDEAL MAXPAC TOTAL SYSTEM ,3,"February 26, 2010", 2010,Medtronic Inc,"Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components inclu",EXPIRATION DATING: Incorrect or No Expiration Date,"Consignees were sent a Medtronic ""Urgent Medical Device Recall Notice"" dated December 14, 2009. The letter was addressed to ""Valued Customer."" The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, ""Medtronic Recall Certificate (FCA 1002)."" For additional information, contact the firm at 763-514-9605.",Contact the recalling firm for information,24,24,"CA, CO, JAPAN, CHINA.",Terminated,"April 20, 2011",418,36,Not_Computer,N/A,N/A,N/A
Z-0867-2010,53649,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA.Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).",Variant II Turbo Hemoglobin A1C Program,2,"February 26, 2010", 2010,Bio-Rad Laboratories Inc,"Product update kit CD rom will not upload. As a result, the device cannot be run.",OTHER/UNDETERMINED: Pending,"The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.",N/A,21,21 kits,"Worldwide Distribution -- USA, Hong Kong, and New Zealand.",Terminated,"December 17, 2010",294,21,Not_Computer,N/A,N/A,N/A
Z-0866-2010,54355,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),"EXXCEL Soft Standard Wall EPTFE Vascular Graft;D:8 mm: L: 50 mm straightMaquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470",EXXCEL Soft Standard Wall EPTFE Vascular Graft,2,"February 26, 2010", 2010,"Maquet Cardiovascular, LLC","Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.",Contact the recalling firm for information,18,18 units,"Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.",Terminated,"July 06, 2010",130,18,Not_Computer,N/A,N/A,N/A
Z-0895-2010,54487,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws¶_ Temperature Management Units: Models 850 and 875Bair Hugger¶_ Temperature Management Units: Models 500/OR, 505, 750 and 775Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.",BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850,2,"March 01, 2010", 2010,Arizant Inc,"Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws¶_ Temperature Management Units: Models 850 and 875Bair Hugger¶_ Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775Ranger¶_ Blood/Flui",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Urgent Medical Device Power Cord Recall"" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements).If you have any questions, please contact the Aziant at (877) 47-1487.",N/A,91917,"Total distributed for all devices: 84,537 US, 7,380 OUS.","Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.",Terminated,"April 19, 2012",780,91917,Not_Computer,N/A,N/A,N/A
Z-0871-2010,53768,"enzymatic esterase--oxidase, cholesterol",CHH,Cholesterol (total) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711.Intended to provide a quantitative measurement of total cholesterol in whole blood.",PTS Panels Cholesterol test strips,2,"March 01, 2010", 2010,"Polymer Technology Systems, Inc.",The memory chip was coded with incorrect product information.,PRODUCTION CONTROLS: Process Control,"Polymer Technology Systems, Inc. issued an ""Urgent - Field Correction"" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product.For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.",N/A,486,486 vials,Nationwide Distribution,Terminated,"October 20, 2010",233,486,Other,N/A,Replace,Remove or Replace
Z-0800-2010,54285,"system, peritoneal, automatic delivery",FKX,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has a PRO card, a small electronic data card, which stores information from the nurse or doctor and automatically sets up the system for the patient.",HomeChoice PRO Automated Peritoneal Dialysis Systems,1,"March 01, 2010", 2010,Baxter Healthcare Renal Div,"Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.",DESIGN: Labeling Design,"Urgent Product Recall letters dated January 8, 2010 were mailed to all Peritoneal Dialysis Clinicians on January 8, 2010 and letters dated January 12, 2010 to all Home Care Coordinators and Home Dialysis Patients on January 12, 2010, informing them of steps to take to help reduce or eliminate overfill, also referred to as Increased Intraperitoneal Volume, associated with HomeChoice/Homechoice Pro cyclers. Baxter Healthcare Corporation explained that they had received complaints of IIPV. The accounts were requested to complete and return the enclosed response form, indicating that they received and understood the notification, and if they still had a HomeChoice System or not. Any questions from the Home Care Coordinators are to be directed to the Baxter Global Technical Services at 1-800-553-6898.",Contact the recalling firm for information,32678,"32,678 units","Worldwide Distribution -- United States, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom and Venezuela.",Open,N/A,N/A,94076,Not_Computer,N/A,N/A,N/A
Z-0908-2010,49449,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.",Rubella IgG EIA test kit,3,"March 02, 2010", 2010,Bio-Rad Laboratories,Elevated optical density (OD) values with the kit Negative Control.,TRAINING: Employee Error,"An ""Urgent Product Correction"" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed.If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.",Contact the recalling firm for information,82,82 kits,"Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC",Terminated,"April 08, 2010",37,82,Not_Computer,N/A,N/A,N/A
Z-0921-2010,48648,"c-reactive protein, antigen, antiserum, and control",DCK,C-reactive protein immunological test system.,Immunology,Immunology,510(k),"IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280.Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.",IMMAGE CReactive Protein (CRP) Reagent,3,"March 02, 2010", 2010,Beckman Coulter Inc,"IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.",OTHER/UNDETERMINED: Pending,"Customers were sent Urgent: Product Corrective Action letters dates, 1/22/2008. The letter identified the issue, discussed the impact, and listed the following actions/resolution.* To eliminate the hook effect when using these lots, run CRP samples beginning with the 1:216 dilution. ~ A limited correlation of patient samples run in the 1:36 dilution compared to the same samples run in the 1:216 dilution verifies acceptable performance (there may be a shift of up to 0.8 mg/dL for samples between 1.0 and 8.0 mg/dL).* Controls run in the 1:216 dilution may recover differently than those run in the default 1:36 dilution. A limited number of control samples were also run in the 1:216 dilution.* The IMMAGE 800 system can be set to default to a non-standard dilution for each chemistry. Change CRP to a Non-Standard Dilution of 1:216 in the Setup section of the software. Detailed instructions for configuring a Non-Standard dilution as default are located in chapter 5 of the IMMAGE 800 Immunochemistry System Operations Manual.* The IMMAGE system does not allow resetting the default dilution of a chemistry. Instructions for running CRP samples beginning in a Non-Standard Dilution are enclosed.* Complete and return the enclosed response form within 10 days so we may maintain our records.Customers are to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. Questions regarding this letter should be directed to 800-854-3633 or customers can contact their local Beckman Coulter Representative.",No consumer action necessary,878,878 kits,"Nationwide Distribution -- Including states of AL, CA, CT, DC, FL, FL ,GA, HI, IA, IL ,IN, KY ,MA, MD, ME, MI, MO, NE, NJ, NY, OH, OR, PA, RI, TX, VA, WI, and WV.",Terminated,"July 02, 2012",853,878,Not_Computer,N/A,N/A,N/A
Z-0909-2010,50150,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ.Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.",Trident Acetabular Hip System,2,"March 02, 2010", 2010,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.",DESIGN: Process Design,"Stryker Orthopaedics issued an ""Important Market Withdrawal"" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm.For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.",N/A,594,594 units total - all products.,Worldwide Distribution -- United States and Canada.,Terminated,"March 03, 2010",1,594,Not_Computer,N/A,N/A,N/A
Z-0914-2010,50703,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.Intended to be used with the Access Immunoassay System to remove waste from the system.",Access Peristaltic Pump,2,"March 02, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab",OTHER/UNDETERMINED: Pending,"Beckman Coulter contacted consignees via ""Urgent Product Corrective Action"" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.",Contact the recalling firm for information,107,"107 (US), 7 (OUS)",Worldwide Distribution -- United States and Canada.,Terminated,"May 04, 2012",794,107,Not_Computer,N/A,N/A,N/A
Z-0876-2010,54228,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.",Mistique Infusion Catheter,2,"March 02, 2010", 2010,"Merit Medical Systems, Inc.",Infusion catheters may become brittle and break during use.,PRODUCTION CONTROLS: Storage,"All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.",N/A,59,59 units,"Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.",Terminated,"September 13, 2010",195,1389,Not_Computer,N/A,N/A,N/A
Z-0907-2010,54258,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),Aquilion One Whole Body X-Ray CT ScannerWhole body computed tomography scanning,Aquilion One Whole Body XRay CT Scanner,2,"March 02, 2010", 2010,Toshiba American Medical Systems Inc,"When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant enhancement and clinically useful images may not be obtained.",DESIGN: Device Design,"A corrective measure will be installed to prevent measures to avoid this phenomenon until corrective actions have been taken.Customers are advised: (1) When performing scanning in Prospective CTA or Target CTA studies with ECG gating, do not use W-Volume scanning but use Helical Scanning. (2) Please share this information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at facility (3) Please complete and return the attached form and fax it to the toll-free number at the top or by email to raffairs@tams.com. Contact: Paul Biggins.",N/A,28,28 units,Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA,Terminated,"September 12, 2012",925,28,Not_Computer,N/A,N/A,N/A
Z-0904-2010,53872,"photometric method, iron (non-heme)",JIY,Iron (non-heme) test system.,Clinical Chemistry,Clinical Chemistry,Enforcement Discretion,"Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry reagent for the quantitative determination of iron in serum.",Pointe Scientific Iron Buffer Reagent,2,"March 02, 2010", 2010,"Pointe Scientific, Inc.","Turbidity formation could occur, resulting in invalid test results being reported out.",DESIGN: Device Design,Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product. Please call 1-800-757-5313 if you have questions.,No consumer action necessary,443,116 sets plus 327 L,"Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela.",Terminated,"June 06, 2011",461,1480,Not_Computer,N/A,N/A,N/A
Z-0912-2010,54112,"acid, uric, uricase (colorimetric)",KNK,Uric acid test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.",Pointe Scientific Uric Acid (Liquid) Reagent Set,2,"March 02, 2010", 2010,"Pointe Scientific, Inc.",A process deviation occurred during the production of the R1 component which may affect its performance.,DESIGN: Device Design,"Pointe Scientific, Inc. issued an ""Urgent: Medical Device Recall"" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately.For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.",Contact the recalling firm for information,12,12 kits,"Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.",Terminated,"October 08, 2010",220,13,Not_Computer,N/A,N/A,N/A
Z-0915-2010,54359,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.",NextGen Knee ,2,"March 02, 2010", 2010,Zimmer Inc.,"The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.",PRODUCTION CONTROLS: Labeling Mix-Ups,The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.,N/A,14,14 units,US and Korea.,Terminated,"October 17, 2010",229,14,Not_Computer,N/A,N/A,N/A
Z-0916-2010,53431,"material, tooth shade, resin",EBF,Tooth shade resin material.,Dental,Dental,510(k),"Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.",Herculite Ultra,3,"March 02, 2010", 2010,Sybron Dental Specialties,"Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return.For further information, contact Kerr Customer Care at 1-800-537-7123.",Contact the recalling firm for information,442,442,Nationwide distribution,Terminated,"March 19, 2012",748,442,Not_Computer,N/A,N/A,N/A
Z-0922-2010,54124,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.",Rubella IgG ELISA Kit,3,"March 02, 2010", 2010,Diasorin Inc.,DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.,TRAINING: Employee Error,"Consignees were sent a DiaSorin Customer Notification letter dated December 16, 2009. The Letter was addressed to Customer. The letter described the product and the problem and indicated a replacement product will be provided. Requested consignees to complete the acknowledgement receipt form. For questions or concerns please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.",Contact the recalling firm for information,10,10 kits,"US distribution: CA, CT, MA, MD, IL, OR",Terminated,"March 29, 2012",758,10,Not_Computer,N/A,N/A,N/A
Z-0920-2010,54360,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.",8400 Capnocheck Capnometer,2,"March 02, 2010", 2010,"Smiths Medical PM, Inc.","Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary).The affected Electri-Cord AC power cords are eq",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a Smiths Medical PM, Inc letter dated January 12, 2010 starting on 1/15/10. The letter was addressed to Risk/Safety Managers, Distributors, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists, and Nursing, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem and products involved. It provided ""Advice on Action to be Taken by the User"" and requested the return of the ""Urgent Recall Notice Confirmation Form."" Customers are advised to monitor affected equipment. To return Power Cords, for questions regarding this Urgent Recall Notice, or to report any issues with these Power Cords, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.",Contact the recalling firm for information,1358,"1358 cords for all devices (1032 US, 326 OUS) (871 Human, 487 Vet), (Cord # 8404 5 Vet & 325 Human), (Cord # WW3005 482 Vet & 546 Human)","US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY.Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.",Terminated,"March 14, 2012",743,1358,Not_Computer,N/A,N/A,N/A
Z-0917-2010,53480,"resin, root canal filling",KIF,Root canal filling resin.,Dental,Dental,510(k),"Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA.Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.",Sealapex Express,2,"March 02, 2010", 2010,Sybron Dental Specialties,Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.,PRODUCTION CONTROLS: Process Control,"SybronEndo initiated an ""Urgent Medical Device Recall"" notification dated February 19 , 2009. Consignees were instructed to complete a ""return form"" and return any affected product in their inventory to the firm. Any product returned will be replaced at no charge.For further information, contact SybronEndo Customer Care at 1-800-346-3636.",N/A,1309,1309 units,"Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.",Terminated,"March 21, 2012",750,1309,Not_Computer,N/A,N/A,N/A
Z-0968-2010,52901,"test, luteinizing hormone (lh), over the counter",NGE,Luteinizing hormone test system.,Clinical Chemistry,Toxicology,510(K) Exempt,"OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of ovulation; Distributed by Quest Products, Libertyville, ILA rapid saliva indicator for the qualitative prediction of favorable and unfavorable fertile days in women's menstrual cycles.",OvuChek,2,"March 03, 2010", 2010,Quest Products Inc.,The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.,OTHER/UNDETERMINED: Pending,"Quest Products notified their major customer by telephone and e-mail on 11/7/08, requesting the return of all inventory of the OvuChek Saliva Ovulation Test Strips due to a lack of 510(k) clearance for marketing of the device.",N/A,3930,"3,930 cases",Nationwide,Terminated,"March 03, 2010",0,3930,Not_Computer,N/A,N/A,N/A
Z-0969-2010,54152,"dna probe, nucleic acid amplification, chlamydia",MKZ,Chlamydia serological reagents.,Microbiology,Microbiology,510(k),"BD Probetec"" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.","BD Probetec"" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap",2,"March 03, 2010", 2010,Becton Dickinson & Co.,Product was shipped beyond its expiration date.,TRAINING: Employee Error,"The recalling firm notified end users by letter flagged as ""Urgent Product Recall"" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer ServiceDepartment at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.",N/A,242,242 packs,The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.,Terminated,"March 24, 2010",21,242,Not_Computer,N/A,N/A,N/A
Z-0926-2010,54269,"prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer",HSX,Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"JOURNEY "" UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116","JOURNEY "" UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL,",2,"March 03, 2010", 2010,Smith & Nephew Inc,"The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.",DESIGN: Device Design,"All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.",Contact the recalling firm for information,1283,1283 units,"US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England",Terminated,"March 25, 2011",387,36181,Not_Computer,N/A,N/A,N/A
Z-0923-2010,54381,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027.In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery.",Orthopedic Dovetail Clamp,2,"March 03, 2010", 2010,"Medtronic Navigation, Inc","Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.",PRODUCTION CONTROLS: Error in Labeling,"All affected users were notified by a Product Correction Notification letter on 11/03/2009 providing a description of the issue and informing them of the updated instructions for use for the Orthopedic Dovetail Clamp. Customers are to ensure that all users read the letter, place a copy of the letter with the IFUs for the related software applications listed in the letter, and fill out the attached response form indicating the receipt of the information. Further information is available at 720-890-3309.",N/A,244,244 units,"Worldwide Distribution -- USA, including VA, IA, MN and OK and countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Iceland, India, Israel, Italy, Japan, Korea, Lebanon, Malta, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK.",Terminated,"August 13, 2010",163,244,Computer,N/A,N/A,N/A
Z-0978-2010,54068,"discs, strips and reagents, microorganism differentiation",JTO,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico***Lactophenol cotton blue is a blue stain used for direct examination of clinical specimens for fungal elements.",SPOTTEST LACTOPHENOL COTTON BLUE STAIN,3,"March 04, 2010", 2010,Becton Dickinson & Co.,An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.,PRODUCTION CONTROLS: Labeling Mix-Ups,"An ""URGENT PRODUCT RECALL"" notice dated September 2009 was issued via UPS letter to customers. The notification letter described the product, problem and the action to be taken by customer. The recalling firm notified distributors and end users to discontinue use of the identified product and discard for replacement. The customers were requested to return an enclosed response form. The customers were requested to provide, within one week, an excel file or a list with name, address and phone number of end-users who were shipped the product from their distribution branches so that the BD may inform them of the issue.For further assistance regarding product replacement contact our Customer Service Department at 1-800-675-0908. For all other inquiries call our Technical Services Department at 1-800-638-8663.",N/A,100,100 shelf packs,"Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.",Terminated,"March 24, 2010",20,100,Not_Computer,N/A,N/A,N/A
Z-0974-2010,53560,lymphocyte separation medium,JCF,Lymphocyte separation medium.,Hematology,Hematology,510(K) Exempt,"Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and ""null"" lymphocytes.",SigmaAldrich Histopaque1077,2,"March 04, 2010", 2010,Sigma-Aldrich Mfg LLC,Some of the product was contaminated with Pseudomonas mendocina,OTHER/UNDETERMINED: Pending,"An ""IMPORTANT PRODUCT NOTIFICATION"" dated September 4, 2009 was sent to customers via regular mail. The notification letter described product, problem and action to be taken. The customers were requested to immediately discontinue use of the product and discard all remaining material. Subrecall was requested if the product was further distributed. The customer is to complete and fax the notification form to (314) 286-7829 to assure proper replacement for material they have not used and which is to be discarded.Should you have any questions, please contact Signma-Aldrich Technical Service at (800) 325-5832.",Contact the recalling firm for information,7308,"6,808/500-ml. bottles","Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.",Terminated,"April 10, 2012",768,6808,Not_Computer,N/A,N/A,N/A
Z-0767-2010,53827,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.,Powerheart 9300D automated external defibrillator,1,"March 04, 2010", 2010,Cardiac Science Corporation,Potential for devices not to deliver therapy,PRODUCTION CONTROLS: Process Control,"Cardiac Science issued an ""Urgent - Voluntary Medical Device Correction AED Resistor Issue"" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures.For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.",N/A,201,201,"Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.",Open,N/A,N/A,200330,Not_Computer,N/A,N/A,N/A
Z-0973-2010,53750,"c-reactive protein, antigen, antiserum, and control",DCK,C-reactive protein immunological test system.,Immunology,Immunology,510(k),"""K-ASSAY CRP (3) Calibrator E"".This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.",IVD calibrator,2,"March 04, 2010", 2010,"Kamiya Biomedical Company, LLC",The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.,OTHER/UNDETERMINED: Pending,"On May 1, 2009 the recalling firm, Kamiya Biomedical Company contacted the 3 consignees by telephone and notified them of the issue. A follow-up e-mail notification on May 4, 2009 was sent to consignees requesting to return the affected product to Kamiya Biomedical Company for a free replacement kit. After the e-mail notifications, an Urgent Medical Device Recall Notice dated May 13, 2009 was also sent to consignees describing the issue and actions to take for returning opened and unopened affected product to the recalling firm for replacement. Direct questions to the Kamiya Biomedical Company by calling 1- 206-575-8068.",N/A,3,3 kits each containing 5 x 2 ml vials,"United States (NY, NJ, and NC).",Terminated,"January 21, 2011",323,3,Not_Computer,N/A,N/A,N/A
Z-0824-2010,54167,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,"Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA.Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.",Circulatory Support System,1,"March 04, 2010", 2010,"Abiomed, Inc.",Console shut down with no audible alarm,PRODUCTION CONTROLS: Process Control,"Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device.For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.",N/A,496,496 units,"Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.",Open,N/A,N/A,496,Other,Device Operation,Correction,Repair
Z-0977-2010,53956,lymphocyte separation medium,JCF,Lymphocyte separation medium.,Hematology,Hematology,510(K) Exempt,"Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.",SigmaAldrich Histopaque1119,2,"March 04, 2010", 2010,Sigma-Aldrich Mfg LLC,Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.,OTHER/UNDETERMINED: Pending,"The recalling firm issued an ""Urgent Field Correction"" notice dated December 7, 2009 via regular mail on December 8, 2009 which explains the reason for the field correction and instructs the user to review the enclosed, revised Instructions for Use (IFU) prior to further use of the product. The customer is requested to complete the acknowledgement information and return it to the recalling firm via FAX or e-mail. Direct questions to Sigma-Aldrich by calling 1-800-505-6275, extension 1232.",Contact the recalling firm for information,11984,"8,640/100-ml. btls and 3,138/6/100-ml. btl packages","Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa.",Terminated,"April 10, 2012",768,44116,Not_Computer,N/A,N/A,N/A
Z-0807-2010,54365,"centrifuges (micro, ultra, refrigerated) for clinical use",JQC,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,StatSpin Express 4 Horizontal CentrifugeModel # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.,StatSpin Express 4 Centrifuge,1,"March 04, 2010", 2010,"StatSpin, Inc., dba Iris Sample Processing","Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.",DESIGN: Device Design,Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.,Contact the recalling firm for information,1510,1510 units,"Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.",Open,N/A,N/A,1510,Not_Computer,N/A,N/A,N/A
Z-0797-2010,54356,"tube, tympanostomy",ETD,Tympanostomy tube.,Ear Nose & Throat,Ear Nose & Throat,510(k),"MICRON¶_ ¶_ BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA.Intended to be implanted for ventilation or drainage of the middle ear.",Micron Bobbin Vent Tube,1,"March 04, 2010", 2010,Gyrus ACMI Corporation,Units of the product in lot MH136952 may have been shipped without being sterilized.,N/A,"The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.",Contact the recalling firm for information,19,19 boxes of 6 units,"Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.",Terminated,"July 27, 2010",145,19,Not_Computer,N/A,N/A,N/A
Z-0815-2010,54525,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton.Intended to allow left heart catheterization procedure to occur through the right atrium.",Transseptal Sheath Introducer Kits,1,"March 04, 2010", 2010,Thomas Medical Products Inc,Radiopaque tip may fracture,DESIGN: Component Design/Selection,"Thomas Medical Products, A GE Healthcare Company, issued an ""Urgent Medical Device Correction"" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts.For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.",N/A,13973,"13,973 units","Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.",Terminated,"January 05, 2011",307,13973,Not_Computer,N/A,N/A,N/A
Z-0863-2010,54344,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell.PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i).Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.",UniCel DxC Synchron Clinical System ,1,"March 04, 2010", 2010,Beckman Coulter Inc.,"Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.",DESIGN: Device Design,"An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. Questions should be directed to the Customer Support Center at 1-800-854-3633.",Contact the recalling firm for information,2630,2630,Worldwide Distribution -- USA and Canada.,Terminated,"April 17, 2012",775,2630,Not_Computer,N/A,N/A,N/A
Z-0783-2010,53954,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)","MAC (TM) Two Lumen Central Venous Access Kit with ARROWgard Blue (R) Access Device,",1,"March 05, 2010", 2010,Arrow International Inc,Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.,N/A,117,117 kits,"The products were shipped to distributors in GA, MD, and VA.",Terminated,"January 18, 2012",684,608,Not_Computer,N/A,N/A,N/A
Z-0988-2010,50691,c. trachomatis (chlamydia group),MGM,Chlamydia serological reagents.,Microbiology,Microbiology,510(k),"Chlamydia Trachomatis IgM ELISA 96 Well Kit, Catalog Number: CT055MThe products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.",Chlamydia Trachomatis IgM ELISA 96 Well Kit,2,"March 05, 2010", 2010,Calbiotech Inc,"The recall has been initiated due to the ""For Export Only"" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.",MISBRANDING: Labeling False and Misleading,"Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via ""FedEx Saver"" service.This recall should be carried out to the wholesale level in order to comply with Federal regulations.Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.",N/A,105,105 kits,"FL, and VA",Terminated,"March 05, 2010",0,651,Not_Computer,N/A,N/A,N/A
Z-1015-2010,51983,"electrode, ion based, enzymatic, creatinine",CGL,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.",reference electrode membranes / A8L8X7 Flex Creatinine Analyzer,2,"March 05, 2010", 2010,Radiometer America Inc,"Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.",OTHER/UNDETERMINED: Pending,"The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert.Please direct questions to the company TechLine at 1-800¶_736¶_0600 opt 2.",N/A,50,50 membranes in U. S. distribution,"The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.",Terminated,"May 09, 2012",796,50,Not_Computer,N/A,N/A,N/A
Z-1005-2010,52101,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ.The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.",Body Fluid Collection Paper,3,"March 05, 2010", 2010,"Whatman, Inc.",'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results,PRODUCTION CONTROLS: Process Control,"Whatman issued an ""Urgent Medical Device Correction "" letter on May 19, 2009. The consignee was instructed to remove cards with duplicate numbers. For further information, contact Whatman Inc. Quality Assurance at 1-207-459-7557.",N/A,11300,"11,300 Cards",Nationwide Distribution -- CA.,Open,N/A,N/A,11300,Not_Computer,N/A,N/A,N/A
Z-1012-2010,53246,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.",CardioChek PTS panels,2,"March 05, 2010", 2010,"Polymer Technology Systems, Inc.","Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.",OTHER/UNDETERMINED: Pending,"Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US).",N/A,962,962,Nationwide.,Terminated,"October 20, 2010",229,962,Not_Computer,N/A,N/A,N/A
Z-1014-2010,52851,"diazo colorimetry, bilirubin",CIG,Bilirubin (total or direct) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.",Pointe Scientific Direct Bilirubin Reagent Set,2,"March 05, 2010", 2010,"Pointe Scientific, Inc.",R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.,PRODUCTION CONTROLS: Error in Labeling,Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.,N/A,2,2,California.,Terminated,"December 06, 2010",276,2,Not_Computer,N/A,N/A,N/A
Z1006-2010,53708,N/A,N/A,N/A,N/A,N/A,N/A,"FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001Cont.1 FIIG20210A MD Mix, 1 x 78 uL2. FIIG20210A R mix, 1 x 78 uL3. FIIG20210A CT, 1 x 50 uL5, FIIG20210A DIL 1 x 1 mLManufactured in GermanyDistributed by Roche Diagnostics, Indianapolis, IN","FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument",2,"March 05, 2010", 2010,"Roche Molecular Systems, Inc.","Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare mutations will lead to an unknown result after performing genotyping.",N/A,"Product Advisory Notices were sent via e-mail on 3/12/09 to Roche Local Safety Officers and Roche county General Manager. Local Safety Officers and General Managers were to communicate to the end users with the Important Product Notice. In addition, Reagent Bulletin 09-052, dated 3/27/09, was issued to Roche U.S. Affiliate of U.S. customers.",N/A,9624,9624 kits,Nationwide Distribution,Open,N/A,N/A,9624,Not_Computer,N/A,N/A,N/A
Z-1013-2010,52719,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA",BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set,3,"March 05, 2010", 2010,Bio-Rad Laboratories Inc,"Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.",OTHER/UNDETERMINED: Pending,"Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information.",N/A,613,613 units,"Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom",Terminated,"February 02, 2011",334,613,Not_Computer,N/A,N/A,N/A
Z-0980-2010,54039,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Dimension Vista LOCI Reaction Vessel,Dimension Vista LOCI Reaction Vessel,2,"March 05, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system.For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.",N/A,408,408 units,"The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.",Terminated,"September 08, 2011",552,408,Not_Computer,N/A,N/A,N/A
Z-1009-2010,53961,"system, blood culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),"BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.",BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA,3,"March 08, 2010", 2010,Becton Dickinson & Co.,The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"An ""URGENT CUSTOMER NOTIFICATION"" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility.If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.",N/A,1267725,"1,267,725 bottles","Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay",Terminated,"May 13, 2010",66,5025698,Not_Computer,N/A,N/A,N/A
Z-1017-2010,52958,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.",Dimension Vista System BUN Flex Reagent Cartridge,2,"March 08, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Incorrect result: patient sample BUN results reported may be higher or lower than actual level.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.,N/A,1254,1254 cartons,"Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.",Terminated,"November 30, 2010",267,1254,Not_Computer,N/A,N/A,N/A
Z-0970-2010,53546,"enzyme immunoassay, gentamicin",LCD,Gentamicin test system.,Toxicology,Toxicology,510(k),"Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190.The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.",Roche/Hitachi cobas ONLINE TDM Gentamicin,2,"March 08, 2010", 2010,"Roche Diagnostics Operations, Inc.","A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.",OTHER/UNDETERMINED: Pending,"Consignees were notified by recall letter dated October 7, 2009. The letter described the affected products, issue and instructed consignees to immediately discontinue use of the products. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions aboutthe information contained in the recall letter.",N/A,13187,"13,187 of all products.",Nationwide Distribution.,Terminated,"December 10, 2010",277,13187,Not_Computer,N/A,N/A,N/A
Z-1026-2010,53650,"system, transport, aerobic",JTW,Microbiological specimen collection and transport device.,Microbiology,Microbiology,510(k),"BD Vacutainer Urine Complete Kit with UA tube and C&C; Preservative Tube for Midstream Specimens. C&S; Preservative Boric Acid 6.70mg/ml, Sodium Formate 3.35 mg/mlPLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C., for In Vitro Diagnostic Use.Becton Dickinson and Company, Franklin Lakes, NJ;Kit contains Sterile Screw-Cap Collection Cup and integrated Transfer Device and 10 mL, 16x100 mm Plus Plastic Round Bottom Tube with Preservative for urinalysis and 5.0 mL 16x75mm Glass C&S; Preservative Tube and Castile Soap Towelettes.",BD Vacutainer Urine Complete Kit ,3,"March 08, 2010", 2010,Becton Dickinson & Company,A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kitcomponents retain sterile interiors and no viable growth was detected on the towelettes.,OTHER/UNDETERMINED: Pending,"Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.",N/A,57150,57150,Nationwide distribution to hospitals and medical device distributors.,Terminated,"March 10, 2010",2,1217900,Not_Computer,N/A,N/A,N/A
Z-1021-2010,54089,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.",SmartInfuser Pain Pump,2,"March 08, 2010", 2010,"Hsmg, Inc. D/b/a Smartinfuser Usa","Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.",PRODUCTION CONTROLS: Process Control,SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.,N/A,6393,"6,393 units",Nationwide.,Terminated,"April 25, 2011",413,6837,Not_Computer,N/A,N/A,N/A
Z-1018-2010,54131,"kit, test, pregnancy, hcg, over the counter",LCX,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C.The product is used as a pregnancy test.,Mainline confirms pregnancy test,2,"March 08, 2010", 2010,"Mainline Technology, Inc.","Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.",PREMARKET APPROVAL: No Marketing Application,"Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.",Contact the recalling firm for information,N/A,Information not provided.,"Worldwide Distribution -- United States, Belgium and Switzerland.",Terminated,"February 04, 2011",333,N/A,Not_Computer,N/A,N/A,N/A
Z-1016-2010,51296,"stainer, tissue, automated",KEY,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B;The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.",Xmatrx FISH ,2,"March 08, 2010", 2010,Biogenex Laboratories,"Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.",DESIGN: Device Design,"On 1/23/09, the firm issued an Advisory Notice to all its direct consignees, informing them of the affected product and providing instructions on the recall.Please contact BioGenex Technical Support at 1-800-421-4149 for any assistance you may need.",N/A,12,12 units,"The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the product is exclusive distributed by Abbott Molecular.",Terminated,"December 02, 2010",269,12,Not_Computer,N/A,N/A,N/A
Z-0979-2010,54194,"culture media, general nutrient broth",JSC,Microbiological assay culture medium.,Microbiology,Microbiology,510(K) Exempt,"Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.",Oxoid CM0225 Brain Heart Infusion IVD,2,"March 09, 2010", 2010,"Remel, Inc",Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.,OTHER/UNDETERMINED: Pending,"The recalling firm issued separate recall letters dated December 21, 2009 addressed to Microbiology Laboratory Supervisors or Distributors explaining the reason for recall and requesting all remaining product be discarded. A Product Inventory Checklist was enclosed to report the amount of product that was discarded by the customer. The Distributor letter requests the consignee contact their customers to notify them of the recall. Direct inquiries concerning this recall to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).",Contact the recalling firm for information,105,105 bottles,"United States (FL, NY, MO, NY, DE, and PA).",Terminated,"July 12, 2011",490,105,Not_Computer,N/A,N/A,N/A
Z-1040-2010,54232,"humidifier, respiratory gas, (direct patient interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(k),"Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.",Concha Therm Neptune Heated Humidifier,2,"March 09, 2010", 2010,Telefelx Medical,"When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.",DESIGN: Device Design,"Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.",Contact the recalling firm for information,15134,"15,134 units","U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.",Terminated,"April 05, 2011",392,15134,Software,Output/Calculation,Software update,Software Update
Z-1032-2010,53893,"container, i.v.",KPE,I.V. container.,General Hospital,General Hospital,510(k),"Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation",ExactaMix,2,"March 09, 2010", 2010,Baxa Corporation,TPN bags may leak fluid due to inadequate sealing.,PRODUCTION CONTROLS: Process Control,Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.,Contact the recalling firm for information,3160,3110/50 bag cases,"Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.",Terminated,"February 24, 2011",352,5966,Not_Computer,N/A,N/A,N/A
Z-1036-2010,54094,"alkaline picrate, colorimetry, creatinine",CGX,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250.For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.",Pointe Scientific Creatinine Reagent R2,2,"March 09, 2010", 2010,"Pointe Scientific, Inc.",An additional 10% picric acid was added to the R2 component during production.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.",Contact the recalling firm for information,625,625 vials,"Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.",Terminated,"October 15, 2010",220,1517,Not_Computer,N/A,N/A,N/A
Z-1049-2010,54080,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 CLAVE ports, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160210401, list number 16021-01",LifeShield Symbiq Pump Set,2,"March 09, 2010", 2010,Hospira Inc.,Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.,PRODUCTION CONTROLS: Process Control,"Hospira, Inc. issued an ""Important Administration Set Information"" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm.For further information, contact Hospira Medical Communications at 1-800-615-0187.",N/A,733200,"733,200 sets","Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.",Terminated,"January 29, 2012",691,3558848,Not_Computer,N/A,N/A,N/A
Z-1029-2010,54187,eosin y,HYB,Dye and chemical solution stains.,Hematology,Pathology,510(K) Exempt,"SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.",Deionized water,3,"March 09, 2010", 2010,"Wescor, Inc",Stains used for diagnostic use may be contaminated with bacteria.,DESIGN: Component Design/Selection,"Customers were notified by letter on Jan. 6, 2010 and asked to destroy any remaining product. A response form was included to note whether or not customer had any remaining stock for replacement purposes. Additional information is available at 800-453-2725 or regaff@wescor.com.",N/A,116,116 bottles,"Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.",Terminated,"April 20, 2010",42,26962,Not_Computer,N/A,N/A,N/A
Z-1039-2010,53686,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Dimension Vista V-LYTE Fluids: Diluent catalog number K835,Dimension Vista VLYTE Fluids Diluent,2,"March 10, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Results can elevate after sensor replacement. Sodium urineresults can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.,OTHER/UNDETERMINED: Pending,The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.,N/A,150,150 units,"The product was shipped to medical facilities nationwide. The product was also shipped to Australia, Canada, Belgium, France, Germany, Italy, Japan, Malaysia, New Zealand, Netherlands, Portugal, Spain, South Korea, and Switzerland.",Terminated,"December 16, 2010",281,150,Not_Computer,N/A,N/A,N/A
Z-1043-2010,53784,"cresolphthalein complexone, calcium",CIC,Calcium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.",Pointe Scientific Liquid Hitachi Calcium Reagent Set,2,"March 10, 2010", 2010,"Pointe Scientific, Inc.","Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by ""Urgent: Medical Device Recall"" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.",N/A,13,4 sets and 9 L,"Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).",Terminated,"December 10, 2010",275,84,Not_Computer,N/A,N/A,N/A
Z-1066-2010,53675,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"IMMULITE 2000 and IMMULITE 2500IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150","Immulite 2000 CMV IgG, and Immulite 2500 CMV IgG",2,"March 10, 2010", 2010,Siemens Healthcare Diagnostics Inc.,The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150.The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot150 can be used with RUB IgG and CMV IgG.Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product.The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.",Contact the recalling firm for information,10,10,Nationwide,Terminated,"April 22, 2010",43,567,Not_Computer,N/A,N/A,N/A
Z-1064-2010,53942,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.",Zimmer Nexgen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Techno,2,"March 10, 2010", 2010,Zimmer Inc.,The titanium portion of the implant may separate from the trabecular metal material.,OTHER/UNDETERMINED: Pending,"On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.",N/A,846,846,"Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.",Terminated,"March 23, 2011",378,846,Not_Computer,N/A,N/A,N/A
Z-0816-2010,54526,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire.Intended to allow left heart catheterization procedure to occur through the right atrium.",TorFlex Transseptal Guiding Sheath,1,"March 10, 2010", 2010,Baylis Medical Corp *,Radiopaque soft tip may fracture.,DESIGN: Component Design/Selection,"Baylis Medical Issued an ""Urgent Medical Device Correction"" letter via overnight courier beginning February 8, 2010. Consignees were instructed to segregate and return all affected product to the firm.For further information, contact Baylis Medical Regulatory Scientific Affairs at 1-905-602-4875 Extension 252.",Contact the recalling firm for information,577,"1,085 units (508 in US, 577 Foreign)","Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom.",Terminated,"September 13, 2010",187,1085,Not_Computer,N/A,N/A,N/A
Z-1044-2010,53896,"filter, conduction, anesthetic",BSN,Anesthesia conduction filter.,Anesthesiology,Anesthesiology,510(k),"Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS.",Millex Syringe Filter Unit,2,"March 10, 2010", 2010,Millipore Corporation,Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.,PRODUCTION CONTROLS: Process Control,"Millipore Corporation issued an ""Urgent: Medical Device Recall"" letter dated November 24, 2009 requesting users to examine inventory and immediately discontinue use and return all affected product to the firm.For further information, contact Millipore Technical Services at 1-800-645-5476.",N/A,539,539 Boxes - 50 per box,"Worldwide Distribution -- United States, Japan and Hungary.",Terminated,"May 23, 2011",439,539,Not_Computer,N/A,N/A,N/A
Z-1067-2010,53841,"culture media, antimicrobial susceptibility test, excluding mueller hinton agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"CHROMagar VRE Base;5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach;CHROMagar, Paris, FranceMedium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.",CHROMagar,2,"March 11, 2010", 2010,DRG International Inc,"CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.",OTHER/UNDETERMINED: Pending,"Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important.If you have any questions, please contact customer service at (908) 233-0758.",N/A,325,"325 (5 x 5000ml), 65 5 L packs",Nationwide distribution,Terminated,"May 14, 2012",795,2561,Not_Computer,N/A,N/A,N/A
Z-1069-2010,54076,"centrifuges (micro, ultra, refrigerated) for clinical use",JQC,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"CLAY ADAMS¶_ Dynac¶_ III Centrifuge, 120V, Model Number 420104DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.",CLAY ADAMS Dynac III Centrifuge,3,"March 11, 2010", 2010,Becton Dickinson & Co.,Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""Urgent Product Recall"" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form.For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.",Contact the recalling firm for information,411,411 units,"Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.",Terminated,"April 22, 2010",42,411,Not_Computer,N/A,N/A,N/A
Z-1100-2010,53892,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System,PET511BTM Multiplane transesophageal transducer (TEE),2,"March 11, 2010", 2010,Toshiba American Medical Systems Inc,Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the PET-511 BTM multi-plane transesophageal transducer (TEE) may result in injury including perforation.,DESIGN: Device Design,"Toshiba America Medical Systems sent a Field Safety Notice to all customers on 5 MAY 2009 indicating its intent to remove the units from the market. The letter requested immediate cessation of use and return to the manufacturer site. It announced plans to replace unit with a new multi-plane transducer at no addle charge.The notice also included a description of the problem that occurred, the proper insertion technique into the esophageal passage, how to avoid and detect bending or buckling of the transducer, and what to do if the transducer does buckle. A revised safety manual and poster reflecting these precautions for the PET-51 IBTM was sent to each customer using this transducer. Shipments of the transducer from December 2008 also contained the Field Safety Notification materials. For additional information, contact the firm at (714) 669 2458.",No consumer action necessary,70,70,Nationwide,Terminated,"March 22, 2012",742,70,Not_Computer,N/A,N/A,N/A
Z-1102-2010,54230,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.","Restoration Modular Revision Hip System,",2,"March 11, 2010", 2010,Stryker Howmedica Osteonics Corp.,The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.,PRODUCTION CONTROLS: Process Control,"Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.",N/A,1,1,1 device distributed to a hospital in GA.,Terminated,"September 14, 2012",918,1,Not_Computer,N/A,N/A,N/A
Z-1071-2010,54113,general surgery tray (kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.",Total Knee Tracecart,2,"March 11, 2010", 2010,DeRoyal Industries Inc,Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009.,Contact the recalling firm for information,194,194 units,LA & MS,Terminated,"May 20, 2010",70,313,Not_Computer,N/A,N/A,N/A
Z-1065-2010,54117,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840.The product is used as an AC powered adjustable hospital bed.",HillRom TotalCare Bed,2,"March 11, 2010", 2010,"Hill-Rom, Inc.","The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm sent a letter to each consignee dated January 4, 2010 advising them that a firm representative will visit the facility to make corrections. Hospitals were requested to take all of the affected beds out of service, if possible, until they are corrected, or to inspect and remove those with a problem out of service until they are corrected if all cannot be removed from service. If you have any questions concerning the recall, please contact Hill-Rom Technical Support at 1-800-445-3720 (U.S.).",N/A,185,185,"Worldwide Distribution -- United States, Australia, Canada, France, Germany, Mexico, United Arab Emirates and United Kingdom.",Terminated,"February 17, 2012",708,185,Not_Computer,N/A,N/A,N/A
Z-1103-2010,54358,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16"", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172.Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces).JD+01U3008-5C 1cc 30G x 5/16""; JD+01U3013-5C 1cc 30G x 1/2""; JD+01U3108-5C 1cc 31G x 5/16""; JD+03U3008-5C .3CC 30 g X 5/16""; JD+03U3013-5C .3CC 30 g X 1/2""; JD+03U3108-5C .3cc 31G x 516""; JD+05U3008-5C .5cc 30G x 5/16""; JD+05U3013-5C .5cc 30G x 1/2""; JD+05U3108-5C .5cc 31G x 5/16"".","NIPRO, GLUCOPRO INSULIN SYRINGES",2,"March 11, 2010", 2010,Nipro Medical Corporation,"Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Each consignee will receive a Recall Notification Letter and response form by either fax or e-mail.Product should be returned to point of sale.Product not distributed should be collected and returned to Nipro Medical Warehouse in Memphis TN and Carolina Puerto Rico.Any questions or concerns can be addressed to the company at 787.769.2522.,N/A,2268600,"2,268,600 pieces","US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.",Terminated,"September 15, 2010",188,2268600,Not_Computer,N/A,N/A,N/A
Z-1082-2010,54482,"pump, infusion, pca",MEA,Infusion pump.,General Hospital,General Hospital,510(k),"Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD¶_¶_-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403.Electri-Cord AC Power Cords are accessories for use with the CADD¶_¶_-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD¶_¶_-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.",CADDSolis ambulatory infusion pumps,2,"March 11, 2010", 2010,"Smiths Medical ASD, Inc.","Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices.Smiths Medical has received no reports of incidents regarding the use of the affected Electri-Cord powercords with their devices.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a Smiths Medical, Inc. ""Urgent Medical Device Recall"" letter dated January 27, 2010. The letter was addressed to Risk/Safety Managers, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Nenatologists, and Nursing, Pharmacy, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem, products involved and provided ""Advice on Action to be Taken by the User"". Consignees were requested to complete and return the ""Urgent Recall Notice Confirmation Form"". To return Power Cords, for questions regarding the recall notice or to report any issues with the affected product, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.",Contact the recalling firm for information,62,62,United States (KY and OH) and Canada.,Terminated,"December 10, 2011",639,62,Battery,Physical Safety Hazards,Return,Remove or Replace
Z-1083-2010,54512,"electrode, ion-specific, chloride",CGZ,Chloride test system.,Clinical Chemistry,Clinical Chemistry,510(k),"OPTI¶_¶_ LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.",OPTI LION EPlus Cassettes,3,"March 11, 2010", 2010,"OPTI Medical Systems, Inc",Outer box labeling shows an incorrect storage temperature range.,PRODUCTION CONTROLS: Process Control,"OPTI Medical Systems, Inc. issued a ""Medical Device Correction"" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card.For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).",Contact the recalling firm for information,127,127 boxes of 25 cassettes each for a total of 3175 cassettes.,"Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.",Terminated,"April 17, 2012",768,127,Not_Computer,N/A,N/A,N/A
Z-1070-2010,54251,"analyzer, heparin, automated",JOX,Automated heparin analyzer.,Hematology,Hematology,510(k),"Medtronic HMS PLUS, Hemostasis Management System, Model 30514.It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges.It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.","Medtronic HMS PLUS, Hemostasis Management System",2,"March 11, 2010", 2010,Medtronic Inc,"Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o",OTHER/UNDETERMINED: Pending,"Consignees were sent a Medtronic ""Urgent Medical Device Notice' dated December 14, 2009. The letter was addressed to ""Valued Customer"". The letter described the product and the problem. Advised customers to configure the HMS Plus appropriately.The Field Notification was sent to all current HMS Plus users. The current HMS Plus users were identified by the sales of HMS Plus disposable product -Heparin Assay Cartridges from the period of August 1, 2008 to date. This time was considered appropriate, being more than twice the longest expiration date of any of the HMS disposable.",N/A,580,580,All states in USA (Including DC) except RI and VT.,Terminated,"December 24, 2011",653,580,Not_Computer,N/A,N/A,N/A
Z-1101-2010,54369,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.",Amplatzer TorqVue Delivery System,2,"March 11, 2010", 2010,AGA Medical Corporation,"In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.",DESIGN: Process Design,"An AGA Medical Product Recall Notice, dated December 18, 2009 was sent to customers on 12/18/2009. The letter identified the affected product, described the issue and asked for devices to be returned. Customers are asked to complete a form attached to the product recall notice and return it to AGA via fax or email.",N/A,57,57,"Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.",Terminated,"March 29, 2012",749,57,Not_Computer,N/A,N/A,N/A
Z-1084-2010,54250,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.",OptiPack Smart Perfusion Pack,2,"March 12, 2010", 2010,"Sorin Group USA, Inc.","Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.",PRODUCTION CONTROLS: Packaging Process Control,"Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.",N/A,21,21 units,"AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.",Terminated,"March 15, 2010",3,280,Not_Computer,N/A,N/A,N/A
Z-1110-2010,54267,"kit, screening, staphylococcus aureus",JWX,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"Lifesign Staph Latex Kits, 6 mlFor In Vitro Diagnostic UseCatalog Number: 50051Manufactured for Lifesign LLC , Somerset, NJ 08873A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.",Lifesign,2,"March 12, 2010", 2010,NERL Diagnostics Corporation,Unreactive Staph latex reagent,PRODUCTION CONTROLS: Process Control,"NERL Diagnostics notified distributors on January 15, 2010, by letter to advise of the recall and request they examine inventory, discontinue use of affected lot numbers and discard any remaining inventory. In addition, if product was further distributed, notify the customers of the product recall. If you have any questions, please telephone 1-401-824-2046.",N/A,125,125 kits,NJ,Terminated,"October 05, 2011",572,271,Not_Computer,N/A,N/A,N/A
Z-1133-2010,53674,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Martel PrinterThe Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.",Martel Printer,2,"March 15, 2010", 2010,Abbott Point of Care Inc.,Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.,N/A,"An ""Urgent Recall Notice"" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to please follow the instructions on the enclosed customer reply cared. If in doubt regarding identification of the affected Martel printers, contact Abbott Point of Care Technical Support. If you have any questions regarding this information or if removing the affected Martel printers from use will negatively impact patient care, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.",N/A,6432,6432 printers (1208 have already been returned and repaired or scrapped),Worldwide distribution,Terminated,"September 14, 2011",548,6432,Battery,N/A,N/A,N/A
Z-1136-2010,53773,"enzymatic esterase--oxidase, cholesterol",CHH,Cholesterol (total) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.",PTS Panels Lipids Panel test strips ,2,"March 15, 2010", 2010,"Polymer Technology Systems, Inc.",Exhibits under-recovery of all analytes.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.",N/A,N/A,Not available.,Nationwide and international.,Terminated,"October 20, 2010",219,N/A,Not_Computer,N/A,N/A,N/A
Z-1132-2010,53759,"system, test, low density, lipoprotein",MRR,Lipoprotein test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753.For the quantitative measurement of LDL cholesterol in whole blood.",PTS Panels LDL Cholesterol test strips,3,"March 15, 2010", 2010,"Polymer Technology Systems, Inc.",The expiration date was extended by 20 weeks without justification.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"An ""URGENT-FIELD CORRECTION"" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.",No consumer action necessary,N/A,not available.,Worldwide distribution,Terminated,"October 20, 2010",219,N/A,Not_Computer,N/A,N/A,N/A
Z-1135-2010,54282,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. Models:M4741A - Extra Large Switched internal PaddlesM4742A - Large Switched internal PaddlesM4743A - Medium Switched internal PaddlesM4744A - Small Switched internal Paddles,Philips HeartStart,2,"March 15, 2010", 2010,Philips Healthcare Inc.,Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips issued Urgent Medical Device Recall notification to customers by letter on 1/25/10 via UPS advising of this defect and providing instructions on how to determine if they have a defective paddle. The customers will be assisted by field service engineers to remove and replace these defective units (those within the date range of September 1, 2008 to December 30, 2008). Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification.Removed units will be replaced free of charge and will be destroyed by Philips. Distribution of the Urgent Medical Device Recall Notification will be managed by Philips representatives in each affected geography.Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification.",N/A,1592,1592 units,"Worldwide distribution: USA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, Estonia, Finland, France, Georgia, Germany, HONG KONG, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Malaysia, Mauritius, Netherlands, NICARAGUA, Norway, Peru, Philippines, POLAND, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Turkey, UKRAINE, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, andVietnam.",Open,N/A,N/A,1592,I/O,Treatment/Delivery/Therapy,Replace device,Remove or Replace
Z-1138-2010,54231,"catheters, salpingography",MOV,N/A,N/A,Obstetrics/Gynecology,510(k),"Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.",Novy cornual cannulation set,2,"March 15, 2010", 2010,Cook Women'S Health,The distal tip may separate from the catheter while the catheter is in the patient.,PRODUCTION CONTROLS: Process Control,Cook Women's Health sent Urgent Recall Notice letters dated 1/8/2010. Consignees were instructed to return product to the manufacturer for credit.,Contact the recalling firm for information,2875,2875,"USA, Ireland, China, Canada, India, Australia, Hong Kong.",Terminated,"December 10, 2010",270,3596,Not_Computer,N/A,N/A,N/A
Z-1139-2010,54281,"culture media, non-propagating transport",JSM,Transport culture medium.,Microbiology,Microbiology,510(k),"remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS.Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.",remel A.C.T. II,2,"March 15, 2010", 2010,"Remel, Inc",Pouch may be inadequately heat sealed compromising sterility,PRODUCTION CONTROLS: Packaging,"An IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE"" dated January 18, 2010, was sent to customers via regular mail. The notice described the product, problem, and action to be taken by the customers. The customers are requested to: review their inventory for the indicated product, discard all remaining units of the product lot, complete the ""Product Inventory Checklist"" enclosed to report the amount of product they wanted replaced or credited, and return by February 1, 2010 regardless if they have affected product and/or have verbally contacted the firm.If you have any inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 (USA) or 913-888-0930 (International).",N/A,164,154/10-unit packages,"Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN",Terminated,"April 25, 2012",772,154,Not_Computer,N/A,N/A,N/A
Z-1140-2010,54623,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAYThe recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.",Pump Fill Kit,1,"March 15, 2010", 2010,Centurion Medical Products,A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles.,OTHER/UNDETERMINED: Pending,"An ""URGENT MEDICAL DEVICE WITHDRAWAL"" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email.Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail info@exelint.com.",N/A,880,880 kits,USA only,Terminated,"November 08, 2010",238,880,Not_Computer,N/A,N/A,N/A
Z-1108-2010,54622,"gauze/sponge, internal, x-ray detectable",GDY,Nonabsorbable gauze for internal use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.",Femoral sponge.,2,"March 15, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.,OTHER/UNDETERMINED: Pending,"A ""Medical Device Recall Notification"" dated January 21, 2010 was issued to customers. The notification described the affected product, issue and actions to take. Consignees were asked to forward the notification to all their affected locations. Customers were instructed to immediately check inventory and quarantine any recalled product found. Consignees were instructed to destroy all product and report how much product was destroyed. For questions regarding this recall, please contact Stryker Instruments by calling 1-800-800-4236, ext. 4354.",No consumer action necessary,9274,"9,274 all products","Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.",Terminated,"October 25, 2010",224,9274,Not_Computer,N/A,N/A,N/A
Z-1131-2010,54191,"tomography, optical coherence",OBO,Ophthalmoscope.,Ophthalmic,Ophthalmic,510(k),"Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CAThe RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.",Optovue RTVue Optical Coherence Tomography with Normative Database,2,"March 15, 2010", 2010,Optovue Inc.,Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.,OTHER/UNDETERMINED: Pending,"The firm is preparing a software ""Roll Back"" version of software to disable the NDB and other features, ensuring that this version will work properly. A customer notification letter is provided as well as a correction verification form, installation instructions and user manual.If there are any questions, please call 1-866-344-8948.",N/A,1800,1800 units,Nationwide and Worldwide,Terminated,"March 24, 2011",374,1800,Software,N/A,Software rollback,Software Update
Z-1154-2010,48976,"component, traction, invasive",JEC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, ""Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE""",Stableloc (TM) External Fixation System,2,"March 16, 2010", 2010,Acumed LLC,Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.,PRODUCTION CONTROLS: Process Control,"The firm sent ""Urgent Field Safety Notice: Medical Device Recall"" letters to customers 7/9-11/08. In addition, the firm sent the letter via e-mail to some of the customers. The notification advised the customer of the recall, identified the product, explained the reason, and asked the customer to locate and segregate any affected product. The customer was asked to notify their customers who they had distributed the affected product to and asked them to complete and return an enclosed response form. The firm provided a model recall letter for its agents/distributors to issue to users. Upon receipt of the response form, the firm will contact customers to arrange for replacement of any affected product. Questions should be directed to the ""Distributor phone number"" or Richard Snyder, Quality Manager at 1-888-627-9957.",N/A,80,80 kits,"Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.",Terminated,"May 21, 2010",66,80,Not_Computer,N/A,N/A,N/A
Z-1141-2010,50102,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R.Mahwah, NJ",Scorpio NRG ,2,"March 16, 2010", 2010,Stryker Howmedica Osteonics Corp.,"A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.",DESIGN: Process Design,Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.,N/A,4,4 units,Product went to 2 US Stryker branches.,Terminated,"March 16, 2010",0,4,Not_Computer,N/A,N/A,N/A
Z-1109-2010,52618,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),PrecisePLAN 2.15 Treatment Planning System.The product is used to plan multiple beam radiation therapy treatments.,PrecisePLAN 2.15 Treatment Planning System,2,"March 16, 2010", 2010,"Elekta, Inc.","The new ""DICOM CT with Body Outline"" method to create a patient case in PrecisePLAN 2.15 may produce incorrectresults for some customers, given several input conditions encountered in the field. Discontinue use of this method ofcreating a patient case until FCO 772 00 540 064, (entitled ""Update for Patient creation method using DICOM CT with Body Outline""), is received from Elekta to update th",OTHER/UNDETERMINED: Pending,"Important Notice A297, ""PrecisePLAN release 2.15 with DICOM CT with Body Outline"" method of patient creation (dated May 8, 2007) was distributed to all customers. An additional Field Change Order 540 073, dated September 30, 2008 was distributed to customers. Important Notice A316 ""Cancellation of Important Notice for PrecisePLAN"" was issued. The Important Notice instructed affected users to dispose of Important Notice A297 and replace it with Important Notice A316.If you have any questions regarding the notification, please contact your local Elekta representative directly.",N/A,280,280 units,"United States -- (AL, AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, , NC, OH, OK,OR, PA, SC, TN, TX, VA, WA and WI) & France.",Terminated,"December 28, 2010",287,280,Not_Computer,N/A,N/A,N/A
Z-1020-2010,53541,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"RapidPoint¶_ 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry.The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.",Siemens Rapidpoint 405 Test System,2,"March 16, 2010", 2010,Siemens Healthcare Diagnostics Inc,Software: Reference sensor failure may result in inaccurate pH reuslts,DESIGN: Component Design/Selection,"An ""Urgent Field Safety Notice"" dated September 2009 was sent via overnight mail to customers and included software Version 3.5.2 with instructions for install that will detect and prevent the reporting of potentially errant test results. The customers are requested to please install the included software update immediately and return the attached Fax back form. Siemens will provide the mandatory update to all customers with the Rapidpoint 400 /405 test system.If you have any questions, please contact your local Technical Support at 508-359-3877.",N/A,4095,4095 units,"Worldwide distribution: USA and Australia, Austria, Bahamas, Barbados, Belgium, Bosnia Herzeg, Brazil, Canada, Canary Islands, Chile, Croatia, Czech Republic, Egypt, France, Germany, Holy See (Vatican City State)Hong Kong, Ireland, Italy, Japan, Macedonia, Malaysia, M¶_xico, New Zealand Not assigned P.R. China, Poland, Portugal, Puerto Rico, Refurb.Systems U.S.ARepublic Korea, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, U.A.E., United Kingdom",Open,N/A,N/A,5093,Software,Output/Calculation,Software update,Software Update
Z-1146-2010,53597,"system, test, her-2/neu, ihc",MVC,N/A,N/A,Pathology,N/A,"VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY(PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.",PATHWAY HER2 (4B5),2,"March 16, 2010", 2010,Ventana Medical Systems Inc,Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recall was initiated on 09/17/2009 with Ventana Medical Systems forwarding Urgent Voluntary Medical Device Recall letters to all the affected customers advising them to discontinue the use of lot number 680957 and have their laboratory retest with product from a different lot of PATHWAY HER2 (4B5) any breast cases scored as 0, 1+, or 2+ that were not reflexed to an approved in situ hybridization (ISH) method.Customers were also instructed to contact Ventana Customer Support at 1-800-227-2155 and select 1 for Technical Support to speak to a Customer Support agent who will work with then to replace or credit any product from this specific lot number.",N/A,433,433 units,"Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada,India, Korea, Morocco & Thailand",Terminated,"April 22, 2010",37,433,Not_Computer,N/A,N/A,N/A
Z-1155-2010,53848,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CAMedical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.",PICCOLO(TM),2,"March 16, 2010", 2010,Abaxis Inc,"Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.",PRODUCTION CONTROLS: Labeling Mix-Ups,"An ""URGENT: PRODUCT RECALL NOTICE"" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers.If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.",N/A,1010,1010 boxes,"Worldwide distribution: USA and Canada, EU and Asia",Terminated,"December 14, 2010",273,1010,Not_Computer,N/A,N/A,N/A
Z-1081-2010,54253,dura substitute,GXQ,Dura substitute.,Neurology,Neurology,510(k),"Suturable DuraGen Dural Regeneration Matrix;Non-Pyrogenic;Sterility guaranteed unless package is damaged or opened. Rx only.Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.",DURAGEN II DURAL REGENERATION MATRIX,2,"March 16, 2010", 2010,Integra LifeSciences Corp,One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.,OTHER/UNDETERMINED: Pending,"An ""URGENT PRODUCT RECALL NOTIFICATION"" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed ""Recall Acknowledge and Return Form"" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned.Please feel free to contact me at 609-936-5407 should you have any additional questions.",Contact the recalling firm for information,94,94,"Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.",Terminated,"March 18, 2010",2,94,Not_Computer,N/A,N/A,N/A
Z-1148-2010,54190,"formulations, paraffin, all",KEO,General purpose reagent.,Pathology,Pathology,510(K) Exempt,"Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase K, 35",Vysis Paraffin Pretreatment Reagent Kit III,2,"March 16, 2010", 2010,Abbott Molecular,The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.,DESIGN: Packaging Design/Selection,"Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.",N/A,17,17 kits,"Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.",Terminated,"January 29, 2012",684,322,Not_Computer,N/A,N/A,N/A
Z-1150-2010,54490,"agent, tooth bonding, resin",KLE,Resin tooth bonding agent.,Dental,Dental,510(k),"Bond-1 Primer/Adhesive.The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.",Bond1 Primer/Adhesive,2,"March 16, 2010", 2010,Sybron Dental Specialties,Some of the material has been found to be gelled and therefore becomes unusable.,DESIGN: Device Design,"An ""Urgent Medical Device Recall"" letter and ""Recall Return Form"" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the ""gelling"" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.",N/A,1400,"1,400","Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.",Terminated,"February 24, 2012",710,1400,Not_Computer,N/A,N/A,N/A
Z-1142-2010,54363,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.",Neutralect,2,"March 16, 2010", 2010,ConvaTec,"Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.",OTHER/UNDETERMINED: Pending,"Unomedical Urgent Medical Device Correction letters were sent to distributors on January 22, 2010 by certified mail. Letters state that the only way to determine if the incorrect product is contained in the carton is to open the box. Distributors are asked to inspect all Diathermy Cables in their possession with order code 3508M or 3405M to ensure that the correct cable is inside. The number of mislabeled product is to be recorded on the Questionnaire for Distributors, and then mislabeled product is to be destroyed by cutting the product in half. The questionnaires include an area for names of customers stating that the distributor will contact them, or requesting that Unomedical contact them directly. Copies of the correction notice and questionnaire for end users are to be forwarded to all customers, asking them to complete the questionnaire and return it to the distributors. Once received by the distributors, end users can discard the cables by cutting them in half. All completed forms should be returned to Unomedical and local reps are to be contacted to arrange for replacement of mislabeled stock and/or credits.",N/A,5130,"5130 cables worldwide, 1270 in US.",Worldwide distribution.,Terminated,"June 10, 2010",86,5130,Not_Computer,N/A,N/A,N/A
Z-1152-2010,53477,"stent, carotid",NIM,N/A,N/A,Cardiovascular,PMA,"Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01)The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.",XACT Carotid Stent System,2,"March 16, 2010", 2010,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.,PRODUCTION CONTROLS: Process Control,Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.,N/A,49,49,"Nationwide: GA, NY, IN, LA, MA and PA",Terminated,"March 30, 2012",745,49,Not_Computer,N/A,N/A,N/A
Z-1157-2010,54537,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006.Has application in endoscopic surgery procedures.,ProTack 5mm Single Use Instrument with 30 Helical Fasteners,2,"March 16, 2010", 2010,Covidien LP,Fixation device may fail to fire and staple.,PRODUCTION CONTROLS: Process Control,"Covidien notified accounts by ""Urgent Medical Device Recall"" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots.",N/A,5638,"5,638 units",Nationwide Distribution,Terminated,"February 28, 2013",1080,5638,Not_Computer,N/A,N/A,N/A
Z-1144-2010,54507,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA.Intended to promote fusion of the cervical spine and occipitothoracic junction.",Ascent Posterior Occipital Cervical Thoracic System,2,"March 16, 2010", 2010,"Blackstone Medical, Inc.",The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm.For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812.",Contact the recalling firm for information,25,25,"Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.",Terminated,"April 09, 2010",24,25,Not_Computer,N/A,N/A,N/A
Z-1143-2010,54278,"electrode, depth",GZL,Depth electrode.,Neurology,Neurology,510(k),"FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software,Catalog # MT-GL4K.Intended to assist in functional neurological procedures.",FHC microTargeting Guideline 4000 ,2,"March 16, 2010", 2010,"FHC, Inc.","The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"FHC notified customers by telephone and by an Urgent: Medical Device Correction email, dated December 2009, beginning December 28th. Customers have been instructed to keep the instruction with the GL4K until FHC can provide a revision to the software; and, to use only ""distance from zero"" or ""distance traveled"" modes (not ""distance from target"" mode) during procedures using the raster tab. Customers are to notify their FHC representative to confirm receipt of the notification. A software patch has been verified and validated and will be installed on all affected units. The new version of the corrected software is Guideline 4000 version 1.41. Questions should be directed to Jason Moyer, product manager or Keri Seitz, recall coordinator at 207-666-8190.",Contact the recalling firm for information,10,10,"Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.",Terminated,"March 18, 2010",2,10,Software,Output/Calculation,Software update,Software Update
Z-1145-2010,52889,"system, test, systemic lupus erythematosus",DHC,Systemic lupus erythematosus immunological test system.,Immunology,Immunology,510(k),"BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as ""REF 425-2025"" and ""LOT CPM-591"". in vitro diagnostic.",AntiCardiolipin IgM ELISA Test Kit,3,"March 16, 2010", 2010,Bio-Rad Laboratories Inc,The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Bio-Rad initiated its field correction on July 14, 2009. The firm notified domestic consignees by phone followed by fax, and each subsidiary will be given an urgent notice, subsidiary response form, customer medical device correction notification, acknowledgement form and a listing of consignees. The subsidiaries must contact customers as instructed.",N/A,213,213 kits,"Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.",Terminated,"March 18, 2011",367,213,Not_Computer,N/A,N/A,N/A
Z-1149-2010,54374,"antigens, all groups, shigella spp.",LIA,Shigellaspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA.Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.",BD Shigella poly Group D Antiserum S. sonnei,3,"March 16, 2010", 2010,Becton Dickinson & Co.,In vitro diagnostic test reagent may exhibit decreased reactivity.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BD Diagnostic Systems issued an ""Urgent Product Recall"" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit.For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908.",N/A,1096,1096 units,Nationwide Distribution,Terminated,"May 21, 2010",66,1096,Not_Computer,N/A,N/A,N/A
Z-1156-2010,53463,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA.The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.",CircuCool Fluid Circulation Pump,2,"March 17, 2010", 2010,Boston Scientific Corp,"Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm has issued notification letters via Federal express with reply verification tracking forms. A follow up letter and telephone survey as needed will be sent to follow up with non-responders. The firm is asking its consignees to return any recalled product.If there are any questions, please call 1.408.935.4952.",N/A,75,75 units,"US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium",Terminated,"December 27, 2010",285,75,Hardware,Output/Calculation,Return,Remove or Replace
Z-1158-2010,54554,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell Gamma Knife Perfexion, Article #715000.Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.",Leksell Gamma Knife Perfexion,2,"March 17, 2010", 2010,"Elekta, Inc.",Need to modify the closing speed of the shielding doors in the event of an emergency exit,OTHER/UNDETERMINED: Pending,"A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 ""Replacement of Door Servo Board"" dated 9/16/08 was released.",N/A,19,19,"Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.",Terminated,"March 25, 2010",8,19,Not_Computer,N/A,N/A,N/A
Z-1151-2010,54372,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"BIOMET MICROFIXATION, ""1.5MM"" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.",BIOMET MICROFIXATION SYSTEM BONE SCREW ,3,"March 17, 2010", 2010,"Biomet Microfixation, Inc.","Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.",PRODUCTION CONTROLS: Process Control,"Biomet Microfixation Issued an ""Urgent Medical Device Recall Notice"". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.",Contact the recalling firm for information,831,831 screws,"Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.",Terminated,"April 07, 2010",21,831,Not_Computer,N/A,N/A,N/A
Z-1163-2010,54634,endoscope and/or accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343LUsed in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall.",Olympus Trocar Spikes,2,"March 18, 2010", 2010,Olympus America Inc.,weak weld seams,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product.",N/A,45,45,"Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada",Terminated,"May 25, 2010",68,45,Not_Computer,N/A,N/A,N/A
Z-1159-2010,54559,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta SL Series/Precise Digital Accelerator.The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",Elekta SL Series/Precise Digital Accelerator.,2,"March 18, 2010", 2010,"Elekta, Inc.",Customer reported larger than expected variations in wedge factory with gantry rotation.,DESIGN: Device Design,"Important Notice A280 ""Wedge Matching Procedure"" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.",N/A,315,315 units,"United States, Canada and Mexico.",Terminated,"March 25, 2010",7,315,Not_Computer,N/A,N/A,N/A
Z-1160-2010,54619,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278.The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.",ATEC 090912 handpiece,3,"March 18, 2010", 2010,"Hologic, Inc.",The product is labeled as ATEC0909-12 but it actually contains 0909-20.,TRAINING: Employee Error,"Formal recall notification letters and response forms were sent to customers via FEDEX on February 1, 2010. If there are any questions, please call 317.344.7630.",Contact the recalling firm for information,190,190,US and Puerto Rico.,Terminated,"October 08, 2010",204,190,Not_Computer,N/A,N/A,N/A
Z-1162-2010,52299,"catheter, peripheral, atherectomy",MCW,Intraluminal artery stripper.,Cardiovascular,Cardiovascular,510(k),"SilverHawk¶_ Peripheral Cutter Driver Plaque Excision SystemREF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.",SilverHawk Peripheral Cutter Driver Plaque Excision System,2,"March 18, 2010", 2010,"Ev3, Inc.",ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk¶_ Cutter Drivers (Model Number FG 02550) because of damage to the packaging.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Consignees were sent an ev3 ""Medical Device Recall"" letter dated January 21, 2010. The letter was addressed to Cath Lab Manger/Risk Manager. The letter described the Issue Summary, Affected Product, and Required Action. The letter instructed customers to locate and remove from use the specified Cutter Driver(s). Customers are to complete and return the ""Device Recall Field Action Reconciliation Form."" An ev3 rep will assist in arranging for the return of all unused product and a replacement will be provided. Questions regarding the recall should be directed to ev3 Customer Service at 1-800-716-6700.",Contact the recalling firm for information,8330,"8,330","Worldwide Distribution -- USA, with the exception of AK and VT, and countries of AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, POLAND, SAUDI ARABIA, SOUTH KOREA, SPAIN, SWEDEN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Terminated,"April 26, 2012",770,8330,Not_Computer,N/A,N/A,N/A
Z-1164-2010,52825,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),Aquilion 32 CT System; Model number TSX-101 A/E The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation.,Aquilion 32 CT System,2,"March 19, 2010", 2010,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.",DESIGN: Component Design/Selection,"Customer notification was sent and a software upgrade will be issued to all customers affected by the field correction.If you have questions, please call (800) 521-1968.",No consumer action necessary,65,65,Nationwide,Terminated,"June 01, 2012",805,692,Computer,N/A,N/A,N/A
Z-1171-2010,52832,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),Aplio 50; SSA-700A; software version 5.5r002,Aplio 50,2,"March 19, 2010", 2010,Toshiba American Medical Systems Inc,"Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.",DESIGN: Component Design/Selection,Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice.,N/A,8,8 units,Nationwide Distribution,Terminated,"April 18, 2012",761,200,Computer,N/A,N/A,N/A
Z-1174-2010,54703,"system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy",MEQ,N/A,N/A,Gastroenterology/Urology,N/A,"UROLOGIX¶_ CTC Advance"" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance"" Long Microwave Catheter (4.5+ cm), CTC Advance"" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX¶_, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447.The CTC Advance"" catheters and RTU Plus are used as part of the Targis¶_ System.Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.","UROLOGIX CTC Advance"" Standard Microwave Catheter ",2,"March 19, 2010", 2010,"Urologix, Inc.","Urolgix¶_ is recalling certain lots of CTC Advance"" catheters and RTU Plus devices which are integral components of the Targis¶_ System. The reason for this Recall is a labeling error only; the issue involves a discrepancy in the""Use Before"" date printed on the product label. In the affected lots, the ""Use Before"" date , commonly known as the expiration date, is printed as 2012-12 when it should r",EXPIRATION DATING: Incorrect or No Expiration Date,"Consignees were sent a UROLOGIX "" Important Recall Information"" letter dated February 18, 2010. The letter was addressed to the client's name. The letter described the problem and product involved. It provided Instructions for ""Returning and Replacing Affected Product"" and requested the return of the ""Customer Acknowledgement Form"".If you have questions, please call (763)-475-1400.",Contact the recalling firm for information,154,154,"AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.",Terminated,"March 08, 2012",720,154,Not_Computer,N/A,N/A,N/A
Z-1178-2010,53474,"catheter, angioplasty, peripheral, transluminal",LIT,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.",Viatrac 14 Plus Peripheral Dilatation Catheter,2,"March 22, 2010", 2010,Abbott Vascular-Cardiac Therapies dba Guidant Corporation,Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.,N/A,"Abbott Vascular issued an ""Urgent Device Recall"" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm.For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.",Contact the recalling firm for information,26,26,"Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.",Terminated,"March 30, 2012",739,26,Not_Computer,N/A,N/A,N/A
Z-1177-2010,52816,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system,RadrexI DRAD3000E; ,2,"March 22, 2010", 2010,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.",DESIGN: Component Design/Selection,"An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.",N/A,20,20,"Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.",Terminated,"March 21, 2012",730,20,Software,Display/Image,Software update,Software Update
Z-1175-2010,54134,"gown, examination",FME,Examination gown.,General Hospital,General Hospital,510(K) Exempt,Thermoflect Product Line including items for adults and pediatrics.,Thermoflect,2,"March 22, 2010", 2010,Encompass Group LLC,The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.,OTHER/UNDETERMINED: Pending,"A press release distributed through specialized news media, and trade magazines, on/about 12/26/2009. The press release was also posted on the thermoflect.com website. Letters were sent via first class mail to customers, hospitals and doctors in radiology on/about 12/23/2009. In addition to the written notification to the user institutions, Encompass provided adhesive labels sent along with the letter notification. The notice instructed that the labels should be affixed to remaining inventories of the products(s), specifically to the individual package, which holds 5 blankets and to the outermost packaging or carton. The label reads Not for use in MRI, and a symbol showing a circle with a diagonal line through the letters MR. Thermoflect product literature has been quarantine at this time. Instructions were provided showing where the labels where the labels were to be affixed. Encompass also provided a poster indicating the products are for use in the MR environment which is to be displayed in the MR area. All new product literature will indicate that the product is not for ruse in the MR environment. Thermoflect sales representatives will visit with each user institution to confirm their receipt of the recall notice and to be available to answer any question concerning the recall. The sales representatives all of whom have been briefed on the recall strategy will be available to provide training for Radiation Safety Officers and radiology staff, if requested. Following the recall notice, Encompass will conduct Effectiveness Checks to assure that all purchasers/users of the Thermoflect product have been notified and have taken appropriate action to notify their radiology centers and staff. The Encompass recall team will maintain records of the contacts for review by the FDA. A Status Report on the effectiveness of the recall effort will be filed with the Atlanta District Office on a monthly basis until the recall is terminated.",No consumer action necessary,700000,"700,000 units (of various product lines)","AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and Switzerland.",Terminated,"October 27, 2010",219,700000,Not_Computer,N/A,N/A,N/A
Z-1184-2010,54538,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"AOS Trochanteric Nail, 11mm x 20cm x 130¶_, Product Part Number: 1036-200.",AOS Trochanteric Nail,2,"March 22, 2010", 2010,Advanced Orthopaedic Solutions Inc,"The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.",PRODUCTION CONTROLS: Process Control,"The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.",N/A,237,237,Nationwide and Japan,Terminated,"April 26, 2012",766,1981,Not_Computer,N/A,N/A,N/A
Z-1176-2010,54633,"device, storage, images, ophthalmic",NFF,Medical image storage device.,Radiology,Ophthalmic,510(K) Exempt,Image Consultant (IC) Software,Image Consultant (IC) Software,2,"March 22, 2010", 2010,"R.O. Gulden & Co., Inc.",Software not validated; inaccurate results may occur.,OTHER/UNDETERMINED: Pending,"On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.",N/A,20,20,"The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.",Terminated,"June 14, 2010",84,20,Software,Output/Calculation,Remove,Remove or Replace
Z-1198-2010,50777,"insufflator, laparoscopic",HIF,Laparoscopic insufflator.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.",Pnemosure Insufflators,2,"March 23, 2010", 2010,Stryker Endoscopy,Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and interruption of ongoing surgical procedures.,DESIGN: Component Design/Selection,"Recall initiated 12/29/2009. Sales representatives were notified via phone and e-mail, while product advisory notices were sent to consignees via FedEx. Consignees are provided with a response form, and are instructed to run a software correction.",N/A,884,884 devices,"Product was distributed throughout the US and to Argentina, Brazil, Canada, Chile and Latin America, as well as to 16 government facilities.",Terminated,"March 24, 2011",366,884,Hardware,Device Operation,Software update,Software Update
Z-1197-2010,54773,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO.Intended as tubing for use in compounding, used to connect up to 24 source ingredients.",ExactaMix TM Valve Set,2,"March 23, 2010", 2010,Baxa Corporation,Molding defect in the valve body causes leaking.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm.For further information, contact Baxa Corporation at 1-303-617-2242.",Contact the recalling firm for information,3230,3230 cases; 32300 units (10 units/case),"Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.",Terminated,"April 09, 2012",748,3230,Not_Computer,N/A,N/A,N/A
Z-0849-2010,54641,"table, radiographic, tilting",IXR,Radiologic table.,Radiology,Radiology,510(K) Exempt,"EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations.",EasyDiagnost,2,"March 23, 2010", 2010,Philips Medical Systems North America Co. Phillips,Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the issue, a Philips rep should be contacted at 800-722-9377.",N/A,11,11 units,"Devices were distributed through out the US in the following states:AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY.",Terminated,"January 25, 2011",308,144,Not_Computer,N/A,N/A,N/A
Z-1202-2010,54663,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI.The TOM bone mill is designed to grind any type of cortical or cancellous bone.",TOM(R) Bone Mill,2,"March 23, 2010", 2010,Stryker Craniomaxillofacial Division,"The firm has received 328 customer complaints for this device. Most of the complaints were involving non-functioning of the ratcheting handle or complete device, or the presence of metal shavings or discoloration.",PRODUCTION CONTROLS: Equipment Maintenance,"An ""URGENT MEDICAL DEVICE CORRECTION"" letter dated February 18, 2010, was sent to the customers. The letter describes the product, problem, scope of affected products, potential patient risks and actions to be taken by the customers. The customers should review the letter with all users of the TOM(r) Bone Mill and follow the instructions on the proper inspection and maintenance of the device enclosed with the letter. The customers should fax the accountability form within 5 days to help Stryker ensure their receipt of the information. If the accountability form is not received, addition communication will be sent.If you have any urgent questions or concerns, please contact us at (269) 323-4258. Please ref: PFA #2009-128. Our normal business hours are Monday-Friday 8am-5pm (GMT+1:00)On 7/8/2010 the firm sent an Urgent Medical Device Recall letter to its customers. The letter stated thatt upon consultation with regulatory agencies outside of the United States, the firm had intiated a devicd removal. The letter instructed the customers to return any devices that they had to the recalling firm.",N/A,596,596 units,"Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.",Terminated,"November 24, 2010",246,596,Not_Computer,N/A,N/A,N/A
Z-1195-2010,53816,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A",Heartstart,2,"March 23, 2010", 2010,Philips Medical Systems,Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.,N/A,1,1 unit internationally,Worldwide Distribution.,Terminated,"May 23, 2013",1157,100,Hardware,N/A,N/A,N/A
Z-1200-2010,54845,permanent pacemaker electrode,DTB,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.","Medtronic, Sutureless, unipolar, myocardial, screwin pacing lead",2,"March 23, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,"Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.",PRODUCTION CONTROLS: Packaging,"Consignees were sent a Medtronic ""Important Medical Device Recall"" Letter dated February 2010 on 2/25/10. The letter described the problem and the product. Medtronic recommended to immediately remove the affected leads from inventory. Customers with questions, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-505-4636.",N/A,11191,"4,863 (US); 6,328 (OUS)","All States in continental USA including DC except Alaska.OUS: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vatican City, Venezuela, and Yemen.",Terminated,"January 07, 2012",655,11191,Not_Computer,N/A,N/A,N/A
Z-1199-2010,54453,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.",Avanta Fluid Management Injection System,2,"March 23, 2010", 2010,Medrad Inc,The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued an Urgent Medical Device Recall letter dated 1/6/10 to all customers that received the affected lots. The customers were instructed to determine whether or not they had the affected product lots. Customers are to discontinue use and contact MEDRAD Customer Support or their MIP Rep to make arrangements for return of the recalled product. Any affected product returned will be replaced at no charge to the customer. Customers are also to complete and sign the attached form and fax it back to the firm. Questions concerning this recall are to be directed to Deb Easler, Product Manager, at 412-767-2400.",Contact the recalling firm for information,2625,2625 pieces,"Worldwide Distribution -- USA, including stated of AL, AZ, CA, DC, FL, GA, IL, KS, MD, MO, NM, NY, OH,OK, PA, TN, TX, and WI. and countries of Belgium, Germany, and Italy.",Terminated,"April 08, 2010",16,2625,Not_Computer,N/A,N/A,N/A
Z-1205-2010,53321,"lipase hydrolysis/glycerol kinase enzyme, triglycerides",CDT,Triglyceride test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use.",Dimension Vista System StreamLAB Analytical Workcell,2,"March 24, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.,DESIGN: Software Design,Siemens healthcare Diagnostics issued an Urgent Field Safety Notice letter to each customer regarding the issue dated September 2009. The letter informed the user of the problem and volume change instructions. Customers can call Technical Solutions Center at 800-441-9250.,N/A,81,81 units,"Worldwide distribution: USA, Australia, Canada, France, Germany, Malaysia, Netherlands, Spain, and Switzerland.",Terminated,"September 15, 2010",175,81,Software,N/A,N/A,N/A
Z-1204-2010,54481,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use onlyProduct Code: 1015.122MVygon/Churchill Medical System",Nutrisafe 2 Syringe,3,"March 24, 2010", 2010,"Churchill Medical Systems, Inc.",Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Churchill Medical issued an Urgent: Product Advisory Customer Notification on January 29, 2010 to customers and distributors via overnight delivery. The letter identified the affected product along with the corresponding lot numbers and explained the problem. Accounts are requested to complete the enclosed form and fax it to 215-672-6740, attention Marie Benson. The affected products should be quarantined and customer service should be contacted to arrange return of product. Questions should be directed to Marie Benson at 800-473-5414.","Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.",99900,"99,900 eaches","Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.",Terminated,"September 23, 2010",183,129600,Not_Computer,N/A,N/A,N/A
Z-1206-2010,53501,"probe, rectal, non-powered",EXX,Manual gastroenterology-urology surgical instrument and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. VIPA Set Includes: VIPA Urethropexy Tip Catalog No. 350-374 (Also sold individually); VIPA Urethropexy Elbow Catalog No. 350-375 (also sold individually); VIPA Vaginal Cuff Tips (small) Catalog No. 350-376 (Also sold individually); VIPA Vaginal Cuff Tips (large) Catalog No. 350-378 (Also sold individually); VIPA Rectal Probe Catalog No. 350-380 (Also sold Individually); VIPA Fiber Optic Cable (Storz to ACMI Connection) Catalog No. 350-372 (Also sold individually). For use in Urethropexy Procedures and Paravaginal Repairs (accurate suture placement by illuminating the anatomy lateral to the bladder neck); in Sacrocolpopexy (steadies the vaginal vault and provides a suture platform with fiberoptic illumination); in Vaginal surgery (illuminates the rectum to visualize endometriosis lesions on the rectovaginal septum).",VIPA IntraFiberoptic Pelvic Assistant,2,"March 25, 2010", 2010,Marina Medical Instruments Inc.,"Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A ""PRODUCT RECALL NOTICE"" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.",N/A,47,47,Nationwide distribution.,Terminated,"September 03, 2010",162,96,Not_Computer,N/A,N/A,N/A
Z-1210-2010,54669,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific, Ultra-thin"" Diamond"" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, IrelandRecommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.","Boston Scientific, Ultrathin"" Diamond"" Balloon Dilatation Catheters",2,"March 25, 2010", 2010,Boston Scientific Corporation,"Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the catheter packaging (i.e. outer pouch side seal) of the affected products may be compromised. An undetected breach in sterility of the outer pouch may lead to contami",PRODUCTION CONTROLS: Packaging,"Two ""URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED"" letters dated February 17, 2010 and February 18, 2010 were sent to the customers. The letters described the Action Description, Affected Product and Recall Instructions. The customers should immediately discontinue use of and remove all affected recalled product from your inventory, segregate the product in a secure location for return to Boston Scientific, complete and return the enclosed Account Reply Verification Tracking Form (even if you do not have any product to return) -fax to: Customer Service Call Center (866) 213-1806, and package/ship the recalled product per instructions. Your local sales Representative can answer any questions that you may have regarding this Recall Removal.If you have any question, please contact (763) 494-7971.",Contact the recalling firm for information,99,99,"Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.",Terminated,"December 10, 2011",625,172,Not_Computer,N/A,N/A,N/A
Z-1209-2010,55008,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, Release 4.51.00.",XiO Radiation Treatment Planning System,2,"March 25, 2010", 2010,Computerized Medical Systems Inc,"Inconsistent MLC positions, dose, and monitor units",DESIGN: Software Design,"Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information.For further information, contact Elekta at 1-408-830-8023.",Contact the recalling firm for information,25,Planning system is loaded 25 in locations,"Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.",Terminated,"August 24, 2011",517,25,Software,Output/Calculation,Software update,Software Update
Z-1212-2010,53430,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.",Zimmer Dental Torque Wrench,3,"March 26, 2010", 2010,Pro-Dex Inc dba Dyna-Dent,Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value.,PRODUCTION CONTROLS: Error in Labeling,"A ""Voluntary Firm Initiated Recall"" letter dated January 22, 2009, was sent to the customer. The letter describes the product, problem and action to be taken by the customer. The customer should immediately cease distribution or use of the noted lot; evaluate inventory and distribution records to ensure that this lot is removed from any potential point of use, and return the product to Returns Department at Pro-Dex, Inc . and include the RMA number on the shipping box. If you have any questions or concerns regarding this matter, please call (949) 769-3200.",N/A,70,70,Nationwide distribution: CA,Terminated,"July 06, 2011",467,70,Not_Computer,N/A,N/A,N/A
Z-1213-2010,54616,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),Axiom Iconos R200 X-Ray,Axiom Iconos R200,2,"March 27, 2010", 2010,"Siemens Medical Solutions USA, Inc",table can tilt/move when it is not intended,DESIGN: Software Design,The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.,N/A,169,169 units,Nationwide Distribution.,Terminated,"August 11, 2010",137,169,Software,N/A,N/A,N/A
Z-1214-2010,54477,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.",N'Vision software Application Card,2,"March 29, 2010", 2010,Medtronic Neuromodulation,Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump programming errors that result in overdos,OTHER/UNDETERMINED: Pending,"Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system.A Medtronic ""Medical Device Correction"" letter was left behind for consignees. The letter was addressed to ""Healthcare Provider"" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.",N/A,8499,8499 US,All States in the US including DC.OUS: AustriaBelgiumCroatiaCyprusCzech RepublicDenmarkEstoniaFaroe IslandsFinlandFranceFrench PolynesiaGermanyGreeceHungaryIndiaIrelandIsraelItalyKuwaitLebanonMaltaMartiniqueNetherlandsNew CaledoniaNorwayPolandPortugalReunionRussian FederationSan MarinoSaudi ArabiaSouth AfricaSpainSwedenSwitzerlandTurkeyUnited KingdomVatican City StateCanadaMexicoBrasil,Terminated,"July 10, 2012",834,8499,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1080-2010,54181,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Acacia Catalog # 385166 Dual ""Y"" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte",Acacia IV Extension Set with BD QSyte,1,"March 30, 2010", 2010,Medical Product Specialist Inc dba MPS Acacia,"Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.",DESIGN: Process Design,"A letter dated December 18, 2009 was sent to Acacia customers with the following instructions. 1. Immediately review your inventory of Acacia IV Extension Sets with BD Q-Syte for REF numbers and lot numbers listed and remove them from all inventory printed on the unit packaging , shelf box and shelf shipper containers.2. Complete the Distributor Recall response Card (Attachment 1) and return by fax immediately to the number on the Distributor Recall Response Card for product in your facility at the time of receipt of this letter. This form must be completed and f axed to Acacia, Inc even if there is no product in inventory.3. Acacia, Inc is currently working to ensure that replacement products are readily available. Once you have identified how much product you will be returning, please call your Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, to arrange for product replacement.Questions are to be directed to the Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, between 8:00AM and 5:00PM MST, Monday-Friday.",N/A,9515,"9,515",US Only,Terminated,"January 05, 2011",281,136441,Not_Computer,N/A,N/A,N/A
Z-1117-2010,54723,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and with 3-Gang 4-Way Stopcocks, Y-Injection Site and T-Connector.An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.",Positive Pressure Blood Pump Sets,1,"March 30, 2010", 2010,Arrow International Inc,Sterility may be compromised.,DESIGN: Component Design/Selection,"The recalling firm issued an ""Urgent Medical Device Recall"" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.",N/A,70959969,"70,959,969 of total units","Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.",Terminated,"November 08, 2012",954,70959969,Not_Computer,N/A,N/A,N/A
Z-1073-2010,53880,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.","Medical Action Industries, IV Start Bundle Kit",1,"March 30, 2010", 2010,Medical Action Industries Inc,"Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.",N/A,12000,"12,000 kits",Nationwide distribution,Terminated,"June 01, 2011",428,18800,Not_Computer,N/A,N/A,N/A
Z-1215-2010,54677,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).",ADVANCE TIBIAL WEDGE AUGMENT,2,"March 31, 2010", 2010,Wright Medical Technology Inc,The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).,PRODUCTION CONTROLS: Packaging Process Control,"The firm initiated their recall of the product by letter on February 19, 2010. The notification letters were addressed to distributors, hospital administrators, and surgeons with a fax back response form. The letter described the affected product and reason for the recall. Customers were instructed to examine their inventory and return the recalled product to Wright Medical Technology, Inc. Customers may contact Customer Service by calling 1-800-238-7117 for return instructions and replacement inventory. Direct questions regarding this matter to Wright Medical Technology, Inc. by calling 1-800-874-5630.",N/A,47,47 units,"Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.",Terminated,"July 08, 2011",464,47,Not_Computer,N/A,N/A,N/A
Z-1217-2010,54655,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare.Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.",Live Better U100 Insulin Syringe,2,"March 31, 2010", 2010,"Ulti Med, Inc.","UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.",TRAINING: Employee Error,"An "" IMPORTANT - DEVICE PRODUCT RECALL""letter dated February 3, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. The customers should check their inventory for the affected lot, complete the recall tracking form and return by mail or fax and contact UltiMed for return instructions.If you have any questions concerning this recall, please call UltiMed, Inc. at 877-854-3434 and ask to speak to Jill.",Contact the recalling firm for information,25,25 units (each dispense and dispose sharps unit contains 100 syringes),Nationwide distribution: CT and NJ,Terminated,"May 07, 2011",402,25,Not_Computer,N/A,N/A,N/A
Z-1216-2010,55074,"mattress, air flotation, alternating pressure",FNM,Alternating pressure air flotation mattress.,General Hospital,General Hospital,510(K) Exempt,"AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA.The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.",EncompassTSS,2,"March 31, 2010", 2010,Encompass Therapeutic Support Systems dba BG North America,Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An ""URGENT RECALL NOTIFICATION"" letter dated March 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers should immediately discontinue use of the control unit, turn off the unit and disconnect from the wall socket and quarantine the unit away from any patient's room. The customers should immediately examine your inventory and quarantine the products listed; identify and notify any facility where they may have further distributed or transferred the listed products; and complete and return the REPLY/FAX-BACK FORM as soon as possible to Fax: (626) 796-7856 or mail to EncompassTSS, 100 E. Corson Street, Ste 310, Pasadena, CA 91103.Please contact EncompassTSS Customer Service at 800-822-8288 if you have any questions regarding this recall notice.",N/A,349,349,"Nationwide distribution: CA, TX, IN, OR, and MO.",Terminated,"March 21, 2012",721,349,Not_Computer,N/A,N/A,N/A
Z-1219-2010,54742,"lamp, surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393.Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.",Harmony LA 700,2,"April 01, 2010", 2010,Steris Corporation,Premature Bulb Failure,DESIGN: Device Design,"STERIS issued an ""Urgent Field Correction Notice"" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit.For further information, contact STERIS Field Service Dispatch at 1-800-8828.",Contact the recalling firm for information,344,344 units,"Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.",Terminated,"June 04, 2012",795,14730,Not_Computer,N/A,N/A,N/A
Z-1326-2010,54719,"chair, dental, with operative unit",KLC,Dental chair and accessories.,Dental,Dental,510(k),"Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.Intended for the properly positioning of patients to perform dental procedures.","Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest",2,"April 01, 2010", 2010,Pelton & Crane Company,Magnetic headrests may affect patients with implantable pacemakers and defibrillators.,DESIGN: Device Design,"Pelton & Crane Issued an ""Urgent Field Safety Alert"" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take. For further information, contact Pelton & Crane at 1-704-588-2126.",Contact the recalling firm for information,498,Total: 498 chairs and 619 replacement upholstery spare parts,"Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.",Terminated,"October 28, 2010",210,498,Not_Computer,N/A,N/A,N/A
Z-0975-2010,53761,"enzymatic esterase--oxidase, cholesterol",CHH,Cholesterol (total) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795.The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.",PTS Panels CHOLHDL Panel test strips,3,"April 02, 2010", 2010,"Polymer Technology Systems, Inc.","Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.",PRODUCTION CONTROLS: Process Control,"Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.",Contact the recalling firm for information,3748,"3,748 vials",Worldwide Distribution.,Terminated,"October 20, 2010",201,3748,Not_Computer,N/A,N/A,N/A
Z-1222-2010,54656,"accessories, solution, ultrasonic cleaners for lenses",LYL,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,N/A,"Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767.This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.",STERIDYNE STERILE PRESERVED SALINE SOLUTION,2,"April 02, 2010", 2010,K C Pharmaceuticals Inc,The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.,OTHER/UNDETERMINED: Pending,"An ""Urgent: Medical Device Recall Notification"" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock.Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number.Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to:KC Pharmaceuticals-SALP Recall,3201 Producer Way,Pomona, CA 91768.Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.",N/A,2004,"2,004 units",Nationwide Distribution.,Terminated,"January 05, 2011",278,46428,Not_Computer,N/A,N/A,N/A
Z-1228-2010,51926,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System.The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed.",Component of Ortho Development Balanced Knee Modular Tibial System.,2,"April 05, 2010", 2010,Ortho Development Corporation,A component of knee prosthesis was assembled incorrectly.,PRODUCTION CONTROLS: Process Control,"E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.",N/A,422,422 units,"United States (AZ, FL, OR, TX and UT) and Japan.",Terminated,"June 30, 2010",86,790,Not_Computer,N/A,N/A,N/A
Z-1161-2010,53214,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.",da Vinci S Surgical System IS2000,2,"April 05, 2010", 2010,"Intuitive Surgical, Inc.","Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.",DESIGN: Software Design,"Recall initiated the recall on July 1, 2009. US consignee recall was initiated on July 7, 2009. All affected consignees have been notified via e-mail communication followed by a field service engineer visit. Customers with questions or with need for additional assistance regarding the notification, please contact the firm's Intuitive Surgical Customer Service Department at 1-800-876-1310 toll free.",N/A,782,782 units,"Product was distributed to 551 consignees throughout the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV AND WY, as well as to Puerto Rico, and to Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway,Qatar, Romania, Spain, Sweden, Switzerland, Turkey, the United Kingdom, Argentina, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico, Russia, Saudi Arabia, Singapore and South Korea.",Terminated,"February 11, 2011",312,782,Software,N/A,N/A,N/A
Z-1235-2010,54284,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"CADD-LEGACY¶_ 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.",CADDLegacy 1 Model 6400 Ambulatory Infusion Pump ,2,"April 05, 2010", 2010,"Smiths Medical ASD, Inc.","The CADD-Legacy¶_ 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.",TRAINING: Employee Error,"Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy¶_ 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.",Contact the recalling firm for information Contact the recalling firm for information,1,1,MI,Terminated,"December 10, 2011",614,1,Not_Computer,N/A,N/A,N/A
Z-1232-2010,55063,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.",Radionuclide radiation therapy system,2,"April 05, 2010", 2010,"Elekta, Inc.",There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.,DESIGN: Software Design,"Elekta, Inc. issued a Field Change Order 200 091 titled ""Update Frame Adapter with New Frame Fixation Axle"" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device.For further information, contact Elekta, Inc. at 1-770-300-9725.",Discard product or return to place of purchase for a full refund or exchange,32,32 units,"Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.",Terminated,"December 14, 2010",253,32,Software,N/A,N/A,N/A
Z-1231-2010,54886,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.Indicated for use in the stereotactic irradiation of intracranial structures.",Radionuclide Radiation Therapy System,2,"April 05, 2010", 2010,"Elekta, Inc.","There has been an issue with ""Image Fushing"" where low precision calculation caused images to become inaccurate.",DESIGN: Software Design,"Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take.For further information, contact Elekta, Inc. at 1-770-300-9725.",N/A,18,18 units,"Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.",Terminated,"December 28, 2010",267,18,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-1237-2010,54999,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Axiom Artis Systems operating with A100 Generator,Axiom Artis Systems operating with A100 Generator,2,"April 05, 2010", 2010,"Siemens Medical Solutions USA, Inc","Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by repeated release of the x-ray footswitch or button.To remedy the issue described above, a revised cabling has been installed in all potentially affected syste",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm issued a Customer Safety Advisory to affected customers via Update Instructions AX006/10/S. The letter informs customers of the potential issues and provides additional information on the implemented resolutions. For additional information, please contact the firm at 888-826-9702.",No consumer action necessary,1373,1373 units,The product was shipped to medical facilities nationwide.,Terminated,"July 05, 2012",822,1373,Hardware,Treatment/Delivery/Therapy,Repair,Repair
Z-1230-2010,54564,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092.Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.",Leksell Gamma Knife Perfexion,2,"April 05, 2010", 2010,"Elekta, Inc.",Radiation unit doors could close too fast on emergency exit.,DESIGN: Software Design,"Field Change Order 200 070 ""MCU CS SW 8.3"" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product.For further information, contact Elekta, Inc. at 1-770-300-9725.",N/A,19,19 units,"Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, UT and VA.",Terminated,"December 28, 2010",267,19,Software,N/A,N/A,N/A
Z-1238-2010,53993,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S",Vertier Surgical Table,2,"April 06, 2010", 2010,Stryker Communications Corp,"In certain positions, product is susceptible to fluid instrusion which could possibly result in short circuit or unsolicited movement.",OTHER/UNDETERMINED: Pending,Firm notified all consignees by letter sent 11/13/2009. Contact the firm at 972-410-7100 with questions relating to this recall.,Contact the recalling firm for information Contact the recalling firm for information,206,206,"United States (GA, AR, ND, KY, CO, CA, SD, PA, OH, TX, SC, NY, MS, IL, KS, NJ, OR, WA, MN, VA, IL, OK, WY, IN, ID, UT, MO, FL, and DC) and Canada.",Terminated,"August 11, 2010",127,206,Hardware,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1234-2010,54279,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),ATAC Serum Control Kit.The device is used for monitoring the performance of clinical chemistry methods within the clinical range.,ATAC Serum Control Kit,2,"April 06, 2010", 2010,"Vital Diagnostics, Inc.",Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means.The ranges were adjusted to reflect the analyzer population.,OTHER/UNDETERMINED: Pending,"Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822.",No consumer action necessary,802,802 Kits,Nationwide.,Terminated,"July 25, 2012",841,1673,Not_Computer,N/A,N/A,N/A
Z-1251-2010,54144,"system, catheter control, steerable",DXX,Steerable catheter control system.,Cardiovascular,Cardiovascular,510(k),"Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA",Artisan brand Extend Control Catheter,2,"April 06, 2010", 2010,Hansen Medical Inc,"Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter.",OTHER/UNDETERMINED: Pending,"Recall Initiation Date: October 19,2009 (FedEx shipments on October 19, for October 20 delivery) via letters explaining the reason for the recall and requesting the product be returned. Customers with questions are instructed to call the company at 650-404-5940.",Contact the recalling firm for information,N/A,N/A,Nationwide to 12 states.,Terminated,"February 09, 2011",309,N/A,Not_Computer,N/A,N/A,N/A
Z-1250-2010,54540,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),MaxTorque Cannulated Screw Model # MSD-010-55-060S,MaxTorque Cannulated Screw,2,"April 06, 2010", 2010,Orthohelix Surgical Designs Inc,A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.,OTHER/UNDETERMINED: Pending,"On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification.For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.",Contact the recalling firm for information,45,45 pieces,"Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.",Terminated,"October 20, 2010",197,45,Not_Computer,N/A,N/A,N/A
Z-1249-2010,54517,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Cardiovive 92532 automated external defibrillator.This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).Brand name: Burdick.Product name: Cardiovive.Device Operation: Semi-automatic.Color: Blue.Voice Prompt Level: Basic.CPR Metronome: No.Rescue Ready Indicator: Yes.Text Display: Yes.ECG Display: No.,Cardiovive AED,2,"April 06, 2010", 2010,Cardiac Science Corporation,A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.,OTHER/UNDETERMINED: Pending,"The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website.Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).",Contact the recalling firm for information,1,1,"Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries:AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.",Terminated,"December 08, 2011",611,10339,Not_Computer,N/A,N/A,N/A
Z-1252-2010,54934,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,"CareSuite"" - Critical Care Manager, PACU Manager and Anesthesia ManagerSoftware: CareSuite 5.1 and later",CareSuite,2,"April 06, 2010", 2010,Picis Inc.,"Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala",DESIGN: Software Design,"Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.",N/A,23,23,"NJCanada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.",Terminated,"July 01, 2013",1182,23,Software,Device Operation,Software update,Software Update
Z-1253-2010,54618,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),Qwix 4.3mm Stabilization Screws - 32mm,34mm Qwix Screws,2,"April 07, 2010", 2010,Integra LifeSciences Corporation,The screws were etched incorrectly as 34mm instead of the correct 32mm.,PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned.,N/A,N/A,N/A,"Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.",Terminated,"October 27, 2011",568,N/A,Not_Computer,N/A,N/A,N/A
Z-1255-2010,54702,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551",Patella Trial,2,"April 07, 2010", 2010,"Encore Medical, Lp",One lot of product was incorrectly manufactured. Pegs are larger than specification.,PRODUCTION CONTROLS: Process Control,Firm notified consignees by e-mail on 2/22/2010.,Contact the recalling firm for information,2,2 units,United States (FL and ID).,Terminated,"July 22, 2010",106,2,Not_Computer,N/A,N/A,N/A
Z-1242-2010,54891,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N; 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.",PROMOS Inclination set,2,"April 07, 2010", 2010,Smith & Nephew Inc,Firm received complaints of Inclination Set Screws fracturing.,DESIGN: Device Design,"All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on January 23, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 23, 2009. They were instructed to immediately quarantine the product for return to Stericycle, Inc., 2670 Executive Dr. Suite AIndianapolis, IN 46241. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-6153.",Contact the recalling firm for information,362,362 units,"Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.",Terminated,"April 10, 2012",734,3025,Not_Computer,N/A,N/A,N/A
Z-1256-2010,54982,full-montage standard electroencephalograph,GWQ,Electroencephalograph.,Neurology,Neurology,510(k),"NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.",NicoletOne vEEG System,2,"April 07, 2010", 2010,CareFusion,"CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain.Users are being provided with instructions for removingthese protocols and verifying that the deletion has beenprop",DESIGN: Software Design,"Consignees were sent a CareFusion ""Urgent Medical Device Correction"" letter dated March 3, 2010. The letter described the problem and product involved. The letter included ""Action to be taken by Users,"" ""Instructions for deleting protocols,"" and ""Photos-Amplifier label and Headbox insert to be discarded"". It also included a ""Verification Form"" to be completed by recipient.For questions, notify CareFusion-NeuroCare, Attention: Sue Niesen, at (800) 356-0007 ext. 5129, or via email at susan.niesen@carefusion.com.",No consumer action necessary,6131,"2,984 US; 3,147 OUS","All States in the United States including DC.UNITED ARAB EMIRATES, ALBANIA, ARGENTINA, AUSTRIA, AUSTRALIA, AZERBAIJAN, BANGLADESH, BELGIUM, BULGARIA, BAHRAIN, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECHOSLOVAKIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, EGYPT, SPAIN, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GREECE, GUAM, GERMANY, HONG KONG, HUNGARY, CRO ATIA, INDONESIA, IRELAND, ISRAEL, INDIA, ICELAND, ITALY, JORDAN, JAPAN, KOREA SOUTH, KWAI T, KAZAKHSTAN, LEBANON, LIECHTENSTEIN, LATVIA, MOROCCO, MALDOVA, MACEDONIA, MALTA, MAURITIUS, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PUERTO RICO, PALESTINIAN TERRITORY, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVEN IA, SLOVAK REPUBLIC, THAILAND, TURKEY, TAIWAN, URUGUAY, UKRAINE, VENEZUELA, YEMEN, VI ET NAAM, YUGOSLAVIA, SOUTH AFRICA,",Terminated,"July 05, 2012",820,6131,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1257-2010,53869,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novametrix or Respironics/Novametrix products. Philips HeartStart MRx Defibrillator/Monitor model number M3535A, ID number 861288.For use for the termination of ventricular tachycardia and ventricular fibrillation.",HeartStart MRx Defibrillator/Monitor,2,"April 08, 2010", 2010,Philips Healthcare Inc.,Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside plug. The issue affects medical device power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug (""taller bridge"" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected. Urgent Medical Device Correction letters were sent to Distributors describing the problem and giving them instructions for notifying customers and actions to be taken. Customers are to visually inspect the affected cords, complete the Customer Reply Power Cord Order Form, and follow the instructions to dispose of affected cords. Further information or support concerning this issue can be obtained by contacting a Philips representative at 1-800-722-9377.",N/A,16705,"16,705","Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, Aruba, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, Denmark, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MAURITIUS, MEXICO, NETHERLANDS, NETHERLANDS ANTILLES, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SAINT LUCIA, SAIPAN, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and VIRGIN ISLANDS.",Open,N/A,N/A,38473,Battery,N/A,N/A,N/A
Z-1310-2010,54823,"dressing,wound,occlusive",NAD,Occlusive wound dressing.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402.The product is used for Central Line Dressing Change.",Aplicare Advantage Dressing Change System,3,"April 08, 2010", 2010,"Aplicare, Inc.",Incorrect expiration date on outer kit label-extended.,PRODUCTION CONTROLS: Error in Labeling,"Aplicare notified customers by telephone on March 3, 2010 followed with ""Product Recall Notice"" letter issued by e-mail to the distributor level. Product will be labeled with correct expiration date. Direct questions to your sales representative or customer service by calling 1-800-760-3236.",Contact the recalling firm for information,103,103 cases (20 each),"United States (CT, RI, NJ and OH).",Terminated,"March 16, 2012",708,103,Not_Computer,N/A,N/A,N/A
Z-1313-2010,54851,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Datascope AS3000 Anesthesia System;Mindray, North America.The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.","NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401",2,"April 08, 2010", 2010,"Mindray DS USA, Inc., dba Datascope Patient Monitoring","An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.",OTHER/UNDETERMINED: Pending,"An ""URGENT PRODUCT FIELD CORRECTIVE ACTION"" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost.If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or k.maine@mindray.com.",N/A,372,"372 units in US, 107 internationally.","Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA",Terminated,"April 25, 2012",748,372,Not_Computer,N/A,N/A,N/A
Z-1314-2010,54981,"film, radiographic",IWZ,Radiographic film.,Radiology,Radiology,510(K) Exempt,"KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904Intended use: Imaging film",KODAK TMAT L/RA Film,3,"April 08, 2010", 2010,"Carestream Health, Inc.","Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"A ""MEDICAL DEVICE RECALL (VOLUNTARY)"" letters and Response Forms (dated 3/12/10) were sent to the customers on 3/12/10 via Certified Mail, Return Receipt Requested. The foreign sales offices are being notified via e-mail (started on 3/12/10) so that they in turn can notify the foreign consignees of the recall action and report back to Carestream Health. The letter describes the products, problem and action to be taken by the customers. The customers should identify and remove from inventory shelves any product that is listed in the recall, complete and return the attached Product Information Form whether they have affected product or not by fax to Carestream Health Customer Service 1-800-445-9967. Carestream Health will organize the return through designated carriers and will pay for transportation; and supply replacement stock in a timely manner.If you have any questions, concerns, or product technical questions, please call or fax Customer Service or Technical support at 1-800-328-2910.",N/A,560,560 boxes,"Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand",Terminated,"July 07, 2010",90,1435,Not_Computer,N/A,N/A,N/A
Z-1312-2010,54846,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392.Intended use: Angiographic x-ray system.","Axiom Artis Operating Systems with VB22, VB23, VB30, and VB31",2,"April 08, 2010", 2010,"Siemens Medical Solutions USA, Inc",Communication problems can occur which may result in unavailability of Bypass Fluoro.,DESIGN: Device Design,"The recalling firm issued a Customer Safety Advisory Notice dated 2/16/10 to inform their customers of the problem. The letter identified the affected product and stated that the problem had been solved by the service technician by the time that customers would receive the letter. The letter also explained when the problem occurred and the possible risks associated with it. In addition, the firm stated what will be done to avoid the problem.",Contact the recalling firm for information,640,640 units,Nationwide Distribution,Terminated,"July 05, 2012",819,640,Not_Computer,N/A,N/A,N/A
Z-1316-2010,53479,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01.The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.",ABBOTT ARCHITECT System Software ,2,"April 09, 2010", 2010,"Abbott Laboratories, Inc",ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.,DESIGN: Software Design,"Technical Service Bulletins dated September 11, 2009 were issued to affected consignees. The correction was issued via the Technical Service Bulletins (TSB) to provide a software patch to re-establish the correct parameters on the LLS board. Direct questions to Abbott Laboratories, Inc. by calling 1-972-518-6000.",N/A,11,11 in the USA; 104 worldwide,Worldwide.,Terminated,"January 25, 2011",291,11,Software,N/A,Software update,Software Update
Z-1311-2010,54809,"chair, dental, with operative unit",KLC,Dental chair and accessories.,Dental,Dental,510(k),Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.,Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair,3,"April 09, 2010", 2010,Pelton & Crane Company,The Dental Chair lacks a valid Device History Record.,OTHER/UNDETERMINED: Pending,"An ""URGENT MEDICAL DEVICE RECALL"" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA.Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.",Contact the recalling firm for information,1,1 unit,Nationwide distribution: NC,Terminated,"August 11, 2010",124,1,Not_Computer,N/A,N/A,N/A
Z-1317-2010,54892,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A).The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.",Philips Medical HeartStart MRx Defibrillator Monitor ,2,"April 09, 2010", 2010,Philips Healthcare Inc.,"Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.",DESIGN: Component Design/Selection,"An ""Urgent Medical Device Correction"" letter with a Field Safety Notice was issued on March 4, 2010 to affected customers. The Instructions for Use Addendum/Application Note is included with the communication describing when to replace the unit's 14.8-Volt Lithium Ion Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please contact your local Philips representative.",Contact the recalling firm for information,37674,"37,674 units","Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA,AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA;,BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA,CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRANCE,GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA,IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON,LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NAMIBIA,NETHERLANDS, NETHERLANDS ANTILLES, NETHERLANDS ANTILLES, NEWCALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALAU,PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTORICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY,UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM and YEMEN.",Open,N/A,N/A,37674,Battery,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-1319-2010,54375,"driver, prosthesis",HWR,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28"")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.",Patient Distractor Driver,2,"April 11, 2010", 2010,"Biomet Microfixation, Inc.","The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.",DESIGN: Device Design,"Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.",Contact the recalling firm for information Contact the recalling firm for information,73,73,"US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa",Terminated,"May 14, 2010",33,73,Not_Computer,N/A,N/A,N/A
Z-1320-2010,52175,"processor, tissue, automated",IEO,Automated tissue processor.,Pathology,Pathology,510(K) Exempt,ThermoFisher Scientific Microm STP 420D automated tissue processor.,ThermoFisher Scientific Microm STP 420D ,2,"April 12, 2010", 2010,Thermo Fisher Scientific,"The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.",OTHER/UNDETERMINED: Pending,"Consignees were notified of the problem by letter, on or about 6/3/09, updating the instructions for use. The units were subsequently upgraded on or before 9/8/09. For additional questions and information, please contact ThermoFisher's Technical Support department , Subject: PT Module Advisory Notice.",N/A,16,16,"Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.",Terminated,"June 29, 2011",443,16,Not_Computer,N/A,N/A,N/A
Z-0762-2010,54169,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Stryker Reflex Hybrid Screw Extractor;Not Sterile: Manufactured by: Stryker Spine SAS,Cestas, France; Distributed in the USA by: Stryker Spine, 2 Pearl Court, Allendale, NJ.The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.",Stryker Reflex Hybrid Screw Extractor,2,"April 12, 2010", 2010,Stryker Spine,"The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.",TRAINING: Employee Error,"An ""Urgent Product Recall"" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370.Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.",N/A,1791,"1,791",Worldwide Distribution.,Terminated,"September 06, 2012",878,2774,Not_Computer,N/A,N/A,N/A
Z-1170-2010,54087,general purpose laser products,RDW,N/A,N/A,N/A,N/A,"LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defective type""A"" fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Lockheed Martin Aculight, Bothell, WA, 98021.Pulsed laser energy generator intended for use as an OEM component for the LiDAR/Rangefinding, Surveillance, Mapping, and Sensing.",Perseus,2,"April 12, 2010", 2010,Lockheed-Martin Aculight,"Defect of optical fiber - The Perseus device with type ""B"" fiber has been found to emit potentially hazardous laser radiation.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Radiation Warning Notification was sent to all customers. The notification stated the purpose and problem. In addition, a Notification of Potential Perseus Laser Safety Issue letter was sent to the only customer who received the defective type ""B"" fiber product. The letter identified the affected product and stated that the product was not considered eye-safe. The firm recommended that the customer cease using the laser with the Part Number: 35-001466-032 and Corresponding Unit Serial Numbers: 00001,00002, and 00003. The customer is to return the affected product for additional testing and warranty repair. Questions should be directed to Rick Whitty on 425-482-1100 or at Richard.j.whitty@lmco.com.",N/A,3,3,"Worldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada.",Terminated,"April 30, 2012",749,3,Not_Computer,N/A,N/A,N/A
Z-1318-2010,54729,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 The intended use: The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination also aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.","ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345",2,"April 12, 2010", 2010,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained usingthe same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained withUniCel Dxl systems have been demonstrated to have a positive bias compared to valuesobtained with Access or Access 2 systems.,OTHER/UNDETERMINED: Pending,"An ""URGENT: PRODUCT CORRECTIVE ACTION (PCA)"" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM.If consignees need assistance or have any questions regarding the notification, they were instructed to contact TechnicalSupport at 1-800-854-3633 in the United States and Canada.",N/A,196071,"196,071 kits",Worldwide distribution: USA and Canada,Terminated,"May 09, 2012",758,196071,Not_Computer,N/A,N/A,N/A
Z-1321-2010,54930,"classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer",NYI,Gene expression profiling test system for breast cancer prognosis.,Immunology,Immunology,510(k),"Agendia MammaPrint, Catalog Numbers MP01, MP US version 03",Agendia MammaPrint,2,"April 12, 2010", 2010,Agendia Inc,"Over a period of about 6 months in about 15% of results provided Agendia has been ""over reporting"" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk.This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Communication with physicians was initiated by the firm's Chief Medical Officer on March 3, 2010. The firm's representatives will meet with treating physicians in person while having the corrected results in hand to inform each in person of the action, to allow a decision of the best course of action. Physicians will be provided with background information on the issue at hand and corrected results.As follow up, the physician would receive a corrected report per patient by FedEx in order to register the reception of corrected information. Because each user received a personal visit, no other contact information was planned or provided by Agendia.",N/A,107,107,Nationwide.,Terminated,"June 18, 2010",67,107,Not_Computer,N/A,N/A,N/A
Z-1322-2010,54373,"system, dialysate delivery, single patient",FKP,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.",Baxter 1550 Hemodialysis Machine,2,"April 12, 2010", 2010,Baxter Healthcare Renal Div,Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.,N/A,"An ""Urgent Device Correction"" letter dated January 29, 2010 was sent to the direct accounts via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letter informed the accounts that subsequent to a prior device field correction in 2003-2004, some 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. The accounts were instructed to confirm the software version in their systems and replacement boards. Instructions for checking the software version were attached to the letter. A complementary software upgrade will be made available to the account if their 1550 instrument and/or spare circuit board inventory has a software version other than 3.0A or 4.1B. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and listing the serial numbers and software versions of those instruments that do nit have software 3.0A or 4.1B.Home patients were not notified directly, the information was sent to their Dialysis Center. The 1550 operator's manual was revised during the 2003 device field correction. The manual correctly warns the operator to discontinue treatment if the 1550 experiences a FL04, FL07, or FLOg fault code.To make arrangements for the software upgrade or questions regarding the communication were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3.For additional questions, contact the company Monday through Friday from 8:00 AM to 5:00 PM CST at (Toll Free): 800-422-9837.",Contact the recalling firm for information,443,443 boards,"Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.",Terminated,"February 03, 2011",297,443,Software,N/A,Software update,Software Update
Z-1323-2010,55137,"reservoir, blood, cardiopulmonary bypass",DTN,Cardiopulmonary bypass blood reservoir.,Cardiovascular,Cardiovascular,510(k),"The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.",Bigger BetterBladder,2,"April 13, 2010", 2010,Circulatory Technology Inc,"During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.",PRODUCTION CONTROLS: Process Control,"The firm, Circulatory Technology, Inc., sent an email to Bigger Better-Bladder end user accounts on 6/03/09 and again on 6/13/09. The firm followed up with phone calls to the user customers. The emails and calls discussed the product, problem and the actions to be taken by the customers. The customers are ask to examine their stock of Bigger Better-Bladder for the affected units and then visually examine each unit to assure that adhesive has been applied and when the tube is bent away from cap, no separation is visible along the joint between the two according to the picture provided. The customers should return for full credit or a replacement of any product that has a separation of the seal.Please feel free to contact Mr. Yehuda Tamari at 516-624-2424 with any questions.",Contact the recalling firm for information,144,144 units,"Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.",Terminated,"May 14, 2010",31,144,Not_Computer,N/A,N/A,N/A
Z-1236-2010,55001,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),Leksell Gamma Knife.Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures,Leksell Gamma Knife.,2,"April 13, 2010", 2010,"Elekta, Inc.","After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.",OTHER/UNDETERMINED: Pending,"Field Change Order 0000203 ""Replacement of obsolete actuator sleigh on Helmet Changer"", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.",N/A,5,5 units,"United States (CA, TN, TX and WA) and Taiwan.",Terminated,"December 28, 2010",259,5,Not_Computer,N/A,N/A,N/A
Z-1327-2010,54079,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced injection sites and OPTION-LOK MICRODRIP SOLUSET, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12722-65.",Lifeshield burette set.,2,"April 15, 2010", 2010,Hospira Inc.,"Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.",DESIGN: Component Design/Selection,"Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.",N/A,760,760 sets,"Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.",Terminated,"January 29, 2012",654,35723417,Not_Computer,N/A,N/A,N/A
Z-1399-2010,54542,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PHThe intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.",Quick Connect Adapter ,2,"April 15, 2010", 2010,Orthohelix Surgical Designs Inc,The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument.Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were,OTHER/UNDETERMINED: Pending,"Two ""IMPORTANT RECALL NOTICE"" letters, one dated October 16, 2009, and the second letter dated November 19, 2009, were sent to the customers. The letters described the product, problem and action to be taken by the customers. The customer are requested to discontinue use of the adapters and return them to the firm, Orthohelix Surgical Designs. The firm will replace the adapters as soon as possible. Should you have any questions about the systems please contact Kristin Wolff at 330-247-1445 or Jim Bragg at 330-247-1444.",Contact the recalling firm for information,127,127 pieces,"Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.",Terminated,"April 11, 2012",727,127,Not_Computer,N/A,N/A,N/A
Z-1397-2010,54175,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes).Probe Cover for use with the SmarTemp Reusable Temperature Probe.",SmarTemp Probe Covers,2,"April 15, 2010", 2010,"Mindray DS USA, Inc., dba Datascope Patient Monitoring",SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.,PRODUCTION CONTROLS: Process Control,"Mindray DS USA, Inc. issued an ""Urgent Product Recall"" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost.For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.",Contact the recalling firm for information,20,"Total: 33,976 boxes of 20 (boxes of 20 packaged into boxes of 200) in US, 801 boxes OUS","Worldwide Distribution -- United States, Canada and Australia.Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.",Terminated,"December 09, 2011",603,33976,Not_Computer,N/A,N/A,N/A
Z-1395-2010,55040,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.",GE Centricity Web Diagnostic 1.0(WebDX) Software,2,"April 15, 2010", 2010,Ge Healthcare It,There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.,DESIGN: Software Design,"An ""Urgent Medical Device Correction"" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.",No consumer action necessary,36,36 units,"Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.",Open,N/A,N/A,670,Software,N/A,N/A,N/A
Z-1007-2010,51256,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166,Product is manufactured and distributed by BD Biosciences, San Jose, CAThe reagents are for in vitro diagnostic use on a BD FACSCount instrument.",BD FACSCount Controls Kit,3,"April 16, 2010", 2010,"BD Biosciences, Systems & Reagents","The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.",DESIGN: Packaging Design/Selection,"On 1/29/09, the firm initiated the recall and its notification was via Important Product Information letters identifying the affected product and explaining the reason for the recall. Customers who experienced error codes with the affected product were to contact their local BD Biosciences representative or distributor to receive replacement BD FACSCount controls.",N/A,17,17 units,"Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR.",Terminated,"March 08, 2011",326,17,Not_Computer,N/A,N/A,N/A
Z-1404-2010,53031,"applicator, transurethral, radio frequency, for stress urinary incontinence in women",NVJ,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA",Renessa RF System,2,"April 16, 2010", 2010,Novasys Medical Inc,"Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation",DESIGN: Labeling Design,"A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.",N/A,436,As of 6/12/09 there were 436 Probes at customer accounts.,"US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .",Terminated,"January 08, 2011",267,436,Not_Computer,N/A,N/A,N/A
Z-1400-2010,54004,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"V-Probe, Endocare Cryo V Probe model # Cryo 206V.The product is used in a minimally invasive, percutaneous approachto treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.",CRYOCARE SURGICAL SYSTEM,2,"April 16, 2010", 2010,"Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.",Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.,OTHER/UNDETERMINED: Pending,"The recall was initiated with Endocare sending a notification letter to identified customers on December 5, 2008 and offering an optional replacement unit. The initial correspondence was sent out via an e-mail if the correspondence was returned undeliverable or an e-mail address was not available it was then sent Federal Express to those recipients.The notification letter explained the reason for recall and requested providers refocus their attention on the Indications & Safety Review information contained in the Endocare's Physician Training Materials. Physicians were instructed to contact the firm at 1-949-450-5412 to discuss any questions they may have about the information in the notification letter.",N/A,22741,"22,741 units total for all products",Nationwide.,Terminated,"October 21, 2010",188,22741,Not_Computer,N/A,N/A,N/A
Z-1407-2010,54783,"monitor, bed patient",KMI,Bed-patient monitor.,General Hospital,General Hospital,510(K) Exempt,"Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.",AliMed IQ Cupid Pull Cord Alarm,2,"April 16, 2010", 2010,AliMed Corporation,"Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by AliMed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. Failure of the alarm",DESIGN: Device Design,"Letter sent to customers stating that some units may have been subjected to excessive heat during the manufacturing process causing internal distortion to a key alarm component. The letter also request that the Health Care professional review records and notify all users to whom the product may have been issued and if any product has been issued outside of their facility, to forward this correspondence to them. Firm has enclosed a form for return of the product and issuance of a new product. For questions, please contact the firm using the information provided in the letter.",N/A,30,30 units,All product was distributed domestically with the exception of one unit sold in Canada. AliMed sells and distributes this product to medical health professionals and distributors as well as directly to end users,Terminated,"July 25, 2011",465,30,Not_Computer,N/A,N/A,N/A
Z-1403-2010,55037,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.",GE Centricity Web Diagnostic (WebDX) Software,2,"April 16, 2010", 2010,Ge Healthcare It,There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.,DESIGN: Software Design (Manufacturing Process),"GE Healthcare issued ""Urgent Medical Device Correction"" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. Accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.",N/A,13,13 units,"Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom",Terminated,"November 15, 2010",213,42,Software,N/A,N/A,N/A
Z-1409-2010,55190,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4,Bionic NAVIGATOR Clinician Programmer Model Number SC71504,2,"April 16, 2010", 2010,Boston Scientific Neuromodulation Corporation,"Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.",OTHER/UNDETERMINED: Pending,"In a letter dated March 19, 2010 Boston Scientific informed consignees that it determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers, and telling them that they may be in possession of an affected product. They were advised that a Boston Scientific representative will contact them to arrange for an inspection of the Clinician Programmer (SC-7150-4).Until they have determined if the battery pack is affected, consignees were told they can only use their Toshiba portable computer with the original AC adapter power cord supplied with that computer, and were asked to remove the battery pack until its status is determined.Included with the letter was a Reply Verification Tracking Form which consignees were asked to complete the form following the instructions on the form and return to Boston Scientific in the enclosed postage paid return envelope or fax it to (877) 856-3546 by March 31, 2010.If they experience any issues they were told to cease using the Clinician Programmer and contact Boston Scientific's 24-hour Patient Care Hotline at (866) 360-4747.Customers can also contact the Field Action team by phone at (866) 684-7504 or by fax at (877) 856-3546 if they had any questions.",Contact the recalling firm for information,62,62 units,"Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WIInternationally: Italy",Terminated,"February 29, 2012",684,62,Battery,Physical Safety Hazards,Remove,Remove or Replace
Z-1408-2010,55177,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),The BleaseSirius and BleaseFocus Anaesthesia Systems.,Anesthesia system,2,"April 16, 2010", 2010,"Blease Medical Equipment, Ltd.","Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.",OTHER/UNDETERMINED: Pending,"On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010.The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives.For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089.Non US Customers, call Global Technical Support - +44 1494 784422.",N/A,40,40 units,"Distributed to 2 U.S. hospitals and to customers in the following countries:Panama, Poland, Australia, Singapore, United Kingdom, Bangladesh, Nicaragua, Vietnam, Argentina, Finland, and Columbia.",Terminated,"August 23, 2011",494,40,Not_Computer,N/A,N/A,N/A
Z-1405-2010,55101,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092.Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",Elekta Synergy XVI Medical Linear Accelerator,2,"April 16, 2010", 2010,"Elekta, Inc.","It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.",DESIGN: Software Design,"Elekta, Inc. issued an ""Important Notice"" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided.For further information, contact Elekta, Inc. at 1-770-300-9725.",N/A,76,76 units,"Nationwide Distribution -- AL, AZ, CO, CT, FL, GA, ID, KS, KY, MA, MI, MN, MS, NE, NY, OH, OK, OR, PA, TN, TX, VA, WA and WV.",Terminated,"December 28, 2010",256,76,Software,N/A,N/A,Other
Z-1406-2010,55100,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),PrecisePLAN 2.10 Treatment Planning System,PrecisePLAN 2.10 Treatment Planning System,2,"April 16, 2010", 2010,"Elekta, Inc.",Error in dose rates which were calculated at exactly twice the expected values.,DESIGN: Software Design,"As described in a prior related submission, Phase I - ""Important Notice A285, Scrolling Selected Frame Dose Calculator Error"" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken.Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.",N/A,40,40 units,"Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland",Terminated,"December 30, 2010",258,40,Software,Output/Calculation,Software update,Software Update
Z-1201-2010,54478,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Howmedica Restoration ADM Trial Cup Holder;Non Sterile;Benoist Girard, Cedex, France;Distributed by Howmedica Osteonics Corp.Mahwah, NJ.The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum.",Restoration (TM) ADM Trial Cup Holder,2,"April 19, 2010", 2010,Stryker Howmedica Osteonics Corp.,The Restoration ADM Trial Cup Holder may not have been assembled correctly.,OTHER/UNDETERMINED: Pending,"An ""URGENT PRODUCTION OPERATION"" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158.",N/A,5,5 units,"Nationwide distribution: AZ, CA and OR",Terminated,"June 20, 2012",793,5,Not_Computer,N/A,N/A,N/A
Z-1421-2010,54547,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.",Cordis Avanti Sheath Introducer,2,"April 20, 2010", 2010,Cordis Corporation,"Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays.",DESIGN: Packaging Design/Selection,"Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products.",N/A,1850,1850 units,Nationwide.,Terminated,"July 27, 2012",829,1850,Not_Computer,N/A,N/A,N/A
Z-1413-2010,54640,"tape and bandage, adhesive",KGX,Medical adhesive tape and adhesive bandage.,General Hospital,General & Plastic Surgery,510(K) Exempt,"3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.",3M Micropore Surgical Tape,2,"April 20, 2010", 2010,3M Company / Medical Division,"Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 yard rolls (CAT #1530-1) as a substitutio",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.A second 3M ""Urgent Medical Device Recall"" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to ""Valued Kit manufacturer"" described the problem and the product, provided instrucitions for ""Action Requried by the Kit Manufacturer"", ""Action Requried by the Kit Manufacturer to the End-User"", and ""Action Required for Future Tape Orders from 3M"". A Product Recall Form is aked to be faxed back to 3M.",Contact the recalling firm for information,100,"165,826 boxes, 100 rolls per box (16,582,600 rolls)","Nationwide distribution, and Puerto Rico.",Terminated,"February 04, 2012",655,3862731,Not_Computer,N/A,N/A,N/A
Z-1422-2010,54769,"device, monitoring, intracranial pressure",GWM,Intracranial pressure monitoring device.,Neurology,Neurology,510(k),"Integra, Licox Ref 1P2.P;Brain PMO-Probe KitRx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes,REF CC1/P1 Combined Oxygen & Temperature Probe.Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.",Integra Licox,2,"April 20, 2010", 2010,Integra LifeSciences Corp.,One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.,PRODUCTION CONTROLS: Process Control,"An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.",N/A,1,1,"One hospital in Omaha, NE.",Terminated,"April 20, 2010",0,1,Not_Computer,N/A,N/A,N/A
Z-1423-2010,55108,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),Syngo Imaging XS model number 10496279The intended use: image processing radiological,Syngo Imaging XS,2,"April 20, 2010", 2010,"Siemens Medical Solutions USA, Inc",images can be overwritten,DESIGN: Software Design,"A ""Customer (Safety) Advisory notice"" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S.If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center (michael.mib.braun@siemens.com).",No consumer action necessary,6,6 units,"Nationwide distribution: CA, NC, NY, PA, and TX",Terminated,"July 05, 2012",807,6,Software,Display/Image,Software update,Software Update
Z-1412-2010,54648,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.",Eclipse Treatment Planning System,2,"April 20, 2010", 2010,Varian Medical Systems Oncology Systems,"Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.",DESIGN: Software Design,"Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.",N/A,3177,3177 unit,Nationwide distribution and Mexico.,Terminated,"February 24, 2012",675,3177,Software,Output/Calculation,Software fix,Software Update
Z-1426-2010,54858,"test, qualitative and quantitative factor deficiency",GGP,Factor deficiency test.,Hematology,Hematology,510(k),REF 822 IMUBIND(R) Plasma PAI-1 ELISAThe intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.,"IMUBIND Plasma PAI1 ELISA Kit, MODEL 822",2,"April 21, 2010", 2010,"American Diagnostica, Inc.",Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators,PRODUCTION CONTROLS: Process Control,"Three emails ""REF 822 lot 102401 needs to be recalled"" dated March 1, 2010 was sent to three customers. The emails described the product, problem and action to be taken by the customers. The customers should send the kit to the firm (SEKISUI american diagnostica inc.) attention of Leigh Ayres, Director, Regulatoy Affairs and Quality Assurance.If you have any question, please call 1-203-602-7777.",N/A,25,25 kits,"Worldwide distribution: USA and UK, Taiwan and Korea.",Open,N/A,N/A,25,Not_Computer,N/A,N/A,N/A
Z-1410-2010,54894,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA.The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols.",LIFEPAK 15 Monitor/Defibrillator,1,"April 21, 2010", 2010,"Physio Control, Inc.","Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off.",DESIGN: Device Design,"Physio-Control Inc. issued an ""Urgent Medical Device Correction"" notification dated March 2010 to domestic consignees. Foreign consignees were notified by overseas representatives. Consignees were advised to keep the affected device in service and to test the units in accordance with operating instructions. They were further advised that a local service representative will call and schedule a service visit within 60 days. Consignees were asked to forward the notification to all of their sites and to notify the recalling firm if they no longer own the device.For further information, contact Physio-Control Inc. Technical Support at 1-800-442-1142, Option 5, 6:00 am to 4:00 pm (Pacific), Monday-Friday.",Contact the recalling firm for information,3609,"3,609","Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.",Terminated,"January 03, 2012",622,3609,Other,Device Operation,Repair,Repair
Z-1425-2010,55142,"stimulator, spinal-cord, implanted (pain relief)",GZB,Implanted spinal cord stimulator for pain relief.,Neurology,Neurology,510(k),"Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company.Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.","SwiftLock Anchor, Model 1192",2,"April 21, 2010", 2010,"Advanced Neuromodulation Systems, Inc",Directions For Use of product incorrectly stated lead compatibility information.,OTHER/UNDETERMINED: Pending,"An ""Urgent Medical Device Correction"" letter dated March 8, 2010, was sent to the customers (note: Firm verbally informed consignees on February 22, 2010.). The letter describes the product, problem and action to be taken by the firm -St. Jude Medical. The firm's Sales Representatives will contact the customers to update any DFUs in their possession.If you need additional copies of the insert or more information and if you have any questions or concerns, please contact your St. Jude Medical Sales Representative at 1-651-490-4470.",N/A,902,"1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives)","Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.",Terminated,"July 22, 2010",92,1120,Not_Computer,N/A,N/A,N/A
Z-1428-2010,55144,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),Leksell SurgiPlan,Leksell SurgiPlan,2,"April 22, 2010", 2010,"Elekta, Inc.",Images from a different patient can be imported without a warning for the user.,OTHER/UNDETERMINED: Pending,"Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..",N/A,57,57 units,"Nationwide, Canada and Mexico.",Terminated,"December 14, 2010",236,57,Software,Output/Calculation,Software update,Software Update
Z-1430-2010,54541,"bit, drill",HTW,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.Used to drill or cut bone prior to implantation of screws",Mini Max Torque Drill Bit & Countersink,2,"April 22, 2010", 2010,Orthohelix Surgical Designs Inc,The epoxy is flaking off the drill bits and countersinks.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625.,N/A,74,74 pieces,"Nationwide Distribution -- CO, OH, PA, SD, TX & VA.",Terminated,"February 28, 2012",677,74,Not_Computer,N/A,N/A,N/A
Z-1429-2010,55148,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),Leksell Gamma Knife C,Leksell Gamma Knife C,2,"April 22, 2010", 2010,"Elekta, Inc.",Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate.,OTHER/UNDETERMINED: Pending,"Phase 1 - Technical Notes Leksell Gamma Knife C version 1.2 (dated August 2006) ""Potential Problem with Error Handling"" was sent to all users. Phase 2 - Mandatory Field Action 0000748, ""Helmet Changer Actuator, MTB and MCU SW Upgrade Kit was released December 3, 2007. This Field Change Order includes two mod kits and a software upgrade to provide a permanent solution to the issues. Phase 3 - Technical Note 200 068, ""Safety issue with helmet host actuator"", released on May 15, 2008. This Technical Note includes a warning to customers of a potential quality problem with the helmet hoist actuator that is installed in the Leksell Gamma Knife. Phase 4 - Mandatory Field Action 200 067, ""Investigation and Correction of Helmet Changer Actuators"", released on May 15, 2008. This FCO includes a list of user machines which must be monitored for quality issues and provides a solution for replacement of parts should a deficiency be detected. Phase 5 - Mandatory Field Action 200 075, ""Helmet Changer Actuator, MTB and MCU SW upgrade, release two"", released on September 16, 2008. This FCO applies to machines within specific serial number ranges. Due to a material change in FCO-0000748 and baselines (conducted without notice by the manufacturer) the quality of said part was found to be inadequate. After reversing the material change, FCO 200 075 is released to update the installed base with the new type of actuator and to finish the remaining sites never or partially updated by the now superseded FCO-0000748.For further information, contact Elekta R&D; Jonas Hallstensson onphone no. +46 709 843 553 or via e-mail jonas.hallstensson AT elekta.com.",N/A,51,51 units,"AL, CA, CO, CT, FL, GA, IL, MD, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA",Terminated,"December 14, 2010",236,51,Not_Computer,N/A,N/A,N/A
Z-1431-2010,54975,"electrode, electrocardiograph",DRX,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"Unilect ECG ElectrodesUnomedical, McAllen Texas.Intended use:Cardiac monitoring","DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560",2,"April 22, 2010", 2010,ConvaTec,"In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.",DESIGN: Process Design,"The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a ""URGENT : MEDICAL DEVICE RECALL"" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product.If you have any questions, please contact Convatec at 908-904-2425.",Contact the recalling firm for information,567000,"567,000 units",Nationwide distribution: CA,Terminated,"June 21, 2011",425,567000,Not_Computer,N/A,N/A,N/A
Z-1411-2010,55099,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Synergy XVIThe intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5,2,"April 22, 2010", 2010,"Elekta, Inc.",Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.,DESIGN: Device Design,"The following Important Notices were sent to customers: 1) Important Notice A305-Possible Synergy XVI panel position error (dated September 19, 2007) was sent to customers with versions R3.5, R4.0 and R4.1., 2) Important Notice A306-Possible Synergy XVI panel positioning error (dated November 8, 2007) was released to encompass customers with version R4.2., and 3) Important Notice A328 dated March 10, 2009, and sent again on April 29, 2009, included a modification kit to address the original issue and an expanded range of serial numbers affected. This Important notice A328 entitled, Elekta Synergy kV Detector Position Readback Modification Kit supersedes A305 and A306 for customers who have serial numbers within the range specified. The letter describes the product and the problem and advises the customer to follow any instructions or recommendations covered in this Notice.If you have any questions, please contact Elekta at 770-670-2548.",N/A,166,166 units,"Worldwide distribution: USA and Puerto Rico, Canada and Mexico.",Terminated,"August 09, 2012",840,166,Not_Computer,N/A,N/A,N/A
Z-1432-2010,55103,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),Precise Treatment TableIntended as a universal patient treatment support and positioning table for radiation therapy and simulation use.,Precise Treatment Table,2,"April 23, 2010", 2010,"Elekta, Inc.","In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.",OTHER/UNDETERMINED: Pending,"Mandatory Field Change Order (FCO) 528 053 ""Check for zinc plated Precise Table 'Z' mechanism fixation bolts"", dated 1/11/2007 was distributed to all affected customers. The Change Order identified the product, stated the reason for the FCO, and the procedure to check and resolve the problem identified.",N/A,185,185 units,"Worldwide Distribution -- USA, Puerto Rico, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Russia, Serbia, Spain, Sudan, Sweden, Taiwan, Thailand, Turkey & United Kingdom.",Terminated,"December 28, 2010",249,185,Not_Computer,N/A,N/A,N/A
Z-1427-2010,54562,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),"InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.",InterGard Knitted Collagen Coated Vascular prostheses,2,"April 23, 2010", 2010,Intervascular S.A.S.,Packaging was mislabeled.,PRODUCTION CONTROLS: Labeling Mix-Ups,"InterVascular SAS issued a ""Recall Notification - Product Recall RC 020"" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated.For further information, contact InterVascular SAS at +33 442 08 77 84.",N/A,9,9,Nationwide Distribution - Arizona.,Terminated,"April 27, 2010",4,9,Not_Computer,N/A,N/A,N/A
Z-1437-2010,55252,"stimulator, photic, evoked response",GWE,Evoked response photic stimulator.,Neurology,Neurology,510(k),"Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.",Enfant Pediatric VEP Vision Testing System,3,"April 26, 2010", 2010,"Diopsys, Inc.",The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.,DESIGN: Software Design,Field Service personnel were sent an e-mail notification on 4/2/2007 which included a TZedit file to be downloaded. E-mails instructed reps to install the patch on their customers devices immediately. Field correction was completed 7/31/2007.,N/A,175,175 units,Nationwide distribution.,Terminated,"April 27, 2010",1,175,Software,Device Operation,Software update,Software Update
Z-1436-2010,55064,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.",iView GT,2,"April 26, 2010", 2010,"Elekta, Inc.",Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.,DESIGN: Software Design,"Elekta sent IMPORTANT NOTICE number A329, dated 31 July, 2009 to all customers. This corresponds with Field Change Order - Documentation 764 00 551 060 ""An Important Notice (A329) has been issued for replacement of iViewGT R3.4 Service Pack 2 (SP2) installation CD"". Mandatory Field Change Order 764 00 551 059 ""Replacement of iViewGT R3.4 installer disk""supersedes FCO 764 00 551 053.",Contact the recalling firm for information,121,121 lots,Nationwide & Puerto Rico,Terminated,"December 14, 2010",232,121,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-1433-2010,55171,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445.Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.",3D Knee Tibial InsertDCM,2,"April 26, 2010", 2010,"Encore Medical, Lp",Affected product had incorrect color label which is a secondary visual indicator for sizing.,PRODUCTION CONTROLS: Packaging Process Control,"Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm.For further information, contact Encore Medical, LP at 1-888-838-3668.",N/A,7,7 units,"Worldwide Distribution -- United States (UT, IA) and Germany.",Terminated,"July 22, 2010",87,7,Not_Computer,N/A,N/A,N/A
Z-1438-2010,55180,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003",TIGER Canulated Screw System,2,"April 26, 2010", 2010,Trilliant Surgical LTD,"Firm received several complaints of field failures, e.g., ""broke during surgery"" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.",OTHER/UNDETERMINED: Pending,Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.,N/A,32,32 units,"WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD",Terminated,"May 03, 2010",7,32,Not_Computer,N/A,N/A,N/A
Z-1440-2010,54686,implantable pacemaker pulse-generator,DXY,Implantable pacemaker pulse generator.,Cardiovascular,Cardiovascular,N/A,"Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.",Medtronic EnRhythm pacemaker,2,"April 26, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,"Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were given a Medtronic ""Important : Medical Device Correction"" letter addressed to ""Dear Doctor"" and dated February 2010. In the letter, Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. The letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.",Contact the recalling firm for information,120061,"approximately 120,061 worldwide","All States in the USA including Guam, Puerto Rico and DC.OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, Viet Nam, Virgin Islands",Terminated,"January 08, 2013",988,120061,Battery,Device Operation,Software update,Software Update
Z-1424-2010,53608,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Cardiac Science, Bothell, WA 98021.Indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.","Powerheart, CardioVive, Nihon Kohden and/or Responder AED",1,"April 27, 2010", 2010,Cardiac Science Corporation,"Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198 and 2023440. The affected devices were manufactured between October 29, 2003 and February 10, 2009.",DESIGN: Process Design,"Cardiac Science issued ""Urgent - Medical Device Corrective Action"" notices dated October 2009. Customers were instructed to identify the affected product and arrange for product replacement with the firm. Where possible, end user information was requested for further follow-up by the firm.For further information, contact Cardiac Science at 1-877-402-4599 or by email at AED155@cardiacscience. com.",N/A,1171,"1171 (US: 569, OUS: 602)","Worldwide Distribution -- Distributed to the United States, Australia, Belgium, Canada, Chile, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Marshall Islands, Nigeria, Norway, Philippines, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.",Terminated,"February 13, 2012",657,1171,Hardware,N/A,Replace,Remove or Replace
Z-1441-2010,55098,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Elekta SynergyIntended to be used for radiation therapy treatment of malignant neoplastic diseases.,Elekta Synergy,2,"April 27, 2010", 2010,"Elekta, Inc.",Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control,"An Important Notice A319 ""Instructions for Use for Elekta Synergy kV Source Touchguard"" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 ""kV Source touchguard for systems with touchguard ready source covers"" dated 10/17/08 was sent to all affected customers. FCO 514 260 ""kV Source touchguard for systems with the original source covers"" dated 10/17/08 was sent to all affected customers.",Contact the recalling firm for information,184,184 units,Nationwide Distribution -- Including Puerto Rico.,Terminated,"December 14, 2010",231,184,Not_Computer,N/A,N/A,N/A
Z-1443-2010,55049,extractor,HWB,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two.Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.,Implant Extraction Set Implant Extraction Guide Module One & Two,2,"April 27, 2010", 2010,Stryker Howmedica Osteonics Corp.,Literature did not include the design change to a smaller cannulation diameter.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"An Urgent Correction - Operative Technique letter was sent to direct accounts, Hospital Risk Management, Chief of Orthopaedics and Surgeons that use the Gamma3 system. Notification letters were sent via Federal Express on March 2, 2010. The letter identified the product and described the issue. It also discussed the potential hazards and risk mitigation. Customers are to contact Customer Service at 1-866-OR-ASSIST or any of the other firm representatives listed in the letter.",N/A,790,790 unit,Nationwide Distribution,Terminated,"August 06, 2012",832,790,Not_Computer,N/A,N/A,N/A
Z-1134-2010,54631,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell GammaPlan.Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.",LEKSELL GAMMAPLAN,2,"April 27, 2010", 2010,"Elekta, Inc.","Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.",OTHER/UNDETERMINED: Pending,"Important Notice A325 ""Error in ImageMerge"" dated November 21, 2008 was sent to affected customers and field service engineer as notification of the problem. The notice advises users not to use ImageMerge except if it is judged that the transformation error has no clinical significance. Information is provided in the release to help the user to make an informed decision on this issue. Field Change Order 200 084, ""NTPS 8.3 SP1 for NTPS 8.0, 8.2 and 8.3"" released January 28, 2009 was sent to affected customers as notification of the fix to this issue. This notice includes instructions to assist Elekta field service personnel in successfully upgrading the affected systems. Once the upgrade is in place, the issue will be corrected.",Discard product or return to place of purchase for a full refund or exchange,72,72 units,"Nationwide Distribution -- (AL, AZ, AR, CA, CO, FL, GA, HI, IL,KY, MA, MI, MS, NE, NV, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN TX and UT).",Terminated,"December 14, 2010",231,72,Not_Computer,N/A,N/A,N/A
Z-1442-2010,54995,"pump, breast, powered",HGX,Powered breast pump.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps:a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;",Instructions for Use for Symphony Double Pumping Kit,2,"April 27, 2010", 2010,Medela Inc,The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"An ""IMPORTANT:DEVICE RECALL"" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.",N/A,13834,"13,834 kits",Nationwide distribution,Terminated,"December 10, 2010",227,13834,Not_Computer,N/A,N/A,N/A
Z-1434-2010,55182,"pin, fixation, threaded",JDW,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy.Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.",XCaliber MetaDiaphyseal Complete Kit,2,"April 28, 2010", 2010,Orthofix Srl,"During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Orthofix issued an ""Urgent: Field Safety Notice"" dated February 22, 2010. Consignees were informed of the affected product and instructed to cease use and to return the product to the firm.",N/A,9,9,"Nationwide Distribution -- TX, ND, NY, FL and CA.",Terminated,"May 05, 2010",7,34,Not_Computer,N/A,N/A,N/A
Z-1439-2010,54889,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.,InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Va,2,"April 28, 2010", 2010,Intervascular S.A.S.,The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.,OTHER/UNDETERMINED: Pending,"The firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.",N/A,5,5,"US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.",Terminated,"April 29, 2010",1,5,Not_Computer,N/A,N/A,N/A
Z-1531-2010,52777,"indicator, physical/chemical sterilization process",JOJ,Sterilization process indicator.,General Hospital,General Hospital,510(k),"Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.",CROSSCHECKS P plasma sterilization indicator,2,"April 29, 2010", 2010,"Steritec Products Mfc. Co., Inc.",This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling.,OTHER/UNDETERMINED: Pending,"Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled.Questions are directed to the firm at (303) 660-4201.",N/A,2656,2656 cases,"Nationwide distribution: IL, MI, NY, OH, VA",Terminated,"June 28, 2010",60,2719,Not_Computer,N/A,N/A,N/A
Z-1528-2010,55016,"acid, folic, radioimmunoassay",CGN,Folic acid test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA; product code 2A6222.",Baxter RenAmin (Amino Acid) Injection,2,"April 29, 2010", 2010,Baxter Healthcare Corp.,"Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. Baxter decided to remove all potentially affected products even though there have been no out-of-specification pH results at the 0, 6 and 12 month intervals. The recall was initiated on 2/15/10.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit.The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303.",N/A,4164,"4,164 units","United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia",Terminated,"January 29, 2012",640,148032,Not_Computer,N/A,N/A,N/A
Z-1525-2010,55175,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),"PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in MexicoIndicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.",TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER,2,"April 29, 2010", 2010,Bard Access Systems,8F PowerPort stems were mixed with 6F PowerPorts and packaged.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm, Bard Access Systems, Inc. (BAS) sent a ""URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL"" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS.Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.",N/A,200,"200 units total (100 units of each lot, see code information)","Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.",Terminated,"October 01, 2010",155,200,Not_Computer,N/A,N/A,N/A
Z-1533-2010,54850,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),Leksell Gamma Knife C,Radionuclide Radiation Therapy System,2,"April 29, 2010", 2010,"Elekta, Inc.","Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.",OTHER/UNDETERMINED: Pending,"Phase 1 - Field Change Order FCO-DOC-06-0003 ""Technical Note - Potential risk of dropping the collimator helmet"" (dated Aug. 28, 2006) was sent to affected customers as notification of the problem. Phase 2 - Technical Notes Leksell Gamma Knife C version 1.2 (dated July 2006) ""Important Notice - Potential risk of dropping the collimator helmet"" was sent to all Elekta Service Engineers as notification of the problem.The firm planned to create an upgrade kit for the effected Leksell Gamma Knife C1.2 systems. A service representative from Elekta will contact each site to decide on a suitable implementation schedule.",Contact the recalling firm for information,88,88 units,"Nationwide, Austria, Belgium, Canada, China, Croatia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey.",Terminated,"December 14, 2010",229,88,Computer,N/A,N/A,N/A
Z-0820-2010,52635,"sensor, glucose, invasive",MDS,N/A,N/A,Clinical Chemistry,N/A,"Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA.Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.",Freestyle Navigator Continuous Glucose Monitor System,2,"April 30, 2010", 2010,"Abbott Diabetes Care, Inc.","Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.",PRODUCTION CONTROLS: Process Control,"Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.",N/A,5449,"5,449 of total units","Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.",Terminated,"March 31, 2011",335,5449,Not_Computer,N/A,N/A,N/A
Z-1535-2010,53836,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Vista CHEM 3 calibratoris an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System","DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130",2,"May 04, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",patient results are depressed,OTHER/UNDETERMINED: Pending,"An ""Urgent Field Safety Notice"" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product.If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.",N/A,1753,1753 cartons,"Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.",Terminated,"June 22, 2010",49,1753,Not_Computer,N/A,N/A,N/A
Z-1534-2010,54264,"monitor, patient position, light-beam",IWE,Light beam patient position indicator.,Radiology,Radiology,510(K) Exempt,"Hitachi Oasis Magnetic Resonance Scanners Software V1.0CThe intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.",Hitachi Oasis Magnetic Resonance Scanners Software ,2,"May 04, 2010", 2010,Hitachi Medical Systems America Inc,The device has a software error that could potentially lead to a misdiagnosis.,DESIGN: Software Design (Manufacturing Process),Sites have already been corrected. Software updated from V1.0C to V2.0B.,N/A,43,43,"Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY.",Terminated,"February 24, 2012",661,43,Software,Output/Calculation,Software update,Software Update
Z-1536-2010,55251,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1"" x 4.7""), Warwick, RIProduct Code: 0010211The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.",VENTRIO HERNIA PATCH,2,"May 04, 2010", 2010,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeled: Product labeled as Small Oval (3.1"" x 4.7"") may contain Small Circle (3.0"")",N/A,"An ""URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015"" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter, if they are a distributor, to their customers who have received the product and lot number. All products returned will be held at the Davol, Warwick location.Please contact your Davol Territory Manager or C.R. Bard's Medical Service Support Department at 1-800-562-0027 if you have any other questions.",N/A,198,198 units,Nationwide distribution,Terminated,"October 27, 2011",541,198,Not_Computer,N/A,N/A,N/A
Z-1524-2010,55191,finger semi-constrained pyrolytic carbon uncemented prosthesis,NEG,N/A,N/A,Orthopedic,PMA,"Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001.Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.",Ascension PyroCarbon PIP Total Joint Trials,2,"May 04, 2010", 2010,"Ascension Orthopedics, Inc",Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.,DESIGN: Device Design,"Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement.For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.",Contact the recalling firm for information,129,"129 units (64 US, 65 OUS)","Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.",Terminated,"September 27, 2010",146,129,Not_Computer,N/A,N/A,N/A
Z-1537-2010,55169,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112.A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.","Medtronic HMS PLUS, Hemostasis Management System with Heparin Assay Controls",2,"May 04, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,"The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Medtronic issued an ""Urgent Medical Device Notification"" letter dated March 8, 2010 addressed to ""Dear Valued Customer"" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification.For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.",Contact the recalling firm for information,544,"508 US, 36 OUS","Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.",Terminated,"December 31, 2011",606,544,Not_Computer,N/A,N/A,N/A
Z-1538-2010,54091,"accessories, catheter",KGZ,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605Permits venous access and catheter introduction to the central circulation.",Percutaneous Sheath Introducer (PSI) Arrow Select Kit ,2,"May 05, 2010", 2010,Arrow International Inc,Some central venous catheter sets had the incorrect lid stock.,N/A,"Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.",N/A,295,295 kits,Nationwide Distribution -- MA.,Terminated,"July 29, 2011",450,295,Not_Computer,N/A,N/A,N/A
Z-1221-2010,54165,spectroscopy instrument,REM,N/A,N/A,N/A,N/A,"Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X.Laboratory instrument.",Point Scanning Confocal Microscope TCS SP5/TCS SP5 X,2,"May 06, 2010", 2010,"Leica Microsystems, Inc.",A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Service Note was sent to service organizations on November 12, 2009. The communication asked customers to check if they must exchange their shutters and send their planned exchange date by 2009-11-20 to clsm.qc@leica-microsystems.com. Customers were also asked to check the serial numbers of the one-wire chips of the shutters. Then lastly, the were asked to exchange the shutters and confirm the exchange.",N/A,23,15 microscopes and 8 spare part shutters,"Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.",Terminated,"May 11, 2010",5,23,Not_Computer,N/A,N/A,N/A
Z-1540-2010,55286,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.","AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES",2,"May 06, 2010", 2010,"Encision, Inc.",Electrosurgical electrode tip insulation may crack and break off during use.,N/A,"A ""Confirmation of Product Recall"" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.",N/A,20,20 units,"Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.",Terminated,"May 21, 2010",15,1140,Not_Computer,N/A,N/A,N/A
Z-1517-2010,55354,tube tracheostomy and tube cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.",Shiley Specialized Tracheostomy Tube,1,"May 06, 2010", 2010,Nellcor Puritan Bennett Inc. (dba Covidien Ltd),"Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.",DESIGN: Process Design,"Covidien issued an ""Urgent Medical Device Recall"" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.",N/A,20,20 units,"Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.",Terminated,"January 18, 2012",622,559545,Not_Computer,N/A,N/A,N/A
Z-1550-2010,55179,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI.The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a craniomaxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium and mid-face.",Inion Baby Screw,2,"May 07, 2010", 2010,Stryker Craniomaxillofacial Division,"During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Stryker, issued two ""URGENT PRODUCT RECALL NOTIFICATION"" letters, dated March 5, 2010 and March 19, 2010, to customers. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory for the catalogue and lot numbers, return the enclosed confirmation indicating the location of the affected product, return any remaining product to Stryker at the noted address, and provide a copy of this notification to any site that they may have distributed the product to.If you have any further questions, contact Rob Yamashita, Sr. Regulatory Affairs Rep at (269) 323-4258 or email: rob.yamashita@stryker.com.",N/A,184,184 packs (5/pack),"Nationwide distribution: CA, CO, CT, FL, GA, IL, LA, MA, MD, ME, MO, MT, NC, NH, NJ, NM, NY, OH, PA, RI, SC, TX and WI.",Terminated,"June 06, 2012",761,184,Not_Computer,N/A,N/A,N/A
Z-1547-2010,55115,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA.Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.",ZOLL E Series Defibrillator/Pacemaker/Monitors,2,"May 07, 2010", 2010,"ZOLL Medical Corporation, World Wide Headquarters",Device issued Shock Advised message but failed to auto-charge the defibrillator.,DESIGN: Software Design,"Zoll Medical Corporation issued an ""Urgent Medical Device Correction"" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded.For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.",N/A,1383,1383 units,"Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.",Terminated,"January 23, 2014",1357,1383,Software,Device Operation,Software update/Replace,Software Update
Z-1548-2010,55147,"nail, fixation, bone",JDS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723SSynthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures.",7.5mm Ti Solid Humeral Nail 230 mm Sterile,2,"May 07, 2010", 2010,"Synthes USA (HQ), Inc.",potential compatibility issue,DESIGN: Device Design,"The recalling firm, Synthes, issued an ""URGENT: MEDICAL DEVICE RECALL"" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at lewis.lynne@synthes.com. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.",N/A,1,1 unit,"Nationwide distribution: LA, MA, ME, NC, PA and VA.",Open,N/A,N/A,6,Not_Computer,N/A,N/A,N/A
Z-1551-2010,54566,"processor, tissue, automated",IEO,Automated tissue processor.,Pathology,Pathology,510(K) Exempt,"Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005",Peloris Rapid Tissue Processor,2,"May 07, 2010", 2010,"Leica Microsystems, Inc.","Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies.",OTHER/UNDETERMINED: Pending,"Leica Microsystems sent Medical Device Correction letters dated 2/9/10 to the affected customers via first class mail on the same date, informing them of the potential for tissue damage during processing and outlining the software upgrade being made to minimize the risk of tissue damage. Customers were informed that their local Leica Microsystems representative will contact them to arrange the software upgrade and to provide training on the use of the new software. The letters also provided the necessary steps required to avoid tissue damage during processing while they are awaiting the software upgrade. The accounts were asked to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147.Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.",Contact the recalling firm for information,574,574 units,"Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia.",Terminated,"June 30, 2011",419,574,Other,Physical Safety Hazards,Software update,Software Update
Z-1560-2010,54239,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),One Touch Ping Insulin Pump using ezManager Max diabetes management software,One Touch Ping Insulin Pump,3,"May 08, 2010", 2010,Animas Corporation,"Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users.,N/A,21,21 pumps,"The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA",Terminated,"June 22, 2010",45,21,Software,Display/Image,Replace unit,Remove or Replace
Z-1553-2010,55216,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.",TELIGEN Implantable Cardiac Defibrillator,2,"May 08, 2010", 2010,Boston Scientific CRM Corp,Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration.,PREMARKET APPROVAL: No Marketing Application,"BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers.For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).",N/A,1330,1330,nationwide within US only (OUS distribution not affected).,Terminated,"April 05, 2012",698,2490,Not_Computer,N/A,N/A,N/A
Z-1561-2010,55117,"ventilator, emergency, manual (resuscitator)",BTM,Manual emergency ventilator.,Anesthesiology,Anesthesiology,510(k),PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.,PM1000 Flow Selector,2,"May 09, 2010", 2010,"Precision Medical, Inc.","The on/off outlet is mislabeled so that when a user/operator turns selector to ""on"", it actually may be turned ""off""",PRODUCTION CONTROLS: Labeling Mix-Ups,The recalling firm issued Customer Alert Product Recall letters on 3/5/10 to inform users of the problem and how to identify affected product.,Contact the recalling firm for information Contact the recalling firm for information,19518,"19,518","The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada",Terminated,"December 13, 2010",218,19518,Not_Computer,N/A,N/A,N/A
Z-1574-2010,54083,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3;XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile","Stryker Orthopaedics, Scorpio XCelerate",2,"May 10, 2010", 2010,Stryker Howmedica Osteonics Corp.,"The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.",DESIGN: Device Design,"Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100.",N/A,9833,"9833 Scorpio Cutting Blocks, total.","Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.",Terminated,"September 14, 2012",858,9833,Not_Computer,N/A,N/A,N/A
Z-1552-2010,49383,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR",Intramedullary Fixation Rod,2,"May 10, 2010", 2010,Acumed LLC,"Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.",OTHER/UNDETERMINED: Pending,"On 8/21/2008 the firm initiated telephone contact with consignees, followed by an e-mail, and a letter. Consignees were instructed to return product to the firm. Consignees were provided with a response form to complete and return to the firm. For additional information, please contact the firm directly at telephone 888-627-9957.",N/A,36,36 devices,"Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.",Terminated,"May 14, 2010",4,36,Not_Computer,N/A,N/A,N/A
Z-1590-2010,54683,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.",Stryker Endoscopy SDC HD and SCD HDi,2,"May 10, 2010", 2010,Stryker Endoscopy,Video device is not able to assign the correct time/date stamp.,DESIGN: Device Design,"Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.",N/A,12896,12896 devices,"US government facilities and other US domestic consignees(nationwide), and to foreign countries",Terminated,"February 17, 2011",283,12896,Software,Output/Calculation,Software update,Software Update
Z-1568-2010,55189,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ConMed Goldline Hand Controlled, Rocker Switch, Safety Holster and 10 FT Cable, Bulk, REF 130339A, Non-Sterile, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.",Electrosurgical pencil,2,"May 10, 2010", 2010,ConMed Electrosurgery,Electrosurgical pencil may remain activated or self activate after power switch is released.,N/A,"Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.",N/A,2500,"2,500 (US)","Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.",Terminated,"September 27, 2010",140,791970,Not_Computer,N/A,N/A,N/A
Z-1591-2010,55446,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,N/A,"VNS Therapy¶_ Demipulse¶_ Generator, Model 103 and VNS Therapy Demipulse Duo¶_ Generator, Model 104VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software",VNS Therapy System,2,"May 10, 2010", 2010,"Cyberonics, Inc",Battery life projection is inaccurate.,DESIGN: Software Design,"Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic.The issue can also be corrected during the initial implant procedure with the instructions provided.Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.",N/A,8109,Model103: 8109 units; Model 104: 1722 units; Programmers: 8891,Worldwide distribution.,Terminated,"August 20, 2012",833,18722,Software,Alarm/Message,Reprogram,Other
Z-1592-2010,54680,"dilator, vessel, for percutaneous catheterization",DRE,Vessel dilator for percutaneous catheterization.,Cardiovascular,Cardiovascular,510(k),"Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.",none,2,"May 11, 2010", 2010,Galt Medical Corp,Potential problem with pouch seal thus affecting sterile product.,PRODUCTION CONTROLS: Packaging Process Control,"Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.",N/A,400,400 units,"Nationwide Distribution -- MI, PA, IL, & Washington, D.C.",Terminated,"March 21, 2011",314,400,Not_Computer,N/A,N/A,N/A
Z-1527-2010,55355,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"GE, 1009-9002-000 Avance Anesthesia Machine and Monitor",GE Avance,1,"May 11, 2010", 2010,"Ge Healthcare, Llc","Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.",DESIGN: Process Design,"Consignees were sent a GE Healthcare ""Urgent Medical Device Correction"" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering.The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.",Contact the recalling firm for information,18,"18 (4 USA, 14 OUS)","Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Terminated,"January 30, 2012",629,33,Hardware,Device Operation,Correction,Repair
Z-0339-2010,52852,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021.The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.",Orthopediatrics IM Femoral Nail ,2,"May 12, 2010", 2010,Orthopediatrics Corp,The potential exists for the nails to fracture during insertion of the nail.,DESIGN: Device Design,"Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.",N/A,23,23 of all products,Nationwide.,Terminated,"October 25, 2010",166,23,Not_Computer,N/A,N/A,N/A
Z-1594-2010,55213,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis.",Accolade Distal Spacer,2,"May 12, 2010", 2010,Stryker Howmedica Osteonics Corp.,One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.,PRODUCTION CONTROLS: Process Control,"Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.",N/A,15,15,Nationwide distribution.,Terminated,"July 09, 2010",58,32,Not_Computer,N/A,N/A,N/A
Z-1595-2010,55305,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.",Centurion,2,"May 12, 2010", 2010,Centurion Medical Products,"The firm is conducting a sub recall of kits containing ConMed Goldline Rocker Switch Pencils. The pencils activation switch may remain in the ""on"" position after the switch has been depressed with excessive force, thereby continuously activating the pencil.",N/A,"Centurion sent out an ""Urgent Product Recall Notice"" to one customer on 4/9/2010. The customer was instructed to discontinue use of the product. The customer was also instructed to return any instock product .",Contact the recalling firm for information,74,74 kits,TX,Terminated,"October 25, 2010",166,74,Not_Computer,N/A,N/A,N/A
Z-1598-2010,55303,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ev3 Prot¶_g¶_ EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929.Intended as a palliative treatment of malignant neoplasms in the biliary tree.","Protg EverFlex"" SelfExpanding Biliary Stent System",2,"May 13, 2010", 2010,"Ev3, Inc.","ev3 is conducting a voluntary recall on three lots of the Prot¶_g¶_ EverFlex"" Biliary Stent System. They determined that a lot of 120mm Prot¶_g¶_ EverFlex"" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Prot¶_g¶_ EverFlex"" Biliary Stent System may contain a 120 mm length Self-Expanding stent.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"ev3 issued ""Medical Device Recall"" notifications dated March 31, 2010 addressed to ""Dear Risk Manager or Cath Lab Manager"". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return.For further information, contact ev3 Customer Service at 1-800-716-6700.",N/A,19,19,"Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.",Terminated,"March 08, 2012",665,19,Not_Computer,N/A,N/A,N/A
Z-1601-2010,55199,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920.Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.",Distal Centralizer Exeter II Hip System,2,"May 13, 2010", 2010,Stryker Howmedica Osteonics Corp.,Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.,PRODUCTION CONTROLS: Error in Labeling,"Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.",N/A,24,24 units,"Nationwide Distribution -- FL, MN, & OR.",Terminated,"September 10, 2012",851,24,Not_Computer,N/A,N/A,N/A
Z-1600-2010,55222,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.",Radiological Image Processing Software,2,"May 13, 2010", 2010,"Vital Images, Inc.","Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2. because incorrect measurements may result. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.",DESIGN: Software Design,"Consignees were sent a Vital ""Urgent Medical Device Software Recall Notice"" letter dated 23 February 2010. The letter was addressed to ""Dear Customer."" The letter described the problem, product affected and provided recommendation to their customers. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.",No consumer action necessary,95,95,"AZ, AR, CA, COT, CT, FL, GA, IN, IA, KY, LA, MD, MA, MI, MN, NV, NJ, NY, ND, OH, PA, SC, TX, VA, WA, WV, WI.AUSTRALIA, SPAIN, FRANCE, BELGIUM, NETHERLANDS, PERU, NIGERIA, SWEDEN, CANADA, SWITZERLAND, EGYPT, CHINA, GERMANY, PANAMA, TAIWAN, HONG KONG, VENEZUELA, SOUTH AFRICA, CHILE, MEXICO, KOREA, COLOMBIA.",Terminated,"June 07, 2012",756,95,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-1597-2010,55254,"knife, ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,"BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA.Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.",BD Visitec EdgeAhead MVR Knife,3,"May 13, 2010", 2010,Becton Dickinson and Company,"A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.",PRODUCTION CONTROLS: Packaging Process Control,"BD Medical issued a ""Voluntary Advisory Notice"" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm.For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.",Contact the recalling firm for information,1170,"1170 (US 810, OUS 360)","Worldwide Distribution -- United States, Canada and Japan.",Terminated,"August 06, 2012",816,1170,Not_Computer,N/A,N/A,N/A
Z-1599-2010,55503,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX.Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.","Eon Mini"" Implantable Pulse Generator (IPG)",2,"May 13, 2010", 2010,"Advanced Neuromodulation Systems, Inc","Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.",PRODUCTION CONTROLS: Manufacturing Material Removal,"St. Jude Medical issued an ""Important Medical Device Information"" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm.For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.",No consumer action necessary,7,7 devices,"Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.",Open,N/A,N/A,7,Not_Computer,N/A,N/A,N/A
Z-1603-2010,53197,"apparatus, traction, non-powered",HST,Nonpowered orthopedic traction apparatus and accessories.,Orthopedic,Orthopedic,510(K) Exempt,"Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA",Stryker Endoscopy PrepStrap Shoulder Sleeve,2,"May 14, 2010", 2010,Stryker Endoscopy,Latex-- Certain lots of Product contain undeclared latex.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An Urgent: Device Removal notice, dated 7/27/2009 was sent to the sole distributor, Stryker Orthopaedics in New Jersey. The distributor will execute the sub-recall. The firm intends to scrap all returned product at that facility, who will provide a record of disposition. The distributor will notify consignees via a mail packet that will be sent via FedEx overnight mail. Consignees will be instructed to return all product to the distributor, with credit provided per policy.",Contact the recalling firm for information,842,842 units,Nationwide Distribution,Terminated,"December 08, 2010",208,842,Not_Computer,N/A,N/A,N/A
Z-1602-2010,55184,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.",cortical bone screw,2,"May 14, 2010", 2010,Acumed LLC,Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw,TRAINING: Employee Error,"On May 18, 2009, the firm, ACUMED, began calling customers. On May 19, 2009, the ACUMED sent e-mails and a ""URGENT NOTICE: DEVICE RECALL"" Initial Notice letter to all customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to identify the product having the lot code(s) and quarantine them, return all products from the lot code(s) to Acumed immediately, to please notify the customers of this recall if you further distributed this product, and complete and return the Acumed Product Recall Effectiveness Form.Please contact Acumed Customer Service at 1-888-627-9957 for any questions regarding this notification.",N/A,83,83,"Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan",Terminated,"May 17, 2010",3,83,Not_Computer,N/A,N/A,N/A
Z-1606-2010,55317,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight.SterileIntended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.,EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS,2,"May 14, 2010", 2010,"Maquet Cardiovascular, LLC","This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, MAQUET Cardiovascular, LLC, sent a ""DEVICE REMOVAL IMMEDIATE ACTION REQUIRED"" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products.Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.",N/A,22,22 units,"Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.",Terminated,"April 23, 2012",710,23,Not_Computer,N/A,N/A,N/A
Z-1605-2010,55498,"cabinet, table and tray, anesthesia",BRY,"Anesthetic cabinet, table, or tray.",Anesthesiology,Anesthesiology,510(K) Exempt,"Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.",Stryker Flat Panel Arm,2,"May 14, 2010", 2010,Stryker Communications Corp,Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at",Contact the recalling firm for information,1498,1498,"Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .",Terminated,"March 30, 2011",320,1498,Not_Computer,N/A,N/A,N/A
Z-1604-2010,54890,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell GammaPlan 8.0 image fusionLeksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.",LEKSELL GAMMAPLAN,2,"May 14, 2010", 2010,"Elekta, Inc.",The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2.,OTHER/UNDETERMINED: Pending,"Phase 1 - Important Notice and Technical Note #200 058 - ""Accuracy problems in Leksell GammaPlan 8.0 image fusion"", dated December 10.2007 and Field Change Order #200 058, ""Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion"", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2.For further question, do not hesitate to contact your Elekta support respresentative at.",N/A,66,66 units,"Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IL MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WA.",Terminated,"December 28, 2010",228,66,Software,Output/Calculation,Software update,Software Update
Z-1608-2010,55428,"suture, absorbable, synthetic, polyglycolic acid",GAM,Absorbable poly(glycolide/l-lactide) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed.Intended use: Soft Tissue approximation.",Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture,2,"May 18, 2010", 2010,"Ethicon, Inc.",Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.,OTHER/UNDETERMINED: Pending,"""Expansion of 2008 Voluntary Recall"" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business reply card to Stericycle. The customers should notify their end customers of this recall. If their end customers have the affected product they should first call 1-888-345-0483 to get appropriate shipping labels. THIS RECALL EXPANSION ONLY IMPACTS THE VICRYL RAPID SUTURE. THIS DOES NOT INCLUDE THE VICRYL* ADN VICRYL* PLUS PRODUCTS.Please don't hesitate to contact Christie Bielinski directly at 908-218-2553 or via email at cbielinsi@its.jnj.com should you have any questions or require additional information.",N/A,118332,"118332 eaches were sent to the US Distribution Center, of which 69936 eaches were shipped to primary consignees.","Worldwide distribution: USA and Austria, Belgium, Canada, Chile, China, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Middle East, Netherlands Antilles, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom",Terminated,"July 19, 2011",427,118332,Not_Computer,N/A,N/A,N/A
Z-1609-2010,55280,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Odyssey Intended use: Radiation treatment planning system,Odyssey ,2,"May 18, 2010", 2010,"PerMedics, Inc.","Anomaly 1, Invalid Characters in Patient ID Error:Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter or number (including spaces). Odyssey removes the invalid character when moving it to a patient folder. Due to this, it is possible that two different patient studies could be listed within Odyssey",OTHER/UNDETERMINED: Pending,"A letter dated March 23, 2010 was mailed to customers acknowledging the anomalies and informed the reader that the mandatory version correcting the software will be provided by May 19, 2010. Customers with version 4.4 will receive 4.4.04:t hose with version 4.5 will receive 4.5.04; and those with version 4.6 will receive 4.6.01 containing the corrections to these issues. In the meantime, the following recommendations are provided. For Anomaly I . Invalid Characters in Patient ID Error, it 1s recommended that the users do not create patient IDS that contain characters other than letters or numbers. For Anomaly 2.0dysse.v Muchitle Library Collimator Type Error, it is recommended that the customer contact PerMedics ifany modifications to the library have been performed. The primary view should also be examined and used to detect and avoid the conditions causing the anomaly. Finally, independent field shape and monitor unit checks should be performed as part of a routine quality assurance program. For Anomaly 3, OOdyssey MLC Block Error, it is recommended to avoid using the MLC Block feature until the mandatory version correcting this anomaly is installed. If you need to use this feature, then it is recommended that a physical block tray is used during treatment for each beam that contains an Odyssey MLC Block. If customers believe a patient treatment has been affected by any of these issues, they should notify Customer Support as soon as possible at 877-4PerMed (877-473-7633) or support@permedics.com.",Contact the recalling firm for information,16,16,"Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.",Terminated,"July 30, 2012",804,16,Software,Output/Calculation,Software update,Software Update
Z-1610-2010,55215,"stapler, surgical",GAG,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W.Designed to close incisions during a surgical procedure.",Disposable Skin Stapler 35 Wide,2,"May 19, 2010", 2010,Cardinal Health,The sterility of the staplers is questionable.,OTHER/UNDETERMINED: Unknown/Undetermined by the firm,"Cardinal Health issued an ""Urgent: Product Recall"" letter dated April 1, 2010 to all customers who may have received affected product. Customers were instructed to immediately quarantine any affected inventory, return the notification acknowledgement form and return the product to the firm.For further information, contact Cardinal Health Customer Service at 1-888-444-5440.",Contact the recalling firm for information,1638,"1,638 units",Nationwide Distribution,Terminated,"August 17, 2011",455,1638,Not_Computer,N/A,N/A,N/A
Z-1596-2010,55165,hepatitis a test (antibody and igm antibody),LOL,Hepatitis A virus (HAV) serological assays.,Microbiology,Microbiology,510(k),"ARCHITECT HAVAB-M ReagentA chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.",ARCHITECT HAVABM Reagent,2,"May 19, 2010", 2010,"Abbott Diagnostics International, Ltd.",There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.,N/A,"Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.",N/A,1326,"1,326",Nationwide Distribution -- Including Puerto Rico.,Terminated,"August 31, 2011",469,1326,Not_Computer,N/A,N/A,N/A
Z-1616-2010,55555,"coil, magnetic resonance, specialty",MOS,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO","Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner ",2,"May 19, 2010", 2010,Hitachi Medical Systems America Inc,"Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.",OTHER/UNDETERMINED: Pending,"On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.",N/A,56,56 devices,"Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.",Terminated,"September 21, 2012",856,56,Not_Computer,N/A,N/A,N/A
Z-1613-2010,55508,"tap, bone",HWX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.",N/A,2,"May 19, 2010", 2010,"Blackstone Medical, Inc.",Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Orthofix issued an ""Urgent Product Recall"" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.",N/A,92,92,Nationwide and to one location each in Australia and Spain.,Terminated,"August 10, 2010",83,465,Not_Computer,N/A,N/A,N/A
Z-1617-2010,55504,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport e360 VentilatorThe e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.",Newport e360 Ventilator,2,"May 19, 2010", 2010,Newport Medical Instruments Inc,The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360ventilator. Ventilators manufactured between September and December 2009 areaffected by this field correction. All affected ventilators require the replacement of the PCB2104A board to avoid early failure of t,OTHER/UNDETERMINED: Pending,"The firm, Newport Medical, sent a ""Field Correction Notice"" dated April 14, 2010, to all customers. The notice describes the product, problem and actions to be taken by the customers. The customers were instructed to: 1) provide your affected customers with a copy of this letter and advise them to pay close attention to pressure errors which can be an early warning sign of the pressure transducer failure; 2) Schedule their ventilators for replacement of the PCB2104A board as quickly as possible to avoid any unanticipated disruption in their use of their product;3) Contact our Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers) to request the replacement kits you will need; and4) Complete the attached form and return it to Newport Medical as you complete your PCB2104A replacements. This will allow us to ensure that all affected ventilators have been addressed and close this field action.For questions, customers were instructed to contact Newport Medical Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers).",No consumer action necessary,990,990,"Worldwide distribution: USA including states of CA, KY, NM, NY, UT and internationally to: Armenia, Bolivia, Brazil, Bulgaria, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Malaysia, Mauritius, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, South Africa, Sri Lanka, Syria, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, Vietnam.",Terminated,"August 18, 2011",456,990,Hardware,N/A,Replace board,Remove or Replace
Z-1620-2010,49126,"test, hepatitis b (b core, be antigen, be antibody, b core igm)",LOM,N/A,N/A,Microbiology,N/A,"Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, ""MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052""For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.",Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit,3,"May 20, 2010", 2010,Bio-Rad Laboratories,"The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.",PRODUCTION CONTROLS: Packaging Process Control,"All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723.",N/A,795,795 kits,Worldwide Distribution -- USA and Canada.,Terminated,"May 20, 2010",0,795,Not_Computer,N/A,N/A,N/A
Z-1621-2010,52527,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))The B-P Knee Replacement System is composed of several components used to provide surgeons with different intra-operative options. All metallic components are available in six sizes and are fabricated from Ti-6Al-4V titanium alloy by Endotec. BP Knee Replacement System Component, Modular Femoral Component:Size 5 Left Modular Femoral Component, Catalog: 04-31-2105, Lot No. 04-31-2105A; Size 4 Left Modular Femoral Component, Lot No. 04-31-2104A, Size 6 Left Femoral Component, Lot No. 04-31-2106A1. BP Knee Replacement System Component, Narrow Femoral Component:Size 3 Right Narrow Femoral Component Lot No. 04-31-1303C, Size 3 Left Narrow Femoral Component Lot No. 04-31-2303C, Size 4 Right Narrow Femoral Component Lot No. 04-31-1304C, Size 4 Left Narrow Femoral Component Lot No. 04-31-2304C. BP Knee Replacement System Component, All Poly Patella:Size 1 All Poly Patella Lot No. 04-34-0201B, 04-34-0201C, 04-34-0201D, 04-34-0201E. Size 2 All Poly Patella Lot No. 04-34-0202B, 04-34-0202C, 04-34-0202D, 04-03-0202E. BP Knee Replacement System Component, 3 Peg Patella:Size 4 3-Peg Patella Lot No. 04-34-0004H. BP Knee Replacement System Component, Conforming Bearing:1x0mm Conforming Bearing Catalog: 04-33-001, 1x2.5mm Conforming Bearing Catalog: 04-33-0011, 1x5mm Conforming Bearing Catalog: 04-33-0021, 1x7.5mm Conforming Bearing Catalog: 04-33-0031, 2x0mm Conforming Bearing Catalog: 04-33-0002, 2x2.5mm Conforming Bearing Catalog: 04-33-0012, 2x5mm Conforming Bearing Catalog: 04-33-0022, 2x7.5mm Conforming Bearing Catalog: 04-33-0032, 3x0mm Conforming Bearing Catalog: 04-33-0003, 3x2.5mm Conforming Bearing Catalog: 04-33-0013, 3x5mm Conforming Bearing Catalog: 04-33-0023, 3x7.5mm Conforming Bearing Catalog: 04-33-0033, 4x0mm Conforming Bearing Catalog: 04-33-0004, 4x2.5mm Conforming Bearing Catalog: 04-33-0014,4x5mm Conforming Bearing Catalog: 04-33-0024, 4x7.5mm Conforming Bearing Catalog: 04-33-0034, 5x0mm Conforming Bearing Catalog: 04-33-0005, 5x2.5mm Conforming Bearing Catalog: 04-33-00155x5mm Conforming Bearing Catalog: 04-33-0025, 5x7.5mm Conforming Bearing Catalog: 04-33-0035, 6x0mm Conforming Bearing Catalog: 04-33-0006, 6x2.5mm Conforming Bearing Catalog: 04-33-0016, BP Knee Replacement System Component, Screw Stop:Size 4-6 Screw Stop Catalog: 03-12-0036.BP Knee Replacement System Component, Tibial Component Type 1 w/o Biocoat:Size 1 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0401, Size 2 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0402, Size 3 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0403, Size 4 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0404, Size 5 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0405, Size 6 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0406.BP Knee Replacement System Component, Tibial Component Type 1:Size 1 Type 1 Tibial Component Catalog: 04-32-0001,Size 3 Type 1 Tibial Component Catalog: 04-32-0003, Size 4 Type 1 Tibial Component Catalog: 04-32-0004.BP Knee Replacement System Component, Tibial Component Type 2:Size 3 Type 2 Tibial Component Catalog: 04-32-0013.BP Knee Replacement System Component, Tibial Component Type 0:Size 5 Type 0 Tibial Platform Catalog: 04-32-0065.BP Knee Replacement System Component, Femoral Component w/o Biocoat:Size 1 Right Femoral Component w/o Biocoat Catalog: 04-31-1201, Size 1 Left Femoral Component w/o Biocoat Catalog:04-31-2201, Size 2 Right Femoral Component w/o Biocoat Catalog: 04-31-1202, Size 2 Left Femoral Component w/o Biocoat Catalog:04-31-2202, Size 3 Right Femoral Component w/o Biocoat Catalog:04-31-1203, Size 3 Left Femoral Component w/o Biocoat Catalog:04-31-2203, Size 4 Right Femoral Component w/o Biocoat Catalog:04-31-","Endotec, Prosthesis Knee",2,"May 20, 2010", 2010,"Endotec, Inc.","Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.",OTHER/UNDETERMINED: Pending,Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.,N/A,3169,3169 Pieces,"Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain.Domestic: OH, TX, CA, FL, NJ, TN.",Terminated,"October 22, 2013",1251,3477,Not_Computer,N/A,N/A,N/A
Z-1628-2010,53212,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA",CELLDYN 1700,2,"May 20, 2010", 2010,Abbott Laboratories,"Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter.For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.",N/A,274,274,"Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.",Terminated,"December 03, 2010",197,2090,Not_Computer,N/A,N/A,N/A
Z-1619-2010,55304,"amplifier, physiological signal",GWL,Physiological signal amplifier.,Neurology,Neurology,510(k),"Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT.Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.",component of NeuroPort Array brain monitoring device.,2,"May 20, 2010", 2010,I2s Micro Implantable Systems Llc,Component of cranial array may not allow sufficient tightening to maintain inserter position.,DESIGN: Device Design,"The firm, Blackrock Microsystems, sent a ""RECALL"" letter dated March 26, 2010, to all customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of all affected devices and promptly return any inventory, perform a physical account of your inventory for the recalled product and email a list of all serial numbers to Andrew Gotshalk at agotshalk@blackrockmicro.com, and to please email Andrew Gotshalk even if you do not have any inserter wand holders or have destroyed or removed from use the inserter wand holders. Blackrock will rework or replace all Inserter Wand Holders that is returned under this recall. If you have any questions regarding this recall please call 801-582-5533 x 275.",N/A,22,22 units,"Nationwide distribution: CA, MA, NY, RI, and UT.",Terminated,"May 25, 2010",5,22,Not_Computer,N/A,N/A,N/A
Z-1632-2010,55241,"microscope, surgical, general & plastic surgery",FSO,Surgical microscope and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models :a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;","Leica Footswitch, Type B ",2,"May 20, 2010", 2010,"Leica Microsystems, Inc.",The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.,OTHER/UNDETERMINED: Pending,"Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.",N/A,54,"54 units (52 - U.S., 2 - Canada)","Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia",Terminated,"February 15, 2011",271,57,Not_Computer,N/A,N/A,N/A
Z-1631-2010,53322,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Boston Scientific, LATITUDE¶_ Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)",LATITUDE,2,"May 20, 2010", 2010,Boston Scientific CRM Corp,"Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test will not be displayed for physician review",DESIGN: Software Design,"Consignees were sent on 9/10/09 a Boston Scientific ""Urgent Medical Device Information"" letter dated September 9, 2009. The letter was addressed to ""Dear Doctor"". The letter provided the information related to the LATITUDE Patient Management system recall as to Background, Description, Rate of Occurrence, Patient management, Devices Affected and Further Information. Patients were also sent a Boston Scientific letter dated September 9, 2009. The letter addressed Background information, Why are we communicating, What You Should Do and Questions.",N/A,390,"25,656 (USA), 390 (OUS)","All States in the US including Puerto RicoUnited Kingdom, Switzerland, Netherlands, Italy, Germany, France, Finland, Denmark, Belgium, Austria",Terminated,"April 05, 2012",686,26046,Software,Alarm/Message,Notification,Safety Notice/Insructions
Z-1639-2010,54174,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820.Intravascular administration set.",Churchill Medical Systems,2,"May 21, 2010", 2010,"Churchill Medical Systems, Inc.","Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Churchill Medical Systems issued an ""Urgent: Product Advisory Customer Notification"" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.",N/A,283900,"283,900 each",Distributed to Florida.,Terminated,"March 28, 2013",1042,283900,Not_Computer,N/A,N/A,N/A
Z-1637-2010,55436,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.",ADVANCE DURAMER TIBIAL INSERT,2,"May 21, 2010", 2010,Wright Medical Technology Inc,The left medial pivot and right medial pivot inserts were co-mingled,PRODUCTION CONTROLS: Packaging Process Control,"Wright Medical Technology, Inc. issued an ""Urgent: Medical Device Voluntary Recall"" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm.For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.",N/A,47,47 units,"Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.",Terminated,"October 21, 2010",153,70,Not_Computer,N/A,N/A,N/A
Z-1635-2010,55407,"acid, hyaluronic, intraarticular",MOZ,N/A,N/A,Physical Medicine,N/A,"Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054;Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel.Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.",Euflexxa (1 sodium hyaluronate),3,"May 21, 2010", 2010,Ferring Pharmaceuticals Inc,Out of Specification results for molecular weight or viscosity through the established expiration date.,PRODUCTION CONTROLS: Process Control,"Ferring Pharmaceuticals issued a ""Medical Device Recall"" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm.For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.",Contact the recalling firm for information,3,"29,376 cartons with 3 syringes per carton.",Nationwide distribution.,Terminated,"July 27, 2010",67,29376,Not_Computer,N/A,N/A,N/A
Z-1643-2010,55477,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, 067000233. Used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.",SwitchPoint Element (SPE) Control System,2,"May 21, 2010", 2010,Stryker Communications Corp,Installation records are incomplete.,TRAINING: Employee Error,"An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.com.",N/A,9,9,Nationwide Distribution,Terminated,"January 24, 2011",248,1495,Not_Computer,N/A,N/A,N/A
Z-1638-2010,52291,"knife, orthopedic",HTS,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454.Intended for use in arthroscopic procedures.",BD Beaver ArthroLok Pointed Tip 4mm Blade,2,"May 21, 2010", 2010,Becton Dickinson and Company,Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.,PRODUCTION CONTROLS: Packaging Process Control,"Becton Dickinson issued an ""Urgent: Field Safety Notice"" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested.For further information, contact Becton Dickinson and Company at 1-781-906-7900.",N/A,354,354 units,"Worldwide Distribution -- United States, Japan and Belgium.",Terminated,"January 26, 2012",615,354,Not_Computer,N/A,N/A,N/A
Z-1618-2010,55235,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx Defibrillator Monitor, Model M3535AHeartStart MRx Defibrillator Monitor, Model M3536AThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician",Philips Heartstart MRx Defibrillator Monitor,2,"May 24, 2010", 2010,Philips Healthcare Inc.,ECG signal processing chip may fail causing failure to deliver therapy in AED mode or the failure to indicate poor electrical contact (very high impedance) with the patient in Manual Defib mode.,DESIGN: Component Design/Selection,"The firm, Philips Healthcare, sent an ""URGENT voluntary Medical Device Correction"" Field Safety Notice, letter dated April 7, 2009, to all customers via UPS. The letter describes the product, problem and the actions to be taken by customers, with precautions to follow if the device is used before upgrade is installed. The customers were instructed to check their serial numbers for the affected product, if the device is affected, it may remain in service prior to correction using the following precautions 1) if using AED, have a back up AED; 2) if using external defibrillator paddles, disregard paddles and manually ensure good paddlet-to-patient contact, and 3) if monitoring, be prepared to switch back to the primary ECG that was initially obtained for a given patient if other leads are lost. Customers will be contacted and assisted by Philips field service engineers to install the software upgrade which corrects the problem.Should you have any questions or concerns about this Device Correction, please contact your local Philips representative at 1-800-722-9377.",Contact the recalling firm for information,1379,1379 units,"Worldwide distribution:USA and Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Iceland, India, Ireland, Italy, Japan, Korea, Republic of Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Switzerland, Thailand, Trinidad, and Tobago, Ukraine, United Arab Emirates, United Kingdom.",Terminated,"February 20, 2013",1003,1379,Hardware,Treatment/Delivery/Therapy,Software update,Software Update
Z-1652-2010,55079,"reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification",OPU,N/A,N/A,Microbiology,EUA - Emergency Use Authorization,"Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.",Cepheid Xpert Flu A Panel (GXFLUPANELCE10),3,"May 25, 2010", 2010,Cepheid,"Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to ""Invalid"" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.",OTHER/UNDETERMINED: Pending,"Cepheid issued a notification to consignees regarding the affected product. Additional instructions were provided to consignees in order to avoid further ""Indeterminate Results"".For further information, contact Cepheid at 1-888-336-2743.",Contact the recalling firm for information,944,944 kits,"Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.",Terminated,"March 23, 2011",302,2747,Not_Computer,N/A,N/A,N/A
Z-1663-2010,54268,"system, image management, ophthalmic",NFJ,Picture archiving and communications system.,Radiology,Ophthalmic,510(k),Bausch & Lomb Millennium Microsurgical System.,Bausch & Lomb Millennium Microsurgical System,2,"May 26, 2010", 2010,Bausch & Lomb Inc,"The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A ""URGENT: POWER CORD RECALL"" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.",N/A,N/A,Quantity never provided by firm,"Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru.",Terminated,"May 17, 2013",1087,N/A,Battery,N/A,Replace component,Remove or Replace
Z-1681-2010,54473,"hearing aid, air conduction",ESD,Hearing Aid.,Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"InSound Medical, Inc, Lyric in-canal hearing aid.",Lyric Hearing Aid,2,"May 26, 2010", 2010,"InSound Medical, Inc.",Manufacturing error could result in electrolyte leakage from the product's battery.,DESIGN: Process Design,"InSound sent to its consignees a ""Dear Lyric Provider"" letter of explanation on 2/1/2010.",N/A,2019,2019 units,Distribution only in US ( nationwide). No foreign consignees involved.,Terminated,"August 02, 2011",433,2019,Not_Computer,N/A,N/A,N/A
Z-1654-2010,55300,"system, photopheresis, extracorporeal",LNR,N/A,N/A,Gastroenterology/Urology,PMA,"Therakos CellEx Photopheresis System;Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;",Therakos CellEx Photopheresis System,2,"May 26, 2010", 2010,Therakos Inc,Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter.On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.",N/A,280,280 units in US (1 sales unit contains 3 kits each),"Nationwide Distribution, and Canada and Germany",Terminated,"July 18, 2013",1149,280,Not_Computer,N/A,N/A,N/A
Z-1653-2010,55002,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.",Blackstone Medical Hallmark,2,"May 26, 2010", 2010,"Blackstone Medical, Inc.",The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.",N/A,98,"98 units domestically, 14 units internationally.","Nationwide distribution, including Puerto Rico, and to Australia.",Terminated,"September 09, 2011",471,98,Not_Computer,N/A,N/A,N/A
Z-1657-2010,55176,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Coulter¶_ LH 500 Series System. Beckman Coulter, Inc. Brea, CA.Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.",Coulter LH 500 Series System,3,"May 26, 2010", 2010,Beckman Coulter Inc.,"Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'Issue 2: The system will omit the character ~ regardless of language.Impact: There is a potential for Specimen",DESIGN: Software Design,"Beckman Coulter, Inc. issued ""Urgent: Product Corrective Action"" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned.For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.",N/A,1520,1520 units,Distributed Nationwide and Canada.,Open,N/A,N/A,1576,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1656-2010,55194,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA.Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.",UniCel DxH 800 Coulter Cellular Analysis System,2,"May 26, 2010", 2010,Beckman Coulter Inc.,"Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results.Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files.Impact: If the last run for a control lot",DESIGN: Software Design,"Beckman Coulter, Inc. issued an ""Urgent: Product Corrective Action"" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.",Contact the recalling firm for information,63,63 units,"Nationwide Distribution (AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, WA, and WI) and Canada.",Terminated,"May 23, 2012",728,63,Software,N/A,N/A,N/A
Z-1661-2010,55445,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)",GE Healthcare Innova,2,"May 26, 2010", 2010,"Ge Healthcare, Llc","A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios thatwill cause the next exam to fail and the inability to recall acquired sequences.",DESIGN: Software Design,"Consignees were sent on 3/24/10, a GE Healthcare "" Urgent Medical Device Correction"" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.",N/A,92,92,"Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.",Terminated,"May 21, 2013",1091,195,Software,Device Operation,Software update,Software Update
Z-1655-2010,55361,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Elekta XiO Radiation Treatment Planning System,Elekta XiO Radiation Treatment Planning System,2,"May 26, 2010", 2010,Computerized Medical Systems Inc,"Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening",DESIGN: Software Design,"Elekta issued an undated ""Important Safety Notice"" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.",N/A,34,The release is being used by 34 customers that also have an Elekta linear accelerator,"Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.",Terminated,"June 07, 2012",743,34,Software,Treatment/Delivery/Therapy,Instructions/Workarounds,Safety Notice/Insructions
Z-1683-2010,53668,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Responder 2000 Defibrillator/MonitorModels: 2025653, 2026109, and 2026114.Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The 3-lead and 5-lead ECG monitoring allows for identification of interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.",Automatic External Defibrillator (AED),2,"May 26, 2010", 2010,Cardiac Science Corporation,"The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing and holding down the Charge or Shock button on the Responder 2000 for more than 5 seconds causes a ""Button Stuck"" error. With the ""Button Stuck"" error, the device will automatically exit Manual mode and enter Monitor mode. The user cannot apply therapy while the device is in Monitor mode.",OTHER/UNDETERMINED: Pending,"The firm, Cardiac Science, sent an ""Urgent-Medical Device Corrective Action"" letter dated October 15, 2009, was sent to customers. The letter describes the product, problem and action to be taken by the customers. Cardiac Science requested GE to provide the end users with the Operator's Manual addendum. The customers are instructed to place the Operator's Manual addendum with their Responder 2000 Operator's Manual for future reference.If you have any questions about your Responder 2000, please contact Cardiac Science technical support at +44.161.926.0011 or our EU Representative, Ludger Moller, MDSS GmbH at +49.511.6262.8630.",Contact the recalling firm for information,1838,1838 devices,"Worldwide distribution: USA and Australia, Brazil, Columbia, Costa Rica, Denmark, Finland, France, Germany, Italy, Korea, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Africa, Spain, and Uruguay.",Terminated,"December 07, 2011",560,1838,Not_Computer,N/A,N/A,N/A
Z-1680-2010,55462,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA.Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.",UniCel DxH 800 Coulter Cellular Analysis System,2,"May 26, 2010", 2010,Beckman Coulter Inc.,The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.,DESIGN: Software Design,"Beckman Coulter, Inc. issued an ""Urgent: Product Corrective Action"" notification dated December 8, 2009. Consignees were informed of the affected product and provided temporary solutions until further support will be made available.For additional information, contact your local Beckman Coulter Representative or call 800-526-7694.",Contact the recalling firm for information,42,42 units (40 in US),Distributed Nationwide and Canada.,Terminated,"June 04, 2012",740,42,Not_Computer,N/A,N/A,N/A
Z-1682-2010,55385,"catheter,intravascular,therapeutic,long-term greater than 30 days",LJS,"Percutaneous, implanted, long-term intravascular catheter.",General Hospital,General Hospital,510(k),Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.,Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits,2,"May 26, 2010", 2010,Arrow International Inc,"Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the ""kit supplied"" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Arrow International issued an Urgent Medical Device Recall letter dated 3/29/10 to inform their customers of the problem and the need to return the product.,N/A,6719,6719,"Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.",Terminated,"September 27, 2012",855,6719,Not_Computer,N/A,N/A,N/A
Z-1671-2010,55365,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, Sterile, REF 11-104947, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.",Mallory Head Calcar Femoral,2,"May 26, 2010", 2010,"Biomet, Inc.",The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Biomet Orthopedics issued an ""Urgent Medical Device Recall Notice"" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm.For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.",Contact the recalling firm for information,6,6,"Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.",Terminated,"October 18, 2010",145,81,Not_Computer,N/A,N/A,N/A
Z-1704-2010,54168,"stimulator, auditory, evoked response",GWJ,Evoked response auditory stimulator.,Neurology,Neurology,510(k),"Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016",SmartEP,2,"May 27, 2010", 2010,Intelligent Hearing Systems Corp.,This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions,DESIGN: Device Design,"Intelligent Hearing Systems sent a letter ""Information Regarding the Discontinued Use of the SmartEP Evoked Response System for Vestibular Evoked Myogenic Potentials (VEMP) Testing"" dated September 30, 2008 to customers and distributors. Each customer will receive an upgrade and VEMP removal kit which will remove the VEMP feature.",Contact the recalling firm for information,50,50,Nationwide distribution.,Terminated,"September 21, 2011",482,50,Not_Computer,N/A,N/A,N/A
Z-1685-2010,55529,"binder, medical, therapeutic",MDR,Therapeutic medical binder.,General Hospital,General Hospital,510(K) Exempt,Juxta-Lite compression wrap Medium Short 28cm Length with Anklet Catalog 23024017,Juxta Lite,2,"May 27, 2010", 2010,Circaid Medical Products Inc,"Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25"") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level",PRODUCTION CONTROLS: Process Control,"CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.this listing for product returns.",N/A,372,"372 total, all sizes","Worldwide distribution: USA, Japan, Canada, Netherlands",Terminated,"January 06, 2011",224,372,Not_Computer,N/A,N/A,N/A
Z-1705-2010,55538,"lens, contact (other material) - daily",HQD,Rigid gas permeable contact lens.,Ophthalmic,Ophthalmic,510(k),"Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887.Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.",Boston ES Rigid Gas Permeable Contact lens,2,"May 27, 2010", 2010,Bausch & Lomb Inc,The amount of D&C; #6 Dye added to the formulation exceeded specified amounts.,PRODUCTION CONTROLS: Process Control,"Bausch & Lomb issued an ""Urgent Voluntary Medical Device Recall"" notification dated April 20, 2010. Consignees were informed of the issue and asked to identify and return all affected product to the firm.For further information, contact Bausch & Lomb, Inc. at 1-585-338-5477.",N/A,2575,2575 buttons,"Nationwide Distribution -- TX, IN and WI.",Open,N/A,N/A,2575,Not_Computer,N/A,N/A,N/A
Z-1706-2010,55570,"lenses, soft contact, extended wear",LPM,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,N/A,"AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097.Toric lenses approved for daily wear and extended wear up to 6 nights.",AIR OPTIX,2,"May 27, 2010", 2010,Ciba Vision Corporation,The lenses inside the package do not match the prescription information for power labeled on the primary package.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm.For further information, contact your CIBA Vision sales representative or call 1-877-542-5928.",No consumer action necessary,5040,"Lot #8717082, total 5040 lenses and Lot #8717066 total 5394 lenses","Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI.",Terminated,"October 22, 2010",148,10434,Not_Computer,N/A,N/A,N/A
Z-1707-2010,55715,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804.Infusion Catheter.",PULSESPRAY INFUSION SYSTEM,2,"May 27, 2010", 2010,"Angiodynamics, Inc.","This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.",PRODUCTION CONTROLS: Process Control,"Angiodynamics issued an ""Urgent Medical Device Recall"" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax.For further information, contact Angiodynamics Customer Service at 1-800-772-6446.",N/A,20,20 units,"Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.",Terminated,"July 25, 2012",790,20,Not_Computer,N/A,N/A,N/A
Z-1703-2010,55744,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head,Sendax MDI,2,"May 27, 2010", 2010,3m Imtec Corporation,"Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.",PRODUCTION CONTROLS: Packaging Process Control,"IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.",N/A,189,189 Implants,Nationwide.,Terminated,"July 14, 2010",48,189,Not_Computer,N/A,N/A,N/A
Z-1708-2010,54200,"unit, phacofragmentation",HQC,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.",Bausch & Lomb Millennium Basic Venturi Phaco Pack,2,"May 28, 2010", 2010,Bausch & Lomb Inc,Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate,DESIGN: Component Design/Selection,"The recalling firm, Bausch & Lomb, issued an ""URGENT: PHACO NEEDLE WRENCH CORRECTION"" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.",Contact the recalling firm for information,7268,"7,256/12-pack boxes","Worldwide distribution: USA and Germany, France, Italy, Norway, Sweden, Finland, The Netherlands, Switzerland, U.K., Austria, Luxembourg, Ireland, Hong Kong, New Zealand, India, Australia, and Japan.",Terminated,"April 02, 2012",675,72264,Not_Computer,N/A,N/A,N/A
Z-1732-2010,55647,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355.Intended for x-ray, angiographic use.",Axiom Artis systems with Motor Controller Unit,2,"May 28, 2010", 2010,"Siemens Medical Solutions USA, Inc",sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.,DESIGN: Device Design,"Siemens issued an ""Urgent Field Safety Notice"" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance.For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.",N/A,83,83 units,Nationwide Distribution,Terminated,"April 11, 2013",1049,83,Hardware,Device Operation,Repair,Repair
Z-1733-2010,55713,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.",ANGIODYNAMICS BENEPHIT(TM) XT Infusion System,2,"May 28, 2010", 2010,"Angiodynamics, Inc.","Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"Angiodynamics, Inc. issued an ""Urgent Medical Device Recall"" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm.For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.",N/A,741,741,Distributed Nationwide and to Italy,Terminated,"July 25, 2012",789,763,Not_Computer,N/A,N/A,N/A
Z-1731-2010,55661,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.",Vessel Sizing Angiographic Catheter,2,"May 28, 2010", 2010,"Merit Medical Systems, Inc.","Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.",PRODUCTION CONTROLS: Process Control,"Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm.For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.",N/A,96,96 units,"Nationwide Distribution -- GA, IL, MO, NY, PA and WI.",Terminated,"June 01, 2010",4,96,Not_Computer,N/A,N/A,N/A
Z-1735-2010,55723,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5.Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems.",Horizon Medical Imaging Systems,2,"May 28, 2010", 2010,Mckesson Medical Immaging,"Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.",DESIGN: Software Design,"McKesson Medical Imaging Company issued an ""Advisory Notice"" dated May 7, 2010. Consignees were notified of the affected product and advised to contact McKesson Customer Support department to review their sites current configuration and install the appropriate product software update(s). For further information, contact McKesson Medical Imaging Customer Support at 1-800-663-2533. On June 19, 2010 the recall was amended to include the following actions to follow: Instead of highlighting the anchor study in the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsing through other documents. A software update that prevents the problem from occurring is currently under development for all affected releases and will be available in approximately three months. Consignees will be notified when the software update is ready to be installed on their system.",N/A,100,100 units,"Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada",Terminated,"August 15, 2012",810,100,Software,Output/Calculation,Software update,Software Update
Z-1736-2010,55659,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,EVA 450 Patient Lift Battery Charger., EVA 450 Patient Lift Battery Charger,2,"June 01, 2010", 2010,"Romedic, Inc.",Incorrect battery chargers were supplied with the EVA 450 Patient Lifts. Charger unit stops working and will not charge lift. New chargers were supplied to customers.,OTHER/UNDETERMINED: Pending,"The recalling firm sent out a letter with instructions as follows: 1) Locate EVA 450 Patient Lift(s), 2) Fill out Customer Response Form and fax to 888-691-1091, 3) Replace battery charger(s) with new battery charger(s) supplied with this notification; NEW battery charger to be used according to EVA 450 Instructions, 4) Repackage replaced battery charger(s) in original packing in which shipment was recieved, 5) Apply supplied sticker ""EVA 450 Battery Charger RECALL"" on outside of box, 6) Apply supplied UPS return label on outside of box and contact UPS for pickup and mail to the following Address: RoMedic, Inc., 300 West Chestnut St., Ephrata, PA 17522; Attn: EVA 450 Battery Charger Recall.Additional questions are directed to the company at phone: 888-625-4343.",Contact the recalling firm for information,76,76 units,Nationwide distribution.,Terminated,"September 30, 2010",121,76,Not_Computer,N/A,N/A,N/A
Z-1737-2010,55234,"gauze/sponge, internal, x-ray detectable",GDY,Nonabsorbable gauze for internal use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3"" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669.",ARTERIAL LINE KIT,2,"June 02, 2010", 2010,"Argon Medical Devices, Inc",There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.,DESIGN: Packaging Design/Selection,"Argon Medical Devices issued an ""Urgent Medical Device Recall"" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.For further information, contact Argon Medical Devices at 1-903-677-9375.",Contact the recalling firm for information,10,10 kits,"Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.",Terminated,"July 29, 2010",57,199455425,Not_Computer,N/A,N/A,N/A
Z-1747-2010,55387,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.",Seno Advantage 2.2 workstations with software version 22_01 and 22_02,2,"June 02, 2010", 2010,"Ge Healthcare, Llc","GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety.When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may a",DESIGN: Software Design,"The firm, GE Healthcare, sent an ""Urgent Medical Device Correction"" letter dated February 8, 2010 to customers. The letter described the Safety Issue, Affected product details, Safety Instructions to prevent further inaccurate scale factor annotation, Product Correction and Contact Information. GE Healthcare will correct all affected workstations by providing a software upgrade and an updated Operator Manual. The GE service representative will contact customer to arrange for this correction.If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800-437-1171, Japan: -0120-055-919. For other countries, please contact your local GE Healthcare Service Representative.",Contact the recalling firm for information,73,73 devices,"Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JAPAN, ITALY,GREECE, FRANCE, COLOMBIA, CHILE, CANADA, BELGIUM, and BAHRAIN.",Terminated,"December 18, 2011",564,73,Software,Display/Image,Software update,Software Update
Z-1746-2010,55613,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008.Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.",Trestle Anterior Cervical Plate,2,"June 02, 2010", 2010,"Alphatec Spine, Inc.","The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaginglabel indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Alphatec Spine initiated a recall communication via telephone beginning August 25, 2009. Customers were given an explanation of the problem and instructed to check their inventory for the affected product. The firm indicated that they would arrange to have Federal Express contact customers for pick-up of the affected product(s) and replacement product would be sent out immediately.For further information, contact Alphatec Spine at 1-800-922-1356.",N/A,13,13 units,"Nationwide Distribution -- AL, CA, FL, TN, TX and UT.",Terminated,"June 07, 2010",5,13,Not_Computer,N/A,N/A,N/A
Z-1748-2010,53856,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.","PLAC Test Reagent Kit, immunoturbidimetric method",2,"June 03, 2010", 2010,"DiaDexus, Inc","Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.",OTHER/UNDETERMINED: Pending,"Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance.UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.",N/A,N/A,all lots,Product was distributed to 123 consignees throughout the US.,Terminated,"January 26, 2011",237,N/A,Not_Computer,N/A,N/A,N/A
Z-1754-2010,55527,"filter, bacterial, breathing-circuit",CAH,Breathing circuit bacterial filter.,Anesthesiology,Anesthesiology,510(k),"Xenon Diagnostic Circuit Kits labeled as ""Xenon Diagnostic Circuit"", ""Xenon Circuit"", and Needleless Xenon Diagnostic Circuit"" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. (""Xenon Curcuit"" Model number's 2304, 2306).Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.",Xenon Diagnostic Circuit Kits,2,"June 03, 2010", 2010,"Continental Medical Labs,Inc","CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component of their Xenon Kit (ViroMax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"The firm, A-M Systems, sent two ""URGENT: Notification of Product Recall/Correction"" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers.Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: rthompson@a-msystems.com with any questions, comments or concerns.",Contact the recalling firm for information,5520,5520,Nationwide distribution: WI,Terminated,"April 05, 2012",672,5520,Not_Computer,N/A,N/A,N/A
Z-1755-2010,55693,"probe, radiofrequency lesion",GXI,Radiofrequency lesion probe.,Neurology,Neurology,510(k),"The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.",Baylis Medical LumbarCool Pain Management System,2,"June 03, 2010", 2010,Baylis Medical Corp *,Name of the device reflected on the product packing sleeve is incorrect.,PRODUCTION CONTROLS: Error in Labeling,"The firm, Baylis Medical, notified US Distributor by email and sent a ""URGENT Field Corrective Action Notice"" dated May 12, 2010, to customer. The notifications described the product, problem and action to be taken by customer. The customers were given the follow options: Option 1: In order to prevent confusion in identification of the product before use, please immediately remove and dispose the package sleeve that covers the tray packaging of the LumbarCool Pain Management Kit.Option 2: Alternatively, you may exchange your kit from Lot LKFA160310 with a correctly labeled replacement LumbarCool Pain Management Kit by contacting Kimberly-Clark Health Care sales representative. The customers were ask to fill out the Field Corrective Action Acknowledgment and return it.Any question please call Baylis Sales Representative at 905-602-4875 and/or contact your local sales representative for any further information you may require.",Contact the recalling firm for information,58,58,Nationwide distribution: TX,Terminated,"October 04, 2010",123,58,Not_Computer,N/A,N/A,N/A
Z-1757-2010,51812,"treadmill, powered",IOL,Powered exercise equipment.,Physical Medicine,Physical Medicine,510(K) Exempt,"Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).","Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).",2,"June 04, 2010", 2010,Cardiac Science Corporation,"28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the el",OTHER/UNDETERMINED: Pending,"On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer.For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.",Contact the recalling firm for information,28,28 treadmills,"Distributed domestically (including Puerto Rico) to 20 end-user accounts and 2 distributor accounts;Distributed internationally to: Canada, Mexico, Portugal, and Saudi Arabia.",Terminated,"January 10, 2012",585,28,Hardware,Treatment/Delivery/Therapy,Remove,Remove or Replace
Z-1758-2010,55166,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"COULTER PrepPlus, Part Number: 286600","COULTER PrepPlus, Part Number: 286600",2,"June 04, 2010", 2010,Beckman Coulter Inc.,The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials loaded onto the Preppies or PrepPlus 2 systems. Affected systems have a syringe pump with part number A46748 (see illustrations below) which cause the probe to prematurely dispense Isoflow prior to arriving at the wash station.This condition only occurs with worklist panels which include both,OTHER/UNDETERMINED: Pending,"A Product Corrective Action (PCA) letter with attached PCA Response Form was sent on the week of January 25, 2010 to all customers who purchased the pipetting and diluting system: COULTER PrepPlus, or COULTER PrepPlus 2. The letter provides the customers with an explanation of the problem identified and an instruction on proper placing antibody reagent when using a worklist panel which involves both blood specimens and antibody reagents. Customers were also instructed to complete and return the PCA Response Form in addition to sharing the information contained in the PCA with their laboratory staff. If consignees had any questions they were told to contact their local Beckman Coulter Representative. Questions can be directed to the company's Customer Service office at (800) 526-7694.",No consumer action necessary,193,193 units in total,Domestically and Canada.,Terminated,"April 04, 2012",670,193,Not_Computer,N/A,N/A,N/A
Z-1766-2010,55701,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804","DURAMAX Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit",2,"June 04, 2010", 2010,"Angiodynamics, Inc.",The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.,OTHER/UNDETERMINED: Pending,"Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.",N/A,208,208,"Nationwide and St. Thomas, VI",Terminated,"July 25, 2012",782,2950,Not_Computer,N/A,N/A,N/A
Z-1756-2010,55807,"lenses, soft contact, extended wear",LPM,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,PMA,"Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.",Fancy i Color cosmetic lens,2,"June 04, 2010", 2010,Kim's Trading Inc,Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.,PREMARKET APPROVAL: No Marketing Application,"Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed.For further information, contact Kim's Trading Inc. at 1-484-895-3773.",Contact the recalling firm for information,300,300 pairs of contact lens,All product was distributed to one distributor in the Bethlehem PA area.,Terminated,"August 11, 2010",68,300,Not_Computer,N/A,N/A,N/A
Z-1772-2010,55740,"forceps, biopsy, non-electric",FCL,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy ForcepsInner Pouch 240cm, Box 20UPN/Catalog Number: M00513331",Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps,2,"June 04, 2010", 2010,Boston Scientific Corporation,Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.,PRODUCTION CONTROLS: Process Control,"Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.",N/A,320,320 units,Nationwide; Panama.,Terminated,"September 20, 2011",473,320,Not_Computer,N/A,N/A,N/A
Z-1760-2010,55620,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeable distal tip. The tip area consists of a radio-opaque gold-plated tungsten spring coil wound around a stainless-steel inner core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm.Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single. Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box. Material (UPN) H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX, FLEX C, Single/ Single.Material (UPN) H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX C TIP B5/5 per Box. Material (UPN) M001306020; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP, SINGLE/Single.Material (UPN) M001306021; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5 per Box.","Boston Scientific, BackUp Meier Steerable Guidewires",2,"June 04, 2010", 2010,Boston Scientific Corporation,"Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of the Back-up Meier Steerable Guidewires of the identified lots/batches have the potential for PTFE delamination. Inconsist",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent a Boston Scientific ""Urgent Medical Device Recall"" letter dated April 19, 2010. The letter was addressed to Risk Manger/Field Action Contact. The letter described the problem and product affected and recommended that to immediately discontinue use of and segregate recalled product. They also requested the consignee to complete and return the Account Reply Verification Tracking Form.Customers with questions are directed to the firm's Field Action Coordinator at (763-) 494-1417.",Contact the recalling firm for information,885,"US 885 single units (177 boxes), OUS 630 single units (126 boxes)","AL, AZ, AR, CA, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MS, MO, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN TX, VT, VA, WA.SWITZERLAND, GERMANY, FINLAND, FRANCE, ITALY, JORDAN, POLAND, SWEDEN, CANADA.Complete consignee list not available at this time.",Terminated,"December 10, 2011",554,1515,Not_Computer,N/A,N/A,N/A
Z-1775-2010,54643,"wheelchair, stair climbing",IMK,Stair-climbing wheelchair.,Physical Medicine,Physical Medicine,N/A,iBOT 4000 Mobility System Battery pack.,INDEPENDENCE iBOT 4000 Mobility System,2,"June 05, 2010", 2010,Independence Technology LLC,A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.,DESIGN: Device Design,"The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.",Contact the recalling firm for information Contact the recalling firm for information,192,192 devices,Nationwide and to the United Kingdom.,Terminated,"October 01, 2010",118,192,Not_Computer,N/A,N/A,N/A
Z-1780-2010,53611,"surgical device, for ablation of cardiac tissue",OCL,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,Cardiovascular,510(k),"St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA",Epicor Ultra Wand LP Handheld Ablation Device,2,"June 07, 2010", 2010,St. Jude Medical Atrial Fibrillation Division Inc,"The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has",OTHER/UNDETERMINED: Pending,"St. Jude Medical issued a Market Bulletin, dated 06/15/2009, to their Field Representatives who were instructed to contact customers to make them aware that changes were made to the Instructions for Use (IFU) by SJM and that the customer may notice an extra IFU included in the shipping package. All such worldwide regulatory approvals will be needed before a revised IFU can eventually be included directly within the device package (as opposed to the shipping box). Existing instructional materials including the Epicor LP System Set-up ACS hang sheet and the EpicorLP In-service slides are being revised to reflect the UltraWand LP IFU changes The forthcoming Epicor LP In-service video is also being updated to reflect these changes. An Important Medical Device Safety Information letter, dated 11/06/2009 was sent via FedEx beginning 11/10/2009 to all US customers and will also shipped to all OUS customers beginning 11/13/2009. A copy of the new IFU will be sent with the letter which is being sent to all customers that have purchased or consigned the SJM UltraWand LP product since its commercial release in July of 2008. The customer notification includes the SJM Marketing managers and director for questions on the action.",N/A,1813,"1813 (1155 US, 658 OUS)","AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. OUS to include Australia, Canada, Japan, Korea, Singapore",Terminated,"March 02, 2012",634,1813,Not_Computer,N/A,N/A,N/A
Z-1777-2010,55638,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case).",MoblVac Portable Wound Care Pump,2,"June 07, 2010", 2010,Ohio Medical Corporation,Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.,OTHER/UNDETERMINED: Pending,"Ohio Medical sent Urgent Medical Device Recall letters dated 5/7/10 to the direct accounts on 5/10/10, with follow-up telephone calls on 5/11/10. The accounts were informed of the one report of an explosion of the pump, and were requested to take the pumps out of service and return the pumps to Ohio Medical. The accounts were requested to complete and fax back to Ohio Medical the enclosed acknowledgement form indicating the number of pumps being returned. Any questions were directed to Anita Christ at 847-855-6270. Follow-up letters dated 5/13/10 were sent to the accounts on 5/14/10, providing instructions for the return of the pumps and bags. Shipping boxes will be sent to the accounts based on the number of pumps reported on the acknowledgment form.",No consumer action necessary,375,375 units,Nationwide and internationally to Qatar and Oman,Terminated,"August 19, 2011",438,593,Not_Computer,N/A,N/A,N/A
Z-1776-2010,55505,"electrode, electrocardiograph",DRX,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.,MicrV Alternans Sensors,2,"June 07, 2010", 2010,"Cambridge Heart, Inc.","Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.",PRODUCTION CONTROLS: Process Control,"The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.",Contact the recalling firm for information,2740,2740,Nationwide,Terminated,"September 20, 2011",470,2740,Not_Computer,N/A,N/A,N/A
Z-1779-2010,55637,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002 Intended use: Preparation of the Radius prior to device implantation",RAYHACK DRILL GUIDE ANGLED,2,"June 07, 2010", 2010,Wright Medical Technology Inc,Drill guides from 2 lots may not seat properly on the compression block.,OTHER/UNDETERMINED: Pending,"The firm, Wright Medical Technology, Inc., sent an ""URGENT: Medical Device Voluntary Recall Letter"" on April 8, 2010 via FedEx to customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please examine their inventory of the products and check it against the information provided, and to immediately return any affected products to Wright as soon as possible. The customers were also instructed to contact Customer service at 800-238-7117 for return instructions and replacement inventory. In addition, the customers were to immediately complete and return by fax at 901-867-7401 the attached response confirming receipt of the notice.If you have any questions regarding this matter, please contact Debby Daurer at 800-874-5630.",N/A,13,13 units,Worldwide: USA and The Netherlands,Terminated,"May 17, 2011",344,13,Not_Computer,N/A,N/A,N/A
Z-1647-2010,54884,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2"" x 4"", 3 units per box, Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920.Intended as reinforcement of soft tissue where weakness exists.",Bard Mesh Monofilament Knitted Polypropylene,1,"June 08, 2010", 2010,Ram Medical Inc,Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Ram Medical Inc., contacted Customers by phone beginning March 4, 2010 and issued ""Urgent Device Recall"" notifications beginning March 8, 2010. Further notifications were issued to expand the scope of the recall by the firm. Each notification described the affected product and asked the User to complete a Recall Acknowledgement Form and return it to the firm. All affected product should be returned to the firm.For further information, contact Ram Medical, Inc. at 1-973-633-0400 Monday through Friday, 9:00 AM to 5:00 PM EST.",N/A,102,102 boxes of 3 units each,"Nationwide Distribution -- CO, IL , NY, MO and FL.",Open,N/A,N/A,250,Not_Computer,N/A,N/A,N/A
Z-1783-2010,54630,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454.Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.",Nova StatStrip Glucose Test Strips,2,"June 10, 2010", 2010,Nova Biomedical Corporation,Glucose strips report low glucose results,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.",Contact the recalling firm for information,392,392 Cases (1800 strips each),"Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.",Terminated,"July 22, 2011",407,392,Not_Computer,N/A,N/A,N/A
Z-1784-2010,55256,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256.Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.",Modular Foot System,2,"June 10, 2010", 2010,Orthohelix Surgical Designs Inc,On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.,TRAINING: Employee Error,"OrthoHelix Surgical Designs, Inc. issued an ""Important Field Correction Notice"" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm.For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.",N/A,62,62 pieces,"Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.",Terminated,"September 10, 2012",823,62,Not_Computer,N/A,N/A,N/A
Z-1781-2010,55497,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.",Lifeline AED DDU100 semiautomatic external defibrillator used with the DBP2800 Battery Pack,1,"June 10, 2010", 2010,Defibtech LLC,"The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy",DESIGN: Device Design,"Defibtech, LLC issued an ""Urgent Medical Device Safety Information and Correction"" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement.For further information, contact your distributor or Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.",N/A,N/A,N/A,"Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.",Open,N/A,N/A,N/A,Battery,Treatment/Delivery/Therapy,Replace,Remove or Replace
Z-1785-2010,55572,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430.Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.",Passport V Monitor,2,"June 10, 2010", 2010,"Mindray DS USA, Inc., dba Datascope Patient Monitoring","An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.",DESIGN: Software Design,"Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product.For further information, contact Mindray DS USA, Inc. at 1-201-995-8391.",N/A,24,"24 US, 17 International","Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.",Terminated,"June 22, 2011",377,24,Software,N/A,N/A,N/A
Z-1788-2010,54276,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp","Triage Total Controls 5, Level 1",2,"June 11, 2010", 2010,Biosite Inc,Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.,OTHER/UNDETERMINED: Pending,"The firm, Biosite Incorporated, sent an ""URGENT MEDICAL DEVICE RECALL"" dated February 6, 2009, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to immediately discontinue all use and/or sale of the listed products, discard all affected product in accordance with their local regulations, complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the product replacement will be sent to them. Contact Inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you.Should you have any questions about the information contained in this notification, please contact (877) 441-7440 or email: Recalls@biosite.com.",N/A,N/A,N/A,Nationwide distribution,Terminated,"September 01, 2011",447,N/A,Not_Computer,N/A,N/A,Other
Z-1801-2010,55352,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, CARESCAPE"" Monitor B850, Software version 1.0.1.13 and 1.0.2.1The CARESCAPE "" Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.","The CARESCAPE"" Monitor B850 version 1.0.1.13 and 1.0.2.1",2,"June 11, 2010", 2010,"Ge Healthcare, Llc","GE Healthcare has become aware of a safety issue associated with the CARESCAPE"" MonitorB850 when monitoring ECG. The safety issue includes the potential for a delay in treatment.",DESIGN: Software Design,"The customers were sent on May 6, 2010, a GE Healthcare ""Urgent Medical Device Correction"" letter dated April 22, 2010. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter listed the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to immediately discontinue use of the ""Update Lead Set"" function until the device software has been upgraded.If you have any questions regarding this medical device correction or identification of affected items, please contact Technical Support at 1-800-558-7044, or your local service representative.",No consumer action necessary,798,"798 units. (229 USA, 569 OUS)","Worldwide distribution: USA including CO, MA, NC, WI, and countries of UNITED KINGDOM, SWITZERLAND, SWEDEN, SPAIN, SINGAPORE, PORTUGAL, NORWAY NETHERLANDS, ITALY, INDIA, GERMANY, FRANCE, FINLAND, BELGIUM, and AUSTRALIA.",Terminated,"June 05, 2012",725,798,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1798-2010,54652,"device, hematocrit measuring",JPI,Hematocrit measuring device.,Hematology,Hematology,510(K) Exempt,"i-STAT E3+ cartridgesThe i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.",iSTAT E3 cartridges,2,"June 11, 2010", 2010,Abbott Point of Care Inc.,Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.,OTHER/UNDETERMINED: Pending,"The firm, Abbott Point of Care, sent an ""Urgent Field Safety Notice Product Recall"" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.",N/A,40446,"40,446 total cartridges, all varieties",Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; Oman; Panama; Paraguay; Peru; Poland; Portugal; Qatar; Russian Federation; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; Trinidad and Tobago; Turkey; United Arab Emirates; Uruguay; Yemen; Netherlands Antilles; Venezuela; Australia; Belgium; France; Germany; Italy; New Zealand; Spain; Sweden; and The Netherlands.,Terminated,"July 25, 2012",775,40446,Not_Computer,N/A,N/A,N/A
Z-1786-2010,55404,"plasma, coagulation control",GGN,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),directCHECK Whole Blood Control;for Hemochron J. Microcoagulation Systems.,directCHECK Whole Blood Control,2,"June 11, 2010", 2010,International Technidyne Corporation,Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.,PRODUCTION CONTROLS: Error in Labeling,"Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.",Contact the recalling firm for information,94,94 boxes,"Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.",Terminated,"September 23, 2010",104,94,Not_Computer,N/A,N/A,N/A
Z-1800-2010,55674,"syringe, antistick",MEG,Piston syringe.,General Hospital,General Hospital,510(k),"InviroSnap¶_ Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.",InviroSnap,2,"June 11, 2010", 2010,"Inviro Medical Devices, Inc",Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification.,OTHER/UNDETERMINED: Pending,Consignees were notified by letter on or about 05/10/2010. Consignees were instructed to review their inventory of InviroSnap Safety Syringes for the lot numbers and remove them from inventory and to return the affected product to Inviro Medical. They were instructed to pass on the information to anyone who uses or orders Inviro Snap Safety Syringes at their facility and to ensure a copy of the letter is provided to any other organizations to which affected devices have been transferred. A Response Card was included to be completed and faxed back to Inviro Medical Devices even if there is no product in inventory to verify receipt of notification. Questions regarding the recall were directed to the company's Customer Service number at (866) 914-2259. All product from Group 1 will be scrapped. Product from Group 2 will be retained in Quarantine until such time as the product can be exported the permission of the importing countries Ministry of Health.,Contact the recalling firm for information,623000,"623,000 units","CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada",Terminated,"December 08, 2011",545,623000,Not_Computer,N/A,N/A,N/A
Z-1787-2010,55697,"culture media, selective and differential",JSI,Selective culture medium.,Microbiology,Microbiology,510(K) Exempt,"Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152***",Difco (TM) Decarboxylase Base Moeller,3,"June 11, 2010", 2010,Becton Dickinson & Co.,Diagnostic test reagents may not meet quality control specifications.,OTHER/UNDETERMINED: Pending,"The recalling firm notified distributors by letter flagged as ""Urgent Product Recall"" on 12/09/09. The letter instructed distributors to discontinue distribution and discard product. Distributors were asked to provide customer lists and the recaller subsequently notified the end users to discontinue and discard identified lots for replacement. Customers were asked to return a response form.If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.",N/A,209,209 bottles,The product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.,Terminated,"June 14, 2010",3,209,Not_Computer,N/A,N/A,N/A
Z-1799-2010,55658,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601.Intended to display mammographic images.",Drystar DT2 Mammo,3,"June 11, 2010", 2010,AGFA Corp.,The RF tags on the white protection sheets of the media stacks were incorrect.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"AGFA Healthcare issued an ""Urgent Safety Notice"" dated April 22, 2010 requesting a check of warehouse inventory and a request for a sub-recall, if necessary. All affected product should be returned to the firm for replacement.For further information, contact AGFA Healthcare at 1-877-777-2432.",N/A,180,180 boxes,"Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.",Terminated,"February 01, 2011",235,180,Not_Computer,N/A,N/A,N/A
Z-1802-2010,53126,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA.Medical device system consisting of a balloon-expandable intraluminal stent premounted onto the balloon of an over the wire delivery catheter. The system as two radiopaque markers on the inner member and positioned to each side of the stent, to aid in the placement of the stent during fluoroscopy. The system is compatible with labeled guidewires. The device is provided sterile and pyrogenic. It is indicated for use in the palliation of malignant neoplasms in the biliary tree.",Medtronic Racer Biliary Stent System,2,"June 14, 2010", 2010,Medtronic CardioVascular,Mislabeling-- The incorrect Instructions for use may have been included with this product.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm, Medtronic, Inc., sent an ""URGENT- VOLUNTARY MEDICAL DEVICE RECALL"" dated July 30, 2009, to custumers (Sales Representatives, to health care provider, patient, and risk manager, hospital administrator). The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to immediately segregate any Racer Biliary units from model number XD518YF (L#0000705315) in their possession to prevent inadvertent use. Medtronic, Inc., representative will contact the customer to review the labeling and retrieve the device should it be in their inventory. The customers are being ask to cooperate by providing the representative with access to the product.If you have any questions, please contact 707-566-1548.",N/A,13,13,Worldwide distribution: USA and Greater China.,Terminated,"January 31, 2011",231,13,Not_Computer,N/A,N/A,N/A
Z-1803-2010,55624,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room.The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE) are designed as an integrated voice, video, data router and teleconferencing interface for the operating room. The primary intent of the SPI2 and SPE product lines is to allow operating room personnel a center point for controlling all equipment and communication during surgery. The SPI2 and SPE route surgical and non-surgical images throughout the operating room to facilitate operating procedures. All video inputs and video outputs of the router require the use of various signal and cables types. Digital and analog video signals transmit from the auxiliary devices in the room through the SPI2 and SPE router to designated monitors. The primary difference between the SPI2 and SPE systems is that the SPE is a more compact version of the SPI2 offering less video inputs and outputs, and is intended to be used in smaller clinics.",SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE),2,"June 15, 2010", 2010,Stryker Communications Corp,"Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a ""Page Not Found"" error message, missing drop down options, or a frozen touch panel.",DESIGN: Component Design/Selection,"The firm, Stryker, sent an ""URGENT: Medical Device Correction"" letter dated May 4, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The firm recommended that the customer continue to use their SwitchPoint Infinity 2 or SwitchPoint Element. The customer is instructed to refer to their user manual, in the event they experience any failures; drive on module failure and/or product failure during a procedure. A Stryker representative will contact the customers facility to coordinate a service event to replace the existing component with a new component at no cost. Should the customer experience any of the aforementioned failures and require urgent technical support, please call Stryker Technical Support at 1-866-841-5663.If you have any questions regarding this letter or the implementation of this correction, please contact Shanta McKinzie at (972) 410-7319 or via email at StrykerCommunicationsRA@stryker.com.",N/A,1118,"1,118 devices","Worldwide distribution: USA and countries of Australia, EMEA, Canada, China, S. Africa, India, Japan, Latin America, Korea, Mexico, New Zealand, Taiwan, and Signapore.",Terminated,"April 25, 2011",314,1118,Software,Display/Image,Replace,Remove or Replace
Z-1805-2010,55698,"bone grafting material, synthetic",LYC,Bone grafting material.,Dental,Dental,510(k),Calcium Sulfate Hemihydrate 0.5 gram kits.,Calcium Sulfate Hemihydrate,2,"June 16, 2010", 2010,"Ace Surgical Supply Co., Inc.","Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection.",PRODUCTION CONTROLS: Process Control,Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits.Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.,Contact the recalling firm for information,4133,4133,"Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies.Item Number 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.",Terminated,"February 02, 2012",596,12063,Not_Computer,N/A,N/A,N/A
Z-1804-2010,55438,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,Synthes Medullary Tubes,Synthes ,2,"June 16, 2010", 2010,"Synthes USA (HQ), Inc.",After repeated sterilizations product may become discolored and break including while in the medullary canal. Synthes has determined that the Medullary Tube will be a single use item that is to be discarded after one sterilization cycle.,OTHER/UNDETERMINED: Pending,"The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter.Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant.",N/A,18505,"18,505 tubes",The product was shipped to medical facilities nationwide.,Open,N/A,N/A,18505,Not_Computer,N/A,N/A,N/A
Z-1808-2010,55724,"lamp,uvc,(for treating skin and wounds)",MXG,N/A,N/A,General & Plastic Surgery,510(k),"Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a ""Harris UV Lamp Training Manual""",Harris Medical UV Lamp,2,"June 16, 2010", 2010,Harris Medical Resources,"The Harris UV Lamp was promoted for sub-lingual treatment of HIV/AIDS; Hepatitis B; Hepatitis C; Malaria, Typhoid, Amoeba Infections and other blood diseases. The product was marketed without a 510(k), or an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). Questions are directed to the firm at 773-583-7500.",N/A,"Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.",N/A,20,20 units,"Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru",Terminated,"December 10, 2010",177,20,Not_Computer,N/A,N/A,N/A
Z-1807-2010,55410,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Ulnar Shorting Saw Blade is labeled in part: ""Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA"". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered.Intended use: Cutting Bones",Ulnar Shortening Saw Blade,2,"June 16, 2010", 2010,Acumed LLC,"The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.",OTHER/UNDETERMINED: Pending,"On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes. The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form .Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the recall.",N/A,718,718 units,"Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.",Terminated,"June 28, 2010",12,718,Not_Computer,N/A,N/A,N/A
Z-1811-2010,55649,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),CS100 Intra-Aortic Balloon Pump.,CS100 IntraAortic Balloon Pump.,2,"June 21, 2010", 2010,Datascope Corporation,"Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.",N/A,"Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail.Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.",Contact the recalling firm for information,161,161 total devices,"Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.",Terminated,"October 27, 2010",128,161,Not_Computer,N/A,N/A,N/A
Z-1810-2010,55603,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate).Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.,Powerheart 9390E automated external defibrillator,2,"June 21, 2010", 2010,Cardiac Science Corporation,"The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.",OTHER/UNDETERMINED: Pending,"Customer notification letters were mailed to US end users and distributors (final consignees) between December 18 and 23, 2009 by USPS certified mail, return receipt requested.Notification letters were sent by FedEx to Canadian distributors (final consignees) on December 23, 2009. Secondary consignee (distributor) letters were mailed on December 23, 2009.Letters advise user to check the status indicator on front of AED to determine if it is rescue ready. Users are advised to keep the AED in service and to perform the Daily and Monthly Scheduled Maintenance as outlined in the Operator and Service Manual.Questions about this communication should be addressed to 1.877.901.1788 toll free from inside the US, or to email",Contact the recalling firm for information,332,332 units,Domestic: 323 units to distributors and end users.Canada: 9 units to 2 distributors.,Terminated,"December 08, 2011",535,332,Other,N/A,N/A,N/A
Z-1816-2010,55535,"tube, sedimentation rate",GHC,Erythrocyte sedimentation rate test.,Hematology,Hematology,510(K) Exempt,"Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy.Slider allows a larger label to be applied to the ESR tube.",Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes,3,"June 22, 2010", 2010,"Vital Diagnostics, Inc.",The tube may fall out or separate from the Slider adapter,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked ""Urgent Recall Information Inside"", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form.For further information, contact Vital Diagnostics at 1-800-345-2822.",N/A,4723,"4,723 units",Distributed Nationwide and Canada.,Terminated,"September 13, 2010",83,4723,Not_Computer,N/A,N/A,N/A
Z-1815-2010,55051,"disinfectant, medical devices",LRJ,General purpose disinfectants.,General Hospital,General Hospital,510(K) Exempt,"CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9"" x 9"" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174.General purpose disinfectant wipe for hard, non-porous surfaces, patient care equipment and point of care equipment.",CaviBleach Wipes,2,"June 22, 2010", 2010,"Medtrol, Inc.",The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.,PRODUCTION CONTROLS: Process Control,"Medtrol telephoned Metrex on December 2, 2009, informing them that Medtrol was requesting the recall of the affected product.Metrex sent Urgent Medical Device Recall letters dated December 3, 2009 to their accounts, requesting them to examine their inventory for the affected product, and return any found for credit. They also requested their accounts to sub-recall the product to the retail level. Metrex also requested their accounts to complete and return the enclosed reply sheet, acknowledging receipt of the recall letter and indicating the amount of product being returned. For further information, contact Metrex Customer Care Center at 1-800-841-1428.",Contact the recalling firm for information,150,150 cases,Nationwide Distribution -- Including state of Michigan.,Terminated,"June 23, 2010",1,150,Not_Computer,N/A,N/A,N/A
Z-1814-2010,55405,"oximeter, ear",DPZ,Ear oximeter.,Cardiovascular,Anesthesiology,510(k),"DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500",DatexOhmeda TruSat,2,"June 22, 2010", 2010,"Ge Healthcare, Llc","GE Healthcare has recently become aware that theTruSat Pulse Oximeter with external power supply doesnot comply with current safety standards. It is possiblethat the external power supply could leak electricalcurrent. This current could cause third degree burns oran abnormal heart rhythm that, if untreated, could leadto death.",DESIGN: Component Design/Selection,"Consignees were sent on 4/29/10 a GE Healthcare ""Urgent Medical Device Correction"" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider. The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.",N/A,28442,"28,442 units","Worldwide distribution: USA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH,BELGIUM, BOLIVIA, BRAZIL, CANADA, INDIAN OCEAN TERRITORY, CHILE COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON LIBYAN ARAB JAMAHIRYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MEXICO, MOZAMBIQUE, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM, ZAMBIA.",Terminated,"December 03, 2013",1260,28442,Battery,N/A,N/A,N/A
Z-1890-2010,55676,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.Intended use: The ADAPt Balloon Open Access Port is indicated for the use in thoracic, abdominal and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. This a single use device, provided sterile.",TAUT ADAPt ,2,"June 23, 2010", 2010,Teleflex Medical,Balloon does not hold air or water once inflated.,OTHER/UNDETERMINED: Pending,"The firm, Teleflex Medical, sent an ""Urgent Medical Device Recall"" letter dated May 10, 2010 to customers The letter described the product, problem and action to be taken by the customers. They were instructed to return all of the affected product to Teleflex. Each distributor was instructed to forward the letter to their customers to retrieve relevant product from those locations. A second mailing to non-responding customers will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, email, or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. Teleflex Medical will communicate to FDA on the status of recall activities.If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.",Contact the recalling firm for information,366,366 eaches,"Worldwide distribution: USA including states of AR, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NY, OR, PA, WI, WV and country of France.",Terminated,"October 27, 2010",126,366,Not_Computer,N/A,N/A,N/A
Z-1891-2010,52206,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,IMMULITE 2000/2500 Chemiluminescent Substrate ModuleFor the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.,IMMULITE 2000/2500 Chemiluminescent Substrate ,2,"June 24, 2010", 2010,Siemens Healthcare Diagnostics Inc.,These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.,DESIGN: Device Design,"An Urgent Field Safety Notice dated May 2009 was sent to consignees of record for the previously mentioned lots. The Notice advised the following:These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. ActionsIf you are using one of these lots with your instrument, please take the following actions:1. Upon receipt of a non-affected substrate lot, discontinue using IMMULITE 2000/2500 Chemiluminescent Substrate. Prior to receiving a non-affected substrate lot, you can continue to use the affected substrate if you follow the Interim Procedure.2. Discard all bottles of the affected Substrate lots remaining in your inventory once non-affected Substrate lots are available.3. The first time ONLY that you switch from one of the affected substrate lots in Table 1 to a non-affected lot, you should follow the procedure and steps below during instrument Startup:a. Empty the substrate reservoir completely before adding the new lot.b. Prime the instrument to cleanse the lines of the previous lot of substrate.c. Add the new lot of substrate to the reservoir and prime the instrument again.*d. Adjust all methods run on that instrument.*Note: Prime the substrate line as instructed on Page 83, Priming the Substrate Probe , of the IMMULITE 2000/2500 Operators Manual Rev. A.4. Discuss the contents of this letter with your laboratory director.5. Complete the Completion Notification Form that accompanies this notice and return it as directed on the form. Submitting this form indicates that you have received the information in the Urgent Field Safety Notice and have either discarded all lots of the affected IMMULITE 2000/2500 Substrate, or are following the Interim Procedure while awaiting the receipt of a non-affected Substrate lot and will discard the affected lots as soon as the non-affectedlots are received in your laboratory.Interim ProcedureSiemens recognizes that you.",N/A,41573,"41,573",Nationwide Distribution,Terminated,"January 18, 2011",208,41573,Not_Computer,N/A,N/A,N/A
Z-1899-2010,55597,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Horizon Cardiology Hemo Monitoring SystemA programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.",Horizon Cardiology Hemo Monitoring System,2,"June 24, 2010", 2010,McKesson Provider Technologies - Medical Imaging Group,McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.,DESIGN: Software Design,"The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer",N/A,22,22 devices,"Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.",Terminated,"June 25, 2010",1,22,Hardware,Display/Image,Replace component,Remove or Replace
Z-1896-2010,55939,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146.Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.",Trilogy 100 Ventilator,2,"June 24, 2010", 2010,"Respironics, Inc.","It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips Respironics has contacted all of its consignees by phone and instructed them to remove the potentially affected external battery packs from their inventory and any that may be on their patients/end users. These consignees have been instructed to quarantine batteries they have removed away from flammable materials. Product return/replacement instructions were provided.For further information, contact Philips Respironics at 1-877-387-3311.",N/A,23,23 units,"Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.",Terminated,"November 18, 2010",147,23,Battery,Physical Safety Hazards,Return/Replace,Remove or Replace
Z-1900-2010,55673,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USADrill guide used as manual surgical instrument during knee replacement surgeries.",GENESIS II TIBIAL DRILL GUIDE,2,"June 24, 2010", 2010,Smith & Nephew Inc,Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side,PRODUCTION CONTROLS: Process Control,"All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.",Contact the recalling firm for information,12,12 units,"International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.",Terminated,"December 07, 2011",531,12,Not_Computer,N/A,N/A,N/A
Z-1897-2010,55857,"device, measuring, lens radius, ophthalmic",HLF,Ophthalmic contact lens radius measuring device.,Ophthalmic,Ophthalmic,510(K) Exempt,"Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland.Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.",Lenstar LS 900,2,"June 24, 2010", 2010,Haag-Streit USA Inc,"During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in",PREMARKET APPROVAL: No Marketing Application,"HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated.For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255.",N/A,45,45 units,"Nationwide Distribution -- Including AL, AZ, CA, FL, ID, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, VA, VT, WA and WV.",Terminated,"February 24, 2012",610,45,Software,Output/Calculation,Software update,Software Update
Z-1892-2010,55651,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.",Syngo Imaging ,2,"June 24, 2010", 2010,"Siemens Medical Solutions USA, Inc","Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.",DESIGN: Device Design,"The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.",No consumer action necessary,3,3 units,"Nationwide Distribution -- Including CT, NM, & WI.",Terminated,"July 05, 2012",742,3,Software,Output/Calculation,Software update,Software Update
Z-1817-2010,55784,"prosthesis, tracheal, expandable",JCT,Tracheal prosthesis.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Single Use, Rx only. Boston Scientific, Natick, MA 01760.Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.",Ultraflex tracheobronchial Stent System,2,"June 25, 2010", 2010,Boston Scientific Corporation,Suture related device failures during deployment and repositioning of the stent,N/A,"Boston Scientific issued an ""Urgent Medical Device Recall - Immediate Action Required"" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form.For further information, contact Boston Scientific at 1-866-868-4004.",N/A,N/A,N/A,Worldwide Distribution - Only US distributed product is affected by recall,Terminated,"October 20, 2011",482,N/A,Not_Computer,N/A,N/A,N/A
Z-1901-2010,51498,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.",VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5,2,"June 25, 2010", 2010,Bio-Rad Laboratories Inc,Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.,DESIGN: Software Design,"Bio-Rad Laboratories, Inc. issued and ""Urgent: Medical Device Correction"" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution.For further information, contact Bio-Rad Laboratories at 1-510-724-7000.",N/A,N/A,N/A,"Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.",Terminated,"March 22, 2011",270,N/A,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1913-2010,55765,"transurethral occlusion insert, urinary incontinence-control, female",OCK,N/A,N/A,Gastroenterology/Urology,N/A,"FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200.Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.The FSSTDSUP product is a Clinician Supply Pack that is provided directly toclinics. The Clinician Supply Pack is a package containing 2 multi-packboxes of product. The corresponding retail box label for this product(FSSTDSUP) is the REF 70200. The Multi-pack products contains 28 devices of the following:-8 of size 1 Standard;-4 of size 2 Standard;-4 of size 3 Standard;-4 of size 1 Long;-4 of size 2 Long; and-4 of size 3 Long.","FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes MultiPack.",2,"June 25, 2010", 2010,Rochester Medical Corp,"Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac",PRODUCTION CONTROLS: Packaging,"Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical ""Urgent Medical Device Recall"" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.",N/A,15400,"15,400 devices","AL, AK, AZ, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY, WI,.AUSTRIA, BANGLADESH, CANADA, CYPRUS, ETHIOPIA, FRANCE, GERMANY, GREECE, INDIA, JAPAN, KOREA, NETHERLANDS, P.R. CHINA, SAUDI ARABIA, SCOTLAND, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM.",Terminated,"December 28, 2011",551,104981,Not_Computer,N/A,N/A,N/A
Z-1905-2010,55495,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Unicel DxH 800 Coulter Cellular Analysis System,Part number(s): 629029",Unicel DxH 800 Coulter Cellular Analysis System,2,"June 25, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It wasdetermined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.",OTHER/UNDETERMINED: Pending,"Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee.The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States or contact your local Beckman Coulter Representative.",N/A,7,7,"Nationwide to: AZ, LA, IL, NY, PA & TN",Terminated,"April 04, 2012",649,7,Not_Computer,N/A,N/A,N/A
Z-1904-2010,55953,"generator, high-voltage, x-ray, diagnostic",IZO,Diagnostic x-ray high voltage generator.,Radiology,Radiology,510(K) Exempt,"Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237.Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.",Hydradjust IV DR Urological Table Sedecal Generator ,2,"June 25, 2010", 2010,Mallinckrodt Inc,Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.,PRODUCTION CONTROLS: Process Control,"Covidien Issued an ""Urgent Device Correction"" notification dated June 14, 2010 informing their customers of the potential problem. Consignees were instructed that Field Service Engineers will be in contact arrange a service visit to perform corrections on the affected units.For further information, contact Covidien Product Monitoring at 1-800-778-7898.",Contact the recalling firm for information,144,144 units,"Worldwide Distribution -- United States, Canada and China.",Terminated,"February 25, 2012",610,144,Not_Computer,N/A,N/A,N/A
Z-1914-2010,53698,"radioimmunoassay, angiotensin i and renin",CIB,Angiotensin I and renin test system.,Clinical Chemistry,Clinical Chemistry,510(k),"GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285.Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.",GammaCoat Plasma Renin Activity 125 I RIA Kit,2,"June 28, 2010", 2010,Diasorin Inc.,The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were Emailed or faxed a ""DiaSorin Customer Notification"" letter dated October 21, 2009. The letter was addressed to ""Dear Valued Customer"". The letter described the Product name and the problem and provided the correct range for the Renin Activity Control provided with the kit. The letter also stated that replacement product for any previous failed runs. Customers are to complete the bottom portion of the letter and return it to the firm. Questions or concerns should be directed to DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.",N/A,289,289 kits,"Worldwide Distribution -- USA, including states of CA, CT, IN, LA, MI, NC, OH, TN, UT, and WA and countries of CANADA, BELGIUM, BRAZIL, INDIA, NORWAY, PORTUGAL, SPAIN, and SWEDEN.",Terminated,"April 17, 2012",659,289,Not_Computer,N/A,N/A,N/A
Z-1916-2010,55579,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Automated External Defibrillator(AED) of brand name ""Philips HeartStart HS1 OnSite"" (Model number M5066A).Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally",Philips Heartstart HS1 OnSite,2,"June 28, 2010", 2010,Philips Medical Systems,Seventeen AEDs failed production line testing (Final Acceptance Test).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.",N/A,205,205,"Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.",Terminated,"December 10, 2012",896,471,Not_Computer,N/A,N/A,N/A
Z-1918-2010,55818,"unit, cryophthalmic",HPS,Cryophthalmic unit.,Ophthalmic,Ophthalmic,510(k),MIRA CR4050 12mm Finger Probe 12mm surface x 27mm LengthIntended for the destruction of tumors.,MIRA CR4050 Finger Probe,2,"June 29, 2010", 2010,"Mira, Inc.",Devices distributed without an approved 510(k),PREMARKET APPROVAL: No Marketing Application,Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.,N/A,5,5 units,"Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.",Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-1922-2010,55552,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova 3100/ 3100IQ system with InnovaIQ Table OptionIndicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally,rotational imaging procedures.",Innova 3100/ 3100IQ with InnovaIQ Table Option,2,"June 29, 2010", 2010,"Ge Healthcare, Llc","GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.",DESIGN: Device Design,"Consignees were sent on 6/3/10 a GE Healthcare ""Urgent Medical device Correction"" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.",N/A,13,13,"Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.",Open,N/A,N/A,92,Not_Computer,N/A,N/A,N/A
Z-1941-2010,55850,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"STERIS 4085, 5085 & 5085SRT Surgical Tables","STERIS 4085, 5085 & 5085SRT ",2,"June 30, 2010", 2010,Steris Corporation,"STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit.",N/A,79,79 units,"Worldwide distribution: USA, Australia, India, Korea & New Zealand",Terminated,"February 24, 2012",604,79,Not_Computer,N/A,N/A,N/A
Z-1943-2010,54366,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"BIOMET MICROFIXATION REF: 91-6103 ""1.5MM"" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.",BIOMET MICROFIXATION ,3,"June 30, 2010", 2010,"Biomet Microfixation, Inc.",Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.,DESIGN: Process Design,Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.,Contact the recalling firm for information,91,91 units,"US distribution: CA, CO, MI, and MO.",Terminated,"December 15, 2010",168,91,Not_Computer,N/A,N/A,N/A
Z-1940-2010,55654,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis",BD FACS Sample Prep Assistant II (SPA II),2,"June 30, 2010", 2010,"BD Biosciences, Systems & Reagents","Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.,Contact the recalling firm for information,349,349 units,"Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.",Terminated,"May 18, 2011",322,349,Not_Computer,N/A,N/A,N/A
Z-1942-2010,55801,"complement c1q, antigen, antiserum, control",DAK,Complement components immunological test system.,Immunology,Immunology,510(k),"Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021",BINDAZYME ,3,"June 30, 2010", 2010,Inova Diagnostics Incorporated,"The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as ""tissue Transglutaminase Coated Wells"" instead of ""C1q Coated Wells"".",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009.The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.",N/A,700,700 kits,"Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.",Terminated,"June 30, 2010",0,700,Not_Computer,N/A,N/A,N/A
Z-1939-2010,55749,"control, pump speed, cardiopulmonary bypass",DWA,Cardiopulmonary bypass pump speed control.,Cardiovascular,Cardiovascular,510(k),"Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console¶_ 550 centrifugal pump console, Model #95180, Catalogue #95180, E95180, R95180.Medtronic Bio-Console¶_ 560 centrifugal pump consolesModel # 560BC, Catalogue #560BC, 560BCS, 560BCS1.Medtronic autoLog¶_, Model # ATLG110, Catalogue # ATLG110, ATLG110EATLG110R.Medtronic Sequestra¶_ 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.","Power cord used on BioConsole, autoLog, Sequestra",2,"June 30, 2010", 2010,Medtronic Cardiovascular Revascularization & Surgical Therap,"The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent on 4/21/10 a Medtronic ""Urgent Medical Device Recall Notice"" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.",N/A,699,"619 USA, 80 OUS","Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.",Terminated,"December 24, 2011",542,699,Battery,Treatment/Delivery/Therapy,Remove,Remove or Replace
Z-1936-2010,55885,"tray, start/stop (including contents), dialysis",FKG,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI",Centurion Port Access Dressing Change Tray,2,"June 30, 2010", 2010,Centurion Medical Products,The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.,OTHER/UNDETERMINED: Pending,"The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.",Stop use and contact the recalling firm for information.,3144,3144 kits,Nationwide Distribution -- AR and OH.,Terminated,"February 09, 2011",224,3312,Not_Computer,N/A,N/A,N/A
Z-1935-2010,55796,"electromyograph, diagnostic",IKN,Diagnostic electromyograph.,Physical Medicine,Neurology,510(k),"Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices. The first is a system of capital equipment referred to as CERSR Electromyography System, which includes a cart. The second device is disposable electrodes arrays, which are single use devices, used with the capital equipment that is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping.",Lumbar Matrix Scan (LMS),2,"June 30, 2010", 2010,SpineMatrix Inc,"A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input requirement. One requirement found that it was possible for the physician to think they were reviewing one patients scan, but were actually reviewing a scan from a different patient. This event did not happen; however,",DESIGN: Device Design,"On 1/29/2010 all customers were provided a Voluntary Product Recall Notification letter that was sent via U.S. Postal Service Certified Mail and they were contacted by phone to arrange for pick up of the devices. The letter identified the affected product and described the problem. Customers are to check their inventory for the affected product and contact SpineMatrix Customer Service to receive instruction as to how to return the affected product, if the firm did not already contact the customer. Customers must complete the verification form and return it. Questions should be directed to Customer Service.",Contact the recalling firm for information,1166,"CERSR - 14 units, Electrode Arrays - 1,152 units","Nationwide Distribution -- CA, OH, OR & TX.",Terminated,"September 19, 2012",812,1166,Not_Computer,N/A,N/A,N/A
Z-1944-2010,55186,"monitor, bed patient",KMI,Bed-patient monitor.,General Hospital,General Hospital,510(K) Exempt,"Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Senior Technologies, Lincoln, NE.","Tabs Professional Monitor, Model 25022",2,"July 01, 2010", 2010,"Stanley Security Solutions, Inc.",Product might not indicate low battery alarms or exit alarms when powered by a DC power supply.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"The firm made phone calls beginning 3/26/10 to customers who purchased the 12-volt power supply informing them of the recall and instructing them to determine the number of units that will need to be returned for replacement. Important Safety Notice letters dated 3/25/10 were issued via regular mail on 3/26/10 and also providing the reason for the recall, instructions, and customer service contact information to arrange for return of the units.",Contact the recalling firm for information,84,84 units,Nationwide Distribution,Terminated,"September 16, 2011",442,187,Battery,Alarm/Message,Replace,Remove or Replace
Z-1903-2010,55853,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"LIFEPAK 20 defibrillator/monitor.Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.",LIFEPAK 20 defibrillator/monitor.,1,"July 01, 2010", 2010,"Physio Control, Inc.","A failure on the power supply assembly can result in either ""No DC power"" or ""No DC or AC power."" A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Firm began mailing Urgent Medical Device Correction notifications to affected customers on May 26, 2010 regarding the power supply to the device. All affected power supplies will be updated; this will be accomplished in two phases. Devices at a higher risk will be updated first in phase 1. The remaining lower risk devices will be updated afterward in Phase 2. Customers are advised to keep the defibrillators in service, and to follow recommended daily Operator Checklist steps, while service updates are scheduled. Customers with questions should contact the firm at 800-442-1142 between 6 am and 4 pm Pacific Time, Monday - Friday.",N/A,43001,"43,001 units","Worldwide distribution. In US, distributed domestically including to gov't accounts; and internationally to the following countries: ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.",Open,N/A,N/A,43001,Battery,Device Operation,Upgrade Battery,Repair
Z-1887-2010,55786,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),"Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.",Vaxcel ,1,"July 01, 2010", 2010,"Navilyst Medical, Inc",FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Navilyst Medical, Inc. is recalling Vaxcel Ports and Vaxcel Ports with PASV Valve with valid expiration dates worldwide. Navilyst sent ""Urgent Medical Device Recall - Immediate Action Required"" letter/recall notification packages on May 13, 2010, via Federal Express to 471 domestic consignees; on May 14, 2010, via e-mail to 14 international consignees and to Boston Scientific Corporation (prior owner of the affected products) via facsimile and Federal Express. On June 3, 2010, Navilyst Medical sent Recall Notification Packages on behalf of Boston Scientific Corp. via Federal Express to 182 domestic consignees. The letter instructs the customer to immediately discontinue use of and segregate recalled product, complete and return the reply verification tracking form to fax# 518-742-4450 and package and return the recalled product to the address provided.If you have any question, please call Navilyst Medical, Inc., Customer Service at 1-800-833-9973 or Michael Duerr at 1-518-742-4571.",N/A,N/A,N/A,"Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.",Terminated,"August 03, 2012",764,N/A,Not_Computer,N/A,N/A,N/A
Z-1898-2010,55670,"system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen",NQX,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA.Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.",Cepheid Xpert MRSA/SA Blood Culture,1,"July 01, 2010", 2010,Cepheid,"The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Cepheid, issued a technical bulletin to customers on April 5, 2010 and an updated to the April 5 bulletin dated April 9, 2010 instructing them to perform a reflexive repeat test on any blood culture results initially determined as having SA.If further information on this please contact your Cepheid Sales Representative 1-888-336-2743 or www.CEPHEID.COM.",Contact the recalling firm for information,5510,"5,510 units","Worldwide distribution: USA and Europe, Taiwan, and Australia.",Terminated,"May 25, 2011",328,5510,Not_Computer,N/A,N/A,N/A
Z-1953-2010,55776,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN.Intended for soft tissue to bone fixation.",Toggleloc Artificial ligament fixation device ,2,"July 01, 2010", 2010,"Biomet, Inc.",The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.,PRODUCTION CONTROLS: Process Control,"Biomet Sports Medicine issued an ""Urgent Medical Device Recall Notice"" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.",No consumer action necessary,2466,2466 both products,"Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.",Terminated,"August 06, 2012",767,2466,Not_Computer,N/A,N/A,N/A
Z-1951-2010,55771,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Optiflux¶_ F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.",Optiflux F180NR Dialyzer,2,"July 01, 2010", 2010,Fresenius Medical Care North America,Hemodialyzer may leak at the header/end cap,PRODUCTION CONTROLS: Process Control,"Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.",N/A,34152,"34,152 units",Nationwide Distribution,Terminated,"September 13, 2011",439,34152,Not_Computer,N/A,N/A,N/A
Z-1888-2010,55824,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"22ga x 1"" Straight Huber NeedleThis product is a small gauge needle intended for single use hypodermic access to implanted ports.",Huber Needle,1,"July 02, 2010", 2010,"Multi-Med, Inc.",FDA sample determined the needles to be coring.,N/A,"The firm, Multi Med, Inc., sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated May 26, 2010 to their sole consignee Navilyst Medical, Inc., via email and overnight courier with signature notification. The letter describes the product, problem and action to be taken by customer. The customers was instructed to immediately examine their inventory and quarantine product subject to recall, if the product was distributed to others customers, identify and notify them at once and include recall notification letter,. Recall has been initiated due to FDAs sample analysis that these needles may core implanted port septums.If you have any questions, call me, Sue Starkey, at 603-357-8733 or via email at astarkey@multimedinc.com.",N/A,5169,5169,Worldwide distribution,Open,N/A,N/A,10169,Not_Computer,N/A,N/A,N/A
Z-1949-2010,55825,"sealant,polymerizing",NBE,N/A,N/A,General & Plastic Surgery,N/A,"Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074.Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.",Coseal Surgical Sealant ,2,"July 02, 2010", 2010,Baxter Bioscience,The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.,PRODUCTION CONTROLS: Process Control,"The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return.The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete theCustomer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.",N/A,15262,"15,262",Nationwide Distribution,Terminated,"December 22, 2010",173,26440,Not_Computer,N/A,N/A,N/A
Z-1895-2010,55854,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica.Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.",Hospira brand Symbiq TwoChannel Infuser,1,"July 02, 2010", 2010,Hospira Inc,Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.,DESIGN: Device Design,"Hospira issued a ""Urgent: Medical Device Recall Notification"" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form.For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.",N/A,28485,"28,485 total","Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and United Arab Emirates.",Terminated,"December 03, 2013",1250,28485,Not_Computer,N/A,N/A,N/A
Z-1956-2010,54371,"screw, fixation, intraosseous",DZL,Intraosseous fixation screw or wire.,Dental,Dental,510(k),"BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.",Gold Slotted Screw,2,"July 06, 2010", 2010,"Biomet 3i, LLC","Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.",OTHER/UNDETERMINED: Pending,"Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a faxed letter. International customers were first notified by e-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.Questions or concerns are directed to Kelly Taylor at the firm at 561-776-6700.",N/A,495,495 screws,"Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.",Terminated,"August 30, 2010",55,495,Not_Computer,N/A,N/A,N/A
Z-1955-2010,55774,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),SSH-880CV Aplio Artida System,SSH880CV Aplio Artida System ,2,"July 06, 2010", 2010,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer.When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI",DESIGN: Software Design,"The software will be replaced. To accomplish this, Toshiba America Medical Systems (TAMS) will notify consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention.For questions or concerns, please contact your Toshiba representative or the firm at (714) 730-5000.",N/A,22,22,"Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).",Terminated,"March 21, 2012",624,22,Software,Display/Image,Software update,Software Update
Z-1971-2010,55316,"enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific",LGC,Herpes simplex virus serological assays.,Microbiology,Microbiology,510(k),"Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.20 test KitIn Vitro Diagnostic test for Herpes Simplex Virus 2",Biokit and SureVue HSV2 Rapid Test,2,"July 08, 2010", 2010,Biokit U.S.A. Inc.,"Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353.,N/A,8,8 kits,"US (CA, FL, GA, IN, KY, MA, NY, VA) and UK",Terminated,"January 26, 2012",567,200,Not_Computer,N/A,N/A,N/A
Z-1968-2010,55710,"instrument, manual, surgical, general use",MDM,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418.Manufactured by: Stryker Spine SAS, Cestas, France;Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.Intended for use in the thoraco-lumbar spine.",AVS TL Trial Spacer,2,"July 08, 2010", 2010,Stryker Spine,Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.,PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.",N/A,139,139 units,Nationwide Distribution.,Terminated,"September 06, 2012",791,2110,Not_Computer,N/A,N/A,N/A
Z-1969-2010,55721,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA.Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.",Starion Instruments TLS3 35C Thermal Ligating Shears,2,"July 08, 2010", 2010,Starion Instruments,"Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the ""v"" of the jaw.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees.The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained.,N/A,N/A,N/A,Worldwide distribution,Terminated,"November 27, 2010",142,N/A,Not_Computer,N/A,N/A,N/A
Z-1972-2010,55750,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CAIntended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.",Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears,2,"July 09, 2010", 2010,Starion Instruments,"Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.",PRODUCTION CONTROLS: Process Control,"The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose.If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.",Contact the recalling firm for information,217,217 units,Worldwide distribution.,Terminated,"October 27, 2010",110,217,Not_Computer,N/A,N/A,N/A
Z-1973-2010,55419,"twister, wire",HXS,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.",TORQ Sternal Closure Device,2,"July 09, 2010", 2010,KARDIUM INC.,A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use.,OTHER/UNDETERMINED: Pending,"The firm, Kardium, informed it's US distributor on March 30, 2010 by e-mail. The distributor was instructed to return all unused product to Kardium. The units remaining at hospitals will be returned to Kardium by the distributor sale reps. If you have any questions, please contact (604) 248-8891.",N/A,420,420 units,Worldwide distribution: USA and Canada.,Terminated,"October 07, 2010",90,420,Not_Computer,N/A,N/A,N/A
Z-1974-2010,55598,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit.Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M.A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.",Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit,2,"July 09, 2010", 2010,McKesson Provider Technologies - Medical Imaging Group,McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cariology Hemo Real Time Monitor Screen.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, McKesson, sent an ""Advisory Notice"" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202.If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.",Contact the recalling firm for information,26,"26 units; 19 in operational use, 8 as emergency replacement units.","Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .",Terminated,"July 21, 2010",12,26,Software,Display/Image,Replacement,Remove or Replace
Z-1954-2010,55894,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK",Stellant CT Dual Syringe Kits,2,"July 09, 2010", 2010,Medrad Inc,"Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.",DESIGN: Component Design/Selection,"The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices.For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction.",Contact the recalling firm for information,1382889,"1,382,889 kits","nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA.",Terminated,"October 13, 2010",96,1382889,Not_Computer,N/A,N/A,N/A
Z-1995-2010,55206,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.",Access AccuTnI Assay,2,"July 12, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has confirmed additional reports that each of the following assays may produce lower than expected results when run in conjunction with Access AccuTnl (REF A78803):(1) Access Testosterone (REF 33560);(2) Access Thyroid Uptake (REF 33810);(3) Access Total T4 (REF 33800).This issue can occ",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, issued a ""URGENT: PRODUCT CORRECTIVE ACTION"" (PCA) letter with attached Customer Response form dated March 24, 2010 to all customers. The letter describes the issue, impact, action and resolution. In the PCA beckman Coulter recommends the following mitigation to reduce the risk of generating erroneous results: (1) Verify the APF software on the immunoassay system. If the updated APF software listed in the table above was already loaded , skip the remainder of this section and proceed to the Resolution section;(2) If the updated APF software has not yet been loaded, but is available, load the software appropriate for the system, skip the remainder of this section and proceed to the Resolution section;(3) If the updated APF software is not immediately available, please contact Technical Support at 1-800-854-3633 in the United States and Canada. Consignees outside the United States and Canada, contact their local Beckman Coulter Representative and follow the instructions below until the software has been loaded on their system. (a) Access and Access 2 users should batch process Access Testosterone, Thyroid Uptake, or Total T4 samples; (b) For UniCel DxI users, assign Access AccuTnI (REF A78803) to a different reagent pipettor(s) than Access Testosterone, Thyroid Uptake, or Total T4;(c) The Access Testosterone, Thyroid Uptake, or Total T4 results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Abnormally low Access Testosterone, Thyroid Uptake, or Total T4 results from samples tested in conjunction with Access AccuTnI (REF A78803) should be reviewed in the context of other diagnostic tests.Customers were instructed that after loading the updated APF software, the Access AccuTnI assay (REF A78803, test code TropI, test ID 275) must be recalibrated. Recalibrate of the Access Testosterone, T.",N/A,32407,"32,407 units","Worldwide distribution: USA and countries of Algeria, Australia, Bangladesh, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Lebanon, Libyan Arab Jamahiriya, Monaco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Swaziland, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.",Terminated,"May 04, 2012",662,32407,Other,Output/Calculation,Instructions/Software update,Software Update
Z-2022-2010,54688,"system, applicator, radionuclide, manual",IWJ,Manual radionuclide applicator system.,Radiology,Radiology,510(K) Exempt,"Angiotech Prostate Stabilization Set.Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180.MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A.Intended Use: Prostate Stabilization Set",Angiotech Prostate Stabilization Set,2,"July 13, 2010", 2010,"Medical Device Technologies, Inc.","Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.",OTHER/UNDETERMINED: Pending,"Angiotech sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated September 1, 2009, to all customers. on September 2, 2009 by UPS 2nd day delivery with an assigned tracking number. The letter described the product, problem and action to be taken by customers. The customers were instructed to please review your current inventory and segregate the affected lot numbers, complete the attached Customer Acknowledgement Form and return via fax to our Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you are a distributor of this product, you are responsible for notifying any customer you may have sold the product to.If you have any questions concerning this notification, please contact Shannon Brooks at (352) 338-0440 ext.355 or Katrenia Williams at ext. 353.",N/A,4180,"4,180","Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.",Terminated,"February 25, 2011",227,305698,Not_Computer,N/A,N/A,N/A
Z-1924-2010,55648,"unit, phacofragmentation",HQC,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue Number: 8065751145The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.",Constellation Vision System,1,"July 13, 2010", 2010,"Alcon Research LTD dba Alcon Laboratories, Inc.","Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.",DESIGN: Software Design,"The firm, Alcon, sent a ""URGENT: MEDICAL DEVICE RECALL"" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system.For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.",Contact the recalling firm for information,824,824 units total,Worldwide distribution.,Terminated,"September 19, 2011",433,824,Computer,N/A,N/A,N/A
Z-1999-2010,55790,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),Microstream O2/CO2 NASAL FILTERLINE ADULT 25UNPart Number: 006912,Microstream O2/CO2 NASAL FILTERLINE ADULT ,2,"July 13, 2010", 2010,Oridion Medical 1987 Ltd.,The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.,DESIGN: Process Design,"Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.",N/A,2,2 units,"AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,",Terminated,"June 21, 2012",709,350827,Not_Computer,N/A,N/A,N/A
Z-1997-2010,55544,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.,PVT681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems,2,"July 13, 2010", 2010,Toshiba American Medical Systems Inc,Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversedhorizontally on the Aplio XG (SSA-790A) and the Xario XG (,OTHER/UNDETERMINED: Pending,Toshiba America Medical Systems (TAMS) will issue notification to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. matter. Questions regarding this letter are directed to the firm at (800) 421-1968 or to your local Toshiba representative.,Contact the recalling firm for information,27,27,Nationwide,Terminated,"February 29, 2012",596,27,Not_Computer,N/A,N/A,N/A
Z-1998-2010,55675,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"O-Arm Imaging SystemThe O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.",OArm Imaging system,2,"July 13, 2010", 2010,"Medtronic Navigation, Inc.",The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.,N/A,"The firm, Medtronic, Inc., sent an ""Urgent Field Safety Notice"" letter dated May 10, 2010, to all custmers. The letter describes the product, problem and actions to be taken by customer. The firm recommended that the users of the O-Arm Imaging System reveiw the information provided to ensure patient safety remains uncompromised during use of the product. The customers were instructed to discontinue use and contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200, if the image is not updating as expected. A Medtronic Navigation representative will be contacting you within the coming months to schedule a time to evaluate and service the potentially affected components within your system. A service visit will also be scheduled starting November 2010 to update your system with a software based solution that will prevent this issue from occuring.If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200.",Contact the recalling firm for information,221,221,"Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and India.",Terminated,"October 07, 2011",451,221,Software,Display/Image,Software update,Software Update
Z-1996-2010,55895,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"i-STAT PT/INR CartridgeAbbott Point of Care, Princeton, NJ",iSTAT PT/INR Cartridge,2,"July 13, 2010", 2010,Abbott Point of Care Inc.,A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.,OTHER/UNDETERMINED: Pending,"Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-366¶_8020, Option 1 or your Abbott Point of Care representative.",N/A,44976,"44976 in US, 3648 in rest of world.","Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.",Terminated,"September 22, 2011",436,44976,Not_Computer,N/A,N/A,N/A
Z-2025-2010,55867,"antigens, febrile, slide and tube, all groups, salmonella spp.",GNC,Salmonellaspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***","Difco Salmonella 0 Group A Antigen, catalog 240731, ",3,"July 15, 2010", 2010,Becton Dickinson & Co.,"In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form.Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.",N/A,93,93 units,Product was sold to distributors nationwide and to affiliates in Belgium and Korea.,Terminated,"July 21, 2010",6,93,Not_Computer,N/A,N/A,N/A
Z-2027-2010,54565,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto RicoMedical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).",OneTouch SureStep ,2,"July 17, 2010", 2010,Lifescan Inc,Products may provide inaccurate results at readings over 400 mg/dL,OTHER/UNDETERMINED: Pending,"The firm, Lifescan, Inc., issued two ""Urgent Medical Device Recall"" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.",N/A,1014350,"1,014,350","Worldwide distribution: USA and countries of Europe, Latin America and Asia.",Terminated,"December 08, 2010",144,9640700,Not_Computer,N/A,N/A,N/A
Z-2026-2010,54521,"motor, surgical instrument, ac-powered",GEY,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.",ADVANTAGE Turbo 2Button Shaver,2,"July 17, 2010", 2010,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec is recalling Advantage, 2-Button Turbo Handpiece Catalog Number D9924. These products may self-activate due to moisture intrusion into the housing body. This issue has been isolated to products manufactured between June 7, 2004 and June 1, 2006.",OTHER/UNDETERMINED: Pending,ConMed Linvatech notified affected customers by letter sent by FedEx next day delivery. Customers were asked to complete a response form and indicated if they have the product or have transferred the product. A Service Request number will be assigned for the returned product.Additional questions are directed to the firm's Customer Service department at 800-535-8536.,N/A,2373,"2,373","Worldwide distribution. Products were distributed domestically throughout the U.S. Also United Arab Emirates, Argentina, Australia, Belgium, Switzerland, Chile, China, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, Lithuania, Morocco, Netherlands, New Zealand, Singapore, Turkey, South Africa.",Terminated,"August 19, 2010",33,2373,Not_Computer,N/A,N/A,N/A
Z-2032-2010,55575,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Leeds, United Kingdom.","DePuy ASR 100 Acetabular Implant, 46 mm",2,"July 17, 2010", 2010,"Depuy Orthopaedics, Inc.","Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m",OTHER/UNDETERMINED: Pending,"DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.",N/A,1205,1205,Nationwide,Terminated,"May 10, 2012",663,37834,Not_Computer,N/A,N/A,N/A
Z-2030-2010,55900,"clip, implantable",FZP,Implantable clip.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.",Mectronic UCLIP V100D,2,"July 17, 2010", 2010,Medtronic Cardiovascular Revascularization & Surgical Therap,"Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of",OTHER/UNDETERMINED: Pending,"The firm, Medtronic CardioVascular, sent an ""Urgent Medical Device Recall Notice"", dated April 2, 2010, to Risk Managers of each affected account. The letter described the issue, identified affected product, and the action to be taken by customers. The customers were ask to immediately discontinue use of affected devices and to quarantine all unused V100D U-Clip inventory. The letter stated that a Medtronic representative will contact the account to arrange return of the V100D U-Clips devices and that credit will be issued upon return of unused devices. Medtronic has stopped manufacture of the product therefore replacements will not be available. Devices can be returned to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428. The customers were ask to please fill out the Medtronic Recall Certificate and fax it to 651-367-2620.If you need additional information, please contact CardioVascular LifeLine Technical Services at 877-526-7890, or you local Medtronic sales representative.",Contact the recalling firm for information,22946,"22,946 ( 20,714 US, 2,232 OUS)","Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and countries of Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.",Terminated,"December 17, 2011",518,22946,Not_Computer,N/A,N/A,N/A
Z-2029-2010,56013,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),Medtronic StealthStation S7 System,Medtronic StealthStation S7 System,2,"July 17, 2010", 2010,"Medtronic Navigation, Inc","Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.",DESIGN: Device Design,"Customers were notified by letter on Jun 14, 2010, advising them of the problem. Instructions were provided to continue using existing retractable power cords until they could be replaced with non-retractable cords by Medtronic, beginning on Aug 17. Further information is available from the company by calling 800-595-9709.",N/A,370,370 units,"Nationwide, including 3 VA facilities. No military distribution. Foreign accounts in Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.",Terminated,"February 18, 2011",216,370,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-2061-2010,56004,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),Hemashield Gold Woven Double Velour Vascular Branch Graft,Hemashield Gold Woven Double Velour Vascular Branch Graft,2,"July 22, 2010", 2010,"Maquet Cardiovascular, LLC","Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.",DESIGN: Packaging Design/Selection,"Letters were sent by Federal Express commencing July 12, 2010.Distribution has to be obtained from Boston Scientific.Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.",Contact the recalling firm for information,N/A,xx,Nationwide Distribution.,Terminated,"July 14, 2011",357,N/A,Not_Computer,N/A,N/A,N/A
Z-2073-2010,56139,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5.",Mast Roller Pump,2,"July 22, 2010", 2010,"Sorin Group USA, Inc.","Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.",PREMARKET APPROVAL: No Marketing Application,The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.,Contact the recalling firm for information,1,1 unit,"CA, PA, TN.",Terminated,"July 21, 2010",-1,3,Not_Computer,N/A,N/A,N/A
Z-2072-2010,56056,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy Hi-Art System¶_, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¶_ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.","TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2.",2,"July 22, 2010", 2010,TomoTherapy Incorporated,"An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer.With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.",DESIGN: Software Design,"Consignees were sent on 6/23/10 a TomoTherapy ""Urgent Field Safety Notice Medical device Correction"" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution.Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010.Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800.",Contact the recalling firm for information,29,29,"CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.",Terminated,"December 17, 2011",513,29,Software,Output/Calculation,Software update,Software Update
Z-2071-2010,56059,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific, Fathom""-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA."," Fathom""14 Steerable Guidewire, Peripheral Vascular Use, PreShaped 300 cm x 10 cm",2,"July 22, 2010", 2010,Boston Scientific Corporation,"Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a P",DESIGN: Process Design,"Consignees were sent on 6/3/10 an ""Urgent Medical Device Recall"" letter dated 3 June 2010. The letter was addressed to Risk Manger/Interventional Radiology Manger/Material Manger. The letter described the problem and the product involved. The letter included the ""Customer Instructions"" which stated to Immediately discontinue use of an segregate recalled product and, requested customers to return the Reply Verification Tracking Form. Questions are directed to the firm at 510-624-2563.",N/A,78,78 units,"AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MD, MA, MS, NV, NY, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT,VA, WA, WT.",Terminated,"December 10, 2011",506,745,Not_Computer,N/A,N/A,N/A
Z-2076-2010,56084,tube tracheostomy and tube cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.",Cook Medical Ciaglia Blue Dolphin ,1,"July 26, 2010", 2010,"Cook, Inc.",These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.",N/A,28819,"28819 total, all products","Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay.",Terminated,"January 23, 2012",546,28819,Not_Computer,N/A,N/A,N/A
Z-2100-2010,56158,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"19"" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD ArmAgfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.",AGFA Computed Radiography system with NX2.X Workstations,2,"July 26, 2010", 2010,AGFA Corp.,Monitor fell from the mounting bracket used to support the monitor.,OTHER/UNDETERMINED: Pending,"The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE"" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664. If you have any questions about this matter, please feel free to contact me via email at Debbie.norris@agfa.com or call me at 864-421-1754.",N/A,805,805 units,Worldwide distribution: USA and countries of Puerto Rico and Canada.,Terminated,"April 28, 2011",276,805,Not_Computer,N/A,N/A,N/A
Z-2111-2010,56085,"guide, needle, surgical",GDF,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.",Temno,2,"July 28, 2010", 2010,Carefusion 2200 Inc,The introducer needle is only 10 cm in length instead of the required 15 cm.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up ""URGENT: PRODUCT RECALL"" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion.If you have any questions, please contact 800-292-9332.",N/A,65,65 units,"Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.",Terminated,"January 24, 2011",180,65,Not_Computer,N/A,N/A,N/A
Z-2109-2010,56130,"apparatus, exhaust, surgical",FYD,Air-handling apparatus for a surgical operating room.,General & Plastic Surgery,General & Plastic Surgery,510(k),"MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4"" x 9"" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device",Stackhouse laser resistant suction probe,2,"July 28, 2010", 2010,Microtek Medical Inc,Product labeled as sterile was distributed without sterilization.,OTHER/UNDETERMINED: Pending,The firm notified its consignees of the problem and requested return of the product by telephone on 05/25/2010. They followed with a letter dated on 06/03/2010 re: Product Removal stating the reason for the recall and confirming the receipt of the recalled product. For further information please contact (662) 244-3220.,No consumer action necessary,2,2 cases of 10 units,Nationwide distribution including the states of Montana and Georgia,Terminated,"August 12, 2010",15,2,Not_Computer,N/A,N/A,N/A
Z-2108-2010,56169,"plasma, coagulation control",GGN,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk.Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125.Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.",GEM Check Coag Whole Blood Controls,2,"July 28, 2010", 2010,International Technidyne Corporation,Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.,PRODUCTION CONTROLS: Error in Labeling,"Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.",Contact the recalling firm for information,101,101 kits,"Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.",Terminated,"September 23, 2010",57,196,Not_Computer,N/A,N/A,N/A
Z-2110-2010,56114,"assay, heparin",KFF,Heparin assay.,Hematology,Hematology,510(k),RQCHRT HRT Control Level 1 & 2;Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes.20 vials Whole Blood - 2.0mL; dried20 vials Diluent - 4.0 mLThe Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.,HEMOCHRON(R) HEPARIN RESPONSE TEST,2,"July 28, 2010", 2010,International Technidyne Corp.,An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.,OTHER/UNDETERMINED: Pending,"ITC sent ""URGENT MEDICAL DEVICE RECALL"" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail.If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.",Contact the recalling firm for information,38,"38 in US, 3 Out of US","Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.",Terminated,"September 23, 2010",57,38,Not_Computer,N/A,N/A,N/A
Z-2112-2010,56090,electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(k),IMPAX CV Results Manager/Results Manager Administration Tool,"RM, RMAT",2,"July 29, 2010", 2010,AGFA Corp.,Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.,OTHER/UNDETERMINED: Pending,"A letter was sent to the consignee on 6/11/2010 indicating what steps would be taken by Agfa concerning the problem. The letter also included a feedback form which was to be returned to Agfa. The recall was expanded and a ""URGENT SAFETY NOTICE"" was sent to each additional consignee on January 25, 2012. The letter described the potential issue and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the additional consignees.",N/A,358,358,"AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada",Terminated,"July 02, 2013",1069,358,Not_Computer,N/A,N/A,N/A
Z-2113-2010,56057,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, EnglandIntended for use in the hospital environment and operating room.",BleaseSirius Anaesthesia Machine,2,"July 29, 2010", 2010,"Spacelabs Healthcare, Llc",Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.,OTHER/UNDETERMINED: Pending,"On 06/24/2010, Spacelabs began mailing the URGENT-MEDICAL DEVICE CORRECTION letter to their US consignees and e-mailed the same letter to their foreign consignees.The letter describes the touch screen of the BleaseSirius Anesthesia machine goes blank when touched and the possibility that this failure may cause the mechanical ventilation to stop.The consignees are asked to weigh the benefits versus the risk when deciding to use the device or not until the firm upgrades the device. The letter also instructs the consignees to notify their staff about the possibility of the display failure to prevent any adverse event that may occur. The letter states that their field service engineer will contact consignees to schedule a time to visit and upgrade all affected devices at no cost.The US consignees are advised to call 1-800-522-7025, Select 2, and the foreign consignees are advised to call 1-425-657-7200 x5089 for technical support or questions regarding the recall.",N/A,80,80 units total,"Worldwide Distribution -- USA, including states of IA, GA, LA, NC, TN, and TX and countries of AUSTRALIA, CHILE, CHINA, INDIA, ITALY, PHILIPPINES, MEXICO, POLAND, SINGAPORE, THAILAND, TURKEY, UNITED KINGDOM, and VENEZUELA.",Terminated,"December 03, 2010",127,80,Software,Display/Image,Software update,Software Update
Z-2118-2010,55330,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Howmedica Osteonics Corp,Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.",Passport A.R. Knee Instrumentation Distal Guide Stand,2,"August 02, 2010", 2010,Stryker Howmedica Osteonics Corp.,There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.,DESIGN: Device Design,"Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified.",N/A,676,"676 in US, 1305 internationally.",Worldwide distribution.,Terminated,"August 28, 2012",757,676,Not_Computer,N/A,N/A,N/A
Z-2117-2010,55226,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.",Dimension Vista LOCI Reaction Vessels,3,"August 02, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.,DESIGN: Process Design,"Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.",N/A,5544,5544 bags,"Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand.",Terminated,"August 03, 2010",1,5544,Not_Computer,N/A,N/A,N/A
Z-2119-2010,55357,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System",Scorpio,2,"August 02, 2010", 2010,Stryker Howmedica Osteonics Corp.,The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.,DESIGN: Device Design,"Stryker Urgent Device Correction letters dated April 5, 2010, were sent to all Stryker branches/agencies, hospital Risk Management and surgeons who have used the product by Federal Express. Questions on the bulletin should be directed to Scott Solis, Product Manager ,Knee Marketing at 201-831-5665.",N/A,8276,8276,"Worldwide distribution: USA, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay.",Terminated,"August 28, 2012",757,8276,Not_Computer,N/A,N/A,N/A
Z-2164-2010,55605,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"MIKA Speedblock, Size 8-12.The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.",MIKA Speedblock,2,"August 02, 2010", 2010,"Encore Medical, Lp","A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks.",DESIGN: Component Design/Selection,"An ""Urgent Field Safety Notice"" Letter dated May 20, 2010, was sent to the customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to locate, inspect and verify the quantity still in their possession, complete and return the field safety notice response page to Beth Onderlinde at beth.onderlinde@djosurgical.com or fax to 512-834-6313 by June 7, 2010, (completion of form is mandatory), and identify and inform customers that they may have distributed/sold product to, of the notice. The customer was also instructed to please inspect the listed part numbers prior to use and again after use, if a crack is found in the speedblock, contact your Customer Service Representative and be sure to utilize the femoral/tibial impactor (801-01-043) for impaction of the speedblock and reiterate to your physicians that the MIKA mini slaphammer (800-02-290) should be used for speedblock removal. The product will be replaced as it becomes available.If you have any questions, call Director of Commercial Logistics at (512) 834-6330 or International Customer Service at (512) 834-6275. You may also contact our EU Authorized Representative, MDSS GmbH, via email at info@mdss.com or via phone at +49 (0) 511 6262 8630.",Contact the recalling firm for information,796,729 and 67 specials,Worldwide distribution.,Terminated,"December 15, 2011",500,796,Not_Computer,N/A,N/A,N/A
Z-2140-2010,55931,"container, i.v.",KPE,I.V. container.,General Hospital,General Hospital,510(k),"Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.",ExactaMix,2,"August 02, 2010", 2010,Baxa Corporation,"Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.",PRODUCTION CONTROLS: Packaging,Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.,N/A,3306700,"3,306,700 bags","Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay.",Terminated,"August 04, 2011",367,12612066,Not_Computer,N/A,N/A,N/A
Z-2133-2010,55621,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712",BARD DORADO ,2,"August 02, 2010", 2010,Bard Peripheral Vascular Inc,"The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The Bard Peripheral Vascular ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" with attached ""RECALL AND EFFECTIVENESS CHECK FORM"" was sent to the affected consignees beginning May 7, 2010 via FedEx. The recall notice informed the consignees of the reason for recall, the products affected and instructed them not to use or further distribute any affected product.The consignees were also instructed to call the firm's Recall Coordinator Silvia Carrillo at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at silvia.carrillo@crbard.com to facilitate the expedient return of the affected products. Additionally they were asked to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.",Contact the recalling firm for information,72,72 units,Nationwide,Terminated,"February 01, 2012",548,3279,Not_Computer,N/A,N/A,N/A
Z-2120-2010,55367,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.",Stryker Orthopaedics Passport A.R. Knee Instrumentation ,2,"August 02, 2010", 2010,Stryker Howmedica Osteonics Corp.,One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.,DESIGN: Device Design,"Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.",N/A,682,"682 units in US, 1292 units internationally.","Worldwide distribution: USA, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada.",Terminated,"August 28, 2012",757,682,Not_Computer,N/A,N/A,N/A
Z-2116-2010,55874,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands.The product marketing brochure labeled in part: ""SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA"".",PowerPark,2,"August 02, 2010", 2010,"Sonosite, Inc.",PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall.The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.",Contact the recalling firm for information,26,26,"Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.",Terminated,"April 18, 2011",259,26,Battery,N/A,N/A,N/A
Z-2115-2010,56052,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy Hi-Art System¶_, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.","TomoTherapy HiArt System, Version 4.0.0 & 4.0.1. ",2,"August 02, 2010", 2010,TomoTherapy Incorporated,"In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.",DESIGN: Software Design,"Consignees were sent on 2/22/10 a TomoTherapy Incorporated ""Urgent Medical Device Correction Field Safety Notice"" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.",Contact the recalling firm for information,7,7,"Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.",Terminated,"February 10, 2011",192,7,Software,Display/Image,Software update,Software Update
Z-2151-2010,56037,"heat-exchanger, cardiopulmonary bypass",DTR,Cardiopulmonary bypass heat exchanger.,Cardiovascular,Cardiovascular,510(k),"Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACKP/N 65503/70881-02",Terumo Custom Kit ,2,"August 02, 2010", 2010,Terumo Cardiovascular Systems Corp,Vent port may be occluded and prevent delivery of fluid,PRODUCTION CONTROLS: Equipment Maintenance,"Terumo, Ashland, MA notified consignees on 6/8/10, byphone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnightmail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correctionactivities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.",Contact the recalling firm for information,48,48 packs,Distribution USA and Canada,Terminated,"May 07, 2012",644,589,Not_Computer,N/A,N/A,N/A
Z-2121-2010,56063,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"MEDFUSION¶_ SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion¶_ Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.","MEDFUSION SYRINGE INFUSION PUMP, ",2,"August 02, 2010", 2010,"Smiths Medical ASD, Inc.","Smiths Medical is conducting a correction of Medfusion¶_ Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient in",DESIGN: Software Design,"Consignees were sent on 6/22/10 a Smith Medical ""Urgent Medical Device Correction Notice', dated June 11, 2010. The letter was addressed to Dear Risk/ Safety Managers, Distributors, Clinical/ Biomedical Engineering, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists; and Nursing, Pharmacy,and Anesthesia Professionals. The letter described the problem and product involved. It provided Advise on Action to be Taken by the User which included to 1) Determine the software version of their Medfusion pump 2. Complete and return the Confirmation Form 3. Return the completed Software Update Test Form 4. If unable or unwilling to perform the software upgrade they provided information for returning the pumps to Smiths Medical for the upgrade. For further information please contact Smiths Medical at 651-628-7280.",Contact the recalling firm for information,4816,4816,"Worldwide Distribution: AL, AK, AZ, AR, CA,CO, CT, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI. and countries of CANADA, MEXICO, NEW ZEALAND, BRASIL, HONG KONG, and GREAT BRITAIN.",Terminated,"April 17, 2012",624,4816,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2166-2010,55507,"system, measurement, blood-pressure, non-invasive",DXN,Noninvasive blood pressure measurement system.,Cardiovascular,Cardiovascular,510(k),The Well@Home Monitor by Patient Care technologiesModel 179-2150Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.,WellHome Monitor,2,"August 03, 2010", 2010,Zoe Medical Incorporated,Touch panel may become unresponsive.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.",N/A,62,62,Nationwide Distribution -- MA and MD.,Terminated,"August 03, 2010",0,62,Not_Computer,N/A,N/A,N/A
Z-2172-2010,55871,sirolimus test system,NRP,Sirolimus test system.,Toxicology,Toxicology,510(k),"Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25.The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.",Architect Sirolimus Reagent Pack,2,"August 03, 2010", 2010,Abbott Laboratories,The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.,PRODUCTION CONTROLS: Equipment Maintenance,"Abbott sent a ""Product Recall"" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M100, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside the U.S., please contact your local Customer Service representative.",Contact the recalling firm for information,875,875 kits,"Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.",Terminated,"July 15, 2011",346,875,Not_Computer,N/A,N/A,N/A
Z-2171-2010,55557,sirolimus test system,NRP,Sirolimus test system.,Toxicology,Toxicology,510(k),"IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA; list 5C91-21The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.",IMx Sirolimus Reagent,2,"August 03, 2010", 2010,Abbott Laboratories,IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.,OTHER/UNDETERMINED: Pending,"Abbott sent a ""Product Recall"" letter dated April 30, 2010, to all customers receiving the affected lot of reagent. The accounts were informed of the increased frequency of calibration errors, including: 157 Check 1 Out of Range, 161 Check 5 Out of Range, and 173 Mode 1 deviation Factor High. The accounts were requested to determine if they are currently using or have inventory of lot 802873106, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside of the U.S., please contact your local Customer Service Representative.",N/A,466,466 kits,"Worldwide distribution: USA and countries including Puerto Rico, Argentina, Austria, Bahrain, Brazil, Canada, Chile, China, Croatia, Cyprus, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Netherlands, Norway, Philippines, Poland, Russia, Panama, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE and Venezuela.",Terminated,"May 13, 2011",283,466,Not_Computer,N/A,N/A,N/A
Z-2170-2010,56018,"bed, manual",FNJ,Manual adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.",HillRom Basic Care Bed,2,"August 03, 2010", 2010,"Hill-Rom, Inc.","The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off.",N/A,"The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.",Contact the recalling firm for information,962,962 beds,"Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.",Terminated,"March 16, 2012",591,11056,Not_Computer,N/A,N/A,N/A
Z-2165-2010,56055,"stimulator, auditory, evoked response",GWJ,Evoked response auditory stimulator.,Neurology,Neurology,510(k),"SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154",SonaMed Clarity System,2,"August 03, 2010", 2010,Natus Medical Inc,There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.,PREMARKET APPROVAL: No Marketing Application,"Natus sent Urgent Medical Device Recall letters dated 6/4/10 to all known SonaMed Clarity device accounts, to the attention of the Director of Maternal Child Health and the Risk Manager. The letters referenced the letters previously sent to them by Natus in October 2008 and April 2010 informing them of Natus' concerns about whether the Clarity device could be lawfully used to comply with FDA-related requirements and other pertinent professional guidelines/standards for newborn infant hearing screening, and that they concluded that the Clarity devices should no longer be used. Natus recognized the need for the accounts to continue screening without interruption, and are providing on loan at no-charge handheld screener(s) to facilities that do not have alternate screening devices. The accounts were requested to contact Natus Technical Service group at 800-272-8075 to discuss this loaner device option. Natus requested that the accounts stop using the SonaMed Clarity devices; disable the screening function of their Clarity system(s) by returning to Natus, in the enclosed pre-addressed return envelope, either of the two probes (TPI-830- 8-pin ear probe, or the TPI-815- 7-pin ear probe) they may possess and have used in screening, making sure to return all 7- or 8-pin probes for all of your Clarity systems; and complete the attached ""Device Recall Reply Form"" and return it in the enclosed self-addressed stamped envelope. If you have any questions concerning any aspect of this recall notice, please call Natus Technical Support at 1-800-272-8075.",N/A,284,284 units,Nationwide Distribution,Terminated,"June 22, 2011",323,284,Not_Computer,N/A,N/A,N/A
Z-2173-2010,55775,"prosthesis, toe, constrained, polymer",KWH,Toe joint polymer constrained prosthesis.,Orthopedic,Orthopedic,510(k),"Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA",Sgarlato Labs GAIT (Great Toe Implant Technique) Implant,2,"August 04, 2010", 2010,"Sgarlato Med, LLC","Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.",PRODUCTION CONTROLS: Labeling Mix-Ups,Recall initiated in March 2009 via telephone calls.,N/A,27,27 units,Nationwide Distribution,Terminated,"August 19, 2011",380,27,Not_Computer,N/A,N/A,N/A
Z-2174-2010,55813,"reagents, clostridium difficile toxin",LLH,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5***Intended for use as an aid in diagnosis of CDAD.",BD GeneOhm Cdiff Assay,3,"August 05, 2010", 2010,Becton Dickinson & Co.,In vitro diagnostic test kits do not perform to specifications.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,The recalling firm notified accounts by an Urgent Product Recall letter on 03/05/2020. The letter identified the affected product and explained the reason for recall. It also advised customers to discontinue use of the affected product and discard any remaining inventory and fax back an acknowledgement form. The letter stated that BD will provide replacements for any discarded product. Further assistance can be obtained by contacting BD Technical Service at 1-888-436-3646.,N/A,31,31 kits,"Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.",Terminated,"October 15, 2010",71,31,Not_Computer,N/A,N/A,N/A
Z-2175-2010,55908,"apparatus, automated blood cell diluting",GKH,Automated blood cell diluting apparatus.,Hematology,Hematology,510(K) Exempt,"CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVDVeridex, LLCa Johnson & Johnson CompanyIntended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.",CellTracks Auto Prep System,2,"August 05, 2010", 2010,"Veridex, LLC",Complaints of patient sample carryover.,PRODUCTION CONTROLS: Process Control,"On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.",N/A,101,"101 Domestically, 87 Internationally","Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.",Open,N/A,N/A,101,Not_Computer,N/A,N/A,N/A
Z-2177-2010,56049,"accessories, implant, dental, endosseous",NDP,Endosseous dental implant accessories.,Dental,Dental,510(K) Exempt,"Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021.Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.","Impression Set, dental",3,"August 06, 2010", 2010,Straumann Manufacturing Inc.,The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Field Safety Notice, dated June 15, 2010, issued to consignees states that the 040.380 Impression set f. WN solid abutment Lot Y4021 which you purchased is incorrectly labeled Impression set f. RN solid abutment. Customers were asked to return the affected products and completed Customer Confirmation Form for replacements. Questions should be directed towards Bernard McDonald at 978-747-2514.",N/A,163,163,Nationwide Distribution,Terminated,"September 22, 2011",412,163,Not_Computer,N/A,N/A,N/A
Z-2191-2010,49374,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"SonoSite TEE, 8-3 MHz Transducer labeled: ""Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021"".The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.",Transesophegeal Ultrasound Transducer,2,"August 09, 2010", 2010,"Sonosite, Inc.","The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.",OTHER/UNDETERMINED: Pending,"On August 21, 2008, SonoSite began calling 15 consignees who have purchased the TEE/8-3 MHz Transducer and an M-Turbo 1.1 system. The firm provided instruction to discontinue use the system to 11 consignees and left voice messages to the remaining four consignees.On August 21, 2008, SonoSite sent out the URGENT-MEDICAL DEVICE CORRECTION letter and the Urgent Field Safety Notice to all affected consignees in the US and in foreign countries.The URGENT-MEDICAL DEVICE CORRECTION letter describes the recall product as TEE/8-5 MHz Transducer, SonoSite Part Numbers P05183 and P06841. The letter informed the consignees that the TEE transesophageal transducers may exhibit erratic operation of the Scanplane Orientation Indicator on the system display when it connected to the SonoSite M-Turbo Ultrasound System. The letter instructs consignees to discontinue use of the TEE/8-3MHz Transducer with the M-Turbo (or Micromaxx system) immediately, while the firm is working to create a software solution to resolve the issue and offers customers a software upgrade within 6-8 weeks.The consignees are also advised to forward the recall notice to others who need to be aware of the issue or where the potentially affected devices have been distributed.Customers should call the Technical Support at 1-1-425-951-1330 or 1-877-657-8118 from Monday to Friday, 6 am-5 pm PST or e-mail to service@sonosite.com for any questions regarding the recall.",Contact the recalling firm for information,357,357 units,"Worldwide distribution: USA and countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Iran, Ireland, Israel, Italy, Korea, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Switzerland, and Thailand.",Terminated,"August 24, 2011",380,357,Software,Display/Image,Software update,Software Update
Z-2183-2010,55139,"stretcher, wheeled, powered",INK,Powered wheeled stretcher.,Physical Medicine,Physical Medicine,510(k),"Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI",N/A,2,"August 09, 2010", 2010,Stryker Medical Div. of Stryker Corporation,"The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.",DESIGN: Component Design/Selection,"The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.",N/A,61,61 stretchers,"Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.",Terminated,"May 02, 2011",266,4915,Not_Computer,N/A,N/A,N/A
Z-2188-2010,56091,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"CLAW¶_ HEX SCREW CHARLOTTE "" F&A; SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava¶_ 3.5MM - Non-Sterile. Implantation: used in Food and Ankle surgeries.",CLAW HEX SCREWS ,2,"August 09, 2010", 2010,Wright Medical Technology Inc,One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.,PRODUCTION CONTROLS: Packaging Process Control,"The firm initiated their recall to their sales representatives (distributors) via telephone on 06/07/2010 and followed with a letter dated June 15, 2010 sent via Fed Ex on 06/28/2010. The hospital involved was also notified by letter on 06/29/2010. The letter described the product, the problem,and the action to be taken by the customers. The customers were instructed to immediately return any affected product to Wright as soon as possible, and to complete an attached response form confirming receipt of the notice and return a copy by fax to 901-867-7401. Customers may contact customer service for return instructions and replacement inventory at 800-238-7117.If you have any questions regarding this matter, contact Debby Daurer at 800-874-5630.",N/A,8,8 units,"Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA",Terminated,"November 23, 2011",471,8,Not_Computer,N/A,N/A,N/A
Z-2190-2010,56115,"catheter, embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(k),"Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.",QuickCat,2,"August 09, 2010", 2010,Spectranetics Corporation,"Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.",N/A,"Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.",Contact the recalling firm for information,5080,"5080 units (1778 US, 3302 Non-US)","Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.",Terminated,"August 20, 2010",11,5080,Not_Computer,N/A,N/A,N/A
Z-2192-2010,56163,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System.CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Made in USA.The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy.",87k Arthroscopy Tubing Set,2,"August 09, 2010", 2010,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec Largo, FL is recalling 87K Arthroscopy Tubing Set, Product Number 87100, Lots 0904151 to and including 1005201. Product may have a breach in the seal that could potentially compromise the sterility of the contents.",PRODUCTION CONTROLS: Process Control,"ConMed Linvatec Corporation sent an ""URGENT-MEDICAL DEVICE RECALL NOTIFICATION"" letter dated July 6, 2010, via FedEx next day delivery to all customers. The letter described the product, problem and action to be taken by customers within 30 days of receipt of the letter. The customers were asked to PLEASE DISCONTINUE USE OF THE IDENTIFIED PRODUCT WITH LOT NUMBERS BEGINNING WITH 0904151 THROUGH AND INCLUDING 1005201; to immediately check their inventory for the affected lots number and Do Not Use if they have any of the products; to complete and return a Reply Form and to notify their customers if the product was further distributed and return all unused affected product with lot codes starting 0904151 to and including 1005201, to ConMed Corporation, 525 French Road, Utica, NY 13502. On receipt, ConMed Linvatec will issue credit to customers.Should you have any additional questions, please contact our Customer Service department at 800-535-8536 or fax at 727-319-5701 or email: Custerserv1@linvatec.com.",Contact the recalling firm for information,97830,"97,830",Worldwide distribution: USA and Canada.,Terminated,"February 24, 2011",199,97830,Not_Computer,N/A,N/A,N/A
Z-2193-2010,56321,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San JoseMedical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its electrosurgical probe. Examples of use include resection, ablation and coagulation of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints. The probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.",Crossfire Console,2,"August 09, 2010", 2010,Stryker Endoscopy,RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.,DESIGN: Software Design,"Stryker Endoscopy sent an ""Urgent: Device Correction"" letter dated June 28, 2010, via FedEX Mailer to US customers. A letter dated July 9, 2010, was sent to International sites.The letter describes the product, problem, and action to be taken by customers. The Customers were instructed to follow the included instructions and use the USB dongle to install the correction and to complete and sign the enclosed ""acknowledgement of receipt"" form,upon completion of the software correction, and fax to (480) 754-8378 or scan in and email to crossfireconsole@stryker.com. The firm noted that-It is important to send the self addressed confirmation forms back to Stryker RAQA. If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at crossfireconsole@stryker.com.",N/A,989,989 units,"Worldwide distribution: USA and countries including Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EMEA.",Terminated,"March 21, 2011",224,989,Software,Physical Safety Hazards,Software update,Software Update
Z-2194-2010,48998,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.,EasyDiagnost Eleva,2,"August 10, 2010", 2010,Philips Medical Systems North America Co. Phillips,Potential for bright artifacts to appear on the patient image from a previous exposure.,OTHER/UNDETERMINED: Pending,"On July 9, 2008, Philip Medical System began sending out the URGENT-Device Correction letter to their consignees. This letter describes the recalled product as EasyDiagnost Eleva with DRF system with SW release 1.0.The firm informs the consignees that under special circumstances there is a small possibility that bright artifacts appear on a patient image from a previous exposure.The consignees are advised to take care about the X-ray field limitation. If the detector is not affected by direct radiation, no problem will occur. If direct radiation reaches the detector, the collimation should not be too tight, such that the area of direct radiation is larger than 1.2 inch x 1.2 inch (or 30 mm x 30 mm). The minimum area is needed to detect and prevent memory artifacts.The firm will upgrade any affected products with the Field Change Order (FCO)70600031 and it will be implemented before the end of December 2008. The upgrade software is 1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at 800-772-9377, #5, #2.",N/A,7,7,"Product was distributed in AZ, CA, FL and WA.",Terminated,"October 27, 2010",78,7,Software,Display/Image,Software update,Software Update
Z-2195-2010,55787,"nephelometer, for clinical use",JQX,Nephelometer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650",IMMAGE IMMUNOCHEMISTRY SYSTEM,2,"August 10, 2010", 2010,Beckman Coulter Inc.,Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control andpatient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.",Contact the recalling firm for information,1309,1309,"Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France,Germany,Greece,Hong Kong, Iceland,Ireland,Italy,Japan,Liechtenstein,Macao,Malaysia,Netherlands,New Zealand,Norway,Oman,Poland,Qatar,Russian Federation,Singapore,Slovakia,South Africa,Spain,Sweden,Switzerland,Taiwan,Tunisia,Turkey andUnited Kingdom,",Terminated,"May 22, 2012",651,1309,Not_Computer,N/A,N/A,N/A
Z-2202-2010,56092,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),Philips Intellivue Patient Monitor Model MP70 (M8007A),Intellivue,2,"August 10, 2010", 2010,Philips Healthcare Inc.,Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.,DESIGN: Labeling Design,Philips issued on 6/28/10 an Urgent Medical Device Correction notification/Field Safety Notice. Included with the Urgent Medical Device Correction notification/Field Safety Notice is an updated instructions for use and service instructions for these monitors that remind users to follow themounting arm manufacturer's instructions for use when repositioning the monitor and instructing them toperform a periodic check that the monitor is not loose on the arm.,N/A,82019,"82,019 units","Worldwide distribution: USA, Canada, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, Bosnia, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MACAU, MALAYSIA, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA & MONTE NEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, United Arab Emirates, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS (BR), and YEMEN.",Open,N/A,N/A,93548,Not_Computer,N/A,N/A,N/A
Z-2204-2010,55909,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.",Vanguard,2,"August 10, 2010", 2010,"Biomet, Inc.",A knee implant labeled as left was opened and the package actually contained a right knee implant.,PRODUCTION CONTROLS: Process Control,"On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.",N/A,5,5,"1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan",Terminated,"January 19, 2011",162,5,Not_Computer,N/A,N/A,N/A
Z-2200-2010,56117,"plasma, coagulation control",GGN,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic15 vialsFor performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.",directCheck,2,"August 10, 2010", 2010,International Technidyne Corp.,The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.",Contact the recalling firm for information,122,"122 boxes in US, 1 out of US.",Nationwide and one customer in Belgium.,Terminated,"September 23, 2010",44,122,Not_Computer,N/A,N/A,N/A
Z-2196-2010,56157,"clamp, vascular, reprocessed",NMF,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.",FemoStop Reprocessed Femoral Compression Device,2,"August 10, 2010", 2010,"Ascent Healthcare Solutions, Inc.",The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.,PRODUCTION CONTROLS: Process Control,"Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350.",N/A,175,175 devices,"Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.",Terminated,"August 11, 2010",1,175,Not_Computer,N/A,N/A,N/A
Z-2197-2010,56187,"cerclage, fixation",JDQ,Bone fixation cerclage.,Orthopedic,Orthopedic,510(k),"CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, GermanyUsage: Bone fracture fixation",CERCLAGE WIRE,2,"August 10, 2010", 2010,Smith & Nephew Inc,"Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.",PRODUCTION CONTROLS: Packaging,All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.,N/A,1,1 unit,"KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland",Terminated,"January 23, 2012",531,43,Not_Computer,N/A,N/A,N/A
Z-2205-2010,56201,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg.These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.",Pulmonetic Systems,2,"August 10, 2010", 2010,"CareFusion 203, Inc.","CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both",PRODUCTION CONTROLS: Process Control,"Customers were sent a CareFusion ""Urgent Medical Device Recall Notification"" dated July 2, 1010. The letter was addressed to Respiratory Care Manger. The letter described the product , problem and advised consignees to remove the affected product from inventory and promptly return it to CareFusion for replacement.Please contact CareFusion Technical Support at 800-754-1914, option 2, upon receipt of this notification to arrange for prompt return and replacement of any the patient circuits in your inventory.",Contact the recalling firm for information,200,200 boxes (5 each),"Nationwide distribution: AL, CA, FL, GA, HI, IL, IN, KS, MA,MI, MN, MT, NJ, NY, NC, OR, PA, RI, TN, TX, UT, VA, WA, and WI.",Terminated,"December 17, 2011",494,200,Hardware,Treatment/Delivery/Therapy,Return,Remove or Replace
Z-2210-2010,48992,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems.Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.,Motorized Height Ceiling Suspensions (MCS) for CV Xray systems,2,"August 11, 2010", 2010,Philips Medical Systems North America Co. Phillips,Monitor ceiling carriage may separate from the monitor ceiling suspension.,OTHER/UNDETERMINED: Pending,"On 07/02/08, the firm sent a ""Urgent - Device Correction"" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user.The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced.Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.",N/A,1111,1111 units,United States and Canada.,Terminated,"December 02, 2010",113,1111,Not_Computer,N/A,N/A,N/A
Z-2208-2010,55678,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems AFP QC, Part Number: 33219The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.",Access AFP QC,3,"August 11, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established refere",OTHER/UNDETERMINED: Pending,"A Product Corrective Action (PCA) letter was senton the week of April 19, 2010 to all customers whopurchased the Access Immunoassay Systems AFPQC material, lot numbers referenced above. Theletter provided the customers with an explanation ofthe problem identified and instructed the customersto (1) Please discard all remaining inventory of the three Access AFP QC kit lots identified above,including all vials of QC1, QC2, and QC3.(2) Please review your ac and patient results obtained while using the affected control lots. Interpret Access AFP test results in light of the clinical presentation of the patient, including: symptoms,clinical history, data from other tests and other appropriate information.(3) Please share this information with your laboratory staff and retain this notification as part of yourlaboratory Quality System documentation. (4) Complete and return the enclosed response formwithin 10 days so we can be assured that you have received this important notification.For customers that need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.",Contact the recalling firm for information,166,166,Nationwide and Canada,Terminated,"May 07, 2012",635,166,Not_Computer,N/A,N/A,N/A
Z-2206-2010,54370,"screw, fixation, intraosseous",DZL,Intraosseous fixation screw or wire.,Dental,Dental,510(k),"BIOMET MICROFIXATION ""1.5MM"" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM.Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.",1.5x4mm HT XDrive Screw,3,"August 11, 2010", 2010,"Biomet Microfixation, Inc.",Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.,OTHER/UNDETERMINED: Pending,"Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.",N/A,1247,1247 screws,"Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.",Terminated,"August 11, 2010",0,1247,Not_Computer,N/A,N/A,N/A
Z-2207-2010,56031,"maggots, medical",NQK,N/A,N/A,General & Plastic Surgery,510(k),"Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901.Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.",Medical Maggots with the accessory LeFlap dressing,2,"August 11, 2010", 2010,"Monarch Labs, LLC",Monarch Labs initiated the field notification regarding their Medical Maggots from Batch MM090406 with the accessory LeFlap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.,OTHER/UNDETERMINED: Pending,"The customer recall communication was initiated on May 3, 2009 with Monarch Labs notifying all consignees with a via a faxed Recall Letter with fax-back attachment of the initial compliant they had received and the possible infection that may occur if instructions for use are not followed. All therapists, who used maggots from that batch were instructed to contact the firm immediately if they have experienced any adverse events, such as infection, cellulitis, or any other problem. If not, they were asked to simply return the fax-back attachment , noting ""no problem"" .",N/A,14,14 vials,"Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.",Terminated,"December 13, 2012",855,14,Not_Computer,N/A,N/A,N/A
Z-2209-2010,56118,"pulse generator, permanent, implantable",NVZ,N/A,N/A,Cardiovascular,N/A,Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically.,Medtronic Carelink Monitor Model 2490C,2,"August 11, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,"Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a ""ticking sound"" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees ""Medical Device Recall"" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor. Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic.Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtronic Patient Services at 1-800-268-5346.",N/A,37,"37 Foreign, 0 Domestic",International Distribution Only: Australia and Canada.,Terminated,"December 24, 2011",500,37,Software,Device Operation,Replace monitor,Remove or Replace
Z-2212-2010,56131,"prosthesis, hip, semi-constrained (metal cemented acetabular component)",JDL,"Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"DYNASTY¶_ A-CLASS¶_ POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.",DYNASTY ACLASS POLY LINER,3,"August 12, 2010", 2010,Wright Medical Technology Inc,"The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.",PRODUCTION CONTROLS: Error in Labeling,"On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.",N/A,6,6 units,"USA distirbution only, in states of WI, WV, IN, IA, and GA",Terminated,"May 31, 2011",292,6,Not_Computer,N/A,N/A,N/A
Z-2214-2010,55364,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ.Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.",Trabecular Metal acetabular Augments,2,"August 12, 2010", 2010,Zimmer Inc.,The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.,PRODUCTION CONTROLS: Packaging,"The firm sent an ""Urgent Device Removal"" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.",N/A,1972,1972 all products,"US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.",Terminated,"October 21, 2011",435,1972,Not_Computer,N/A,N/A,N/A
Z-2211-2010,55502,"system,network and communication,physiological monitors",MSX,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.",DATEXOHMEDA NETWORK AND ICENTRAL,2,"August 12, 2010", 2010,"Ge Healthcare, Llc","The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring station. Monitoring loss may result in prolonged delay of treatment of potentially lethal arrhythmia.",DESIGN: Software Design,"GE Healthcare sent a ""Urgent Medical Device Correction letter"" dated 6/18/10 on 6/25/10 to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The letter instructs consignees to follow specific detailed instructions for safe use of the device pending provision of a software upgrade by the firm. Consignees will be contacted by a GE Healthcare representative to schedule the software upgrade.",Contact the recalling firm for information,2962,2962,"AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, NE, NH, NH, NY, NC, ND, OH, OK PA, RI, SC, TN, TX VT, VA, WA, WI.ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA , KUWAIT, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND,NICARAGUA, NIGERIA, NORWAY, PHILIPPINES, POLAND, PORTUGAL QATAR, RUSSIAN FEDERATION SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN THAILAND TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN.",Terminated,"August 14, 2012",733,2962,Software,Device Operation,Software update,Software Update
Z-2219-2010,56166,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Hi-Art System, H-0000-0003Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan",TomoTherapy HIART System,2,"August 12, 2010", 2010,TomoTherapy Incorporated,"An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about",DESIGN: Software Design,"Consignee was sent a TomoTherapy ""Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.",N/A,1,1,VA,Terminated,"December 17, 2011",492,1,Software,N/A,N/A,N/A
Z-2213-2010,56189,"accessories, cleaning, for endoscope",FEB,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.,DSD Application Guide (MG040001 revision M) for Pentax Universal Video Scope Hookup:DSD110HU0109,2,"August 12, 2010", 2010,Minntech Corp,"The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte",MISBRANDING: Labeling False and Misleading,"Consignees were sent a Medivators Reprocessing Systems ""Urgent Medical Device Recall"" letter date June 17, 2010. The letter was addressed to ""Dear Medivators Customers"". The letter described the problem and product involved. Recommended consignees to immediately examine the Pentax EG-3630U Ultrasound Endoscope hookups and inform all staff of the notice to ensure that the DSD-11--HU01109 is not used with the Pentax endoscope.Also requested consignees to complete and return the enclosed response form.",Contact the recalling firm for information,185,185,"AZ, AR, CA, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, PA, SC, TN, TX, UT, VA, WA, WV, WI, WY.",Terminated,"December 17, 2011",492,185,Not_Computer,N/A,N/A,N/A
Z-2178-2010,56222,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025"" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.","Engage TR Introducer, 6 F ACT (2.25 mm), 7 cm length, .025"" ",1,"August 12, 2010", 2010,St. Jude Medical Cardiovascular Division,"Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.",DESIGN: Process Design,"Consignees were sent ""Urgent Medical Device Recall Notice"" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum ""Field Action Notice"" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.",Contact the recalling firm for information,5,5 OUS,"Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.",Terminated,"December 27, 2011",502,5120,Not_Computer,N/A,N/A,N/A
Z-1634-2010,55077,"humidifier, respiratory gas, (direct patient interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(k),"Hudson RCI¶_ AQUA+¶_ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.","Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier ",1,"August 13, 2010", 2010,Teleflex Medical,"The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-respiratory arrest.",DESIGN: Device Design,"Teleflex Medical sent an Urgent Medical Device Recall letter on March 22, 2010 to consignees. They were instructed to: 1) Immediately discontinue use and quarantine any products labeled as AQUA+ FLEX, Catalog number 1570 with the lot numbers provided. 2) Complete and fax the Recall Acknowledgment Form to 866-804-9881. 3) After contact by a Customer Service Representative, who will provide them with a Return Goods Authorization Number, return the product to Teleflex Medical for credit. Letters addressed to distributors instructed them to communicate the recall to any of their customers who have received the product using the customer letter template and acknowledgement form provided by Teleflex Medical. Their customers were to return the product and acknowledgment form to the distributor who would consolidate and return the product to Teleflex Medical. Affected products received by Teleflex Medial will be destroyed upon receipt. For additional instructions or information, contact the firm at 1-866-246-6990.",Contact the recalling firm for information,3841,3841 units,"Worldwide distribution in the states of CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI and to the country of Japan.",Terminated,"November 28, 2011",472,3841,Not_Computer,N/A,N/A,N/A
Z-2220-2010,56246,"device, irrigation, ocular surgery",KYG,Ocular surgery irrigation device.,Ophthalmic,Ophthalmic,510(K) Exempt,"CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY.Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA.REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only!Used as an ocular irrigation device.",CORNEA COAT ,2,"August 13, 2010", 2010,"Insight Instruments, Inc.","Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.",PRODUCTION CONTROLS: Packaging,All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.,N/A,16128,"16,128","Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.",Terminated,"February 16, 2012",552,66853,Not_Computer,N/A,N/A,N/A
Z-2222-2010,56256,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system.",SEIMENS Axiom Luminos TF and Sireskop SD,2,"August 13, 2010", 2010,"Siemens Medical Solutions USA, Inc","Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.",DESIGN: Device Design,"Siemens Healthcare Sector sent an ""Urgent Field Safety Notice"" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.",N/A,1296,1296,Nationwide distribution: all 50 US states and PR.,Terminated,"September 29, 2012",778,1296,Not_Computer,N/A,N/A,N/A
Z-2176-2010,56290,"apparatus, nitric oxide delivery",MRN,Nitric oxide administration apparatus.,Anesthesiology,Anesthesiology,510(k),"Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA.The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.",Ikaria INOMAX DS Drug Delivery System,1,"August 13, 2010", 2010,Ikaria Holdings,"The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm",DESIGN: Component Design/Selection,"Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466.",Contact the recalling firm for information,2507,2507,Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia,Terminated,"December 27, 2011",501,2507,I/O,Treatment/Delivery/Therapy,Replace device,Remove or Replace
Z-2223-2010,55804,"cable, transducer and electrode, patient, (including connector)",DSA,Patient transducer and electrode cable (including connector).,Cardiovascular,Cardiovascular,510(k),"Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).",Safe Connect,2,"August 13, 2010", 2010,Remington Medical Inc.,"The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.",DESIGN: Process Design,"Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.",Contact the recalling firm for information,1488,1488 units,"AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.",Terminated,"November 29, 2010",108,1488,Not_Computer,N/A,N/A,N/A
Z-2224-2010,54546,"system, dialysate delivery, single patient",FKP,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA",Fresenius FDS08 Dialysate Delivery Machine,2,"August 15, 2010", 2010,Fresenius Medical Care North America,"Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.",DESIGN: Component Design/Selection,"An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.",Contact the recalling firm for information,33,33,Product distributed to 5404 customers throughout the US and the world.,Terminated,"February 07, 2011",176,72142,Battery,N/A,N/A,N/A
Z-2228-2010,56193,"instrument, manual, surgical, general use",MDM,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008.Used to pass suture through tissue.",Speedpass Suture Lariat,2,"August 16, 2010", 2010,"Biomet, Inc.",The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.,DESIGN: Component Design/Selection,"The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed ""FAX Back Response Form,"" and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the ""Dear Biomet Customer"" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.",N/A,301,301 units total,"Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands.",Terminated,"August 06, 2012",721,301,Not_Computer,N/A,N/A,N/A
Z-2233-2010,56262,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.,AXIOM Artis MP/Artis dMP and Artis zee Multipurpose,2,"August 16, 2010", 2010,"Siemens Medical Solutions USA, Inc","The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.",OTHER/UNDETERMINED: Pending,"Siemens has issued an ""Urgent Field Safety Notice: Customer Safety Information to consignees with Update Instructions AX033/10/S. This letter informed customers of the issue, and provides an Addendum to the User Manual. The Update Instructions describe the process for installation of an additional clamping mechanism provided by Siemens into the existing system, which will be activated if the gearbox is damaged. If activated, the clamping machanism will prevent the C-arm from tilting away, stop regular operation, and alert the operator to check the system and repair the gearbox damage.",No consumer action necessary,131,131 units,"Nationwide distribution: States of AL, AZ, CA, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, and WY.",Terminated,"July 05, 2012",689,131,Not_Computer,N/A,N/A,N/A
Z-2235-2010,56225,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.,medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Chronflex(R) Polyur,2,"August 17, 2010", 2010,"Medical Components, Inc dba MedComp","Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F ""Dignity"" Low Profile CT Port. The kit contains a 6.6F ""Pro-Fuse"" Low Profile CT Port.",TRAINING: Employee Error,Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.,Contact the recalling firm for information,47,47 units,"Worldwide Distribution -- USA, including states of NC and TX and country of Israel.",Terminated,"October 13, 2010",57,47,Not_Computer,N/A,N/A,N/A
Z-2234-2010,56138,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; Distributed by: Hospira, Inc., 275 N. Field Drive, Lake Forest, IL 60045; part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HGAccessory power pack used for use with medical devices.",Hospira Accessory Power Pack,2,"August 17, 2010", 2010,Hospira Inc.,"The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps intended for use with medical equipment. Potential problems could include electrical shock, electrical short or electrical fire.",DESIGN: Device Design,"Hospira sent Urgent Device Recall letters dated 7/1/10 to their direct accounts on 7/2/10 via Federal Express 2 day delivery, informing them of the potential for electrical shock, electrical short, or electrical fire, since the power packs were not certified to UL 60601 standard or Subject 1363A of UL standard 1363 for relocatable power taps intended for use with medical equipment. The accounts were instructed to examine their inventory for the affected product and quarantine it immediately, and Stericycle at 1-800-321-7388 to obtain a return kit for returning the affected product. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. They were also requested to complete the enclosed reply form and return it to Hospira by fax at 1-262-577-6921, indicating the amount of product placed on hold for return, if they further distributed the product and if they notified their retail customers. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187.",N/A,1766,"1,766 units",Worldwide Distribution -- US and Canada.,Terminated,"July 20, 2011",337,1766,Battery,Physical Safety Hazards,Return,Remove or Replace
Z-2236-2010,55663,"snare, flexible",FDI,Endoscopic electrosurgical unit and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.",Olympus SD Snares,2,"August 18, 2010", 2010,Olympus America Inc.,An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.,OTHER/UNDETERMINED: Pending,"Firm initiated this recall following investigation of customer complaints regarding the inability of the snare wire to be retracted into the snare tube. Customers were notified via certified mail, an Urgent: Medical: Device Recall letter issued on May 4, 2010. The letter identified the affected product and the reason for the recall. Customers were instructed to inspect their inventory and identify the affected product. Customers are to remove from use any identified inventory, quarantine, and discard them. Customers should contact the firm to obtain replacement products. Questions should be directed towards Laura Storms-Tyler at 484-896-5688 or laura.storms-tyler@olympus.com.",Contact the recalling firm for information,108,108 units,"Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.",Terminated,"May 20, 2013",1006,108,Not_Computer,N/A,N/A,N/A
Z-2218-2010,54687,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",NWX,N/A,N/A,Cardiovascular,N/A,"AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.","AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore ",1,"August 18, 2010", 2010,AngioScore Inc.,"Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.",N/A,"AngioScore sent an ""Urgent: Medical Device Voluntary Recall"" dated December 4, 2009 addressed to ""Catheterization Lab Manager"" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.",Contact the recalling firm for information,3870,3870 units,Nationwide distribution.,Terminated,"June 21, 2011",307,3870,Not_Computer,N/A,N/A,N/A
Z-2237-2010,49012,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body bycomputer reconstruction of X-ray transmission data taken at differentangles.",NeuViz Dual series Computed Tomography (CT) Scanner System,2,"August 19, 2010", 2010,"Neuisys, LLC","The reference lines for image generated for a Surview scan may appear in the incorrect position in the ""FILM"" display mode.",DESIGN: Software Design,"On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China.The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of ""Incorrect Reference Line in the Film"". When a ""Head first, Couch out"" or a ""Feet first, Couch in"" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in ""FILM"" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis.The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge.The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at helpdesk@pnms.neusoft.com regarding the recall.",N/A,19,19 units in the US,Nationwide Distribution,Terminated,"August 23, 2010",4,19,Software,Display/Image,Software update,Software Update
Z-2238-2010,55921,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova 2000, manufactured by GE Medical Systems, SCS",Innova 2000 Digital Flouroscopic Imaging System,2,"August 19, 2010", 2010,"GE Healthcare, LLC","A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager and the patient. This will result in loss of the x-ray image if the recovery process is not performed. The error message to use the Emergency Back-Out Button for",OTHER/UNDETERMINED: Pending,"GE Healthcare sent a GE ""Urgent Medical Device Correction"" dated June 9, 2010letter to consignees. The letter was addressed to Hospital Administrators / Risk Mangers; Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details; Safety Instruction; Product Correction and Contact Information. The letter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the device on-site to remind operators how to recover from loss of X-ray from SID failure. Consignees may contact GE at 800 437-1171, option 4.",N/A,885,885,"Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT , ECUADOR, COLOMBIA, CHINA, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ALGERIA.",Open,N/A,N/A,885,Hardware,Device Operation,N/A,Other
Z-2240-2010,56258,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063,Usage: Low field MRI device used to gather cranial images.",PoleStar N20 Magnetic Resonance Diagnostic Device,2,"August 19, 2010", 2010,Odin Medical Technologies Ltd.,"Electronic box on headstrap may overheat, causing burn to patient.",DESIGN: Device Design,"Customers were notified by letter on 07/07/2010, advising them of the overheating problem and alerting them that a service rep will be visiting to inspect and upgrade any affected FlexiCoils. Questions were referred to 800-595-9709.",N/A,560,560 units,"CA, CO, DC, IL, IN, MD, MI, MN, MO, NE, NJ, NV, NY, OH, OR, WA, and WI. Foreign distribution to Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Netherlands, Poland, Spain, Russia, Switzerland and Turkey.",Terminated,"November 09, 2010",82,560,Not_Computer,N/A,N/A,N/A
Z-2239-2010,55043,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.",Starion Instruments Thermal Ligating Shears,2,"August 19, 2010", 2010,Starion Instruments,"The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on"".",DESIGN: Device Design,"Starion distributed a ""STLS Device Recall - Important Medical Device Information"" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..",N/A,228,228 units,"Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.",Terminated,"November 27, 2010",100,228,Not_Computer,N/A,N/A,N/A
Z-2241-2010,55153,"chair, dental, without operative unit",NRU,Dental chair and accessories.,Dental,Dental,510(K) Exempt,"The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS):The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are:Marus MaxStar-Agency Model # DC1490;Marus MaxStar-Agency Model # DC1690;Marus NuStar-Agency Model # DC1700;Marus NuStar-Agency Model # DC1702;Marus ProStar-Agency Model # DC1540;Marus ProStar-Agency Model # DC1535;DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.",Dental chair headrest,2,"August 20, 2010", 2010,Dental Equipment LLC,The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.,OTHER/UNDETERMINED: Pending,"DCI Equipment sent an ""Urgent Field Safety Alert"" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.",Contact the recalling firm for information,108,108,Worldwide distribution in the USA and Canada.,Terminated,"January 04, 2012",502,108,Other,Device Operation,Instructions to avoid,Safety Notice/Insructions
Z-2243-2010,56291,"for export only - antigen, anti-cardiac, indirect fluorescent antibody test system",NUK,N/A,N/A,Clinical Chemistry,Contact ODE,"Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.",Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KIT,2,"August 20, 2010", 2010,BioCheck Inc,Products were marketed without 510(k) for diagnostic use. Unapproved device.,PREMARKET APPROVAL: No Marketing Application,"BioCheck sent an ""Urgent Device Recall"" letter dated July 15, 2010 to consignees identifying the products as unapproved and requesting prompt return to the firm. Consignees are asked to sub-recall. The letter requested a reponse form be completed and returned to the firm.Diagnostic claims have been removed from the website. Returned product will be quarantined by the firm pending determination of marketing status and labeling revision.",Contact the recalling firm for information,187,187 kits,"Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.",Terminated,"December 13, 2010",115,187,Not_Computer,N/A,N/A,N/A
Z-2242-2010,56285,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.",CIVCO SurgiTip Transducer cover,2,"August 20, 2010", 2010,Civco Medical Instruments Inc,Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CIVCO sent a ""Urgent - Medical Device Correctdion"" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.",Contact the recalling firm for information,22,22 boxes,"Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.",Terminated,"April 13, 2012",602,22,Not_Computer,N/A,N/A,N/A
Z-2244-2010,56200,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.",3DKnee System,2,"August 22, 2010", 2010,"Encore Medical, Lp",One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Firm notified their consignees by letter on June 28, 2010.",Contact the recalling firm for information Contact the recalling firm for information,18,18,"Florida, Missouri, and Italy",Terminated,"October 04, 2010",43,18,Not_Computer,N/A,N/A,N/A
Z-2261-2010,54701,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"REF 70-0077-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.",ARTHROKNIFE ,2,"August 24, 2010", 2010,Linvatec Corp. dba ConMed Linvatec,This recall was due to the possibility that multiple products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.",Contact the recalling firm for information,35451,"35,451 total","Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.",Terminated,"December 15, 2010",113,35451,Not_Computer,N/A,N/A,N/A
Z-2267-2010,55156,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom Care Assist Bed, Model P1170.",HillRom Care Assist Bed,2,"August 24, 2010", 2010,"Hill-Rom, Inc.",Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.,DESIGN: Device Design,"Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days.",No consumer action necessary,39971,"39,971 both products","Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.",Terminated,"June 06, 2011",286,39971,Not_Computer,N/A,N/A,N/A
Z-2263-2010,56273,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds,Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds,2,"August 24, 2010", 2010,Philips Healthcare Inc.,"The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.",DESIGN: Device Design,"Philips Healthcare issued an ""Urgent Device Correction"" letter dated July 14, 2010 with an addendum to the Instructions for Use including additional instructions for the replacement of the water trap for the Philips M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia Gas Modules. This addendum is being sent along with the Urgent Medical Device Correction notice to all affected customers.Customers will be requested to incorporate the information contained in the Urgent Medical Device Correction notice and the Addendum to the Instructions for Use with the existing labeling (Instructions for Use) provided with the product. Customers can contact Philips at 1-800-722-9377 for further information..",N/A,531,531 units,"Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.",Terminated,"March 09, 2012",563,4675,Not_Computer,N/A,N/A,N/A
Z-2280-2010,52030,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502 ASSEMBLED IN MEXICOABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICOUsage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.","ABC PROBE, 160636",2,"August 25, 2010", 2010,ConMed Electrosurgery,The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.,DESIGN: Process Design,"An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.",N/A,184,Dom: 184 cs (1840 units); Int'l: 47 cs (470 units),Nationwide and International,Terminated,"October 22, 2010",58,5527,Not_Computer,N/A,N/A,N/A
Z-2270-2010,50226,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.",Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.,2,"August 25, 2010", 2010,"Spacelabs Healthcare, Incorporated",Potential for device to print out the wrong waveform data for the time indicated in the printout or display.,DESIGN: Device Design,"On 07/17/2008, Spacelabs Healthcare began sending the MEDICAL DEVICE CORRECTION letter to their consignees. The letter informs the consignees that there is an issue involving ICS G2 Smart Disclosure (Model 92810) which causes the display or printing of an incorrect waveform for the time indicated in the printout or display.The consignees are advised whether to discontinue to use the device until the firm upgrades the system. If the consignees decide to continue to use the device, then they should discontinue any use of the ""Refresh"" button. When they print or view waveform reports,t hey should utilize the Saved Event view functionality of the product rather than Arrhythmia, Alarm or Waveform Views. If the printing from the Arrhythmia, Alarm, or Waveform views, the consignees must visually inspect the print out and verify that the waveform contains what you expected to see printed.The consignees could contact Spacelabs Healthcare at 1-800-522-7052 or 1-425-657-7200, x5089 for any questions about the corrective actions of the affected device. The firm's field service engineer will make a schedule a mutually agreeable time with the consignees to update the ICS G2 system at free of charge.",N/A,135,135 units,"Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.",Terminated,"September 29, 2010",35,135,Software,Display/Image,Upgrade,Repair
Z-2269-2010,54810,"walker, mechanical",ITJ,Mechanical walker.,Physical Medicine,Physical Medicine,510(K) Exempt,"ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers.W1801R-Red, UPC 7 54756 91803 3 all serial numbers.The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds.Warranty Card: ""...lifetime of the original purchaser..."". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.",ENDURANCE HD,2,"August 25, 2010", 2010,"Essential Medical Supply, Inc.","Essential Medical Supply, Inc. is recalling W1801B and W1801R Endurance HD Walkers due to recent reports and tests that show the front caster may detach from the frame. The potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame.",OTHER/UNDETERMINED: Pending,"All Consignees were mailed an Urgent: Product Recall W1801B and W1801R Endurance HD Walkers notification on December 30, 2009. All notifications were sent first class mail in a 9"" X 6"" envelope. Response cards were included. The letter identified the affected product and the reason for recall. Customers were asked to examine their inventory for affected product and to discontinue further use or distribution of the product. If the product was further distributed, customers should contact their customers, advise them of the recall and have them return the units to them. Customers should follow the instructions provided for return and replacement of units.",No consumer action necessary,2954,"2,954 units",Nationwide Distribution,Terminated,"February 21, 2012",545,2954,Not_Computer,N/A,N/A,N/A
Z-1981-2010,55855,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.",FLEXIMA Biliary Stent System,2,"August 25, 2010", 2010,Boston Scientific Corporation,"Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.",PRODUCTION CONTROLS: Packaging,"Boston Scientific sent an ""Urgent Medical Device Recall - Immediate Action Required"" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific.",N/A,1577,1577,"Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.",Terminated,"March 23, 2011",210,13227,Not_Computer,N/A,N/A,N/A
Z-2274-2010,55933,"accessories, catheter",KGZ,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801,Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat,2,"August 25, 2010", 2010,Arrow International Inc,"Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.",N/A,3000,3000 kits,All affected product was distributed to one foreign consignee: Arrow Japan Ltd.,Terminated,"September 29, 2012",766,3000,Not_Computer,N/A,N/A,N/A
Z-2271-2010,56276,"syringe, balloon inflation",MAV,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Medtronic¶_ Everest¶_ 20 Disposable Inflation Device, AC2200.Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.",Medtronic Everest Disposable Inflation Device,2,"August 25, 2010", 2010,"Medtronic, Inc.",Product sterility may be compromised due to breach of package seal integrity.,PRODUCTION CONTROLS: Packaging Process Control,Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.,N/A,2875,"2,875 units","Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.",Terminated,"June 07, 2011",286,4897,Not_Computer,N/A,N/A,N/A
Z-2275-2010,56141,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),CARESCAPE MONITOR B850Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.,CARESCAPE MONITOR B850,2,"August 25, 2010", 2010,"GE Healthcare, LLC","GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE"" Monitor B850:1. Loss of user input when using certain displays or the USB remote control.2. Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off.3. The CARESCAPE Monitor B850 will not use user entered hemo",DESIGN: Software Design,"Consignees were sent on 7/16/10, a GE ""Urgent Medical Device Correction"" letter dated July 12, 2010. The letter was addressed to Healthcare Administrator/Risk Manger, Chief of Nursing, Director of Biomedical Engineering. They stated the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. If you have any questions, please contact Technical Support at 1-800-558-7044.",N/A,875,875,"CA, CO, FL, GA, KY, LA, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TX VA, and WI, Foreign: UNITED KINGDOM, TURKEY, SWITZERLAND, SPAIN , SLOVENIA, SINGAPORE, SAUDI ARABIA, PORTUGAL NETHERLAND, ITALY, GERMANY, FRANCE,FINLAND, DENMARK, CZECH REPUBLIC, BELGIUM, AUSTRIA, and AUSTRALIA.",Terminated,"September 18, 2013",1120,875,Other,Alarm/Message,Instructions,Safety Notice/Insructions
Z-2287-2010,54474,"suture, absorbable, synthetic, polyglycolic acid",GAM,Absorbable poly(glycolide/l-lactide) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Deknatel Bondek¶_ Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical.",Bondek Absorbable Sutures,2,"August 26, 2010", 2010,Telefelx Medical,Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.,N/A,"Teleflex Medical issued consignees a ""Urgent Medical Device Recall"" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.",N/A,17,17 sales units (24 packs per sales unit/408 units),Worldwide Distribution: USA and Germany,Terminated,"April 19, 2011",236,17,Not_Computer,N/A,N/A,N/A
Z-2288-2010,55772,"board, bed",FPS,Bed board.,General Hospital,General Hospital,510(K) Exempt,ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.,ReliaMed Deluxe Portable Adjusting Table,2,"August 26, 2010", 2010,MDC Acquisition Co.,"Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.",DESIGN: Component Design/Selection,"""Urgent: Medical Device Recall"" letters were sent to consignees from Milliken Medical and Meyer Distributing Company in April 2010 describing the issue. They instructed their customers to immediately stop use of the table. customers were instructed to return the tables to the firm with an enclosed Recall Form for future replacement, or for replacement with a comparable table from another menufacturer at no cost, or for refund of the original cost of the device. Consignees may contact Meyer Distributing Company at 800-472-4221 and Milliken Medical at 800-532-1356.",N/A,265,265 Tables,"Worldwide distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA and WI, and the country of Canada.",Terminated,"February 16, 2012",539,265,Not_Computer,N/A,N/A,N/A
Z-2285-2010,56542,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.",ATEC 091220 Handpiece,2,"August 26, 2010", 2010,"Hologic, Inc.",The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.,PRODUCTION CONTROLS: Packaging,"The firm, Hologic, Inc., sent out ""Urgent Medical Device Recall"" letters by FedEx on August 11, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to check their inventories and to quarantine any of the recalled product; if the product was distributed further, identify the users and notify them at once of this product recall; segregate all products from this lot and quarantine them in preparation for return to Hologic, and complete and return the enclosed RECALL RESPONSE FORM by fax at 877-574-3255 or mail. Note: Replacement product cannot be sent until Hologic receives your response form.If you have any questions, please contact Hologic directly at 317-344-7630.",N/A,990,990,"Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.",Terminated,"April 13, 2011",230,990,Not_Computer,N/A,N/A,N/A
Z-2283-2010,55870,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.",Infinity Delta/Gamma X XL Portable Monitor,2,"August 26, 2010", 2010,"Draeger Medical Systems, Inc.","Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.",N/A,"Draeger Medical issued ""Urgent-Medical Device Recall Notification"" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.",No consumer action necessary,8675,8675 units,"Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Benin, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Serbia, Czech Republic, Germany, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Coratia, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon,Lithuania, Latvia, Libya, Morocco, Macedonia, Martinique, Mexico, Netherlands, Norway, Nepal, Peru, Poland, Puerto Rico, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovak Republic, Turkmenistan, Turkey, Ukraine, Uruguay, Venezuela, Mayotte and South Africa. The government accounts are Bay Pines VAMC, Bay Pines, FL; Naval Medical Center, Portsmouth, VA; and Walter Reed Army Medical Center, Washington, DC.",Open,N/A,N/A,9475,I/O,N/A,N/A,N/A
Z-2292-2010,56329,"implant, eye sphere",HPZ,Eye sphere implant.,Ophthalmic,Ophthalmic,510(k),Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer,Sterile BioEye Hydroxyapatite Orbital Implant and Conformer,3,"August 26, 2010", 2010,Integrated Orbital Implants Inc,"Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted.",PRODUCTION CONTROLS: Error in Labeling,Customers were contacted by telephone and email.,No consumer action necessary,40,40 units,"USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey",Terminated,"August 31, 2010",5,40,Not_Computer,N/A,N/A,N/A
Z-2290-2010,56032,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"VERSYS¶_ HIP SYSTEMFEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTHZIMALOY¶_ CO-CR-MO ALLOY STERILE QTY-1MANUFACTURED BY ZIMMER MANUFACTURING B.V.,A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN)The VerSys¶_ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium"" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.",VerSys Femoral Head,2,"August 26, 2010", 2010,Zimmer Inc.,"Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoralhead but contain a 32 mm femoral head. In addition, there is a potential for the patient record label tobe incorrect.",OTHER/UNDETERMINED: Pending,"The firm, Zimmer, Inc., sent an ""URGENT: DEVICE REMOVAL"" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots. For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.",N/A,103,103,"Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.",Terminated,"January 12, 2011",139,103,Not_Computer,N/A,N/A,N/A
Z-2289-2010,56328,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer ITST"" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILEZimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries","Zimmer ITST"" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR",2,"August 26, 2010", 2010,Zimmer Inc.,"Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Zimmer sent ""Urgent: Device Removal"" letters dated July 8, 2010 to consignees identifying the potential for fracture of the device. Consignees were instructed to inventory affected product and record on the Inventory Return Certification Form, to document users of the affected device on the User Facility/HCP Form, and return both forms by fax or email. Affected product is to be returned to Zimmer with a copy of the Inventory Return Certification Form. Returned product will be destroyed. Each of the affected consignees will be provided with a new instrument, manufactured with the correct 17-4 stainless steel.Consignees can contact Zimmer at 800-613-6131 or 574-372-4463.",N/A,20,20 individual units,"Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.",Terminated,"February 25, 2011",183,20,Not_Computer,N/A,N/A,N/A
Z-2297-2010,55877,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Mitek VAPR S90 Suction Electrode (integrated)Product Code: 225370The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9¶_ and S ¶_) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.",Mitek,2,"August 27, 2010", 2010,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility,N/A,"The firm, Depuy Mitek, sent an ""Urgent Voluntary Product Recall"" letter dated June 7, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to not use any of the identified recalled products; to isolate all inventory of the affected product; complete the Business Reply Form, and return the affected products along with the form to Depuy Mitek; ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or fax completed form to 1-508-828-3750. Note the IMPORTANT PRODUCT INFORMATION: Any product that contains a round green sticker has been 100% inspected, meets specifications and is acceptable for use. Please Do Not Return any product that is labeled with the green dots because this product is not affected by the recall.If you have any questions or concerns with regard to this program, please contact your local Depuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682.",Contact the recalling firm for information,545526,"545,526 units","Worldwide distribution: USA and countries including Canada, Argentina, Australia, Bahrain, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhastan, Kuwait, Lebanon, Maylasia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Portugal, Sweden, Switzerland, Syria, Thailand ,Turkey, UK, Ukraine, UAE, Venezuela, Vietnam, and Yemen.",Terminated,"July 12, 2012",685,813657,Not_Computer,N/A,N/A,N/A
Z-2295-2010,56365,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.",VITEK TWO ASTN085 REF 22 225 ,2,"August 27, 2010", 2010,Biomerieux Inc,"Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.",PRODUCTION CONTROLS: Packaging,"BioMerieux issued an Urgent Product Removal Notice, dated July 29, 2010 to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and destroy any remaining inventory of the affected lot, and to notify their customers who received the product. All consignees were instructed to complete and return the Customer Acknowledgement and Product Replacement Form. These cards will be used to distribute replacement cards. Consignees can contact BioMerieux at 1-314- 731-8667.",Contact the recalling firm for information,20,1297/ 20 card boxes,Worldwide Distribution: Country of Canada only. No product was distributed in the US.,Terminated,"November 02, 2010",67,1297,Not_Computer,N/A,N/A,N/A
Z-2294-2010,56281,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.",OptiSeal Valved PTFE Peelable Introducer ,2,"August 27, 2010", 2010,Greatbatch Medical,The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray.,PRODUCTION CONTROLS: Packaging,"Greatbatch Medical issued an ""Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702.",N/A,216,211 5-pack boxes,"Worldwide Distribution: United States, including the states of MN and CA.",Terminated,"December 17, 2011",477,216,Not_Computer,N/A,N/A,N/A
Z-2296-2010,56420,"dissector, surgical, general & plastic surgery",GDI,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"V. Mueller¶_ Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.",V. Mueller Peanut Sponges,2,"August 27, 2010", 2010,"He, Inc","Sterile product packaging contains weak seals, which may result in compromised product sterility.",PRODUCTION CONTROLS: Packaging,"Harod Enterprises, Inc. (HE) issued a ""Notice of Recall"" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product.Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165.",N/A,551,551 cases of 100 packages per case,Nationwide: including state of IL.,Terminated,"November 02, 2011",432,551,Not_Computer,N/A,N/A,N/A
Z-2293-2010,55612,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.",HeartStart MRx Defibrillator/Monitor with QCPRTM,2,"August 27, 2010", 2010,Philips Healthcare Inc.,"Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest compression, which will reduce CPR effectiveness.",DESIGN: Device Design,"Philips issued an ""Urgent Medical Device Recall notification/Field Safety Notice"" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibration will receive free replacement. All CPR meters will be replaced with re-designed meters when they become available.For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.","Contact the recalling firm for information For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.",72,72 units,"Worldwide distribution in the countries of USA, Canada, Australia, China, Germany, Iceland, India, Libyan Arab Jamahiri, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom.",Terminated,"February 19, 2013",907,72,I/O,Output/Calculation,Replace,Remove or Replace
Z-2311-2010,50214,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),"External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.",External Sterilizable Paddles,2,"August 28, 2010", 2010,"Physio Control, Inc.",Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.,MISBRANDING: Labeling False and Misleading,"On 11/14/08, Physio Control began sending the Urgent User Information letter via certified mail to their customers. The letter notified the customers about the modification to the cleaning and sterilization instruction of the External Sterilization Defibrillation Paddles and Pediatric Paddle attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitors The customers are informed to discontinue use of the gas sterilization methods listed as 12/88 Ethylene Oxide (EO) or 100% Ethylene Oxide (OE). They are notified that they can continue to use the sterilization method such as STERRAD per existing Operating Instructions, but limit sterilization cycles from 100 to 50 cycles.The customers are advised that prior to and after each use, they should examine cables and connector for damage or signs of wear such as loose connections, damaged pins, exposed wires and cable connector corrosion and examine paddles for scratched or pitted surfaces and stop using product if damage has occurred. Within 45 days, the firm will update the Operating Instruction that will include revised Sterilization Guidelines on a website www.physio-control.com/products/product-support. Customers can call Technical Support at 1-800-442-1142, #5 or they can visit the firm's website at www.physio-control-notices.com/extpaddles regarding the recall.",N/A,38185,"38,185 units","Devices were distributed to medical facilities through out the US and WORLD WIDE to Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela, and United Arab Emirates(UAE) .",Terminated,"September 28, 2010",31,39874,Not_Computer,N/A,N/A,N/A
Z-2310-2010,56218,general surgery tray (kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"Genzyme Biosurgery Essentials Kit, Item Number 82004","Genzyme Biosurgery Essentials Kit, Item Number 82004",2,"August 28, 2010", 2010,Genzyme Corporation,Revised Labeling of Carticel Essentials Kit clarifiesthe non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.,DESIGN: Labeling Design,"Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. ContactGenzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.",N/A,3132,3132 kits,Nationwide,Terminated,"January 30, 2012",520,3132,Not_Computer,N/A,N/A,N/A
Z-2313-2010,56284,"slide stainer, automated",KPA,Automated slide stainer.,Pathology,Pathology,510(K) Exempt,"VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers:a) list 02J11-013, part number 30-144152 (replacement basins);b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.",VP 2000 Processor Heated Reagent Basins ,2,"August 31, 2010", 2010,Abbott Molecular,"The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.",PRODUCTION CONTROLS: Reprocessing Controls,"Abbott sent Urgent Product Recall letters dated 7/20/10 to the VP 2000 Processor customers on same date via FedEx, informing them that the heated reagent basins could crack along the bottom seam, have non-uniform coating of interior corners, warping of the aluminum housing or incorrect dimensions. These deficiencies could result in leakage or the inability to place the basins into the VP 2000 Processor, resulting in possible exposure to chemical reagents, a slippery floor hazard, and/or delay or failure to start a protocol run. An Abbott Molecular customer service representative will call them to coordinate replacement of all of their heated reagent basins before 10/31/10. Customers were to complete and return the Customer Reply form provided. Any questions were directed to their local Abbott Molecular Representative.*** A second recall letter was sent to all customers on 12/21/10 explaining that the VP 2000 heated reagent basins previously inspected and determined to be acceptable could develop a leak, and that they would be contacted by an Abbott Molecular Customer Service Representative or Field Service representative in early 2011 to coordinate replacement of all of their VP 2000 heated reagent basins. ***.",Contact the recalling firm for information,219,219 basins,"Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.",Terminated,"April 19, 2012",597,219,Not_Computer,N/A,N/A,N/A
Z-2315-2010,56064,"fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis",OAH,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"E.faecalis/OE PNA FISHIntended Use: E. faecalis/OE PNA FISH"" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media",E.faecalis/OE PNA Fish,2,"August 31, 2010", 2010,"AdvanDx, Inc.",Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.,DESIGN: Device Design,"The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under ""limitations"" to include the statement ""some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert.If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email techsupport@advandx.com.",N/A,541,541 units,"Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).",Terminated,"June 06, 2011",279,541,Not_Computer,N/A,N/A,N/A
Z-2335-2010,53811,"orthosis, spinal pedicle fixation",MNI,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2.Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.","Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD",2,"August 31, 2010", 2010,Zimmer Inc.,"The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.",OTHER/UNDETERMINED: Pending,"The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice.For questions or assistance, please contact Zimmer Spine at 800-326-0635.",Contact the recalling firm for information,691,691,Worldwide.,Terminated,"December 22, 2010",113,691,Not_Computer,N/A,N/A,N/A
Z-2334-2010,53427,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in Ireland.Howmedica Osteonics325 Corporate DriveMahwah, NJ 07430The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surf ace of the patella is required, the Duracon patellar components are compatible with the Triathlon components). The Triathlon PS Total Knee System is intended to be used in situation where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene patellare components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously release Triathlon PS Femoral component in situation where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee system is intended to accommodate the posterior cruciate ligament (PCL) if it is present.",Triathlon Tibial Baseplate,2,"August 31, 2010", 2010,Stryker Howmedica Osteonics Corp.,"A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"The firm, Stryker Orthopaedics, sent an ""URGENT PRODUCT RECALL"" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words ""PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice. If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.",N/A,6,Lot Code: SH7RP - 6 in the US. Lot Code SH8NT was not received in the US.,"Nationwide distribution: AL, AZ, CA, MT, NJ and TX.",Terminated,"August 27, 2012",727,6,Not_Computer,N/A,N/A,N/A
Z-2320-2010,56331,"prosthesis, esophageal",ESW,Esophageal prosthesis.,General & Plastic Surgery,Gastroenterology/Urology,510(k),Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9)Material/UPN/Catalog Number: M00513850,Ultraflex Covered Esophageal Stent System,2,"August 31, 2010", 2010,Boston Scientific Corporation,"Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.",PRODUCTION CONTROLS: Process Control,"Boston Scientific issued ""Urgent Medical Device Recall - Immediate Action Required"" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations.Boston Scientific can be contacted at 1-508-683-4427.",N/A,8,8 units,"Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden",Terminated,"October 14, 2011",409,118,Not_Computer,N/A,N/A,N/A
Z-2314-2010,56402,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttlingen, Germany. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation.","PERILOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE",2,"August 31, 2010", 2010,Smith & Nephew Inc,Inner packaging of sterile product was not sealed. Lack of sterility assurance.,N/A,"Smith & Nephew issued an ""Urgent:: Medical Device Recall"" letter dated July 20, 2010 to consignees (International distributors), identifying the issue and affected product. Consignees were requested to identify and quarantine affected stock, and cease distribution. Consignees were instructed to contact Smith and Nephew for a Return Authorization number. The Return Authorization number and an inventory of affected devices are to be recorded on the Verification Section of the notification letter and faxed to the firm. Affected stock is to be sent to Smith & Nephew. Consignees were requested to notify anyone to whom the product was distributed to also contact the firm for return of the product. Smith & Nephew can be contacted at 1-901-399-5441.",Contact the recalling firm for information,10,10 units,"Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa",Terminated,"November 17, 2011",443,10,Not_Computer,N/A,N/A,N/A
Z-2339-2010,52830,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),Toshiba Aquilion ONE CT SystemTSX-301 A/2D,Aquilion ONE CT System TSX301 A/2D,2,"September 01, 2010", 2010,Toshiba American Medical Systems Inc,"ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.",DESIGN: Software Design,"Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.",Contact the recalling firm for information,16,16,"Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.",Terminated,"September 02, 2011",366,16,Software,N/A,N/A,N/A
Z-2342-2010,54265,"bed, manual",FNJ,Manual adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended Use: A stretcher used for eye surgery.",Stryker Eye Surgery Stretcher 1079,2,"September 01, 2010", 2010,Stryker Medical Div. of Stryker Corporation,"The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with excessive wear of the brass nut. T",DESIGN: Device Design,"The firm, Stryker Medical, sent an ""Urgent Medical Device Correction"" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).",Contact the recalling firm for information,729,729,"Worldwide distribution: USA and countries including Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK.",Terminated,"April 21, 2011",232,1866,Not_Computer,N/A,N/A,N/A
Z-2337-2010,55699,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),COULTER LH 500 Series System,COULTER LH 500 Series System,3,"September 01, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System:Issue 1:There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu",DESIGN: Software Design,"The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around.Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the UnitedStates or Canada, or contact your local Beckman Coulter Representative.",Contact the recalling firm for information Contact the recalling firm for information,1373,1373 units in US and 147 units in Canada,Throughout the United States and Canada,Terminated,"September 10, 2010",9,1426,Software,N/A,N/A,N/A
Z-2348-2010,56323,"posterior metal/polymer spinal system, fusion",NQP,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),NFlex Stabilization System 150mmThe Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.,NFlex Stabilization System 150mm,2,"September 01, 2010", 2010,"Synthes USA (HQ), Inc.",package integrity compromised,N/A,"The firm, SYNTHES, sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated February 9, 2009 and an updated letter dated February 12, 2009, with updated expiration information to customers. The letters described the product, problem and action to be taken by customer. The customers were instructed to call Synthes at 1-800-479-6329 if they have any of the identified devices to obtain a Return Authorization Number; complete the enclosed Verification Section attachment and return this letter with the recalled product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If they do not have the identified product ,complete the Verification Section attachment and return the document to Synthes by Fax 610-719-5120 or scan/email: lewis.lynne@synthes.com.If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.",Contact the recalling firm for information,N/A,N/A,"Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-2355-2010,56214,"immunochemical, thyroglobulin autoantibody",JNL,Thyroid autoantibody immunological test system.,Immunology,Immunology,510(k),"Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.","Access Thyroglobulin Antibody II Reagent, Part Number: A32898 ",2,"September 02, 2010", 2010,Beckman Coulter Inc.,The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.,OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an ""Urgent Product Corrective Action"" letter dated June 29, 2010, with attached Customer Response form to the affected customers. The letter identified the affected product and issue.Customers were instructed to:(1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers 916271, 917073, and 918433.(2) Review results in the context of the total clinical presentation of the patient, and rerun questionable results using another reagent.(3) Complete and return a response form within 10 days.(4) For replacement contact Beckman Coulter at (US) 1-800-526-3821, (Canada) 1-800-463-7828. Customer Technical Support can be contacted at 1-800-854- 3633.",N/A,1071,1071 units,"Worldwide distribution : United States, including states of CA, CO, FL, GA. IA, IL, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and country of Canada.",Terminated,"May 04, 2012",610,1071,Not_Computer,N/A,N/A,N/A
Z-2350-2010,56309,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.",CELLDYN 3200,2,"September 02, 2010", 2010,Abbott Laboratories,"Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.",N/A,69,69 units total.,"Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.",Terminated,"December 06, 2010",95,69,Not_Computer,N/A,N/A,N/A
Z-2340-2010,56364,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S.Stryker Trauma GmbH, 24232 Schenjrchen, Germany;distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430.Intended for temporary fixation, correction, or stabilization of the right femur.",Gamma 3 Long Nail Kit R2.0,2,"September 02, 2010", 2010,Stryker Howmedica Osteonics Corp.,The nail has no thread for the set screw hindering insertion.,PRODUCTION CONTROLS: Process Control,"Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.",N/A,12,12 units,"Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.",Terminated,"August 06, 2012",704,12,Not_Computer,N/A,N/A,N/A
Z-2354-2010,56489,"handpiece, belt and/or gear driven, dental",EFA,Dental handpiece and accessories.,Dental,Dental,510(k),"Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free",Titan 3 5K LowSpeed Motor,3,"September 02, 2010", 2010,Dental EZ Stardental Division,The housing of 5K motor is labeled as a 20K motor.,PRODUCTION CONTROLS: Labeling Mix-Ups,"DentalEZ group/Star Dental Division sent a ""Medical Device Recall"" letter to consignees on 8/11/10, informing them that the device's 5K motor was mislabeled as a 20K motor. Customers are to stop using of the device, and return to the manufacturer or to the distributor using supplied shipping labels. Replacement devices will be sent to customers at no charge. Consignees are to complete and return a form indicating whether they have any affected devices, and whether customers have been contacted about this recall. Customers can contact DentalEZ at 866-383-4636 .",Discard product or return to place of purchase for a full refund or exchange,41,41 units,Nationwide Distribution: States of IN and TX,Terminated,"December 13, 2010",102,41,Not_Computer,N/A,N/A,N/A
Z-2356-2010,54625,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments Kalamazoo MI",Luer Cap,2,"September 03, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,"Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.",PRODUCTION CONTROLS: Process Control,"Stryker Instruments issued an ""Urgent Medical Device Recall Notification"" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to:1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product.3) Destroy all affected product using attached instructions.4) Complete and return the Business Reply Form to the firm by fax.Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354.",N/A,18826,"18,826 all products","Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.",Terminated,"March 28, 2011",206,18826,Not_Computer,N/A,N/A,N/A
Z-2380-2010,56561,"warmer, thermal, infusion fluid",LGZ,N/A,N/A,General Hospital,510(k),Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.,enFlow Disposable IV Fluid/Blood Warmer Cartridge,2,"September 03, 2010", 2010,Vital Signs Inc,The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.,PRODUCTION CONTROLS: Equipment Maintenance,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 .",N/A,406596,"385,820 domestic - 20,776 international","Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.",Open,N/A,N/A,406596,Not_Computer,N/A,N/A,N/A
Z-2384-2010,53819,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790,Whatman Body Fluid Collection Paper 903,2,"September 07, 2010", 2010,"Whatman, Inc.",Neonate newborn screening card demographic and filter portion may be detached,PRODUCTION CONTROLS: Process Control,"The firm, Whatman, issued an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions.If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.",N/A,488000,"488,000 cards",Nationwide distribution: CA,Open,N/A,N/A,488000,Not_Computer,N/A,N/A,N/A
Z-2383-2010,56488,"electrode, electrocardiograph",DRX,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.","3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560",2,"September 07, 2010", 2010,3M Company / Medical Division,"The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.",PRODUCTION CONTROLS: Process Control,"3M sent an ""Urgent Medical Device Recall"" letters and a ""Distributor Product Recall Form"" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected devices. Distributors were instructed to notify customers to the end user level and have them return affected lots to the distributor for forwarding to 3M, or forward the customer letter to end-users to instruct them on how to contact 3M for recovery of the device. The 3M Customer Helpline can be contacted at: 1-800-228-3957.",Contact the recalling firm for information,50,"11,063 cases (20 pouches/case, 50 electrodes/pouch)","Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI.",Terminated,"April 19, 2012",590,50,I/O,N/A,N/A,N/A
Z-2382-2010,56315,"pump, blood, cardiopulmonary bypass, non-roller type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Impella 5.0 Circulatory Support SystemCatalog number: 004840The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours",Impella 5.0 Circulatory Support System,2,"September 07, 2010", 2010,"Abiomed, Inc.",Pump may separate at the motor housing while device is explanted,N/A,"ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used.If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com.",Contact the recalling firm for information,10,10 units,International only: Canada and France,Terminated,"September 10, 2010",3,10,Not_Computer,N/A,N/A,N/A
Z-2385-2010,54460,ferrozine (colorimetric) iron binding capacity,JMO,Iron-binding capacity test system.,Clinical Chemistry,Clinical Chemistry,Enforcement Discretion,Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.,Dimension IBCT Flex Reagent Cartridge,3,"September 08, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens issued an ""Urgent Field Safety Notice"" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex¶_ reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.",Contact the recalling firm for information,N/A,unknown - all lots involved,"Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.",Terminated,"October 25, 2010",47,N/A,Not_Computer,N/A,N/A,N/A
Z-2386-2010,54624,"enzyme immunoassay, n-acetylprocainamide",LAN,Digoxin test system.,Toxicology,Toxicology,510(k),"ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.",N acetylprocainamide reagent,2,"September 08, 2010", 2010,"Roche Diagnostics Operations, Inc.",The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.,PRODUCTION CONTROLS: Error in Labeling,"Roche issued an ""Urgent Medical Device Removal"" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.",Contact the recalling firm for information,40,40 kits,"Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.",Terminated,"November 01, 2010",54,40,Not_Computer,N/A,N/A,N/A
Z-2332-2010,56162,"ventilator, emergency, manual (resuscitator)",BTM,Manual emergency ventilator.,Anesthesiology,Anesthesiology,510(k),"BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway.A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.",BagEasy Resuscitatior,1,"September 08, 2010", 2010,Westmed Inc,"This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email kpeterson@westmedinc.com to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist.If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.",Contact the recalling firm for information,22145,22145,Worldwide distribution.,Terminated,"March 22, 2011",195,24879,Not_Computer,N/A,N/A,N/A
Z-2381-2010,56523,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.",Symbiq Infuser,1,"September 08, 2010", 2010,Hospira Inc,"If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.",DESIGN: Device Design,Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.,Contact the recalling firm for information,28485,28485 units,"Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.",Terminated,"March 30, 2012",569,28485,Other,Treatment/Delivery/Therapy,Software update,Software Update
Z-2336-2010,55852,"accessories, operating-room, table (kit)",FWZ,Manual operating table and accessories and manual operating chair and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.",Mayfield Infinity XR2,2,"September 09, 2010", 2010,Integra LifeSciences Corporation,Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases.,PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, Integra Life Sciences Corporation,contacted their customers via telephone and Field Correction Letter on May 19, 2010 to notify their customers of the problem. The firm indicated that their sales representatives will visit the consignees affected, correct the case labeles according to the specific instructions indicated, revise their account tracebility records to reflect the labeling change, then, sign and return the Acknowledgement of Reciept and Return Form for confirmation. For questions regarding the correction, please contact Integra Life Sciences Corporation at (877) 44-1114 or (513) 533-7923.",No consumer action necessary No consumer action necessary,13,13 Units,"Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.",Terminated,"October 27, 2011",413,13,Not_Computer,N/A,N/A,N/A
Z-2387-2010,54743,"calibrator, multi-analyte mixture",JIX,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.",Dimension Vista Chemistry 2 Calibrator,3,"September 09, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","There is incorrect barcode information, which can potentially cause the Alert Message ""Calibrator Insert Missing"" to be displayed.",TRAINING: Employee Error,"The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.",N/A,1310,1310 cartons,"Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.",Terminated,"October 13, 2010",34,1310,Not_Computer,N/A,N/A,N/A
Z-2393-2010,56333,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Invacare AC-Powered Adjustable Hospital Bed.Model 5890 IVC and 5490 IVC.Manufactured by:Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.",N/A,2,"September 09, 2010", 2010,Invacare Corporation,"Invacare Corporation, Florida issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Invacare Corporation issued a notice of an Urgent Field Correction to Consignees on 10/18/2006. Consignees were instructed to check the serial number of their units to see if they were potentially affected. If so, the firm provided inspection and adjustment instructions of the foot actuator to prevent a likelihood of injury. After adjustment, the consignees were requested to complete and return the enclosed tracking sheet acknowledging receipt of the recall notice and correction of the bed(s). For questions or assistance regarding this correction, please contact the Customer Relationship Management Group at (800) 333-6900, or via e-mail at CRMGroup@Invacare.com.",N/A,731,731,Product was distributed throughout the U.S.,Terminated,"September 13, 2010",4,731,Not_Computer,N/A,N/A,N/A
Z-2389-2010,56424,"alkaline picrate, colorimetry, creatinine",CGX,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.",Synchron Systems(s) Creatinine Reagent (CREm),2,"September 09, 2010", 2010,Beckman Coulter Inc.,The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine (CREm) reagent kit lots M911428 and M911519. Beckman Coulter have had reports of erroneous results when using the lots of Creatinine Alkaline Buffer listed above. Singlecreatinine d,N/A,"The firm, Beckman Coulter, sent a ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated August 3, 2010, to all customers. The letter describes the product, problem, and action to be taken by customer. The customers were instructed to: (1) Please discontinue use of Creatinine (CREm) reagent kit lots M911428 and M911519 and discard appropriately.(2) Please contact Beckman Coulter at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discussCREm kit M911428 and M911519 replacement options. Outside the United States and Canada, please contactyour local Beckman Coulter Representative.(3) Please complete and return the enclosed response form within 10 days so that we may maintain our records.(4) Please share this information with their laboratory staff and retain this notification as part of their Quality Systemdocumentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them.If customers have any questions regarding this Product Corrective Action letter, they were instructed to please contact Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/SupportRequests, or call (800) 854-3633 in the United States and Canada.",No consumer action necessary,3106,3106 units,"Worldwide Distribution - USA including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY and country of Canada",Terminated,"July 02, 2012",662,3106,Not_Computer,N/A,N/A,N/A
Z-2390-2010,56464,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira brand Symbiq One-Channel InfuserLIST No. 16026 Symbiq One-Channel Infuser,List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90,16026-13-25/26, 53/54,Distributed by: Hospira, Inc. Morgan Hill, CA",Symbiq Infuser,2,"September 09, 2010", 2010,Hospira Inc,The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.,DESIGN: Device Design,"Hospira issued an ""Urgent: Device Field Correction"" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002.",N/A,N/A,N/A,"Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.",Terminated,"April 01, 2011",204,N/A,Not_Computer,N/A,N/A,N/A
Z-2388-2010,55359,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),",Synchron LX and UniCel DxC Synchron Clinical Systems,2,"September 09, 2010", 2010,Beckman Coulter Inc.,UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.,OTHER/UNDETERMINED: Pending,"Beckman Coulter issued an ""Urgent: Product Corrective Action"" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to:1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose.2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits.Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .",N/A,84186,"84,186 units (79,071 in US & 5,115 in Canada)",Worldwide Distribution: USA and Canada,Terminated,"December 31, 2013",1209,84186,Not_Computer,N/A,N/A,N/A
Z-2392-2010,56133,"forceps, general & plastic surgery",GEN,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25"") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PRODUCT***. The Rees Insulated Forceps are used during surgery to grasp, dissect and coagulate selected tissue. Distributed by:BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218, www.biometmicrofixation.com",Rees Insulated Forceps,2,"September 09, 2010", 2010,"Biomet Microfixation, Inc.",The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.,PRODUCTION CONTROLS: Manufacturing Material Removal,"Biomet Microfixation issued a letter dated July 2010 to their consignees. Each consignee was ask to discontinue use of the affected product and return the product back to the company for credit. Biomet asked their customers to complete a ""Inventory Reconciliation"" form and fax the completed form to Biomet Microfixation. If the consignee has further distributed the product, the consignee is asked to contact their customers. Biomet Microfixation can be contacted at 904 741-4400, ext 468.",N/A,130,130 units,"Worldwide Distribution: USA including states of CA, FL, GA, ID, IL, IN, MA, MD, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, WA, and WI, and countries of Norway, Canada, and Mexico.",Terminated,"June 21, 2011",285,130,Not_Computer,N/A,N/A,N/A
Z-2398-2010,55700,"phosphomolybdate (colorimetric), inorganic phosphorus",CEO,Phosphorus (inorganic) test system.,Clinical Chemistry,Clinical Chemistry,Enforcement Discretion,Clinical Chemistry Phosphorus assay,"AEROSET, ARCHITECTURE C8000 & C16000",2,"September 10, 2010", 2010,Abbott Laboratories Inc.,"Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.",OTHER/UNDETERMINED: Pending,"Abbott Laboratories issued a ""Product Recall: Immediate Action Required"" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to:1) Identify affected product in inventory2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-213) Complete and return an enclosed Customer Reply Form4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-225) For AEROSET Systems, manually update parameters as described in the letter.6) For ARCHITECT cSystems, implement alternative kit sizes without system changes.7) Provide a copy of the letter to other laboratories that have been distributed the affected product.US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U",N/A,3136,3136,"Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.",Terminated,"April 05, 2012",573,3136,Not_Computer,N/A,N/A,N/A
Z-2395-2010,55478,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),Animas 2020 Insulin Infusion PumpsIntended use:deliver insulin therapy,Animas 2020 Insulin Infusion Pumps,2,"September 10, 2010", 2010,Animas Corporation,sensor could be damaged,PRODUCTION CONTROLS: Equipment Maintenance,"An Email was sent by the firm, Animas, to US patients and health care providers where email addresses were on file. Animas sent two ""URGENT: MEDICAL DEVICE CORRECTION "" letters one dated March 18, 2010, to all US customers, HCPs and distributors of One Touch Ping Glucose Management System and the Animas 2020 Insulin Infusion Pump and the other letter to all US patients, HCPs and distributors of Animas 2020 Insulin Infusion Pump, Animas IR 1200 and Animas IR 1250 (1200 plus). Animas also notified all global distributors and affiliates and sent the letter to customers and health care professional in those regions. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow their User Guide instructions; Pay attention to all pump warnings; NEVER rewind the pump motor, load the insulin cartridge, or prime their infusion set while connected, and fill out the enclosed reply card and send it back to Animas as soon as possible.Should you have any questions or concerns, please call the Animas Customer Support Department at 1-866-949-1525 or call toll free number on back of pump at 1-877-937-7867. If you are traveling outside of the U.S., please call 610-644-8990 and press option 1.",N/A,N/A,N/A,"Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.",Terminated,"October 27, 2010",47,N/A,I/O,N/A,N/A,N/A
Z-2349-2010,56330,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),Picasso/Picasso Lite lasers Intended use: Dentistry.,Picasso/Picasso Lite lasers ,2,"September 10, 2010", 2010,"AMD Lasers, LLC",Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the Picasso/Picasso Lite lasers could be removed with force while the key was in the ON position.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Letters, dated April 30, 2010, addressed to Dental Professionals were sent identifying the affected product and reason for the recall. The letter asked customers to check their units and, if applicable, AMD Lasers would replace the key assembly on their lasers. The service would be provided free of charge including round trip shipping charges to the corporate office. Customers are to call to schedule the service and obtain a RMA number and shipping instructions. Questions should be directed to 1-866-999-2635 or support@amdlasers.com.",Contact the recalling firm for information,3000,"3,000 units",Worldwide Distribution,Terminated,"April 21, 2011",223,3000,Not_Computer,N/A,N/A,N/A
Z-2400-2010,55610,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),Stratus CS Acute Care Troponin I TestPak ( Troponin I assay),Stratus CS Acute Care Troponin I TestPak ,2,"September 11, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",False elevated Stratus CS CTNI results,PRODUCTION CONTROLS: Process Control,"Recalling firm issued "" Urgent Field Safety Notice"" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.",Contact the recalling firm for information Contact the recalling firm for information,7500,7500 cartons,Nationwide Distribution,Terminated,"October 25, 2010",44,7500,Not_Computer,N/A,N/A,N/A
Z-2399-2010,56271,"laser, ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(k),Peregrine 20 GA Endo Ocular Adjustable Laser Probe,Peregrine 20 GA Endo Ocular Adjustable Laser Probe (Smart Flex),2,"September 11, 2010", 2010,Peregrine Surgical Ltd,Product did not have proper 510(k) clearance,OTHER/UNDETERMINED: Pending,A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.,Contact the recalling firm for information,132,132 boxes,"Product was distributed to hospitals and eye surgery centers in Florida, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas.",Terminated,"September 30, 2010",19,132,Not_Computer,N/A,N/A,N/A
Z-2401-2010,56268,"tubing, pump, cardiopulmonary bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(k),Maquet HLM Tubing Pack; Bioline Coating,Maquet HLM Tubing Pack,2,"September 12, 2010", 2010,Maquet Inc.,"The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.",PRODUCTION CONTROLS: Process Control,"Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.",Contact the recalling firm for information Contact the recalling firm for information,5,5 units,Distribution: Pennsylvania,Terminated,"August 10, 2011",332,5,Not_Computer,N/A,N/A,N/A
Z-2114-2010,56370,"microwave oven, commercial",RCS,N/A,N/A,N/A,N/A,"Microwave Ovens, Model Number DG-2",Duke Microwave Ovens,2,"September 12, 2010", 2010,Duke Manufacturing Co.,The oven did not meet Federal Performance Standard for certain requirements.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,Letters were sent to Duke Manufacturing Speed Oven Owners. The letters identified the affected product and stated the reason for recall. The letter also states that the firm instituted a repair program on all DG-2 Speed Ovens. The firm will repair of replace all affected products at no charge to the customer. Customer Service personnel will contact customers directly and coordinate the schedule of the required repairs.,N/A,62,62 units,Nationwide Distribution,Terminated,"April 17, 2012",583,62,Not_Computer,N/A,N/A,N/A
Z-2402-2010,56336,"cover, mattress (medical purposes)",FMW,Mattress cover for medical purposes.,General Hospital,General Hospital,510(K) Exempt,"CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,",CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds,2,"September 12, 2010", 2010,Invacare Corporation,"In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, when used with Invacare bed rails. Affected bed packages are BED24IVC, BED25IVC, BED24CA, and BED25CA. The mattresses when used in combination with the IVC a",DESIGN: Device Design,"Consignees were notified of the recall by letter dated October 15, 2007 and entitled ""CareGuard Mattresses Provided Since September 2006 In combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the Value Care Bed Series Semi Electric Bed, and Full and Half-Length Rails"". Depending on the mattress usage the consignees were instructed to either: A: 1) Move the bed rail cross bar from the 5th and 6th spring location on the head section of the bed to the 6th and 7th spring location on the head section of the bed in accordance with the enclosed instructions and document your actions on the enclosed tracking sheet. 2) Return of the Product Tracking Report indicating disposition of the recalled product and acknowledgement of receipt of the recall package. 3) The tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credit. or B) 1) contact Customer Service and request part No. 6022, which is a kit that contains a 2"" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements."" 2) When you have completed placing the label and foam topper on all of your affected mattresses, return the tracking sheet to us and we will credit your account $10 for each mattress you have listed. the tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credi.",Contact the recalling firm for information Contact the recalling firm for information,19143,19143,Nationwide Distribution,Terminated,"September 13, 2010",1,19143,Not_Computer,N/A,N/A,N/A
Z-2403-2010,56335,"cover, mattress (medical purposes)",FMW,Mattress cover for medical purposes.,General Hospital,General Hospital,510(K) Exempt,"Mattress Model 5185 and 5185XL. Manufactured by:Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773.Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.",Mattress Model 5185 and 5185XL used with IVC and ValueCare Series Beds,2,"September 12, 2010", 2010,Invacare Corporation,"In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a",DESIGN: Device Design,Consignees of the product were notified by letter dated 09/05/2007. Consignees were instructed to destroy the affected mattresses and to return the completed confirmation of the destruction form to Invacare.,Contact the recalling firm for information Contact the recalling firm for information,4896,4896,Nationwide Distribution,Terminated,"September 13, 2010",1,4896,Not_Computer,N/A,N/A,N/A
Z-2404-2010,46217,"device, spot-film",IXL,Spot-film device.,Radiology,Radiology,Enforcement Discretion,"Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot.Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.",Diagnost 56/66/76/76 Plus,2,"September 13, 2010", 2010,Philips Medical Systems North America Co. Phillips,Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.,OTHER/UNDETERMINED: Pending,"On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US.If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees are instructed to tilt the table base towards the 0 degree tilting position and do not use the tilting drive movement until the mandatory action by a Philips service representative has been performed. The Field Change Order (FCO) would be implemented on 01/23/08 and expected to be completed by July 2008. The firm's representatives will visit sites and will inspect all systems where the switch has been replaced or adjusted for proper operation of the safety sensor and switch. Two steel bands will be inspected and replaced if any abnormity is noted.In the mean time, consignees should contact Philips Call Center at 800-722-9377, #5, #2 and reference the FCO 70600029 with any questions.",N/A,28,28 units,Nationwide Distribution,Terminated,"September 13, 2010",0,38,Not_Computer,N/A,N/A,N/A
Z-2420-2010,55923,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA)The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.",Stryker Bur Guard REF 2296301,2,"September 13, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,"The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the Nose Cone of the drill. This could result in an injury or burn to the patient and/or user.",DESIGN: Device Design,"Stryker Instruments sent an Urgent Medical Device Recall Notification dated June 10, 2010, to their customers. The letter described the product the problem and the action to be taken by the customers. The customers were instructed to:1) immediately review this recall notification.2) forward this letter and the attached Business Reply Form (BRF) to all affected locations. 3) Immediately check and quarantine any affected product found.4) Destroy all affected product by breaking off at least 3 of the tabs on the bur guard and then dispose of the affected product in normal trash.5) Complete and sign the BRF and fax to Stryker Instruments Regulatory Department, 866-521-2762.NOTE: Upon receipt of the BRF, a replacement bur guard will be sent to the customer's account for each affected bur guard destroyed.For questions regarding this recall please contact Stryker Instruments:1-800-800-4236, ext. 3808jennifer.mars@stryker.com.",Contact the recalling firm for information,10982,10982,"Worldwide Distribution: US AND COUNTRIES OF SCANDINAVIA, AUSTRALIA, CANADA, CHILE, CHINA, BRAZIL, FRANCE, GERMANY, GREECE, SOUTH AFRICA, ITALY, JAPAN, MEXICO, SWITZERLAND, PORTUGAL, SINGAPORE and UK.",Terminated,"April 21, 2011",220,10982,Not_Computer,N/A,N/A,N/A
Z-2407-2010,56145,"enzyme immunoassay, tracrolimus",MLM,Tacrolimus test system.,Clinical Chemistry,Toxicology,510(k),"Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.",Dimension Tacrolimus Flex Reagent Cartridge,2,"September 13, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.",OTHER/UNDETERMINED: Pending,"Siemens issued an ""Urgent Field Safety Notice"" dated June, 2010 to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the TACR Flex reagent lots DC0306, CA0320, DA0334 and GA0348. The letter contains the following instructions: 1) Immediately discontinue use of the affected lots; 2) Discard all remaining inventory of the affected lots; 3) Contact Siemens Healthcare Diagnostics Technical Solutions Center for replacement product; 4) Complete and return the Field Correction Effectiveness Check by fax to 302 631-8467;4) Siemens is recommending that the content of the letter should be discussed with the laboratory director. If unexpectedly low results are obtained on a patient sample, caution should be exercised before decisions regarding therapeutic dosage adjustments are made. As stated in the package insert, ""Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. Also individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made.""Siemens Technical Solutions Center may be contacted at 800-441-9250.",N/A,4580,4580 Cartons,"Worldwide Distribution to USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, LA, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI, and countries of Austria, Belgium, Canary Islands, Egypt, France, Germany, Great Britain, Hungary, Italy, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, United Arab Emirates, Argentina, Brazil, Canada, Columbia, El Salvador, Venezuela, Australia, Hong Kong, India, Japan, Malaysia, New Zealand, South Korea, Singapore, Taiwan and China.",Terminated,"December 16, 2010",94,4580,Not_Computer,N/A,N/A,N/A
Z-2410-2010,55876,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN.This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.","NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS",2,"September 13, 2010", 2010,Zimmer Inc.,The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.,OTHER/UNDETERMINED: Pending,"The firm, Zimmer, Inc., sent an ""URGENT DEVICE CORRECTION"" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.",N/A,68384,"68,384 all products","Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.",Terminated,"March 28, 2011",196,68384,Not_Computer,N/A,N/A,N/A
Z-2422-2010,47477,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.",DigitalDiagnost Xray system,2,"September 14, 2010", 2010,Philips Medical Systems North America Co. Phillips,"When using DICOM print functionality, the printed images may contain data for the wrong patient.",DESIGN: Software Design,"Philips Healthcare issued an ""URGENT PRODUCT CORRECTION "" letter dated March 10, 2008 to their consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Validate that image and patient information are correct on hard copy prints.2) Reprint images that have mixed patient information, and re-check that image and patient information are correct.3) Do not use printed images if the information is incorrect.The firm will issue the Field Change Order (FCO) 71200025 and the field service engineers will visit each consignee and conduct a software upgrade to solves the printing problem. The consignees may contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference ""FCO 71200025"".",N/A,119,119 units,"Nationwide Distribution: including the states of AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI.",Terminated,"September 14, 2010",0,119,Software,Output/Calculation,Software update,Software Update
Z-2421-2010,56422,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA",CELLDYN Sapphire Hematology Analyzer,2,"September 14, 2010", 2010,Abbott Laboratories,"Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.",OTHER/UNDETERMINED: Pending,"Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.",Contact the recalling firm for information,926,926 units,"Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.",Terminated,"May 17, 2011",245,926,Hardware,Output/Calculation,Replace,Remove or Replace
Z-2424-2010,56320,immunohistochemistry reagents and kits,NJT,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(K) Exempt,"NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific",NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4),2,"September 15, 2010", 2010,Lab Vision Corporation,"Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Thermo Fisher Scientific issued an ""Advisory Notice"" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken. Customers were instructed to:1) discard the affected lots, and2) retest specimens using a replacement lot supplied by the firm, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489International distributors were instructed to:1) place the affected lots and replace with a replacement lot supplied by the firm, and 2) provide customers with copies of the customer letter, and3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.",N/A,103,103 units,"Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and Turkey.",Terminated,"March 21, 2011",187,103,Not_Computer,N/A,N/A,N/A
Z-2423-2010,55763,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.",Dimension Vista System,2,"September 15, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens issued an Urgent Field Safety Notice in May 2010 to customers with information on what to do if the battery leaks, overheats, or vents an odor. Firm also issued a Support Bulletin to field service personnel to inspect and replace affected units.",Contact the recalling firm for information,228,228 units,"Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.",Terminated,"October 25, 2010",40,228,Battery,N/A,N/A,N/A
Z-2419-2010,54682,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Vista ECREA Flex Reagent CartridgeThe ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes.",Dimension Vista ECREA Flex Reagent Cartridge,2,"September 16, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",The ECREA test results may be falsely elevated or depressed.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens sent an Urgent Field Safety Notice dated February 2010 to all affected customers. The letter described the product, the problem, and the action to be taken by the customers. The customers were instructed to immediately discontinue the use of and discard the ECREA Flex reagent cartridge lot 09224AA. Customers are to contact their Siemens Customer Service Center at 800-241-0420 to report their additional no-charge replacement needs, and complete and return the enclosed Field Correction Effectiveness Check Form via Fax at 302-631-8467.For any technical questions regarding this Recall contact Siemens Technical Solutions Center at 800-441-9250.",N/A,324,324,"Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands.",Terminated,"October 13, 2010",27,324,Not_Computer,N/A,N/A,N/A
Z-2429-2010,49489,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Edge Nuclear Magnetic Resonance Imaging System. ""1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A."".",Edge 1.5T MRI,2,"September 17, 2010", 2010,Philips Medical Systems North America Co. Phillips,"Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.",OTHER/UNDETERMINED: Pending,"Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference ""FCO 78100232"".",N/A,28,28 units,"Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.",Terminated,"September 17, 2010",0,374,Not_Computer,N/A,N/A,N/A
Z-2426-2010,56564,"bag, stomal",GDS,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes)",Reliamed,3,"September 17, 2010", 2010,BioMed Laboratories,The product may contain the mold Aspergillus ssp.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.",Return product to place of purchase for a full refund Return product to place of purchase for a full refund,33772,"33,772 Units (27,148 8oz bottles. 3,492 4oz bottles. 3,132 1oz bottles).","OH, FL, MI",Terminated,"January 24, 2011",129,72259,Not_Computer,N/A,N/A,N/A
Z-2436-2010,56626,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.",Pleatman Sac Tissue Removal System,2,"September 19, 2010", 2010,"Gyrus Acmi, Incorporated","Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac¶_ Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of th",PRODUCTION CONTROLS: Packaging Process Control,"Gyrus Medical, Inc. of Maple Grove, MN issued an Urgent Medical Device Recall drawing attention to a possible package integrity compromise that could affect the product sterility. USA consignees were contacted via telephone on 8/3/10. The firm directed consignees to inspect their stock to confirm if any of the affected lot of product remains in their possession. Use of remaining affected product should cease immediately. Affected products should be return to Gyrus ACMI. For questions or concerns, consignees should contact the firm at (888) 524-7266.",Contact the recalling firm for information Contact the recalling firm for information,2,2 cases (20 devices),"UT, PA, Canada",Terminated,"August 23, 2012",704,2,Not_Computer,N/A,N/A,N/A
Z-2435-2010,54668,ventilatory effort recorder,MNR,Breathing frequency monitor.,Anesthesiology,Anesthesiology,510(k),The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.,Nasal Cannula Diagnostic Kit,3,"September 19, 2010", 2010,"Ventus Medical, Inc.",The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient .,PRODUCTION CONTROLS: Labeling Mix-Ups,"Ventus Medical, Inc. of Belmont, CA has notified all customers who received distribution from the affected manufacturing lot (1880783) to immediately return the product in question for replacement. If there are any questions regarding this correction, please contact the firm at (650) 632-4165.",Return product to place of purchase for a full refund Return product to place of purchase for a full refund,60,60,Product was distributed in the US through a single distribution supplier.,Terminated,"March 11, 2011",173,60,Not_Computer,N/A,N/A,N/A
Z-2437-2010,53044,"enzyme immunoassay, gentamicin",LCD,Gentamicin test system.,Toxicology,Toxicology,510(k),"SYNCHRON Gentamicin (GEN) ReagentGEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitative determination of Gentamicin concentration in",SYNCHRON Gentamicin (GEN) Reagent,2,"September 20, 2010", 2010,Beckman Coulter Inc.,The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (,OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter dated February 27, 2009 to customers identifying the affected product and issue prompting the recall. The letter asked them to discontinue use and discard the reagent lot, and contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact their local Beckman Coulter Representative to discuss reagent replacement options. They were also asked to complete and return the enclosed response form within 10 days.Customers were directed to call the Customer Support Center (Hotline) at (800) 854-3633 in the US and Canada if they had questions in regards to the PCA letter. Outside the US and Canada they were told to contact their local Beckman Coulter Representative.",N/A,1547,"1,547 Kits","Worldwide Distribution - USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, Belgium, Denmark, France, Germany, Ireland, Lithuania, Netherlands, Spain, Switzerland, United Kingdom, New Zealand, Singapore, Egypt, South Africa, Taiwan, and United Arab Imarets.",Terminated,"July 16, 2012",665,1547,Not_Computer,N/A,N/A,N/A
Z-2441-2010,55163,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Unicel Synchron Clinical SystemsClosed Tube Aliquotter (CTA) for Synchron LXi 725, Part Number: 388982, Domestic; 389695, InternationalThe UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).",Unicel Synchron Clinical Systems,2,"September 20, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated due to "" A loose Aliquot Probe tube fitting in the Closed Tube Aliquotter (CTA), may result in erroneous Access immunoassay results or Synchron chemistry results"".This may result in dilution of the sample with Wash Buffer; patient results can potentially be affected for Access immunoassays or Synchron chemistries. Access Quality Control may also be affected if run throug",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated January 18, 2010, to all affected customers. The letter provided the customer with an explanation of the problem identified, the affected product, and instructions for the customer. The letter requested customers complete the following actions for :(1) CTA Aliquot Probe Inspection and Maintenance:a. Check daily for signs of leaks or damage to the tube fitting by looking and feeling for liquid at the fitting, the end of the probe and the surrounding areas;b. The CTA Aliquot Probe tube fitting should be checked to ensure that it is connected tightly to the Aliquot Probe. Without loosening the tube fitting, ensure it is securely tightened;c. When replacing the CTA Aliquot Probe, ensure that the Aliquot Probe tube fitting is securely tightened, prime the CTA, inspect for leaks, and run Access Quality Control through the CTA;d. If a leaking Aliquot Probe is suspected, review all sample results for both Access and Synchron in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information;e. As this issue may result in dilution of the sample with Wash Buffer; it may be appropriate to discard and redraw any affected sample tubes run on the CTA. The letter also informed customers that Beckman Coulter is currently evaluating potential solutions for this issue and requested they share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected products to another laboratory, they were asked to provide a copy of this letter to them.They were also instructed to complete and return the enclosed response form within 10 days. Customers were told to call Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada with any questions.",N/A,672,672 units for both systems,"Worldwide Distribution - USA: including the states of AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, AND WV and the country of Canada.",Terminated,"August 13, 2012",693,672,Not_Computer,N/A,N/A,N/A
Z-2438-2010,55427,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854","Integrated Data Management System Version 7.1, 7.2 and 7.3;",3,"September 20, 2010", 2010,International Technidyne Corporation,A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients.,DESIGN: Software Design,"ITC sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 10, 2010 to Distributors and First Consignee End Users identifying the affected product and affected summary reports, the reason for recall, and the actions to be taken by the distributors and customers. New Errata Instructions were enclosed with each letter and are to be put in the idms user guide for reference. The new instructions are to be followed when running reports for the ESV or TVT tests run by the Hemochron Response. The enclosed Customer Account Tracking Form is to be completed and returned to ITC indicating that the letter has been received and appropriate questions answered as to the use of the software system. Distributors are asked to check inventory for recalled product. If affected product is found, shipment should be stopped and placed on hold. Distributors should notify customers of the correction and provide them with a copy of the correction letter and updated instructions. This should be done by traceable mail. Distributors should return the account tracking form and return affected software disks for replacement.Questions should be directed to ITC Technical Support at 800-631-5945.",N/A,84,"84 total idms software systems; 66 in US, 18 outside of US.","Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA, TN , TX, UT, VA, WA, and WI, and the countries of Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand.",Terminated,"May 25, 2011",247,84,Software,Output/Calculation,Replace software disks,Software Update
Z-2439-2010,56390,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"TRABECULAR METAL ¶_ FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31.The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.","Zimmer Trabecular Metal"" Femoral Cone Augment",2,"September 20, 2010", 2010,Zimmer Inc.,"Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.",N/A,50,50 total,"Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.",Terminated,"December 22, 2010",93,50,Not_Computer,N/A,N/A,N/A
Z-2446-2010,56183,"electrode, needle, diagnostic electromyograph",IKT,Diagnostic electromyograph needle electrode.,Physical Medicine,Neurology,510(k),"Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.",Disposable Detachable Monopolar Needle Electrode for EMG,2,"September 21, 2010", 2010,Chalgren Enterprises Inc,"Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.",PRODUCTION CONTROLS: Packaging,"Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.",N/A,N/A,N/A,"Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.",Terminated,"March 24, 2011",184,N/A,Not_Computer,N/A,N/A,N/A
Z-2445-2010,56460,"lenses, soft contact, extended wear",LPM,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,PMA,"Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.",ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A),3,"September 21, 2010", 2010,Vistakon,ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper f,PRODUCTION CONTROLS: Error in Labeling,"Vistakon issued an Important Product Notification dated July 28, 2010 to customers identifying the affected product, the labeling issue, and actions to be taken by the customer. Vistakon issued a separate Important Product Notification dated July 28, 2010 to distribuitors identifying the affected product, the labeling issue, and actions to be taken by the distributor. Customers are instructed to check their inventory for affected products and return a business reply card. If replacement -8.50 lenses are needed, the customer can contact Customer Service at 1-800-874-5178.Distributors are instructed to check their inventory for affected products and return them using an enclosed return label. Replacement product will be sent by the firm. Customer Service can be contacted at 1-800-874-5178.Accounts will be instructed to go to their inventory and look for the B006X641, -8.50 lot and open the secondary carton and verify the product inside. If it is the -9.00 product they can keep the product and re-slot it in the proper place within the kit (product is ok, nothing wrong with primary package or lens inside) and order a replacement -8.50 if necessary. Business reply cards will be supplied for accounts to return to third party indicating if they had any mix/mislabeled product.",Contact the recalling firm for information,2123,"2,123 lenses","Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.",Terminated,"March 28, 2011",188,2123,Not_Computer,N/A,N/A,N/A
Z-2447-2010,56327,"patch, pledget and intracardiac, petp, ptfe, polypropylene",DXZ,"Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.",Cardiovascular,Cardiovascular,510(k),"PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis¶_ Surgical Innovations. Intended to be used as a staple line buttress.",PeriStrips Dry Staple Line Reinforcement with Apex Processing (PSD) and PeriStrips Dry with Verita,2,"September 21, 2010", 2010,Synovis Surgical Inovation Div. of,Synovis¶_ Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compromise the sterility of the outside of t,PRODUCTION CONTROLS: Packaging,"Consignees were sent on 6/30/10 a Recall Notification letter dated June 30, 2010. The letter was addressed to ""Risk Manager"". The letter described the problem and product involved. They listed both the device and gel lot numbers since it is possible that some hospitals have separated the pouched gel tubes from the PSD/PSDV products. They advised consignees to quarantine the affected lots and to complete and fax the attached ""Product Return/Replacement"" form to Synovis Surgical Innovations.",N/A,5384,"3,989 gel tubes and 1,395 PSD & PSDV devices.","Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL,IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI and countries of AUSTRALIA, GERMANY, GREECE, HONG KONG, NETHERLANDS, PUERTO RICO, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.",Terminated,"December 17, 2011",452,5384,Not_Computer,N/A,N/A,N/A
Z-2443-2010,56121,"pulse-generator, pacemaker, external",DTE,External pacemaker pulse generator.,Cardiovascular,Cardiovascular,510(k),"Oscor PACE 203H, Dual-Chamber External Pulse GeneratorThe PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.","Oscor PACE 203H, DualChamber External Pulse Generator",2,"September 21, 2010", 2010,Osypka Medical Inc,"The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributorregarding an incompatibility of the PACE 203H with some new types of 9 V batteries.The investigation revealed that PACE 203H of a certain manufacturing period malfunction(i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t",N/A,"OSYPKA Medical sent ""Urgent Medical Device Recall"" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical.If you have any questions call (858) 454-0021 or e-mail to mail@osypkamed.com.",N/A,205,205 units (US Only),Nationwide Distribution: USA including states of CA & FL,Terminated,"August 10, 2012",689,217,Hardware,Device Operation,Return,Remove or Replace
Z-2461-2010,49594,"coil, magnetic resonance, specialty",MOS,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.,Intera 1.5T and 1.5T Achieva MRI systems,2,"September 22, 2010", 2010,Philips Medical Systems North America Co. Phillips,"The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.",OTHER/UNDETERMINED: Pending,"Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers..The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns.The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #3, #1 and reference ""FCO 78100242 - PATIENT CABLE SLEEVE FOR 1.5T SENSE XL TORSO COIL"".",N/A,47,47 units total (Achieva 1.5T and Intera 1.5T),Nationwide Distribution: Throughout USA. No distribution to foreign consignees.,Terminated,"September 30, 2010",8,47,Not_Computer,N/A,N/A,N/A
Z-2464-2010,50066,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),Philips BV Endura Mobile X-Ray system with the extended rotation option.,BV Endura Rel 2,2,"September 22, 2010", 2010,Philips Medical Systems North America Co. Phillips,"The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions.",OTHER/UNDETERMINED: Pending,"Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position.The Philips Call Center can be contacted at 800-722-9377.",N/A,71,71 units,Nationwide Distribution: Throughout the US.,Terminated,"January 07, 2011",107,1420,Not_Computer,N/A,N/A,N/A
Z-2471-2010,50114,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.,Allura XPER 10/10,2,"September 22, 2010", 2010,Philips Medical Systems North America Co. Phillips,A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.,OTHER/UNDETERMINED: Pending,"The firm, Philips, sent ""URGENT-Device Correction"" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display.The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears.The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system.The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.",N/A,70,70 units in US,Worldwide distribution.,Terminated,"August 10, 2011",322,1681,Computer,N/A,N/A,N/A
Z-2465-2010,56179,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC",Spider Flex Monopolar Hook,2,"September 22, 2010", 2010,"Transenterix, INC",The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.,OTHER/UNDETERMINED: Pending,"TransEnterix issued a ""Field Action"" letter dated June 22, 2010 to consignees, identifying the affected product and actions to be taken by the customer. Customers were instructed to return the product to TransEnterix, Inc. using the address label and return information provided. The firm will replace the product at no charge. TransEnterix Customer Care can be contacted at 1-888-879-4111.",N/A,46,46 boxes (6 units per box),"Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.",Terminated,"January 31, 2011",131,46,Not_Computer,N/A,N/A,N/A
Z-2449-2010,56093,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling.The product's brochure is labeled in part: ""Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands"".",BIPLANE XRay Imaging Systems with Velara Generator,2,"September 22, 2010", 2010,Philips Medical Systems North America Co. Phillips,A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.,DESIGN: Software Design,"On 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator.This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.",Contact the recalling firm for information Contact the recalling firm for information,267,267,Nationwide Distribution,Terminated,"September 23, 2011",366,1737,Hardware,Device Operation,Software and Hardware upgrade,Software Update
Z-2425-2010,56190,"instrument, surgical, non-powered",HAO,Nonpowered neurosurgical instrument.,Neurology,Neurology,510(K) Exempt,"Integra NeuroSciences Implants, NeuroBalloon Catheter,Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10",NeuroBalloon,1,"September 22, 2010", 2010,Integra LifeSciences Corp,Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.,DESIGN: Process Design,"All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.",N/A,338,338 units,"Nationwide, Canada, Taiwan and to Integra, Australia.",Terminated,"May 29, 2012",615,338,Not_Computer,N/A,N/A,N/A
Z-2466-2010,56303,"tampon, menstrual, unscented",HEB,Unscented menstrual tampon.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons,Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons,2,"September 22, 2010", 2010,First Quality Hygienic Inc,Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.,PRODUCTION CONTROLS: Labeling Mix-Ups,Consignees were notified via telephone and letter of the need to withdraw product from the market and requested to return all product to manufacturer.,Contact the recalling firm for information,195,195 Cases/2340 Cartons,Canada,Terminated,"October 06, 2010",14,195,Not_Computer,N/A,N/A,N/A
Z-2460-2010,56506,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 100025",2,"September 22, 2010", 2010,Philips Medical Systems (Cleveland) Inc,The gantry covers of the iCT have a latch at the base of the system which holds the cover in the closed position. During the course of maintenance the CT Field Service Engineer (FSE) will activate this latching mechanism which in turn has a potential to penetrate the insulation on cabling which carries 277 VAC. If the latch does come into contact with the cabling there is a potential that the FS,OTHER/UNDETERMINED: Pending,"Philips Healthcare sent an URGENT - Field Safety Notice letter, dated April 14, 2010, to their customers notifying them of the product, the problem, and the action to be taken. The letter asked them to identify the affected product by checking for the serial number tag (s/n 10016 10025), ensure that the electrical power was shut-down before opening or closing the gantry cover to prevent potential of an electrical shock, and that a Field Service Engineer would contact the facility to make arrangements for the implementation of a Field Change Order (FCO) before December to correct the problem. For further information or support concerning this issue, the customer was instructed to contact their Philips representative: Customer Care Center (1-800-722-9377, option 5 or their local Philips Healthcare Office).",N/A,9,9 units,"Worldwide Distribution - USA, including the states: DC, GA, IL, IN, NY and OH; and the countries of Germany and the Netherlands.",Terminated,"September 24, 2012",733,9,Not_Computer,N/A,N/A,N/A
Z-2450-2010,56563,"tubing, noninvasive",GAZ,Vacuum-powered body fluid suction apparatus.,General Hospital,General Hospital,510(K) Exempt,"Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16""), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N56A and NEX56A (European label)",MediVac NonConductive Suction Tube,2,"September 22, 2010", 2010,Cardinal Health,"The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.",OTHER/UNDETERMINED: Pending,"Cardinal Health issued an URGENT: PRODUCT RECALL letter dated August 16, 2010 to consignees, identifying the reason for the recall, the affected lots, and actions to be taken. Cardinal has inspected all packages in their warehouses and removed the affected products. All packages that have been inspected have a 3/4"" green dot on the front of each unit and on the case carton label."" Cardinal Health end users were instructed to segregate and destroy their affected product and request credit or replacement"" Distributor customers were instructed to destroy their product and request credit or replacement"" Distributors were instructed to conduct sub-recalls and return their inventory to Cardinal Health"" To arrange for credit or replacement of the product destroyed, the accounts were instructed to call customer service at 800-964-5227 or 888-444-5440."" All customers were requested to complete the enclosed Recall Acknowledgment Form acknowledging receipt of the letter and the number of tubing units destroyed, and fax it to 847-689-9101.Cardinal Health can be contacted at 800-292-9332.Cardinal sent recall letters dated 8/26/10 to their PreSource kit/module customers via UPS next day air, informing them that the Medi-Vac Non-conductive Suction Tubing listed may have packaging seals that are compromised. The accounts were informed that Cardinal has inspected tubing packages in their warehouses and removed the affected products. All packages that have been inspected will have a 3/4"" green dot on the front of each package. Enclosed with the recall letter were recall labels to affix to each affected Presource pack/module in the account's inventory. These labels instruct the user NOT to use the affected tubing component and to remove and discard the component upon opening the kit. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of packs/modules on hand. Distributo.",N/A,N/A,N/A,"Worldwide Distribution, including USA.",Terminated,"November 28, 2011",432,N/A,Not_Computer,N/A,N/A,N/A
Z-2470-2010,56667,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002",DARTFIRE CANNULATED DRIVER STAR 8 ,2,"September 22, 2010", 2010,Wright Medical Technology Inc,"After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.",N/A,"The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions.",N/A,13,13 units,"TX, PA, TN, VA, GA, and Spain",Terminated,"August 02, 2012",680,13,Not_Computer,N/A,N/A,N/A
Z-2467-2010,56686,"elevator, wheelchair, portable",ING,Wheelchair elevator.,Physical Medicine,Physical Medicine,510(k),"Braun wheelchair lift, model NL, Braun Corporation, Winamac, INA wheelchair lift for motor vehicles.","Braun wheelchair lift, model NL,",2,"September 22, 2010", 2010,The Braun Corporation,The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.,DESIGN: Device Design,"The Braun Corporation issued a Service Bulletin 34273 entitled ""Lift Threshold Sensitivity Bulletin 34273 on October 2007. Braun Corporation also sent a ""Safety Recall"" letter to the Braun lift owner and letters to all customers on or about August 15, 2007. The letters described the product, problem and the action to be taken by the customer. The customers were instructed to notify the National Highway Traffic Safety Administration (NHTSA) and conduct a safety recall if they used recalled lifts as original equipment in a system or vehicle that they built; ensure that any associated customers are notified to discontinue the use of their vehicles until they schedule a repair, and verify the threshold warning system is within the NHTSA specification. The customers were informed to contact the NHTSA with questions by calling the Vehicle Safety Hotline at 1-888-327-4236 or go to http//www.safercar.gov. If they have any problem obtaining the needed repair or wish to schedule service with an approved Braun technician, contact the Braun Corporation Product Support at 1-800-946-7513.",Contact the recalling firm for information,8356,"8,356",Worldwide distribution,Terminated,"May 12, 2011",232,12940,Not_Computer,N/A,N/A,N/A
Z-2482-2010,55360,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"ARCHITECT¶_ i1000SR"" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, ILProduct List Number, Part # or Model: 01L86-01In Vitro Diagnostic use only. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests, utilizing photometry and potentiometric technology, and Immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.","ARCHITECT i1000SR"" Processing Module",2,"September 23, 2010", 2010,"Abbott Laboratories, Inc","During manufacturing, two components of the ARCHITECT i1000SR were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .,Contact the recalling firm for information,404,404 units distributed worldwide (including US),"Worldwide distribution:USA including states of: CO, DC, FL, GA, IL, LA, MA, MN, NY, OH, OK, TX, UT, and WV and countries including: Australia, Brazil, Bogota, Canada, China WFOTC, Columbia, Curacao (NETH ANT), Germany, Hong Kong, Japan, Mexico, Singapore, and Taiwan.",Terminated,"April 13, 2012",568,404,Not_Computer,N/A,N/A,N/A
Z-2480-2010,55911,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI.",Terumo Advanced Perfusion System 1,2,"September 23, 2010", 2010,Terumo Cardiovascular Systems Corporation,"The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM 6 PM EST.",N/A,1340,1340,"Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.",Terminated,"December 20, 2011",453,2655,Not_Computer,N/A,N/A,N/A
Z-2478-2010,56676,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969inhalation anesthesia machine for use in operating, induction and recovery rooms",Fabius GS,2,"September 23, 2010", 2010,"Draeger Medical Systems, Inc.",potential failures to Electri-Cord Manufacturing AC power cord,OTHER/UNDETERMINED: Pending,"Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to:1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear.2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: kathy.benedetto@draeger.com.4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed.NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266.If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).",N/A,1973,up to 1973 products (GS & Tiro),"Worldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela",Terminated,"August 23, 2011",334,1973,Battery,N/A,Replace,Remove or Replace
Z-2462-2010,56560,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"GCX Mountable Downloader-Recharger;(accessory to the i-STAT Portable Clinical Analyzer (model 300).The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or ""arm"" and provide a data connection to an authorized manufacturer's patient monitoring systems.",GCX Mountable DownloaderRecharger;,3,"September 23, 2010", 2010,Abbott Point of Care Inc.,Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.,DESIGN: Device Design,"Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations.The letter identified the product, the issue, and the actions to be taken by the firm and the customers. 1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility.2) Replacement will occur in batches of approximately 50 units at a time.3) Abbott will provide personnel to perform the replacements to help expedite the replacement.4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice.. If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.",N/A,277,277,"Nationwide Distribution - USA, including the state of Indiana",Terminated,"July 25, 2012",671,277,Not_Computer,N/A,N/A,N/A
Z-2484-2010,56498,"pump, breast, powered",HGX,Powered breast pump.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67116S",Medela Symphony & Lactina Double Pumping Kit (Sterile),2,"September 24, 2010", 2010,Medela Inc,The product sterility may be compromised due to possible pinholes in the rigid tray of the package.,PRODUCTION CONTROLS: Packaging,"Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amount of product being returned. Distributors were requested to notify their customers. Questions about the recall process may be directed to Stericycle at 1-877-247-9970. Information on the recall is posted on Medela's website www.medelabreastfeedingus.com.",N/A,2030390,"2,030,390 kits","Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda.",Terminated,"September 07, 2011",348,6924825,Not_Computer,N/A,N/A,N/A
Z-2487-2010,56423,N/A,N/A,N/A,N/A,N/A,N/A,"Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.",Wally's Ear Candles,2,"September 24, 2010", 2010,Wally's Natural Products,"Product is an unapproved medical device. Use as directed may result in accidental damage to the eardrum, leading to injuries up to loss of hearing.",OTHER/UNDETERMINED: Pending,"The firm conducted communications via phone, mail and website, stating that they have stopped manufacturing and distributing ear candles, and asks consumers to return for a refund.",N/A,N/A,Not Specified. All,Nationwide Distribution,Terminated,"March 28, 2011",185,N/A,Not_Computer,N/A,N/A,N/A
Z-2501-2010,54745,"kit, test, pregnancy, hcg, over the counter",LCX,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.,UCG BetaSlide Monoclonal II,3,"September 25, 2010", 2010,Inverness Medical Professional Diagnostics,Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.,OTHER/UNDETERMINED: Pending,"The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.",Contact the recalling firm for information Contact the recalling firm for information,585,585 kits,Distributed Nationwide and to Australia,Terminated,"May 14, 2012",597,1637,Not_Computer,N/A,N/A,N/A
Z-2503-2010,56441,"blade, saw, general & plastic surgery, surgical",GFA,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.","ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter",2,"September 25, 2010", 2010,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier.",PRODUCTION CONTROLS: Packaging Process Control,"Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures. 100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.",Discard product or return to place of purchase for a full refund or exchange Discard product or return to place of purchase for a full refund or exchange,174,174,"Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.",Terminated,"December 14, 2010",80,174,Not_Computer,N/A,N/A,N/A
Z-2499-2010,56406,immunohistochemistry reagents and kits,NJT,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(K) Exempt,"Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue culture supernatant in a 1 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of thyroid transcription factor-1 molecules in paraffin-embedded tissue by immunohistochemical staining; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom; Catalog No.: NCL-L-TTF-1",Novocastra Thyroid Transcription Factor1 (liquid),2,"September 25, 2010", 2010,"Leica Microsystems, Inc.","In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the instructions for use.",DESIGN: Device Design,"Leica Microsystems sent Medical Device Field Correction letters dated 7/28/10 to the affected customers via first class mail on the same date, informing them that in combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the Instructions for Use. Currently they state that lung and thyroid tumors may stain, but Leicas investigation further characterized the expression of the TTF-1 antigen and it may also be present in other tumors, e.g. thymomas. Customers who have received the affected lot numbers of the three products were requested to refer to the new Instructions for Use to review the amendments made to the Results Expected via the following links: http://bsd.leica-microsystems.com/pdfs/products/ttf-1-ce.pdf; http://bsd.leica-microsystems.com/pdfs/products/ttf-1-l-ce.pdf; and http://bsd.leica-microsystems.com/pdfs/products/pa0364.pdf; The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.",Contact the recalling firm for information Contact the recalling firm for information,860,860 units Total for all three products,Nationwide and Canada,Terminated,"January 29, 2012",491,860,Not_Computer,N/A,N/A,N/A
Z-2502-2010,56418,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079","GreenLight HPS Fiber Optics, Model Number 102090",2,"September 25, 2010", 2010,AMS Innovative Center - San Jose,Product may be packed with incorrect external or internal labels and/or missing product insert.,PRODUCTION CONTROLS: Labeling Mix-Ups,Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.,Contact the recalling firm for information Contact the recalling firm for information,11668,11668 units,"Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.",Terminated,"January 25, 2011",122,11668,Not_Computer,N/A,N/A,N/A
Z-2495-2010,56363,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),Femoral Artery Catheterization Set,Femoral Artery Catheterization Set,2,"September 25, 2010", 2010,Arrow International Inc,Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.,Contact the recalling firm for information Contact the recalling firm for information,19,19,"The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.",Terminated,"July 05, 2012",649,113,Not_Computer,N/A,N/A,N/A
Z-2504-2010,56591,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Modular Microplasty Cup inserter 3/8"" thread , REF 31-400600","Modular Microplasty Cup inserter 3/8"" thread ",2,"September 25, 2010", 2010,"Biomet, Inc.","There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of ""music wire"" The recalling frim conducted tests to determine the effects of theis change in materials. The testing showed that the wire would oxidize and there would be early failure of the device.",TRAINING: Employee Error,The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.,Contact the recalling firm for information Contact the recalling firm for information,331,331 total for both products,"US, Australia, Canada, Mexico, Chile, Japan.",Terminated,"October 01, 2012",737,331,Not_Computer,N/A,N/A,N/A
Z-2582-2010,49599,"suture, surgical, absorbable, polydioxanone",NEW,Absorbable polydioxanone surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Product is labeled in part: ""CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30"" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA"".Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.","MonoDox Synthetic Absorbable Suture, Sterile",2,"September 27, 2010", 2010,C P Medical,Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"On 09/17/2008, the firm's Sale Representative began using the Telephone Script and calling all their customers.On 09/19/2008, the firm began sending the Recall Notice, dated 9/17/2008, letter to their customers. The letter states that the recalled product is Polydioxanone Suture, Code M397, Lot Number L0535440, Expiration Date: November 2009.The customers are advised to discontinue selling this product and return any existing stock to CP Medical. The firm also requests their consignees to notify their sub-accounts about this recall notice if the product is further distributed.The customers are instructed to provide return all accounted quantity and provide quantify information and location of any product that they are unable to recover for accountability purposes. Customers could contact CP Medical Customer Service Representative at 1-800-950-2763 for return goods authorization number and shipping account number.",N/A,1696,"1684/12 pcs. Boxes (1628/12 pcs. Boxes to veterinary market, 56/12 pcs. Boxes to human suture market)","Worldwide Distribution -- US, Australia, and Taiwan.",Terminated,"September 28, 2010",1,1684,Not_Computer,N/A,N/A,N/A
Z-2584-2010,56379,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"WECK IMA/ENT Blade Electrode ¶_ (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NCThe blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.",IMA/ENT Blade Electrode,2,"September 27, 2010", 2010,Telefelx Medical,Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.,N/A,"Teleflex Medical sent an ""Urgent Medical Device Recall"" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately four to six seeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly.If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.",N/A,190344,"190,344 eaches","Worldwide distribution: USA and countries of Canada, Australia and Singapore.",Terminated,"April 21, 2011",206,190344,Not_Computer,N/A,N/A,N/A
Z-2579-2010,56199,"defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)",NIK,N/A,N/A,Cardiovascular,N/A,"Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770.Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy",Paradym Defibrillators,2,"September 27, 2010", 2010,ela Medical Llc,"The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events.",DESIGN: Software Design,"Sorin Group issued a ""Medical Device Correction"" letter dated June 7, 2010 to consignees. The letter described the product, the problem, and actions to be taken by customers. A Sorin Group representative will contact customers to update the software. Prior to receiving the software update, customers should program the exercise AV delay to 40 ms, which will trigger a reset in the event of an anomaly. This will restore normal operation after shock delivery. If the anolmaly occurs on an implanted unit, a RV coil or SVC coil continuity test should be started, which will ensure that the device recovers proper operation.Corin Group can be contacted at 1-615-788-1807.",Contact the recalling firm for information,215,215,"Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA.",Terminated,"March 29, 2012",549,215,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2580-2010,56046,"surgical device, for ablation of cardiac tissue",OCL,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,Cardiovascular,510(k),"Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA",Cardima Surgical Ablation Probe (SAP) ,2,"September 27, 2010", 2010,Cardima Inc,"Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.",N/A,"Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available.Cardima Customer Service can be contacted at 800 354-0102.",Contact the recalling firm for information,28,28 units,"Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.",Terminated,"March 23, 2011",177,28,Not_Computer,N/A,N/A,N/A
Z-2585-2010,54561,"expander, surgical, skin graft",FZW,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.",Grafix Tendon Stripper,2,"September 28, 2010", 2010,Linvatec Corp. dba ConMed Linvatec,There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Recall Notification Letters were sent to customers on January 29, 2010. Customers were requested to complete and return a Customer Response Form indicating the number of products available for return and number distributed. Each distributor was asked to notifiy their customers if the product was further distributed.",Contact the recalling firm for information Contact the recalling firm for information,149,149,"Distributed throughout U.S. and Internationally to Arab Emirates, Belgium, Canada, China, Columbia, Cyprus, Germany, Denmark, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Republic of Korea, Lithuania, Morocco, Malaysia, Poland, Portugal, Saudi Arabia, El Salvador, Thailand, Taiwan and Viet Nam. Domestic Distribution to CA, FL, GA, IL, IN, KS, MI, MT, NY, OH, PA, TX, and WA.",Terminated,"January 12, 2011",106,149,Not_Computer,N/A,N/A,N/A
Z-2588-2010,55708,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter;Sterile, Rx only.Manufactured by Integra NeuroSciences Implants S.A.,Sophia Antipolis Cedex, France;distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538;This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.",Integra Suction Reservoir with AntiReflux Valve,2,"September 28, 2010", 2010,Integra LifeSciences Corp.,"The sterility of the product may be compromised. Integra LifeSciences Corp. received a recall notification from Saint-Gobain Performance Plastics, France, contract manufacturer of the Integra Suction Reservoir with Anti-Reflux Valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.",N/A,"Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached ""Recall Acknowledgement. and Return Form"" Integra LIfeSciences can be contacted at 609-936-2495.",N/A,313,313 units,"Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka.",Terminated,"August 27, 2012",699,313,Not_Computer,N/A,N/A,N/A
Z-2609-2010,56160,negative pressure wound therapy powered suction pump,OMP,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy,Engenex Non Acute Care Suction Cup,2,"September 28, 2010", 2010,Convatec Inc.,Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.,DESIGN: Component Design/Selection,"Recall notification letters were sent to 46 customers, acute care facilities and durable medical device distributors on July 9, 2010, by Federal Express.",Contact the recalling firm for information Contact the recalling firm for information,1190,1190 units,Nationwide distribution.,Terminated,"June 07, 2011",252,1190,Not_Computer,N/A,N/A,N/A
Z-2587-2010,56507,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Stryker Zoom Critical Care Bed, Model 2040. Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed.",Stryker Zoom Critical Care Bed,2,"September 28, 2010", 2010,Stryker Medical Div. of Stryker Corporation,"The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Stryker Medical sent an Urgent Medical Device Alert letter dated May 14, 2010 to their customers. The letter identified the product, the problem, and the actions customers should take. The letter instructed users to do the following:"" Return the postcard included with the letter to confirm receipt of the notification."" Locate the recalled beds, verify the Fowler mechanism is functioning properly and does not display uneven motion when raising and lowering, and is not unusually noisy. "" If the Fowler mechanism is not operating correctly, they were to call Stryker at 1-800-STRYKER, option 1, Reference RA-2010-014 to obtain service for the bed. "" If any beds have been loaned or sold, the customer is to forward a copy of the notice to the new users and advise the firm of the new location."" Provide the firm with the serial numbers for any beds that were disposed of."" Retain the revised maintenance manual included with the notification.If the customer had any urgent questions or concerns, they were instructed to call the firm at 800-STRYKER, option 1, reference RA-2010-014, Monday-Friday 8am to 5pm (EST).",No consumer action necessary,4926,"4,926","Worldwide Distribution - USA (all states), and including the countries of ARGENTINA, BRAZIL, CHILE, CHINA, CANADA, MEXICO, GREECE, JAPAN, KOREA, PUERTO RICO, SPAIN, POLAND, TAIWAN, SINGAPORE, INDIA, SWITZERLAND, UK and MALAYSIA.",Terminated,"June 13, 2011",258,14060,Not_Computer,N/A,N/A,N/A
Z-2589-2010,56543,"dressing, wound and burn, interactive",MGR,N/A,N/A,General & Plastic Surgery,N/A,"Apligraf is supplied as a living, bi-layered skin substitute.Article Number: GS100Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.",Organogenesis Apligraf,2,"September 28, 2010", 2010,"Organogenesis, Inc.",Product is contaminated with a yeast identified as Pseudozyma antarctica.,PRODUCTION CONTROLS: Process Control,"Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.",N/A,32,32 units,"Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.",Terminated,"March 10, 2011",163,32,Not_Computer,N/A,N/A,N/A
Z-2608-2010,56709,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length,",Langston Dual Lumen Catheters,2,"September 28, 2010", 2010,"Vascular Solutions, Inc.","Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723.Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib",PRODUCTION CONTROLS: Process Control,"Consignees were sent on 9/2/10, a Vascular Solutions ""Urgent Medical Device Field Action"" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.",Contact the recalling firm for information,1128,"1,128 boxes ( 5pk)","AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY.SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.",Terminated,"April 24, 2012",574,1128,Not_Computer,N/A,N/A,N/A
Z-2601-2010,56522,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.Usage: Bone Coring Device used in ACL and PCL procedures.",Disposable Dowel Harvest Tube,2,"September 28, 2010", 2010,"Biomet, Inc.",The affected instruments are discolored and/or have a sticky residue on the end.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"The firm sent out ""Urgent Medical Device Recall"" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product.Questions relating to this recall should be directed to 574-371-3755.",N/A,35,35,"US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.",Terminated,"August 20, 2012",692,701,Not_Computer,N/A,N/A,N/A
Z-2591-2010,56695,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.",PainPump2,2,"September 28, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product.On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year -so the recall was for all product currently in the supply chain. The letter again directed consignees to locate the recalled products and contact Stryker to arrange return shipment of the recalled product. The firm sent an additional letter dated 9/1/2010 to its customers. This letter stated that Stryker will no longer be offering any of their PainPump2 products.",Contact the recalling firm for information,54568,"54,568 all products","Worldwide Distribution -- US, Canada, and Australia.",Terminated,"April 21, 2011",205,54568,Not_Computer,N/A,N/A,N/A
Z-2607-2010,56485,"radioimmunoassay, human growth hormone",CFL,Human growth hormone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"IGFBP-3 Immunoradiometric Assay (IRMA) Kit, PartNumber: DSL-6600usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.",IGFBP3 IRMA Kit,2,"September 28, 2010", 2010,Beckman Coulter Inc.,The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurementsusing IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels ofIGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF,N/A,"The recall communication was initiated with a Product Corrective Action (PCA) letter that was sent on August 09, 2010 to allcustomers who received the IGFBP-3 IRMA kits, lot numbers referenced. The letter will provide the customers with an explanation of the problem identified and an action to be taken.Customers were instructed to:(1) Discontinue using all lots identified above and discard in accordance withlocal regulations.(2) To continue testing for IGFBP-3 levels, find an alternate method.(3) Immediately notify all parties of interest (e.g., laboratory staff, clinicians) ofthe possibility of erroneously elevated IGFBP-3 results for patient samples tested with these lots, and advise all parties that clinical decision making and patient safety may be impacted.(4) Review patient IGFBP-3 results for the lots listed above, and interpret them in the light of additional tests (e.g., IGF-1) and the patient's clinical status and history.Customers were also asked to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For any questions regarding this notification, customers were to contact the DSLTechnical Support Center at 1-800-231-7970 option 4 in the United States, or contact your local Beckman Coulter Representative.",N/A,63,63,Nationwide in US and Canada,Terminated,"August 13, 2012",685,63,Not_Computer,N/A,N/A,N/A
Z-2596-2010,56366,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UKThe Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.",MODEL P8400 HANDLE,2,"September 28, 2010", 2010,Hemostatix Medical Technologies LLC,Lack of sterility assurance,OTHER/UNDETERMINED: Pending,"On July 27, 2010, the firm, Hemostatix Medical Technologies, LLC, notified their international distributor in Japan of the recall by email. Hemostatix sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated July 29, 2010, to U.S. customers delivered via FedEx Priority Overnight. All non-responding customers were to be notified by telephone after 2 weeks. The other international customer, Italy, were to be notified by email on July 30, 2010. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately check their inventory and remove any affected product found; ensure that satellite facilities/clinics receive the recall notice; complete and return the Recall Response Form via fax to Hemostatix's international fax number at 901-261-0017, and contact the Customer Care Department's recall hotline at 901-261-0012 for further instructions, if they do have affected stock.If you have any questions or concerns, please feel free to contact our Customer Care Department at: 1-800-722-5735 in the USA or 1-901-261-0012 outside the USA.",Contact the recalling firm for information,40,40 units,"Worldwide distribution: USA including CA, GA, LA, MA, MD, MO, NC, OH, OR, PA, SC, TX, VA, and WI; and countries of Japan and Italy.",Terminated,"November 29, 2010",62,259,Not_Computer,N/A,N/A,N/A
Z-2606-2010,56322,"pump, blood, cardiopulmonary bypass, non-roller type",KFM,Nonroller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. CV-164275 is an item number for product that is sold to foreign affiliate.Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.",Sarns Centrifugal Pump with XCoating,2,"September 28, 2010", 2010,Terumo Cardiovascular Corporation,Medical device component may malfunction and require user intervention during surgical bypass procedures.,OTHER/UNDETERMINED: Pending,"The recalling firm notified end users, perfusion groups, and distributors by phone, fax, email and mail on 03/15/10 to advise of the required recall actions with instructions for labeling and returning the involved product from the customer level. The firm expanded their recall to include additional lots on 05/17/10. If you have any questions, please contact Customer Service at 800-521-2818.",Contact the recalling firm for information,28257,28257 pumps,The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.,Terminated,"November 04, 2011",402,28257,Not_Computer,N/A,N/A,N/A
Z-2624-2010,50095,"prosthesis, knee, femorotibial, constrained, cemented, metal/polymer",KRO,Knee joint femorotibial metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"GMRS Extension Piece, 60 mm; SterileStryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland.The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.",Global Modular Replacement System (GMRS) Extension Piece 60 mm,2,"September 29, 2010", 2010,Stryker Howmedica Osteonics Corp.,"Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Stryker issued Important Market WIthdrawal letters dated May 5, 2005 to customers and distributors. The letters identified the affected product, the labeling issue, and actions to be taken by the customer or distributor. Customers were instructed to identify and quarantine affected product, which will be reconciled and returned by the Stryker sales representative. Distributors were instructed to identify affected product, reconcile all product on an attached Product Accountability Form to be faxed to Stryker at 201 831-4825 within two days of receipt of the letter. The affected product was to be returned using the enclosed pre-paid mailing label. Contact the Stryker sales representative to re-order product that is being returned.Stryker can be contacted at 201 831-5825.",N/A,5,5 units,"Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G",Terminated,"October 01, 2010",2,5,Not_Computer,N/A,N/A,N/A
Z-2618-2010,54617,"wheelchair, powered",ITI,Powered wheelchair.,Physical Medicine,Physical Medicine,510(k),Jazzy Select with XLR Port Harness,Jazzy Select with XLR Port Harness,2,"September 29, 2010", 2010,Pride Mobility Products Corp,Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.,OTHER/UNDETERMINED: Pending,"The recalling firm issued recall notifications with response cards to their dealers. Included with the notification was fasteners and an example letter for customer notification of the problem. Dealers were instructed to contact the end users to make arrangements with the customer/end user to verify that the devices were properly set up. If the dealers' inspection revealed that additional fasteners were required they dealer would install them. The recalling firm also issued a recall letter to consumers. The consumer recall letter included instructions that if the correction was completed by anyone other than the wheelchair provider, then the consumer should schedule an appointment with the wheelchair provider to ensure the correction was completed properly.",N/A,N/A,N/A,"The product was shipped to dealers nationwide who further shipped the product to end users. The product was also shipped to distributors in Canada, Australia and United Kingdom",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-2620-2010,55188,"radioimmunoassay, progesterone",JLS,Progesterone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Immunoassay Systems PROGESTERONE, Part Number: 33550",Access Immunoassay Systems PROGESTERONE,2,"September 29, 2010", 2010,Beckman Coulter Inc.,The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I,OTHER/UNDETERMINED: Pending,"Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed :(1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828;(3) Outside of the United States and Canada, contact your local Beckman Coulter Representative.If consignees need assistance or have any questions regarding this notification, they were instructed to contact TechnicalSupport at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.",Contact the recalling firm for information,6412,6412,United States & Canada,Terminated,"April 19, 2012",568,13694,Not_Computer,N/A,N/A,N/A
Z-2622-2010,56110,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.",Stryker Scope Warmer,2,"September 29, 2010", 2010,Stryker Endoscopy,Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.,PRODUCTION CONTROLS: Process Control,"Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed ""acknowledgement of receipt"" and fax to (408) 754-8278.Stryker can be contacted at 800-624-4422.",N/A,191855,191855 units,"Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.",Terminated,"December 16, 2010",78,191855,Not_Computer,N/A,N/A,N/A
Z-2548-2010,56548,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"All Med Medical 22ga x 1"" Straight Hub NeedleModel #M2215HSReorder #55-2235Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.","All Med Medical 22ga x 1"" Straight Hub Needle",1,"September 29, 2010", 2010,"Multi-Med, Inc.",Huber needles may core and result in port leakage or emboli being flushed our of the port.,DESIGN: Device Design,Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.,N/A,494,494 units,Worldwide Distribution -- USA and Mexico.,Terminated,"January 31, 2013",855,546873,Not_Computer,N/A,N/A,N/A
Z-2623-2010,56261,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.8 cm x 8 cmPackaged in an inner foil pouch inside outer foil pouch tertiary carton.LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.",Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement,3,"September 29, 2010", 2010,LifeCell Corporation,Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.,N/A,"LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433.Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.",Contact the recalling firm for information,32,32 units,"Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.",Terminated,"October 01, 2010",2,32,Not_Computer,N/A,N/A,N/A
Z-2633-2010,56505,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Anti-Siphon Valve, Pump Yellow Striped Tubing-SL, 95 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 20635-01",Gemstar Pump Set with Convertible Pin,2,"September 29, 2010", 2010,Hospira Inc.,Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Hospira issued Urgent Device Recall letters dated August 12, 2010 to Hospira's direct accounts, informing them of the potential for under delivery under low rate settings using the affected lots of pump sets. The accounts were instructed to examine their inventory for the affected product, quarantine it immediately, and complete the attached reply form indicating the amount of product being returned, faxing it to Stericycle at 1-877-523-9110. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. Accounts may contact Hospira Customer Care at 1-877-946-7747 or their Hospira Account Manager to obtain replacement product. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187. Customers may contact Stericycle, which is managing this recall, at 877-274-7163 for further information concerning this recall.",N/A,71016,"71,016 sets","Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.",Terminated,"June 21, 2012",631,340728,Not_Computer,N/A,N/A,N/A
Z-2625-2010,56646,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Philips M3002A IntelliVue X2Model: 865039Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities",Philips M3002A IntelliVue X2,2,"September 29, 2010", 2010,Philips Healthcare Inc.,"Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.",DESIGN: Process Design,"Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks.Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the ""Speaker Malfunct."" INOP at power-up.If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative at 1-800-722-9377.",Contact the recalling firm for information,19400,"19,400 units",Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LIBYAN ARAB JAMAHIRI LITHUANIA MALAYSIA MAURITIUS MEXICO MOROCCO NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PARAGUAY POLAND PORTUGAL QATAR ROMANIA RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN THAILAND TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN and VIET NAM,Open,N/A,N/A,22232,I/O,Alarm/Message,Replace,Remove or Replace
Z-2617-2010,56413,"heat-exchanger, cardiopulmonary bypass",DTR,Cardiopulmonary bypass heat exchanger.,Cardiovascular,Cardiovascular,510(k),"Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03",Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation,2,"September 29, 2010", 2010,Terumo Cardiovascular Corporation,Medical device vent port may be occluded and prevent delivery of priming fluid.,PRODUCTION CONTROLS: Equipment Maintenance,"Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.",Contact the recalling firm for information,60,60 kits,The products were distributed nationwide.,Terminated,"February 29, 2012",518,3979,Not_Computer,N/A,N/A,N/A
Z-2590-2010,55173,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Softwareversion: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)","Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems",2,"September 30, 2010", 2010,Beckman Coulter Inc.,"Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take.Customers were instructed to:if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02.Complete and return the enclosed response form within 10 days of the notice.Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them.Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634.",No consumer action necessary,22,22,"Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI",Terminated,"July 02, 2012",641,22,Software,Output/Calculation,Software update,Software Update
Z-2634-2010,55680,"test, urine leukocyte",LJX,Leukocyte peroxidase test.,Hematology,Hematology,510(K) Exempt,"Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.",DiaScreen Reagent Strips,3,"September 30, 2010", 2010,ARKRAY USA INC.,This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on,MISBRANDING: Labeling False and Misleading,"Distributors were sent a Arkray ""URGENT: Voluntary Medical Device RECALL "" letter dated March 24, 2010. The letter described the problem and the product being recalled. The letter requested the distributors to immediately examine their inventory , quarantine and return the product subject to the recall. If the distributors had further distributed the recalled product, then they were requested to notify the customers of the recall. Arkray enclosed a customer recall letter that the distributors were to use for notifying their customers.Distributors were also contacted by phone on March 24, 2010, and were informed of the recall issue, the product involved, instructed to quarantine the product and to notify their customers.",Contact the recalling firm for information,5504,5504,"FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, ILISRAEL",Terminated,"March 08, 2012",525,5504,Not_Computer,N/A,N/A,N/A
Z-2653-2010,56247,"igg, antigen, antiserum, control",DEW,"Immunoglobulins A, G, M, D, and E immunological test system.",Immunology,Immunology,510(k),"SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920",SYNCHRON System(s) Immunoglobulin A (IgA) Reagent,2,"September 30, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M902345. Using these reagent lots, some samples deficient in IgA have yielded results in the normal range.Other samples with normal levels of IgA have yielded falsely high results.",OTHER/UNDETERMINED: Pending,"A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent.Customers were instructed to:(1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options.(2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent.(3) Please complete and return the enclosed response form within 10 days so that we may maintain our records.Customers were also instructed to share this information with your laboratory staff and retain this notification as part of yourQuality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in theUnited States and Canada.",N/A,852,852 units,US Nationwide & Canada,Terminated,"July 31, 2012",670,852,Not_Computer,N/A,N/A,N/A
Z-2636-2010,56220,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots.Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate",Glenoid Head Inserter (RSP Inserter/Impactor),2,"September 30, 2010", 2010,"Encore Medical, Lp",Complaints indicate product's distal threaded tip may fracture under certain circumstances.,DESIGN: Device Design,"DJO Surgical sent an ""Urgent Field Safety Notice"" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to: Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit. Complete and return the Field Safety Notice Response to the firm. Identify and inform any customers who were sold or received the product of the Field Safety Notice Any questions consignees should call the firm at (512) 834-6330.",Contact the recalling firm for information,104,104,"Worldwide Distribution - USA, including the states of AR, AZ, CA, FL, GA, ID, IL, IN, LA, MA, ME, MI, MO, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, and WI; and the countries of Puerto Rico, Germany, and Saudi Arabia.",Terminated,"June 30, 2011",273,104,Not_Computer,N/A,N/A,N/A
Z-2651-2010,56304,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GYRUS ACMI, dissector PlasmaKnife"" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK","GYRUS ACMI, dissector PlasmaKnife ",2,"September 30, 2010", 2010,"Gyrus Acmi, Incorporated",Lack of sterility assurance due to compromised package seals.,PRODUCTION CONTROLS: Packaging,The firm initiated their recall to their direct accounts by Priority Mail with delivery confirmation on 08/06/2010. The letter requested return of the product and was extended to the retail level.,N/A,4244,4244 units,"WorldwideIn the United States: AL, AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and the District of Columbia. Foreign: UK, TAIWAN, SOUTH KOREA, GERMANY, CANADA, AUSTRALIA, SPAIN, ITALY, ISRAEL, NORWAY, LITHUANIA, SWEDEN, SWITZERLAND, SAUDI ARABIA, TURKEY, and GREAT BRITAIN",Terminated,"January 26, 2012",483,4244,Not_Computer,N/A,N/A,N/A
Z-2637-2010,56463,"instrument, ultrasonic surgical",LFL,N/A,N/A,General & Plastic Surgery,510(k),"Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator SystemCUSANXT1:Latex Free, Rx only:Integra LifeSciences (Ireland) Limited,County Offaly, Ireland;Distributed by Integra Life Sciences Corporation311 Enterprise DrivePlainsboro, NJ 08536.",CUSA NXT Ultra Surgical Aspirator System,2,"September 30, 2010", 2010,Integra LifeSciences Corp.,"A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention.",DESIGN: Component Design/Selection,"Integra issued Urgent: Product Recall Notification letters dated July 29, 2010 to all customers on July 29, 2010 identifying the affected products, issue prompting the recall, and actions to be taken by the customer. Letters were also forwarded to all Integra Account Reps.Customers were advised to discontinue use of and quarantine the affected service modules. The Surgical Aspirator may be operated without the Service Module, utilizing the hospitals wall aspiration. Company representatives will contact customers to arrange product return and repair of the affected service modules. Customers are to complete and return an enclosed Recall Acknowledgement and Return Form . The firm can be contacted at 609 936-2485.",N/A,26,"26 in US, 8 in Europe and 1 in Asia (both unit types.","Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.",Terminated,"May 15, 2012",593,26,Not_Computer,N/A,N/A,N/A
Z-2635-2010,56292,"laparoscope, general & plastic surgery, reprocessed",NLM,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Enseal¶_ TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05",EnSeal TRIO,2,"September 30, 2010", 2010,Ethicon Endo-Surgery Inc,"The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.",N/A,"Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees.Consignees were instructed:Do not use the affected product.Identify and quarantine affected product from inventory.Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three daysTo return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.",Contact the recalling firm for information,396,396 instruments,"Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.",Terminated,"February 14, 2011",137,396,Not_Computer,N/A,N/A,N/A
Z-2641-2010,56188,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.",CardioChek PTS Panels CHOLHDLGLU,2,"September 30, 2010", 2010,"Polymer Technology Systems, Inc.","The test strips appear to under-recover Cholesterol, HDL and glucose.",OTHER/UNDETERMINED: Pending,"Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .",N/A,5805,5805,"US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.",Terminated,"May 11, 2011",223,5805,Not_Computer,N/A,N/A,N/A
Z-2652-2010,56481,"laser, ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(k),"Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO",Endo Ocular Directional Laser Probe,2,"September 30, 2010", 2010,"Lumenis, Inc.",Firm did not have proper 510(K) clearance.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.",No consumer action necessary,250,"250 probes (25 boxes, each containing 10 probes)","FL, IL, MD, CO and TX",Terminated,"October 05, 2010",5,250,Not_Computer,N/A,N/A,N/A
Z-2654-2010,49387,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: ""MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021"".",LAP Surgical Transducer,2,"October 01, 2010", 2010,"Sonosite, Inc.",Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.,PRODUCTION CONTROLS: Process Control,"On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer.The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its ""Advanced"" cycle and the potential damage from the use of ""normal"" cycle is being evaluated by the firm.Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall.",N/A,16,16 units,"Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.",Terminated,"October 05, 2010",4,54,Not_Computer,N/A,N/A,N/A
Z-2639-2010,54382,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.",One Touch Ultra Test Strips,2,"October 01, 2010", 2010,Lifescan Inc,"One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.",N/A,9631,"9631 cartons, 4 vials per carton","Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.",Terminated,"March 14, 2011",164,9631,Not_Computer,N/A,N/A,N/A
Z-2658-2010,55196,"radioimmunoassay, free thyroxine",CEC,Free thyroxine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems Free T4, Part Number: 33880",Access Free T4 Assay,2,"October 01, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.",OTHER/UNDETERMINED: Pending,"A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled asVitamin B12 Lot 916277.The PCA requested customers:(1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packslabeled as Access Vitamin B12, lot 916277;(2) Inspect your Access Free T4 reagent kit inventory for any reagent packs labeled as Access Vitamin B12, lot 916277 and discard any reagent packs labeled as Access Vitamin B12, lot916277; (3) Review your historical quality control to ensure that assay performance for Access Vitamin B12 lot 916277 has been within your laboratory specifications.In addition customers were instructed to share this information with their laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that you have received this important notification.If customers need assistance or have any questions regarding the notification, they were instructed to contact Customer Technical Support Center at 1-800-854-3633 in the United States and Canada.",Contact the recalling firm for information,10826,10826,Nationwide In the US & Canada,Terminated,"May 07, 2012",584,10826,Not_Computer,N/A,N/A,N/A
Z-2657-2010,56565,"sleeve, limb, compressible",JOW,Compressible limb sleeve.,Cardiovascular,Cardiovascular,510(k),"AVI Sterile Impad Rigid Sole Foot Cover, Left FootProduct Code:6067",Sterile ImPad Rigid Sole Foot Cover,2,"October 01, 2010", 2010,Covidien LP,Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any questions please contact, Covidien Customer Service at (800) 962-9888, Option 1.",N/A,1436,1436 units (359 cases),Nationwide,Terminated,"June 12, 2012",620,3420,Not_Computer,N/A,N/A,N/A
Z-2642-2010,56593,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment),Olympus VISERA OTVS7V Camera Head,2,"October 01, 2010", 2010,Olympus America Inc.,Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.,PRODUCTION CONTROLS: Labeling Mix-Ups,Asked consignees to return camera heads to correct the labeling.,N/A,217,217 camera heads,nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe,Terminated,"September 27, 2012",727,217,Not_Computer,N/A,N/A,N/A
z-2640-2010,56652,"instrument, ultrasonic surgical",LFL,N/A,N/A,General & Plastic Surgery,510(k),"Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.",N/A,2,"October 01, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode.,N/A,The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board.,N/A,1161,1161,Wordwide,Terminated,"October 19, 2011",383,1161,Not_Computer,N/A,N/A,N/A
Z-0004-2011,56411,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements,AortaScan AMI 9700 ,2,"October 04, 2010", 2010,"Verathon, Inc.",The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.,DESIGN: Software Design,"Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to:""Add the enclosed addendum to their current Users Manual.""Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 orcservice@verathon.com.",N/A,73,73 units,"Worldwide Distribution - USA and the countries of Australia, Canada, China, Columbia, European Union, United Kingdom, Saudi Arabia, and Singapore.",Terminated,"September 08, 2011",339,684,Software,Device Operation,Instructions for reset/Software update,Software Update
Z-0012-2011,49138,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley).The intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.",Essenta DR Xray system,2,"October 06, 2010", 2010,Philips Medical Systems North America Co. Phillips,"When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.",OTHER/UNDETERMINED: Pending,"Philip Medical System sent an ""URGENT-Device Correction"" letter dated August 13, 2008 to their customers. The letter describes the recalled product as Essenta DR Patient and Image Data Software (SW) release 1.0. The firm informs the customers that when patient is selected in patient list and examination tab pressed with background query running at the same time, there is a risk that the wrong patient is selected on the Essenta DR Computed Radiography System.Customers are advised to verify the selected patient's information before releasing an exposure while the firm works on upgrading the Software. All affected units will receive a software upgrade to correct the issue.Customers should contact Philips Customer Care Service at 800-772-9377, #5, #4, #1 and reference FCO 712000031 for any questions or support concerning the recall.",N/A,23,23 units,"Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.",Terminated,"October 07, 2010",1,23,Software,Output/Calculation,Software update,Software Update
Z-0014-2011,50100,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600.Made in Ireland;Howmedica Osteonics;325 Corporate Drive,Mahwah, NJ 07430Intended for primary or secondary reconstruction of the distal femur.",Duracon Total Knee Distal Femoral Locking Screw ,2,"October 06, 2010", 2010,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825.",N/A,7,7 units,Nationwide Distribution -- Including Ohio.,Terminated,"October 07, 2010",1,7,Not_Computer,N/A,N/A,N/A
Z-0011-2011,56728,"tubing, pump, cardiopulmonary bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(k),MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400,MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector,2,"October 06, 2010", 2010,Maquet Inc.,Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.,PRODUCTION CONTROLS: Process Control,"Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form.Maquet Customer Service can bre contacted at 800-777-4222.",N/A,22,22 items,Worldwide Distribution: USA State of IL and country of the Netherlands.,Terminated,"September 25, 2012",720,22,Not_Computer,N/A,N/A,N/A
Z-0013-2011,56026,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143Catalog Number: 2570-00-000The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.",Summit Universal Broach Handle ,2,"October 06, 2010", 2010,"Depuy Orthopaedics, Inc.",Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).,PRODUCTION CONTROLS: Process Control,"On June 3, 2010, an ""Alert: Femoral Broach Handle Repair"" went out to the entire sales force/customers via ""Sales Mail"" and posted to the DePuy Internal website. The Alert stated that ""We have discovered that some of our straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).As you perform routine maintenance on your sets, if you have any of these broaches stamped with the lot numbers listed, it is recommended you have them sent in to be reworked with a new spring device.""Send the broach handles to: DePuy OrthopaedicsAttn: Repairs700 Orthopaedic DrWarsaw, IN 46581Please include return shipping informationIf you have any questions regarding this information or need additional information, call 574-372-7333.",Contact the recalling firm for information,8358,8358,"Nationwide distribution: AR, AZ, CA, FL, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NV, NY, OH, PA, TN, VA, and WI.",Terminated,"November 30, 2011",420,8358,Not_Computer,N/A,N/A,N/A
Z-0010-2011,56599,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland",GE DatexOhmeda Amingo Anesthesia System,2,"October 06, 2010", 2010,"GE Healthcare, LLC","Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety.If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila",TRAINING: Employee Error,"GE Healthcare issued an "" Urgent Medical Device Correction"" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions.Customers were instructed to:1. Ensure the plug is removed at the completion of the Low P Leak check.2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required.All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.",N/A,131,131,"Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.",Terminated,"September 13, 2012",708,7711,Computer,N/A,N/A,N/A
Z-0022-2011,56707,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.,BABIX holder for DigitalDiagnost Xray system,2,"October 07, 2010", 2010,Philips Medical Systems North America Co. Phillips,Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.,PRODUCTION CONTROLS: Equipment Maintenance,"Philips issued URGENT-Device Correction Notice letters dated September 9, 2010 to their consignees identifying the affected products and action to be taken by customers. The letter states that Babix holder used with Philips BuckyDiagnost and DigitalDiagnost X-Ray System - VS Wall Stand Risk of steel cable fracture in the support holder. The consignees are informed that there is a potential of broken strands at the main steel cable within the holder which cannot be recognized by the user. The firm will issue the Field Change Order (FCO) and the Service Engineer will replace the Babix holder.Consignees can call Philips Call Center at 800-722-9377, #5 (then follow prompts) and reference to FCO 70400038 for the BuckyDiagnost X-ray system and FCO 71200046 for the DigitalDiagnost X-ray system.",Contact the recalling firm for information,1,1 unit,"Nationwide Distribution in the states of CA, GA, and TN.",Terminated,"July 22, 2011",288,5,Not_Computer,N/A,N/A,N/A
Z-0020-2011,56536,"catheter, ventricular, general & plastic surgery",GBS,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"HydraGlide Silicone Chest Tube Catheter, 32 Fr StraightProduct Code 14132","Atrium HydraGlide Silicone Chest Tube Catheter, 32 Fr",2,"October 07, 2010", 2010,Atrium Medical Corporation,Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.,PRODUCTION CONTROLS: Packaging Process Control,"Atrium Medical isued Product Recall Notice letters dated August 10, 2010 to customers, identifying the affected product and actions to be taken by customers. Customers were instructed to remove the affected products from inventory and return them to Atrium, and complete and fax a recall notice acknowledgement to Atriuim at 603-821-1420. Customers can contact Atrium at 800 528-7486, x5350 (Joe DePaolo) or x5351 (Karen Hall) for further information.",N/A,1,"1 case, 10/case","Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.",Open,N/A,N/A,11,Not_Computer,N/A,N/A,N/A
Z-0023-2011,56663,"needle, aspiration and injection, disposable",GAA,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,BD 30G1/2 PrecisionGlide¶_ Needle;Catalog/Lot Number: 305106.Needles are intended for use in aspiration and injection of medications.,BD 30G1/2 PrecisionGlide Needle,2,"October 07, 2010", 2010,Becton Dickinson & Company,There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles,N/A,"BD sent out Product Correction letters to all end users of the product on 8/24/10. Letters were mailed by BD via UPS second day air. The letter stated the issue and said that customers should assess the patency prior to injection. The letter also stated that a BD 30 gauge PrecisionGlide Needle from another lot can be used in place of a clogged needle. If customers require replacement needles or further assistance, they can contact BD at 1-888-237-2762. Finally, the letter states that BD has implemented corrective actions to reduce the potential for further recurrence of the blockage issue.",N/A,2599000,"2,599,000 units",Worldwide Distribution -- USA and Canada.,Terminated,"August 25, 2011",322,2599000,Not_Computer,N/A,N/A,N/A
Z-0017-2011,56630,"programmer, pacemaker",KRG,Pacemaker programmers.,Cardiovascular,Cardiovascular,N/A,"Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.",Vitality HE Model T180 Implantable Cardioverter Defibrillator (ICD),2,"October 07, 2010", 2010,Boston Scientific CRM Corp,"Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs (CONTAK RENEWAL¶_ 3 / 3 RF / 4 / 4 RF and VITALITY¶_ HE implantable defibrillators). This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature. This issue may require",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Boston Scientific Issued Urgent Medical Device Correction and Physician Device Advisory Notice letters dated July, 2010 to customers identifying the affected devices, the issue prompting the recall, clinical implications, and actions to be taken by customers.Customers were instructed:1) Physicians should continue routine follow-up sessions, and patients should be reminded to contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device. 2) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated with a programmer and checked per normal standard of care. 3) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detection of a stuck reed switch. [NOTE 1: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements. NOTE 2: Daily Measurements may be unavailable for reasons other than a stuck switch.] 4) Prophylactic explant is NOT recommended.5) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures that programmed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off, a magnet will no longer inhibit tachy therapy, and the Patient Triggered Monitor feature will no longer be available. Do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnet use to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch.In the US, Boston Scientific Cardiac Rhythm Management can be contacted at 800-227-3422, and in Europe, Boston Scientific Europe S.A. can be contacted at +32 2 416 7222.",Contact the recalling firm for information,5821,5821,"Worldwide Distribution: All States in the continental USA including PR and DC , but excluding VT, the countries of Canada, Mexico, and in Europe.ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRITISH VIRGIN ISLANDS, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, PORTUGAL , QATAR, SAINT KITTS & NEOIS, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM,VENEZUELA, URUGUAY, ZIMBABWE, IRAN.",Terminated,"April 03, 2012",544,38377,Not_Computer,N/A,N/A,N/A
Z-0015-2011,56219,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.",Exodus Standard Loop Multipurpose Drainage Catheter,2,"October 07, 2010", 2010,"Navilyst Medical, Inc",One box containing five catheters did not complete the sterilization process prior to distribution.,TRAINING: Employee Error,"On/about 5/24/10, NMI telephoned the consignee. The recall notification package was sent by NMI to the sole consignee on 6/11/10, followed by a telephone call by NMI Quality staff. On 6/15/10, the recall notification package was sent via FedEx to the sole consignee. Subsequently the consignee was provided a return goods authorization (RGA) number for return to NMI. The letter described the product, problem and action to be taken by the consignee/customer. The consignee/customer was instructed to immediately discontinue use of and segregate recalled product; remove the affected lot from their inventory; complete and return the Reply Verification Tracking Form via fax to the QA Manager; Navilyst Medical, Inc., at 1-518-742-4414; to please call the Navilyst Medical Customer Service at 1-800-833-9973 between 8:30 a.m. and 7:00 p.m. (Eastern Standard Time) to obtain a Return Authorization (RGA) Number, and package/ship the recalled product to Navilyst Medical, Inc, Distribution Center, Attn: QA Returns, 10 Glens Falls Technical Park, Glens Falls, NY 12801. If you have any questions, call Navilyst Medical Customer Service at 1-800-833-9973. Subsequent to the initial notification letter, NMI identified that a typo was made to the lot number on the letter. NMI telephoned the consignee and sent a revised letter via fax on 6/25/10 indicating the correct lot number.",N/A,1,1 box unit (contains 5 catheters),Nationwide distribution: Ohio only,Terminated,"October 07, 2010",0,1,Not_Computer,N/A,N/A,N/A
Z-0018-2011,56600,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.",Oxylog 3000,2,"October 07, 2010", 2010,"Draeger Medical Systems, Inc.",Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.,PRODUCTION CONTROLS: Error in Labeling,"The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.",N/A,78,78 potentially afftected units,Nationwide Distribution,Terminated,"November 18, 2010",42,78,Not_Computer,N/A,N/A,N/A
Z-0034-2011,50215,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"The device's marketing brochure states: ""IntelliVue M3150 Information Center...Philips Medical Systems"".The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC.Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.",Philips IntelliVue Information Center,2,"October 08, 2010", 2010,Philips Medical Systems North America Co. Phillips,Potential for Internal Sound Amplifier to malfunction which could delay treatment.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service.The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set.The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 ""Adjusting Alarm Tone Volume"" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301.Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.",N/A,424,424 units in US.,Nationwide Distribution,Terminated,"October 12, 2010",4,424,Hardware,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-0026-2011,54527,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S",SpeedLink 5.5 Transverse Connector ,2,"October 08, 2010", 2010,Zimmer Inc.,The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.,OTHER/UNDETERMINED: Pending,"The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.",Contact the recalling firm for information,23205,"23,205 Units for ALL PRODUCTS IN THIS RECALL",The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.,Terminated,"January 05, 2011",89,23205,Not_Computer,N/A,N/A,N/A
Z-0025-2011,56767,"device, percutaneous, biopsy",MJG,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows:Model Number: 763114100XLot #'s:92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M.Model Number: 763114160XLot #'s92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ.Model Number: 763114200XLot #'s92661WY0, 00751ZYJ, 012420U1Model Number: 763116100XLot #'s92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3.Model Number: 763116160XLot #'s92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HSModel Number: 763116200XLot #'s121KNModel Number: 763116200XLot #'s92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020ITModel Number: 763118100XLot #'s92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX.Model Number: 763118160XLot #s92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO.Model Number: 763118200XLot #s92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I.Model Number: 763120100XLot #s93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF.Model Number: 763120160XLot #s92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8.Model Number: 763120200XLot #s00351Z85, 012020QG, 012420TW.Model Number: 763418200XLot #s92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6.Model Number: 763418250XLot #s92751X60, 00671ZRL,Model Number: 763418250XLot #s92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.",TruCore II Disposable Automatic Biopsy Instrument and TrueCore II URO Disposable Automatic Biopsy ,2,"October 08, 2010", 2010,"Medical Device Technologies, Inc.","Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recall is for the following Model Numbers: 763114100X, 763114160X, 763114",OTHER/UNDETERMINED: Pending,"Angiotech sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated July 2, 2010 and response card to all customers including distributors. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review their current inventory and segregate the affected lot numbers; arrange for return and replacement of the affected product, and complete and return the Customer Acknowledgment Form via fax to the Quality Assurance department at 1-352-338-0662 or 1-800-333-0440.If you have any questions concerning this notification, contact Shannon Brooks at (352) 338-0440 ext 355 or Katrenia Williams at ext 353.",Contact the recalling firm for information,11123,"11,123 boxes (111,230 units)","Worldwide distribution: USA and countries including: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Israel, Japan, New Zealand, Peru, South Africa, , Uruguay, and Venezuela.",Terminated,"June 28, 2011",263,11123,Not_Computer,N/A,N/A,N/A
Z-0024-2011,56645,"detector, bubble, cardiopulmonary bypass",KRL,Cardiopulmonary bypass bubble detector.,Cardiovascular,Cardiovascular,510(k),"Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI",Sarns Ultrasonic Air Sensor,2,"October 08, 2010", 2010,Terumo Cardiovascular Systems Corporation,"Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. .",OTHER/UNDETERMINED: Pending,"The firm sent URGENT MEDICAL DEVICE CORRECTION notices dated September 17, 2010. The notices told consignees that a Terumo representative would visit, inspect the cables and replace the recalled cables. if the customer has a service contract, the visits would occur at the next scheduled preventative maintenance visit. Customers without a service contract will be contacted by Terumo representative to schedule an appointment.Customers can contact Terumo Customer Service at 800-521-2818.",Contact the recalling firm for information,5000,"5,000 estimated","Worldwide Distribution: USA states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Belgium, Canada, Columbia, Chile, Costa Rica, Germany, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Korea, Mexico, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Taiwan, UAE and Vietnam.",Terminated,"June 29, 2012",630,5000,I/O,Alarm/Message,Replace cables,Remove or Replace
Z-0040-2011,55602,"accessories,arthroscopic",NBH,Arthroscope.,Orthopedic,Orthopedic,510(K) Exempt,Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)Catalog Number: 72201713ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.,Smith & NephewAimer Endofemoral ,2,"October 12, 2010", 2010,"Smith & Nephew, Inc. Endoscopy Division",Endofemoral Aimer tip may separate due to failure of the soldered joint,DESIGN: Component Design/Selection,"Smith & Nephew sent a ""Medical Device Recall Information"" letter dated April 29, 2010, with an attached ""Urgent-Product Recall 1st Notification - Urgent"" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be taken by customers. The customers were instructed to immediately check stock for affected product; immediately remove the items from stock and set aside for quarantine; complete and return the attached Urgent-Product Recall 1st Notification - Urgent"" response form, even if no product is being returned, via fax at +1-508-261-3636 attention Cindy Burns or email a PDF to Cindy.Burns@smith-nephew.com; call for a return Authorization number at 1-800-343-5717 Option #3, and return product to Smith & Nephew, Inc., Endoscopy Division as soon as possible. If you have any questions or require additional information, please contact Cindy Burns at 1-508-261-3655.",N/A,577,577 units,"Worldwide distribution: USA and countries including: Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark. Dubal, Finland, France. Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands. Norway, Portugal, Puer To Rico, Singapore. South Africa, Spain. Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.",Terminated,"May 09, 2012",575,3607,Not_Computer,N/A,N/A,N/A
Z-0036-2011,55802,"device, pasteurization, hot water",LDS,Medical washer.,General Hospital,General Hospital,510(K) Exempt,"HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: ""HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com"".Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.",HLD SYSTEM 520,2,"October 12, 2010", 2010,Cenorin,"The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized with enough wat",DESIGN: Component Design/Selection,"On June 7, 2010, firm, CENORIN, sent ""URGENT: MEDICAL DEVICE RECALL"" Initial Notification letter with Recall Response Form, Series 500 Water Level Check Instructions, and the Water Level Switch Upgrade Kit Instruction (service kit P/N # 082395-00) to their consignees. The firm also sent these documents in Spanish language to their foreign consignees. The letter describes the recall product as HLD Systems Medical Device Cleaning and High Level Disinfection Series 500 Washer/Pasteurizer-Model 540, Model 540HT and Model 520. Customers are advised to call the Customer Service at 1-800-426-1402 or e-mail the firm.The Initial Notification letter instructs consignees to conduct and quarantine the recall products and notify their sub-accounts (customers) if products have been further distributed. While waiting for a replacement kit, the consignees are asked to follow the Series 500 Water Level Check Instructions to perform a test to ensure the water tank is completely filled up the expected water level. The firm also advised the consignees to add a cautionary label on the product to avoid any sharp or bump impact that may create any externally induced vibration noise to the device.The firm is developing a replacement kit that should be ready to send out to their consignees by June 30, 2010. A response card would be also sent out with a new kit, and it is used to verify that the kit has been successfully implemented. If you have any questions, please email jbennett@cenorin.com or call 253-395-2400 or toll free: 1-800-426-1042.",Contact the recalling firm for information,9,9 units,"Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.",Terminated,"May 07, 2012",573,93,Not_Computer,N/A,N/A,N/A
Z-0002-2011,56425,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.",Colleague Triple Volumetric Infusion Pumps,1,"October 12, 2010", 2010,Baxter Healthcare Corp.,"The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of al",DESIGN: Device Design,"Baxter Healthcare Corporation sent ""Urgent Product Recall"" letters dated August 4, 2010 to all Colleague Infusion Pump customers in the U.S., to the attention of the Hospital Administrator, Chief Executive Officer, Chief Operating Officer, Chief Medical Officer and Chief Nursing Officer, referencing Baxter's May 3, 2010 announcement to recall all Colleague pumps from the U.S. market pursuant to an order under its existing consent decree with the FDA. The letters provided the customers with important information regarding the actions they must take prior to November 14, 2010 in order to continue using their Colleague pumps during the transition period. Customers were instructed to complete the attached Certificate of Medical Necessity Form and return it to Baxter as soon as possible, but no later than November 14, 2010, by scanning and e-mailing to Baxter at FCA@Baxter.com. Any questions were directed to their local Baxter Sales Representative or by calling the Center for One Baxter 1-800-422-9837, between 8AM and 5 PM Central Standard Time (CST).*** On July 20, 2011 Baxter sent recall letters to those Colleague customers who had not completed a decision form regarding the status and replacement of their Colleague Pumps. The accounts were asked to inform their Baxter sales representative as soon as possible of their pump decision, and to complete the attached customer reply form and return it to Baxter via fax or scanned e-mail. ***.",N/A,81775,"81,775 pumps","Nationwide, including Puerto Rico",Terminated,"November 26, 2012",776,302872,Not_Computer,N/A,N/A,N/A
Z-0006-2011,56257,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"CareFusion Alaris PC Unit Model 8015 (formerly MedleyPC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.",Alaris,1,"October 13, 2010", 2010,CareFusion Corporation,"Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009.",DESIGN: Component Design/Selection,"CareFusion sent the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter is addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, self-addressed mail, fax or email. The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users.The customers were also told that CareFusion will contact their facility through phone or in person within 60 days to initiate implementation of the corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that you return your devices. In the interim, if you observe this issue, remove the device from service and contact CareFusion Recall Center immediately.Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.",Contact the recalling firm for information,17081,"17,081 units (17,050 in US)","Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore",Terminated,"December 12, 2011",425,17081,I/O,Display/Image,N/A,Other
Z-0050-2011,56680,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Scorpio/ NRG 4in1 Cutting BlockThe Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts.",Scorpio/ NRG 4in1 Cutting Block,2,"October 13, 2010", 2010,Stryker Howmedica Osteonics Corp.,Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery.,DESIGN: Device Design,"Stryker Orthopaedics sent an ""URGENT PRODUCT RECALL"" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069.If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100.",N/A,839,839 (total),"Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa",Terminated,"August 30, 2012",687,839,Not_Computer,N/A,N/A,N/A
Z-0058-2011,56694,ventricular (assisst) bypass,DSQ,N/A,N/A,Cardiovascular,N/A,"HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CAThe HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular",HeartMate II System Controller; component of the HeartMate II Left Ventricular Device System (LVAS),2,"October 13, 2010", 2010,Thoratec Corp,Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection,N/A,"Thoratec Corporation sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated August 30, 2010, to all customers. The letter described the affected product, description and symptoms of problem, and immediate action to be taken by the customers. The customers were instructed to:1) contact all ongoing patients using the affected Systems Controllers (serial numbers starting with ""EPC"") to determine if they are experiencing any unexplained intermittent alarms or have any bent pins in the connectors between the System Controller and the power sources, if so, have them return to the hospital so that their power leads can be examined. If further assistance is needed with the evaluation, please contact Thoratec Technical Service (800-456-1477).2) review the attached addendum to the HeartMate II labeling with all VAD clinicians and ongoing HeartMate II LVAS patients, and3) complete and sign the attached Acknowledgment Form via fax to Thoratec Regulatory Affairs at (952) 847-8571.If you have any questions, please contact 925-847-8600.",Contact the recalling firm for information,8965,8965 units,"Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX , UT, VA, WA, and WI; and countries including: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Netherlands, Singapore, Slovenia, Sweden, Switzerland, and the UK.",Terminated,"April 07, 2011",176,8965,Other,N/A,N/A,N/A
Z-0060-2011,56651,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN.This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.",Zimmer Trabecular metal Modular Acetabular system ,2,"October 14, 2010", 2010,Zimmer Inc.,The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.,OTHER/UNDETERMINED: Pending,"The firm, Zimmer, made telephone calls using a phone script document entitled ""Urgent: Medical Device Recall"" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect.If you have any questions, please call (574) 371-8852.",Stop use and contact the recalling firm for information.,24,24,"Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.",Terminated,"February 07, 2011",116,24,Not_Computer,N/A,N/A,N/A
Z-0059-2011,56589,"pusher, socket",HXO,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN.The device is intended to push knots down a limb of suture.",CLOSED KNOT PUSHER,2,"October 14, 2010", 2010,"Biomet, Inc.",The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.,N/A,"Biomet Sports Medicine sent URGENT MEDICAL DEVICE RECALL NOTICES dated 8/2/2010 to its customers and distributors. The notices stated that the use of the device should be discontinued and the products returned to Biomet.Healthcare professionals and consumers were to report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by phone at (800)FDA-1088 or Fax (800)FDA-0178.Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.",N/A,101,101,"Worldwide Distribution - USA, including FL, NY, VA, CA, GA, AL, PA, MI, LA, KS, SD, KY, TX, AR, and WV, and the countries of Belgium, Italy, Argentina, Poland, Netherlands, Turkey and Portugal.",Terminated,"August 20, 2012",676,101,Not_Computer,N/A,N/A,N/A
Z-0071-2011,55157,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN.Used to mate the inserter with the shell implant.",Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control,2,"October 15, 2010", 2010,Zimmer Inc.,The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.,DESIGN: Device Design,"The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all product replaced by 4/30/2010. If there are any questions or additional info needed, consignees should contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.",N/A,1125,1125 all products,"Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.",Terminated,"January 12, 2011",89,1125,Not_Computer,N/A,N/A,N/A
Z-0068-2011,56719,"enzyme immunoassay, tracrolimus",MLM,Tacrolimus test system.,Clinical Chemistry,Toxicology,510(k),"Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 1L77-25The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.",Architect Tacrolimus Reagent Kit,2,"October 15, 2010", 2010,Abbott Laboratories,There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.,OTHER/UNDETERMINED: Pending,"Abbott Laboratories sent a ""Product Recall Immediate Action Required"" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott.com. IMPORTANT NOTE: If you do not currently have replacement material than you may continue to use this reagent lot until your laboratory receives replacement material. Upon receipt of the replacement material, discontinue use of and discard lot 86599M500 and switch to the replacement material. Contact Abbott Customer service for replacement material (1-877-4ABBOTT, Option 1).If you or any of the health care providers you serve have any questions regarding this information, U.S. customers should call Customers Service at 1-877-4ABBOTT. Customers outside of the U.S., please contact your local Customer Service representative.",N/A,1995,"1,995 kits","Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Vietnam.",Terminated,"May 13, 2011",210,1995,Not_Computer,N/A,N/A,N/A
Z-0070-2011,56699,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Interlink System Buretrol Solution Set, 83"" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38"" (97 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, 60 DPM; a sterile Rx IV fluid pathway device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0166The administration of fluids from a container into the patient's vascular system through a vascular access device",Baxter Interlink System Buretrol Solution Set ,2,"October 15, 2010", 2010,Baxter Healthcare Corp.,"There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.",TRAINING: Employee Error,"Baxter sent an ""Urgent Product Recall"" letter dated September 2, 2010, via first class mail to the direct account, to the attention of the Director of Materials Management, with a copy sent to the Director of Nursing, on the same date, informing them that leaks were detected in the Drip Chamber Check Valve Subassembly used in the affected lot of Interlink System Buretrol Solution Sets. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection. The account was requested to examine their inventory in all locations to determine if they have any of the affected lot and remove the affected product from inventory; call Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",N/A,948,948 units,Nationwide distribution: Wisconsin only.,Terminated,"February 25, 2011",133,948,Not_Computer,N/A,N/A,N/A
Z-0069-2011,56278,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates:4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.","Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, ",2,"October 15, 2010", 2010,SCC Soft Computer,"SCC Soft Computer, Clearwater, FL issued a Correction for Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 on 10/05/2007. A software anomaly in the result reporting interface caused result comments entered after an empty line",DESIGN: Software Design,"SCC Soft Computer sent a RISK-TO-HEALTH NOTIFICATION TASK VERBIAGE dated October 5, 2007, through their Task Management System to all affected clients on October 17, 2007. The notice identified the product, the problem and the action clients should take to correct the problem. Clients were to acknowledge receipt of the task notice and to identify if the Workflow or functionality is not used and if they Agree to use alternative working solutions. Each client was asked to grant permission to load the required software to correct the issue.For any questions regarding this recall call (727) 789-0100.",Contact the recalling firm for information,35,35,"Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada",Terminated,"October 19, 2010",4,35,Software,Output/Calculation,Software update,Software Update
Z-0066-2011,56756,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Control Syringe, 12ml, CAT No: CCS201E Version B, Sterile R, Merit Medical Systems, Inc.Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes.",Coronary Control Syringe,2,"October 15, 2010", 2010,"Merit Medical Systems, Inc.",Small holes in the packaging may render the product non-sterile.,TRAINING: Employee Error,"Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product. Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378. If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to: RGA DepartmentMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095-2416For any questions regarding this recall call 801-316-4822 or 801-208-4365.",N/A,199,199 units,"Worldwide Distribution - USA, including IL, PA, WI and WV and the countries China, Greece, Hong Kong, Japan, New Zealand and Spain.",Terminated,"March 21, 2011",157,16574,Not_Computer,N/A,N/A,N/A
Z-0067-2011,56275,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftPath GUI Releases 3.17 through 4.1.0.SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.Manufacture/Distribution Dates:Version 3.17.5 10/14/2003. Version 3.17.6 03/28/2003. Version 3.17.7 07/02/2003. Version 3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003. Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.",SoftPath GUI Releases 3.17 through 4.1.0.,2,"October 15, 2010", 2010,SCC Soft Computer,"SCC Soft Computer, Clearwater, FL issued a Correction for SoftPath GUI Releases 3.17 and 4.1 in March 2007 for clients with high volume output of final reports who use the Batch Print for Final Reports in the Scheduler, there is a potential for some reports not printing. This issue was corrected for the one affected user in October 2003.",DESIGN: Software Design,"SCC Soft Computer sent a SAFETY NOTIFICATION TASK VERBIAGE dated January 5, 2004, to one client. The Notice identified the product, the problem, and the action to be taken by the client. SCC recommended the client set the Search Date Range to a small enough range to assure that the number of cases scanned during the job would be less than 10,000.The client was asked to acknowledge receipt of the task and to indicate if the Workflow or functionality was used/not used and Agree to use the alternative working solution. For any questions regarding this recall call (727) 780-0100, ext. 4235.",Contact the recalling firm for information,84,84,"Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV",Terminated,"October 19, 2010",4,84,Software,Output/Calculation,Software update,Software Update
Z-0075-2011,54550,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)",PathFinder end screw extender sleeve.,2,"October 18, 2010", 2010,Zimmer Inc.,"The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.",DESIGN: Device Design,"Zimmer Spine issued an ""Urgent Medical DeviceCorrection"" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.",N/A,1471,1471 (888 subject to removal),"Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.",Terminated,"February 10, 2012",480,1471,Not_Computer,N/A,N/A,N/A
Z-0078-2011,55150,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"EasyRA Cuvette Segment 1, P/N 007000-001(In Vitro Diagnostic )EasyRA Cuvette Segments included in the following Kits:EasyRA Cuvettes, REF 10700-4Startup Kit - Chemistry, REF 10990Startup Kit - Chemistry & ISE, REF 10991",EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer,2,"October 18, 2010", 2010,Medica Corporation,Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results.The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri,OTHER/UNDETERMINED: Pending,"Medica issued an Urgent Product Recall letter dated March 29, 2010 to customers. Users were requested to cease using and discard the affected product, and complete and return a Response Form in order to obtain replacement product.Customers can contact Medica Technical Support at 877-777-5895.",N/A,14926,"14,926","Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.",Terminated,"June 07, 2011",232,14926,Not_Computer,N/A,N/A,N/A
Z-0079-2011,56805,"prosthesis, hip, constrained, cemented or uncemented, metal/polymer",KWZ,Hip joint metal/polymer constrained cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.Acetabular Liner",R3 Constrained Acetabular Liner,2,"October 18, 2010", 2010,Smith & Nephew Inc,The firm received reports of a femoral head popping out of the liner intraoperatively.,N/A,"Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. 1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. 2) Identify customers that received these products and immediately notify them of the recall.3) Carry out a physical count and record the data on the Verification Section included in the letter.4) Contact their inventory specialist for an RA# and record this on the Verification Section.5) Return the Verfication Section even if they do not have the recalled product.6) Return the recalled product to: Smith & Nephew, Inc. Attn: Return Goods 3303 Holmes Road Memphis, TN 38118Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010.For any questions regarding this recall customers were to call (901) 399-5441.",N/A,118,118 units,"Worlwide Distribution, USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and WI and the countries of Australia and Portugal",Terminated,"September 21, 2011",338,716,Not_Computer,N/A,N/A,N/A
Z-0074-2011,56274,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1.SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03.Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.",Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 ,2,"October 18, 2010", 2010,SCC Soft Computer,Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 HIS may display incorrect collection data for a procedure or test result. Clients using HBO Star RR interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the SCC interf,DESIGN: Software Design,"Client Notification Task Verbiage was sent through the Task Management System on December 3, 2003, identifying the software issue, the clinical impact, and corrective action. Customers were informed that the HIS may display incorrect collection data. Customers received the SQRR Service Pack with revised software, which will will not produce inaccurate information if there are no verified results. Customers were to acknowledge receipt of the task notification and indicate whether they would like the corrected software.SCC Soft Computer proprietary Task Management System is used to manage client communication. Clients use this system to request services, receive and provide software updates for any issue.Customers can contact SCC Soft Computer at 727-789-0100.",Contact the recalling firm for information,5,5,"Nationwide Distribution: including states of GA, LA, and NH.",Terminated,"October 19, 2010",1,5,Software,Display/Image,Software update,Software Update
Z-0073-2011,56789,"pouch, colostomy",EZQ,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier;1 1/4 in., 32mm;Made in Dominican Republic;ConvaTec.Colostomy pouch",ActiveLife OnePiece Drainable Pouch 32mm,3,"October 18, 2010", 2010,Convatec Inc.,"Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.",PRODUCTION CONTROLS: Labeling Mix-Ups,"ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product, For questions call (908) 904-2675.",Contact the recalling firm for information,1,1 case (20 market units),"USA, including IL",Terminated,"October 19, 2010",1,1,Not_Computer,N/A,N/A,N/A
Z-0076-2011,56736,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.",Sequencer,2,"October 18, 2010", 2010,Impac Medical Systems Inc,"Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.",DESIGN: Software Design,Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672.,N/A,797,797 units,"Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK.",Terminated,"June 24, 2011",249,797,Software,Output/Calculation,Software update,Software Update
Z-0077-2011,56729,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED).The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.",Sentry semi automatic external defibrillator (AED),2,"October 18, 2010", 2010,"Defibtech, LLC",Data cards may include an incorrect format which may cause the AED to not function correctly.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service.If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation.For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.",Contact the recalling firm for information,38,38,USA - Nationwide Distribution and Puerto Rico,Terminated,"October 05, 2011",352,38,Other,N/A,N/A,Other
Z-0088-2011,56851,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.",SoftMic Versions 4.0.4.7 and 4.5.1.3,2,"October 19, 2010", 2010,SCC Soft Computer,Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.,DESIGN: Software Design,"SCC Soft Computer issued Risk-to-Health notifications to clients on July 19, 2010 via proprietary communication software. Corrective actions will be via programming correction via hot fix (software modification) or such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and update the task with permission to load the required correction.",Contact the recalling firm for information,35,35,"Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.",Terminated,"July 16, 2012",636,35,Software,Output/Calculation,Software update,Software Update
Z-0090-2011,56280,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftPath GUI version 3.17.6.3.1.SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684.Date of Manufacture:Version 3.17.6.3.1 06/03/2003.",SoftPath GUI version 3.17.6.3.1.,2,"October 19, 2010", 2010,SCC Soft Computer,"For clients using the SoftPath GUI version 3.17.6.3.1 Results Reporting interface with parsed text and having the auto correct and auto formatting functions active in MS Word, there is a possibility for some ANSI characters/symbols to be translated incorrectly to ASCII. SCC Soft Computer initiated a Correction in March 2004 for all affected clients.",DESIGN: Software Design,"SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on March 11, 2007. SCC recommended turning off the autocorrect and autoformatting functions in MS Word if custom configuration parses text to an ASCII file (HIS) for the Result Reporting interface. If this function was turned on at the time of creating the canned message in the setup file, edit and re-save all canned messages in SoftPath. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.",N/A,1,1,Nationwide distribution: One hospital in NY.,Terminated,"November 03, 2010",15,1,Software,Output/Calculation,Software update,Software Update
Z-0087-2011,56502,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1.Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.",Manta Ray ACP System,2,"October 19, 2010", 2010,Theken Spine Llc,The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures.,OTHER/UNDETERMINED: Pending,"Integra sent a Technical Bulletin dated July 29, 2010 via Fedex to their customers. The bulletin identified the product, the problem, and action to be taken by the user/customers (surgeons) of the two (2) reported instances of screws backing out of the plates. The Bulletin provided instructions outlining the proper surgical techniques for implantation of screws using the Manta Ray ACP System. The bulletin also included an attached acknowledgement form which the user/customers were asked to complete and FAX to (609) 275-5363 or E-mail back to the E-mail address provided. The form verified that each customer: 1) received the technical bulletin; and 2) has read and understood the proper technique for surgical placement of the screws as outlined in the bulletin.For technical support customers were to contact the Customer Service Department at (866) 942-8698.",N/A,1081,1081- includes totals distributed for both plates & screws,"Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA.",Terminated,"September 21, 2012",703,1081,Not_Computer,N/A,N/A,N/A
Z-0091-2011,56808,"ligator, hemorrhoidal",FHN,Hemorrhoidal ligator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.",WilsonCook 10 Shot MultiBand Ligator,2,"October 19, 2010", 2010,Cook Endoscopy,A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patients gastrointestinal tract.,OTHER/UNDETERMINED: Pending,"COOK Endoscopy sent an URGENT: PRODUCT RECALL dated September 3, 2010, via USPS Certified Mail and by email to all consignees. The letter identified the products, the problem, and the action to be taken by the consignees. All consignees were instructed to quarantine any affected product and return them to Cook Medical. Distributors were instructed to contact their customers and coordinate the return of the affected product to Cook Medical. Within 2 weeks of the initial recall notification, Level B effectiveness checks (40% of the total number of consignees) will be conducted. These customers will receive a recall effectiveness survey. All non-responding consignees will receive a total of 3 recall notifications (2 follow-up requests for a response in addition to the initial recall notification. Monthly status reports regarding this recall will be provided to FDA. All devices returned as part of this recall will be destroyed by the recalling firm upon receipt of authorization to do so by FDA. Forty percent (40%) of total customers affected received a second notice on 9/17/2010 as part of the effectiveness checks. As of 9/21/2010, 38% of all affected customers have responded.For questions contact the Customer Relations Department at CustomerRelationsNA@cookmedical.com or call 1-800-457-4500, press 4 then enter extension 2146.",N/A,2011,2011 units (total including both 6 & 10 Shooters),"Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.",Terminated,"March 31, 2011",163,2012,Not_Computer,N/A,N/A,N/A
Z-0089-2011,56277,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftPath GUI Versions 3.17 and 4.1.SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760.Manufactured: Version 3.17.7.6 10/23/2003",SoftPath GUI Versions 3.17 and 4.1,2,"October 19, 2010", 2010,SCC Soft Computer,SoftPath Cases with Word Perfect documents that were not signed out in ASCII are printing in GUI as a converted document from Word Perfect to PDF document instead of the current MS Word Document. This affects clients upgrading from ASCII to SoftPath GUI 3.17.7.6 Version. All affected clients have been notified and corrections have been made.,DESIGN: Software Design,"SCC Soft Computer issued Risk-to-Health notifications with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System. beginning on December 30, 2003. Clients were instructed to sign out all Word Perfect documents before upgrading to GUI. The correction for this anomaly is to upgrade to the latest release of version 3.17.7 or 3.17.8. Clients were asked to acknowledge receipt of this Task and indicate whether they would like to take the correction at this time. When the client decides to accept the correction a new task will be created to initiate the patch using the Task Management System.",N/A,5,5,"Nationwide Distribution to the states of IN, NC, NH, and NJ.",Terminated,"November 03, 2010",15,5,Software,N/A,Software update,Software Update
Z-0107-2011,55195,"radioimmunoassay, parathyroid hormone",CEW,Parathyroid hormone test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism",DSL108000 Active IPTH ELISA,2,"October 20, 2010", 2010,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay maynot be achieved for lot numbers: 891198, 990980 and 991448.The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken.Customers were instructed to:(1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448;(2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit;(3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinicaldiagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped.Alternate lots will be provided for current and future replenishment orders or requests.in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of yourlaboratory Quality System documentation. Complete and return the enclosed response form within 10 days.For questions regarding this recall contact (800) 231-7970.",No consumer action necessary,70,70 kits,"Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX",Terminated,"April 27, 2012",555,70,Not_Computer,N/A,N/A,N/A
Z-0099-2011,56282,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftWeb version 4.0.4.10.1.SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.Manufacture Date: 05/16/2006.",SoftWeb Version 4.0.4.10.1,2,"October 20, 2010", 2010,SCC Soft Computer,"If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for",DESIGN: Software Design,"SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting ""Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number"" should be set to ""0"" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.",N/A,1,1,Nationwide Distribution: 1 hospital in Alaska.,Terminated,"November 03, 2010",14,1,Software,Output/Calculation,Software update,Software Update
Z-0098-2011,56687,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Stryker PainPump2 blockAid 400 mL Painpump for continuous Nerve Block, REF 575-100, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.",N/A,2,"October 20, 2010", 2010,Stryker Instruments Div. of Stryker Corporation,The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential,OTHER/UNDETERMINED: Pending,"Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.",Contact the recalling firm for information,11976,"11,976 all products","US, Canada and Australia.",Terminated,"April 21, 2011",183,11976,Not_Computer,N/A,N/A,N/A
Z-0103-2011,56675,"system, peritoneal, automatic delivery",FKX,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.",Fresenius LIBERTY 05087212 Automated Peritoneal Dialysis System Line Cycler Set ,2,"October 20, 2010", 2010,"Fresenius Medical Care Holdings, Inc.","Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.",N/A,363265,"363,265 units",Nationwide Distribution: Throughout USA.,Open,N/A,N/A,370588,Not_Computer,N/A,N/A,N/A
Z-0108-2011,56802,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"2.0/1.0 4 hole long plate (titanium plate ).Lot 120150.Product labeling reads: (1. ) REF: 01-9205, Lot 999999, "" 2.0MM"" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG.(2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com.(3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086",2.0/1.0 4 hole long plate Model 019205,2,"October 20, 2010", 2010,"Biomet Microfixation, Inc.","Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.",N/A,56,56,"Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.",Terminated,"November 19, 2010",30,56,Not_Computer,N/A,N/A,N/A
Z-0093-2011,56279,neurosurgical paddie,HBA,Neurosurgical paddie.,Neurology,Neurology,510(k),"Codman 5/16"" Round Surgical Patties(20 pouches of 10 patties per box)Product code: 80-1396",Codman,2,"October 20, 2010", 2010,"Codman & Shurtleff, Inc.",Surgical Pattie x-ray stripe (radio-opaque marker) became detached,PRODUCTION CONTROLS: Process Control,"Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.",Contact the recalling firm for information Contact the recalling firm for information,673,673 boxes (20 pouches of 10 patties per box),"NationwideForeign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,",Terminated,"July 09, 2012",628,5309,Not_Computer,N/A,N/A,N/A
Z-0102-2011,56272,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.","SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4. ",2,"October 20, 2010", 2010,SCC Soft Computer,"For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software..",DESIGN: Software Design,"SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software.SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch.",N/A,52,52,Worldwide Distribution: Throughout USA and Canada.,Terminated,"November 03, 2010",14,52,Software,Output/Calculation,Software update,Software Update
Z-0106-2011,56346,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA",TrueBeam and TrueBeam STx,2,"October 20, 2010", 2010,Varian Medical Systems Oncology Systems,"Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects ""Apply Shift"" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision.",DESIGN: Software Design,"Varian Medical Systems issued an Urgent Medical Device Correction letter date dated May 24, 2010 to users identifying the affected device, the issue prompting the correction, and the actions to be taken by the user.Customers were asked to set couch tolerance values to small numbers, and for radiosurgical treatment tolerance values to be set to zero. A Varian representative will contact customers to schedule installation of a software version correcting the issue. US Customers can contact Varian at 1-888-827-4265,. European customers can contact Varian at +41 41 749 8844.",N/A,N/A,N/A,"Worldwide Distribution: Two consignees, one in the US and one in Switzerland.",Terminated,"July 20, 2011",273,N/A,Software,Output/Calculation,Software update,Software Update
Z-0101-2011,56682,"bottle, collection, vacuum",KDQ,Vacuum-powered body fluid suction apparatus.,General Hospital,General Hospital,510(K) Exempt,"NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.","NOVAPLUS (TM), SUCTION CANISTER",2,"October 20, 2010", 2010,DeRoyal Industries Inc,Suction canisters may crack during use,OTHER/UNDETERMINED: Pending,"DeRoyal sent a Recall letter dated July 1, 2010 to all their consignees via UPS Air. The letter identified the product, the problem, and action to be taken by the consignees. Consignees were to complete the Recall Response Form by checking their inventory for DeRoyal Suction Canisters V71-3001, Lot #22622679.Indicate the number of replacement products needed on the Recall Response Form, including the address, reference PO#, etc. to be used for the replacement products and fax the form to DeRoyal at 865-362-3755 no later than July 7, 2010.Recalled products were to be returned to DeRoyal via UPS Ground Attn: Quality Control 300 DeBusk Lane Powell, TN 37849Once the recalled product was received by DeRoyal, the replacement product would be shipped per the instructions on the Recall Response Form.Distributors were to forward the recall notice to their end-users, or provide customer listing so that DeRoyal may contact them.For any questions or assistance regarding this recall call 865-362-1037.",Contact the recalling firm for information,N/A,N/A,Nationwide,Terminated,"April 10, 2012",538,N/A,Not_Computer,N/A,N/A,N/A
Z-0035-2011,56685,"saline, vascular access flush",NGT,Intravascular catheter.,General Hospital,General Hospital,510(k),Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride)General hospital use,Excelsior Disposable Syringe W/Normal Saline ,1,"October 20, 2010", 2010,Excelsior Medical Corp,"There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility",DESIGN: Device Design,"Excelsior Medical sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to return the form, and verify that they have returned all unused syringes from any of the listed lots . NOTE: The customers were informed that they may alternatively have the products destroyed and certified to Excelsior that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form via fax. - Excelsior issued a press release on October 14, 2010. The press release advised consumers of the recall and requested that use of the product be immediately discontinued and returned to the point of purchase.Should you have any questions regarding the recalled product, please contact Excelsior Medical Customer Service at (800) 487-4276 or if you prefer by fax (866) 688-3185. You may also contact us at recall10@excelsiormedical.com.",N/A,13734640,"13,734,640",Worldwide distribution: USA and countries including Canada and Brazil.,Terminated,"August 23, 2012",673,13734640,Not_Computer,N/A,N/A,N/A
Z-0100-2011,56283,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.",SoftLab version 4.01 ASCII Lab/Mic Addon,2,"October 20, 2010", 2010,SCC Soft Computer,"For SoftLab version 4.01 ASCII, the qualifying test result does not reach the Call List because the order is locked by either another application, or two Hosparams (HISRR_RBS_sync and Auto_sync_RBS). This creates a lock on the RBS server. The problem was identified in the RBS ""C"" rule which sends qualifying results to the Call List for SoftLab. All affected clients received the upgrade for Soft",DESIGN: Software Design,SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System in June 2006. SCC recommended SoftLab version 4.01 ASCII users change program settings to prevent locking of the RBS server. A software upgrade with corrective patch will be delivered electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software.,N/A,131,131,"Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV.",Terminated,"July 16, 2012",635,131,Software,Device Operation,Software update,Software Update
Z-0110-2011,55922,"defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)",NIK,N/A,N/A,Cardiovascular,N/A,"Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.",Concerto II CRTD,2,"October 21, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u,DESIGN: Software Design,"Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.",Contact the recalling firm for information,18778,"18,778","Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.",Terminated,"March 15, 2012",511,210237,Software,N/A,N/A,N/A
Z-0121-2011,56484,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"EasyLink Informatics Systems QCFIRST Custom RuleThe EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.",EasyLink,2,"October 21, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",the EasyLink QCFIRST custom rule does not operate as intended.,OTHER/UNDETERMINED: Pending,Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System.For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.,N/A,82,82,"Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.",Terminated,"March 19, 2013",880,82,Not_Computer,N/A,N/A,N/A
Z-0120-2011,56701,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"NexGen¶_ Complete Knee Solution Stemmed TibialComponent Precoat Size 3, REF 00-5980-037-01, Sterile, Zimmer, Warsaw, IN.Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.",NexGen Complete Knee Solution Stemmed Tibial,2,"October 21, 2010", 2010,Zimmer Inc.,Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.,TRAINING: Employee Error,"The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.",N/A,61,61 units,"Worldwide Distribution -- US, Canada, Singapore Australia, and India.",Terminated,"October 23, 2010",2,61,Not_Computer,N/A,N/A,N/A
Z-0109-2011,56762,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA.The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.",in2it (I) and (II) Test Cartridges,2,"October 21, 2010", 2010,Bio-Rad Laboratories Inc,Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.,DESIGN: Component Design/Selection,"BIO-RAD Laboratories Deeside sent an ""URGENT: MEDICAL DEVICE CORRECTION"" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal.If you have any questions, contact +44 1244 288888.",Contact the recalling firm for information,4056,4056,"Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.",Terminated,"May 17, 2011",208,4056,Not_Computer,N/A,N/A,N/A
Z-0133-2011,56508,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.",Computed Tomography XRay System MX 8000 IDT 16,2,"October 22, 2010", 2010,Philips Medical Systems (Cleveland) Inc,"Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). If the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken.Customers were instructed to locate and correct the error. Field Service Engineers were to visit each site to update the softwareFor further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377.",N/A,16,16 units,"Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia",Terminated,"September 21, 2012",700,16,Software,Output/Calculation,Software update,Software Update
Z-0123-2011,56627,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.",GE Centricity Laboratory Instrument Interface Software,2,"October 22, 2010", 2010,Ge Healthcare It,Instrument may incorrectly report the result of an antimicrobial sensitivity test.,DESIGN: Software Design,"The firm, GE Healthcare, sent ""Urgent Medical Device Correction"" letters dated August 27, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue associated with the use of GE Centricity Laboratory instrument interface to Biomerieux's Vitek analyzer where results may be incorrectly reported. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.",N/A,22,22 units,"Worldwide Distribution -- USA, including states of Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee, and Texas and countries of Australia, Canada, England, India, New Zealand, Qatar, and Scotland.",Terminated,"July 15, 2011",266,22,Software,Output/Calculation,Software update,Software Update
Z-0131-2011,56791,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"ARRAY and POLARIS Spinal System Medium Cross ConnectorNon SterileBiomet Spine, Parsippany, NJ. 07054",ARRAY and POLARIS Spinal System ,2,"October 22, 2010", 2010,"Ebi, Llc","One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.",OTHER/UNDETERMINED: Pending,"Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken.Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form.Customers and distributors can contact Biomet at 1-800-526-2579.",N/A,82,82 units,"Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.",Terminated,"June 01, 2012",588,82,Not_Computer,N/A,N/A,N/A
Z-0128-2011,56462,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira brand Symbiq Two-Channel Infuser,LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54, Distributed by: Hospira, Inc. Morgan Hill, CA",Hospira brand Symbiq TwoChannel Infuser,1,"October 22, 2010", 2010,Hospira Inc,"Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.",DESIGN: Device Design,"Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers.Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available.Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.",N/A,N/A,N/A,"Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.",Terminated,"December 03, 2013",1138,N/A,Not_Computer,N/A,N/A,N/A
Z-0132-2011,56610,"flowmeter, blood, cardiovascular",DPW,Cardiovascular blood flowmeter.,Cardiovascular,Cardiovascular,510(k),"PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146:Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device.Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access DeviceModel 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices",PD Access Vascular Access Device,2,"October 22, 2010", 2010,Escalon Medical Corp,"The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access Vascular Access Device, Model 78060 Extended 18 Gauge PD Access Vascular Access Device, Model 75010 18 Gauge SmartNeedle Vascular Access Devices with Expiration Da",DESIGN: Packaging Design/Selection,"Escalon Vascular Access issued an ""Urgent: Recall"" letter dated May 5, 2010 to customers. The letter identified the affected product being recalled, described the problem, and the actions to be taken.. Consignees were recommended to immediately examine their inventory, quarantine the product, notify their customers, and return product affected. They also advised them that if they have further distributed the product, to please identify the customers and notify them at once of the product recall. Replacement product can be ordered from Vascular Solutions, Inc at 888-240-6001. Customer service can be contacted at 800-676-0043.",N/A,188375,"188,375","Worldwide Distribution: USA, including the states of AL, AR, AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD.MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, MN, NY, NC, ND, OH, OK OR, PA, RI, SC, SD,TN, TX UT, VA, WA, WV, and WI, and the countries of: Australia, Austria, Bahamas, Canada, Colombia, Denmark, England, Germany, Greece, Hong Kong, Italy, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, and Switzerland.",Terminated,"March 28, 2013",888,188375,Not_Computer,N/A,N/A,N/A
Z-0125-2011,49488,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Allura Xper FD10/10 Biplane X-ray system.Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.",Allura Xper FD10,2,"October 22, 2010", 2010,Philips Medical Systems North America Co. Phillips,Potential for table and stand not to move due to a software error.,DESIGN: Software Design,"Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software.For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.",No consumer action necessary,26,26 units,Devices were distributed to hospitals and medical facilities through out the U.S.,Terminated,"November 19, 2010",28,73,Software,Device Operation,Software update,Software Update
Z-0122-2011,56503,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UKThe in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood Glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. The in2it (I) assay is intended for use in a physicians/doctors' office, the in2it (II) is intended for home use. The in2it Self Test system in intended for testing blood taken from a fingerstick. The test system is for self testing and for in-vitro diagnostic use only (not to be swallowed). The system shows how good glucose control has been over a two to three month period. The test system is the same as the test that has been CE marked for use in a clinical laboratory. The instructions for use have been changed with suggestions from people with diabetes. A patient study was conducted where untrained users ran their own blood tests and produced results which were as accurate as results obtained by trained users.",in2it Self Test System A1c Test Cartridge,2,"October 22, 2010", 2010,Bio-Rad Laboratories Inc,"Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.",DESIGN: Device Design,"BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401. Customers were instructed to run a test and visually inspect the test cartridge to detect any residual clear liquid. If the cartridge did not run properly the test was to be rejected.Customers were to run Quality Control test with each new shipment of test cartridges. Patient's results were not to be reported if the QC failed.Customers were to complete the CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the number provided on the form. For questions customers were to contact their regional BIO-RAD office.",N/A,90703,90703,"Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, New Zealand, China, Hong Kong, Portugal, Czech Republic, United Kingdom, Canada, Russia, Netherlands, Taiwan, Austria, Denmark, Israel, Finland and Belgium as well as to other African and Latin American countries.",Terminated,"October 25, 2011",368,90703,Not_Computer,N/A,N/A,N/A
Z-0126-2011,56730,"calibrators, ethyl alcohol",DNN,Clinical toxicology calibrator.,Toxicology,Toxicology,510(k),EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5,EndoTool Drug Dose Calculator,2,"October 22, 2010", 2010,"Hospira, Inc.",The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.,OTHER/UNDETERMINED: Pending,"Hospira issued an Urgent Device Field Correction letter dated July 23, 2010 to consignees, providing details of the potential issue and the associated patient risk. Hospira is finalizing software enhancements which will resolve this situation within the next 90 days ,and will contact each consignee when it is available to be downloaded from the Hospira website. The notification letter also included a clinical bulletin, outlining mitigation instructions for clinicians to use until the software enhancement is available. Consignees were requested to complete and return an attached Reply Form by fax.Customers can contact the Hospira EndoTool support line at 1-877-349-4582 for clinical inquiries about this recall.",N/A,97,97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5),"Nationwide Distribution in states of CA, FL, IL, IN, KY, KS, MI, MO, MT, NC, NJ, NM, NV, OH, SC, SD, TN, TX, VA, WA, and WY.",Terminated,"February 25, 2014",1222,97,Software,Alarm/Message,Software update,Software Update
Z-0140-2011,49605,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: ""Philips...Mobile C-Arm systems BV Pulsera"".",BV Pulsera R2.2 Mobile Xray system,2,"October 25, 2010", 2010,Philips Medical Systems North America Co. Phillips,"Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor",DESIGN: Component Design/Selection,"On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge.Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference ""FCO 71800024"" with any questions.",N/A,1331,1331 units,Nationwide distribution.,Terminated,"December 07, 2010",43,1458,Not_Computer,N/A,N/A,N/A
Z-0135-2011,56657,"instrument, coagulation, automated",GKP,Coagulation instrument.,Hematology,Hematology,510(k),"ACL TOP (Base)PN 000280000Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters",Instrumentation Laboratory,2,"October 25, 2010", 2010,Instrumentation Laboratory Co.,"Software: New data check, ""Multiple Threshold Check"", was added to identify and fail abnormal (bimodal) clot curves",DESIGN: Software Design,"Instrumentaion Laboratory notified the US Distributor/Canada via BCI Service Modification Notice (#10793) on August 13, 2010. The Mandatory software upgrade to Verison V4.3.0 in the United States and Canada will be conducted by BCI service representatives and tracked through the distributor, Beckman Coulter (BCI). International Affiliates/Dealers:Worldwide Regulatory Notices were e-mailed to IL international affiliates and dealers, notifying them of the mandatory software upgrade, providing issue description and a risk summary and the support. The upgrades were to be handled through the local representatives.",N/A,177,177 units,"Worldwide Distribution, USA and Canada",Terminated,"May 23, 2012",576,1076,Software,N/A,N/A,N/A
Z-0139-2011,56703,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Dimension Vista V-LYTE Standard A, Catalog No K820For the calibration of Na+/K+/Cl- on the Dimension vista System.",Dimension Vista VLYTE Standard A,2,"October 25, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.",OTHER/UNDETERMINED: Pending,"Siemens sent an Urgent Field Safety Notice (dated ""August 2010"") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.","For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.",3706,"3,706 cartons","USA, Nationwide Distribution",Terminated,"October 26, 2010",1,3706,Not_Computer,N/A,N/A,N/A
Z-0143-2011,56790,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"The label (which is affixed to ScanPoint Communications Cradle) states: ""...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA...""",Scanpoint Communication Cradles,3,"October 26, 2010", 2010,"Verathon, Inc.","Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.",DESIGN: Software Design (Manufacturing Process),"On 09/20/10, Verathon issued an URGENT: Medical Device Accessory Recall Notification letter dated September 20, 2010 to consignees, identifying the affected product, the issue prompting the recall, and actions to be taken by consignees.The consignees are instructed to return any cradles within the serial number range between CC012000-CC012084, and the Part Number 0570-0168.The firm will provide a replacement communication cradle at no cost. Consignees can contact Verathon Customer Care at 425-867-1348 or 800-2331-2313 or send e-mail to cservice@verathon.com.",No consumer action necessary,70,70 units,"Worldwide Distribution: U.S. nationwide including states AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, ND, NY, OH, PA, SC, TN, TX, UT, WI, and Washington DC, and the countries of Australia, Canada, France, South Korea, Taiwan, The Netherlands, and United Kingdom.",Terminated,"April 01, 2011",157,70,Software,Device Operation,Replace,Remove or Replace
Z-0413-2011,56580,"solvent, adhesive tape",KOX,Surgical skin degreaser or adhesive tape solvent.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.",Detachol Adhesive Remover,3,"October 26, 2010", 2010,"Ferndale Laboratories, Inc.","There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.",DESIGN: Component Design/Selection,"Ferndale Pharma Group issued an Urgent Medical Device Recall letter dated July 7, 2010 to customers identifying the affected product. Customers were instructed to identify and quarantine all affected product and return it to Ferndale Laboratories for a credit. Customers are requested to complete and return an enclosed response form.Customers can contact Ferndale at 800-621-6003.",N/A,55000,"55,000 bottles",Nationwide Distribution: Throughout the US.,Terminated,"March 02, 2011",127,55000,Not_Computer,N/A,N/A,N/A
Z-0145-2011,56893,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.",Surgical drill guide,2,"October 26, 2010", 2010,"Medtronic Navigation, Inc",Drill guide handle may detach unintentionally during use.,OTHER/UNDETERMINED: Pending,"Medtronic Navigation sent a ""Product Correction Notification"" letter dated September 22, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to set aside and do not use the Vertex Max Drill Guide 9732355, Lot Number 100526 and complete and return the Verification of Field Action Completion form via email: steve.murray@medtronic.com or fax: 720-890-3517. A Medtronic representative will contact the customer, visit their facility, remove the defective product, and provide a replacement Vertex Max Drill Guide that is correctly manufactured.For further information or if you have questions regarding use of the Vertex Max Drill Guide, please contact Medtronic Navigation Technical Services at 1-800-595-9709.",Contact the recalling firm for information,8,8 units,"Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.",Terminated,"April 13, 2011",169,8,Not_Computer,N/A,N/A,N/A
Z-0144-2011,56754,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755Angiographic X-ray System",Axiom Artis,2,"October 26, 2010", 2010,"Siemens Medical Solutions USA, Inc",Sporadic system crash while Perivision is performed.,DESIGN: Software Design,"Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.",N/A,286,286 units,USA - Nationwide Distribution,Terminated,"September 29, 2012",704,286,Not_Computer,N/A,N/A,N/A
Z-0147-2011,56844,"chair, with casters",INM,Mechanical chair.,Physical Medicine,Physical Medicine,510(K) Exempt,"Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. 2009 Model Numbers: 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.",Care Cliner ,2,"October 27, 2010", 2010,"Winco, Inc.","Winco Mfg., LLC, Ocala, Florida is recalling their Care Cliner. Due to malfunctioning axles which become lose from the caster assembly. This chair is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recalled chairs include the following: Care Cliner, XL Care Cliner, Drop Arm Care Cliner",DESIGN: Device Design,"Winco sent an Urgent Device Recall letter dated October 1, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Replacement parts were sent out to the consignees and customers were asked to dispose of the defective casters. Any consignee not reponding by November 15, 2010, would receive an additional letter. The firm placed a follow up phone call to the non responding consignees after two weeks.Customers were advised to call 800-237-3377 or email customer service at customerservice@wincomfg.com with questions or concerns.For questions or concerns regarding this recall call 352-854-2929 x 110.",N/A,18522,"18,522 casters","Worldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.",Terminated,"May 20, 2011",205,18522,Not_Computer,N/A,N/A,N/A
Z-0149-2011,56718,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3"" (13.5 cm), 1.0 mL, Male Luer Lock Adapter with Retractable Collar; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N1196For the administration of drugs and solutions to a patient's vascular system through a vascular access device.",Baxter NonDEHP YType Catheter Extension Set,2,"October 27, 2010", 2010,Baxter Healthcare Corp.,"During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.",DESIGN: Packaging Design/Selection,"Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",N/A,413750,"413,750 sets","Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.",Terminated,"September 07, 2011",315,1607774,Not_Computer,N/A,N/A,N/A
Z-0159-2011,55712,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.",Elekta Impac Software Sequencer,2,"October 28, 2010", 2010,Impac Medical Systems Inc,"Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers.Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery.Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ.IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans.For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.",N/A,19,19 units.,"Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy",Terminated,"March 28, 2011",151,19,Software,Treatment/Delivery/Therapy,Upgrade,Repair
Z-0160-2011,56148,"computer, diagnostic, pre-programmed, single-function",DXG,"Single-function, preprogrammed diagnostic computer.",Cardiovascular,Cardiovascular,510(k),"Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.",Edwards' MHANM8 Pressure Slave Cable,2,"October 28, 2010", 2010,"Edwards Lifesciences, Llc","The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.",DESIGN: Process Design,"Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number.Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned.For any questions regarding this recall call (949) 250-2007.",Contact the recalling firm for information,20,20 units,"Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand",Terminated,"May 24, 2011",208,20,Not_Computer,N/A,N/A,N/A
Z-0162-2011,56826,"accessories, catheter",KGZ,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.,Graft Jacket Xpress Flowable Soft Tissue Scaffold OPTIVA IV catheter component,2,"October 28, 2010", 2010,LifeCell Corporation,Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.",N/A,1507,1507 kits,"Nationwide Distribution: USA, to distributor in TN",Terminated,"August 17, 2012",659,1507,Not_Computer,N/A,N/A,N/A
Z-0167-2011,56975,"calibrator, dose, radionuclide",KPT,Radionuclide dose calibrator.,Radiology,Radiology,510(k),"Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.",Captus 3000 Thyroid Uptake System with Portable Stand ,2,"October 28, 2010", 2010,Capintec Inc,"The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.",TRAINING: Employee Error,"Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer.Customers can contact Capintec concerning this recall at 201 825-9500.",Contact the recalling firm for information,9,9 units,"Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.",Terminated,"July 05, 2012",616,9,Not_Computer,N/A,N/A,N/A
Z-0161-2011,56820,"device, monitoring, intracranial pressure",GWM,Intracranial pressure monitoring device.,Neurology,Neurology,510(k),"Licox Brain PMO Probe Kit;Ref IP2.P;Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe;Contains sterile and non-pyrogenic if package is unopened and undamaged.Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536","Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;",2,"October 28, 2010", 2010,Integra LifeSciences Corp.,"Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).",TRAINING: Employee Error,"Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers.Affected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned.Customers can contact Integra at 609 936-2495.",N/A,23,23kits,"Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.",Terminated,"April 18, 2012",538,23,Not_Computer,N/A,N/A,N/A
Z-0163-2011,56852,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.",Leksell Gamma Knife Perfexion with EXTEND Frame System,2,"October 28, 2010", 2010,"Elekta, Inc.",The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.,OTHER/UNDETERMINED: Pending,"Elekta issued an Important Notice: Urgent Field Safety Notice dated September 17, 2010 concerning Field Change Order 10000202003-A342 ""Important Notice regarding recall of mouthpieces for EXTEND system, to all users of the EXTEND system for LGK Perfexion. the letter identified the issue and associated potential hazard, and requested the identification and return of all affected mouthpieces, and confirmation of receipt of the letter. Elekta will arrange return and replacement through local service representatives.Customers can contact Elekta concerning this recall at 770 300 9725.",N/A,3,3 units,"Nationwide Distribution: to the states of MO, VA, and WA.",Terminated,"November 10, 2010",13,3,Not_Computer,N/A,N/A,N/A
Z-0165-2011,56908,"applier, hemostatic clip",HBT,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"LeMaitre Vascular AnastoClip GC Vessel Closure System-Large SizeModels:4007-03 Large size 3 Pack4008-03 Large size 10 Pack4007-07 Large size 1 PackManufactured by LeMatire Vascular Inc, Burlington, MA 01803",LeMaitre Vascular AnastoClip GC Vessel Closure SystemLarge Size Models: 4007,3,"October 28, 2010", 2010,"Lemaitre Vascular, Inc.","Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control,"LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.",Contact the recalling firm for information,108,108 units,"Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.",Terminated,"September 15, 2011",322,108,Not_Computer,N/A,N/A,N/A
Z-0166-2011,56352,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),"Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany",Siemens brand 550 TxT Patient Table,2,"October 28, 2010", 2010,"Siemens Medical Solutions USA, Inc",An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the Table. Both issues present the potential for injury to a patient or the operator.,OTHER/UNDETERMINED: Pending,"Siemens sent a Customer Information Letter on March 31, 2010, to all consignees. The letter identified the product, the problem, and the action that should be taken. Siemens implemented minor modifications to address the issues. No further action was required for the continual operation of the 550TxT Table. For questions regarding this recall call 925-602-8083.",N/A,326,326 units,Worldwide Distribution including USA,Terminated,"March 01, 2012",490,326,Hardware,Physical Safety Hazards,Correction,Repair
Z-0170-2011,56909,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.","Boston Scientific Peristaltic Tubing Kit, Model 2104",2,"November 01, 2010", 2010,Boston Scientific Corporation,Boston Scientific is conducting a Recall on CircuCool¶_ Tubing Sets used with the Chilli II¶_ Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints.,PRODUCTION CONTROLS: Packaging,"Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product. If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to:Boston Scientific CorporationUS Distribution CenterBoston Scientific Marina BayCustomer Fulfillment Center500 Commander Shea Blvd.Quincy, Massachusetts 02171RGA: _________________For additional questions call (510) 624-2563.",Contact the recalling firm for information,4694,"4031 US , 663 OUS","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan",Terminated,"April 17, 2012",533,4694,Not_Computer,N/A,N/A,N/A
Z-0169-2011,56858,N/A,N/A,N/A,N/A,N/A,N/A,"Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).",Bone Void Filler,2,"November 01, 2010", 2010,Theken Spine Llc,The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes.,OTHER/UNDETERMINED: Unknown/Undetermined by the firm,"Theken Spine Llc sent Recall Notification Letters dated August 26, 2010, to all customers. One (1) document, titled an 'Urgent Product Recall Notification' letter was addressed: 'ATTENTION; PRODUCT RECALL COORDINATOR/RISK MANAGER.' The other letter was titled: 'RECALL NOTIFICATION.' The recall letters were accompanied by an attached 'Recall Acknowledgement and Return Form' and were sent out via Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. The letters requested that the customers review their product in inventory and identify any product remaining from the affected lot numbers; part numbers; and/or item names for immediate return of these items to the recalling firm. The letters also asked that the customer complete and return the attached Recall Acknowledgement and Return form according to the instructions provided on the form. In addition, the 'RECALL NOTIFICATION' letter instructed the distributor/customers provide information concerning their sub-account customers to Theken Spine so they could issue a Recall Notification letter to these customers as well. To obtain instructions from the recalling firm concerning product return and issuance of credit, customers were instructed to call (866) 942-8698. For questions regarding this recall call (330) 825-8258.",No consumer action necessary,2904,2904 units (syringes),"Nationwide Distribution - including UT, SD, TX, AL, PA, CA, MI, OH, NJ, NH, MD, ID, FL, LA, NM, TN, IA, and OR.",Terminated,"October 27, 2011",360,2904,Not_Computer,N/A,N/A,N/A
Z-0171-2011,56921,"system, x-ray, mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),"Mobilett XP and Mobilett XP Hybrid, Mobile radiology deviceSystem, x-ray, mobile",Mobilett XP,2,"November 01, 2010", 2010,"Siemens Medical Solutions USA, Inc",Units not equipped with protective plastic cover over electronics.,DESIGN: Device Design,"Siemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded.For questions regarding this recall call (610) 448-3237.",N/A,177,177 units,"Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.",Terminated,"September 29, 2012",698,177,Not_Computer,N/A,N/A,N/A
Z-0168-2011,56794,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.",Volcano s5/s5i imaging system software version 3.2,2,"November 01, 2010", 2010,Volcano Corporation,"Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.",DESIGN: Software Design,"Volcano issued a Voluntary Recall of Volcano s5 Family Software version 3.2 letter dated June 30, 2010, identifying the software defect and actions to be taken by Volcano. Field Service Engineers will visit each site and reinstall the previous software version, which will resolve the issue.Customers can contact Volcano at 916 281-2790.",N/A,79,79 software kits,"Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.",Terminated,"December 22, 2010",51,79,Software,Display/Image,Reinstall previous version,Software Update
Z-0134-2011,56902,"instruments, surgical, cardiovascular",DWS,Cardiovascular surgical instruments.,Cardiovascular,Cardiovascular,510(K) Exempt,"Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only. The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy.",Medtronic Octopus Nuvo Tissue Stabilizer,1,"November 01, 2010", 2010,Medtronic Perfusion Systems,"Medtronic has received reports regarding the Octopus Nuvo Tissue Stabilizer stating that during use, the collet (a component of the device that stabilizes the head link) fractured, thereby causing immediate separation of the head link from the shaft of the device. The resulting potential hazards are that fragments of the collet could fall into the patient's chest cavity and/or damage the heart ti",DESIGN: Component Design/Selection,"Medtronic sent an ""Urgent Medical Device Recall Notice"" dated September 14, 2010, to Risk Managers at each affected account. The letter described the issue, identified affected lot numbers, asked for immediate discontinued use of the device, quarantine all unused devices and to return unused devices to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428 and requested a recall certificate be faxed back to Medtronic indicated acknowledgement of the Recall Notice and quantity to be returned.If you need additional information, please contact Medtronic Cardiovascular Lifeline Technical Services at 877-526-7890, or your local Medtronic sales representative.",Contact the recalling firm for information,571,571 units,"within the US to: AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and Washington D.C. OUS to include: Belgium, Canada, Germany, Italy, Poland, Switzerland, United Kingdom.",Terminated,"April 16, 2012",532,571,Not_Computer,N/A,N/A,N/A
Z-0288-2011,53863,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"The product is a 19"" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems","Spacelabs Medical Flat Panel Display, Model 9426019",2,"November 02, 2010", 2010,"Spacelabs Healthcare, Incorporated","The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment.",N/A,"On 10/23/09, Spacelabs issued URGENT: MEDICAL DEVICE RECALL notification letters dated October 23, 2009 to their consignees.The notification states the recalled product as Spacelabs Medical 19"" Flat Panel Display, Model 94260-19. The consignees are informed that there is apossibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally.The firm's Field Service Engineer will be contacting the consignees to set up a convenient time to schedule the upgrades of the affected displays. Displays with part number ET1920L-7SKR-1-35S-SPC are not part of this recall and should not be sent in for upgrading.The firm recommends that their consignees brief their staff on the possibility of the display going blank to help prevent an adverse event from happening. The firm will be providing loaners while the affected displays are upgraded at free of charge.If the consignees have any questions about the recall, they could contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support . Consignees outside the United States may call 1-425-657-7200 x 5089.",Contact the recalling firm for information,2560,"2560 units (2020 domestic, 540 international)","Worldwide Distribution: USA in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY, and the following countries: Australia, Austria, Canada, Czech Republic, Egypt, France, Germany, Grand Cayman, Greece, India, Israel, Italy, Kuwait, Lebanon, Mexico, Netherlands, Pakistan, Panama, Poland, Puerto Rico, Saudi Arabia, Singapore, Slovakia , South Africa, Switzerland, Trinidad and Tobago, Turkey, United Kingdom, and Venezuela.",Terminated,"November 03, 2010",1,2560,Hardware,Display/Image,Replace,Remove or Replace
Z-0308-2011,55242,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),Panta Support Device Panta¶_ Arthrodesis Nail Instrumentation Tray One unit per package.The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.,Panta Arthrodesis Nail,2,"November 02, 2010", 2010,Integra LifeSciences Corporation,"Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative.All customers were requested to complete and return a Recall Acknowledgement and Return Form..",N/A,108,108 Units,"Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, South Africa, Spain, Switzerland, and United Kingdom.",Terminated,"February 16, 2012",471,108,Not_Computer,N/A,N/A,N/A
Z-0293-2011,56938,"implant, intragastric for morbid obesity",LTI,N/A,N/A,Gastroenterology/Urology,N/A,"REALIZE¶_ Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V",REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube ,2,"November 02, 2010", 2010,Ethicon Endo-Surgery Inc,"The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca",N/A,"Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken.Consignees were instructed:DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall.Examine inventory and remove the affected product.If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle.If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle.A redesigned replacement product will be sent out to consignees within 30-60 days of product return.Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.",Contact the recalling firm for information,105,105 pieces,"Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.",Terminated,"November 18, 2011",381,127130,Not_Computer,N/A,N/A,N/A
Z-0129-2011,56735,"accessories, soft lens products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.",COMPLETE MultiPurpose Solution,2,"November 02, 2010", 2010,Abbott Medical Optics Inc (AMO),"The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.",PRODUCTION CONTROLS: Process Control,"AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products.Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.",N/A,34080,"34,080 units","International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.",Terminated,"October 13, 2011",345,34224,Not_Computer,N/A,N/A,N/A
Z-0309-2011,56837,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"3.5mm LCP Periarticular Proximal Humerus PlatesIndicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone",3.5mm LCP Periarticular Proximal Humerus Plates,2,"November 02, 2010", 2010,"Synthes USA (HQ), Inc.",screw can pass through plate hole,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Synthes (USA) notified all Synthes Trauma Hospital accounts of record of this recall via an Urgent Medical Device Recall letter dated September 27, 2010. The notification included instructions for hospital accounts to immediately cease use of the product, examine inventory, remove the 3.5 mm LCP Periarticular Proximal Humerus Plates from their shelves and complete and return the attached Verification Section form via mail: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; fax: 610-215-9005 or Scan/email: FieldAction@synthes.com. If they have any of the identified devices, they were to call Synthes at 1-800-479-6329 to obtain Authorization number prior to completing Verification form.If you have any questions, please call 1-800-620-7025 x5403 or contact your Synthes Trauma Sales Consultant.",Contact the recalling firm for information,2849,2849 units,"Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey",Open,N/A,N/A,2849,Not_Computer,N/A,N/A,N/A
Z-0287-2011,56324,permanent pacemaker electrode,DTB,Cardiovascular permanent or temporary pacemaker electrode.,Cardiovascular,Cardiovascular,510(k),"enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.",enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead,2,"November 02, 2010", 2010,Greatbatch Medical,The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.,TRAINING: Employee Error,"Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included:1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical.2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listedGreatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.",Contact the recalling firm for information,34,34,"Worldwide Distribution: to USA and Europe, through distributor in MN.",Terminated,"May 10, 2012",555,34,Not_Computer,N/A,N/A,N/A
Z-0311-2011,55287,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"microTargeting Drive System with Mounted AccessoriesCatalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic)Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.",microTargeting Drive System,2,"November 03, 2010", 2010,"FHC, Inc.",Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.,DESIGN: Device Design,"FHC issued an ""URGENT: MEDICAL DEVICE CORRECTION"" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day.Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.",N/A,18,18 units,"Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.",Open,N/A,N/A,63,Not_Computer,N/A,N/A,N/A
Z-0316-2011,55748,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA.The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.",BD FACS Sample Prep Assistant III (BD SPA III),2,"November 03, 2010", 2010,"BD Biosciences, Systems & Reagents","Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results.The piece of the lid clogging the Probe can be in the processed sample tube. It has the",DESIGN: Device Design,"BD Biosciences sent an ""Important Product Information"" letter dated February 2010 and an ""URGENT: Follow-Up to Letter Dated February 2010"" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers.Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.",N/A,349,349 units,"Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.",Terminated,"May 18, 2011",196,349,Not_Computer,N/A,N/A,N/A
Z-0315-2011,56499,"prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented",KWY,Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.,Orthopedic,Orthopedic,510(k),Distal Centralizer 10 mm,Ortho Development Primaloc Cemented Hip System,2,"November 03, 2010", 2010,Ortho Development Corporation,The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.",N/A,39,39 units,Worldwide Distribution: Japan,Terminated,"November 04, 2010",1,39,Not_Computer,N/A,N/A,N/A
Z-0317-2011,56668,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT cTnl cartridgeAbbott Point of Care,Princeton, NJ 08540",iSTAT cTnl cartridge,2,"November 03, 2010", 2010,Abbott Point Of Care Inc.,"i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.",OTHER/UNDETERMINED: Pending,"Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.",N/A,482500,"482,500 (total number)",Worldwide Distribution: USA and Canada.,Terminated,"September 14, 2011",315,482500,Not_Computer,N/A,N/A,N/A
Z-0310-2011,56825,negative pressure wound therapy powered suction pump,OMP,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"smith&nephew; EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 VIndicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England",Negative Pressure Wound Therapy Powered Suction Pump,2,"November 03, 2010", 2010,Smith & Nephew Inc.,"Smith&Nephew; Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew; between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin",OTHER/UNDETERMINED: Pending,"Smith & Nephew Inc. FEDEXed overnight an URGENT DEVICE RECALL letter dated January 27, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were to check their inventory and identify any affected product, fill out and return the response form by both mail and fax, and return the affected product with the prepaid Federal Express (FedEx) Ground label provided by Smith & Nephew. For any questions regarding this recall contact the Customer Care Center at (800) 876-1261.",N/A,2717,2717 units,"Worldwide Distribution - US including AL, AR, AZ, CA, GA, IL, IN, MA, MD, MD, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and UT and the countries of Australia, UK, South Africa, Canada, Puerto Rico, and New Zealand.",Terminated,"November 10, 2010",7,2717,Not_Computer,N/A,N/A,N/A
Z-0320-2011,52231,"accessories, implant, dental, endosseous",NDP,Endosseous dental implant accessories.,Dental,Dental,510(K) Exempt,"Straumann T-Sleeve 2.8mm, height 6mm, guidedArticle Number: 034.055V46Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.",Straumann TSleeve,3,"November 04, 2010", 2010,Straumann Manufacturing Inc.,Incorrect Inner diameter of the T-sleeve,PRODUCTION CONTROLS: Process Control,"Strauman USA LLC notified the consignee by telephone on June 4, 2009, and sent an Urgent Device Recall letter dated, June 8, 2009 as a follow-up. The letter described the product, the problem, and the action to be taken by the customer. The customer was asked to return any affected product, in the prepaid preprinted mailer pouch as soon as possible to:T-sleeve Recall, Straumann USA, LLC60 Minuteman RoadAndover, MA, 01810Customers were asked to sign and indicate on the Recall Acknowledgement Form if they would like a replacement product or a credit to their account for the product returned and fax the form to (978) 747-0023.For any questions regarding this recall call (978) 747-2575.",Contact the recalling firm for information,3,3 units,Worldwide Distribution - Canada,Terminated,"February 20, 2012",473,3,Not_Computer,N/A,N/A,N/A
Z-0321-2011,56785,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244.Endosseous dental implant healing abutment.","Singlestage 3.5mm Healing Abutment, 4mm",2,"November 04, 2010", 2010,BioHorizons Implant Systems Inc,Healing abutment may not fully seat on the implant.,OTHER/UNDETERMINED: Pending,"Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.",Contact the recalling firm for information,396,396,"Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.",Terminated,"December 13, 2010",39,396,Not_Computer,N/A,N/A,N/A
Z-0305-2011,56164,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.",B. Braun addEASE Binary Connector,1,"November 05, 2010", 2010,B. Braun Medical Inc,"During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.",DESIGN: Device Design,"On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached ""Product Removal Acknowledgement"" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility.Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.",Contact the recalling firm for information,33905600,"33,905,600 units",Worldwide Distribution -- USA and Canada.,Terminated,"October 19, 2011",348,36405600,Not_Computer,N/A,N/A,N/A
Z-0307-2011,56750,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"WalkMed Triton Pole Mount Infusion Pump, Catalog 300000.Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.",Volumetric Infusion Pump,1,"November 05, 2010", 2010,Walkmed Infusion LLC,"Pump door may be in a near shut position, but unlatched, and the ""Door Open"" alarm may not sound.",DESIGN: Device Design,"All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.",Discard product or return to place of purchase for a full refund or exchange,1565,1565 pumps,"Nationwide Distribution -- AL, CA, FL, and PA.",Terminated,"March 14, 2012",495,1565,Software,Alarm/Message,Software update,Software Update
Z-0146-2011,56833,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX.To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.",Sigma Spectrum VOLUMETRIC INFUSION PUMP,1,"November 05, 2010", 2010,"Sigma International General Medical Apparatus, Llc","The infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion.",DESIGN: Device Design,"Urgent: Medical Device Recall Notification letters and forms (dated 9/14/10) were sent to the consignees via Certified Mail on/about 9/15/10. The letters inform the consignees of the recall of the pumps since these units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. Consignees are instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to possible bearing failure, SIGMA is taking the precautionary measure of servicing or replacing all affected Spectrum Infusion Pumps and is requiring the return of the recalled devices to its facility. SIGMA has provided the following instructions for users: (1) Do not use the affected Spectrum Infusion Pumps on patient populations where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death. (2) Do not use on neonatal patients. -- If the user facility has no acceptable alternative methods for delivering therapy, the user should weigh the risks and benefits for the continued use of the affected pumps. If you must use these pumps, SIGMA recommends the following actions which may mitigate the risk. (1) for pediatric and adult patients, an add-on Buretrol may limit the amount of an over-infusion if the failure occurs. Always follow the Buretrol manufacturer's instructions. (2) consider using air-eliminating filters. Under free flow conditions pumps cannot stop fluid flow. If air is in the line with fluid, the air will also infuse. (3) Frequently observe that the drip rate (mL/hr) compares to the programmed pump flow rate. Also, make an observation of the container volume to make sure it is correct. If a discrepancy is observed, immediately remove the pump from service and treat the patient as appropriate. There are additional instructions to Asset Management Customers: SIGMA requests that each A.",Contact the recalling firm for information,17557,"17,557 Infusion Pumps",Nationwide Distribution,Open,N/A,N/A,17557,Not_Computer,N/A,N/A,N/A
Z-0323-2011,55655,"stimulator, muscle, powered",IPF,Powered muscle stimulator.,Physical Medicine,Physical Medicine,510(k),"The device is labeled in part: "" RS Medical RS-4i Stimulator"". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual.This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve pain. The device requires a prescription from a physician. It is programmed by an RS medical employee (or Account Manager) to the physician's specific treatment plan for each patient. The patient is given instructions on how to utilize the device (proper electrode placement). Powered MUSCLE Stimulation indications for use including: 1) Relax muscle spasm. 2) Prevention or retardation of disuse atrophy. 3) Maintain or increase range of motion. 4) Increase local blood circulation. 5) Re-educate muscle. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. INTERFERENTIAL Stimulation indications for use including: 1) Relieve acute pain. 2) Relieve and manage chronic pain.",RS4i Sequential Stimulator; ,2,"November 08, 2010", 2010,"International Rehabilitative Sciences, Inc.","The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and it causes the device to be inoperable.",OTHER/UNDETERMINED: Pending,"Since June 11, 2008, RS Medical has taken the following actions when the device was sent back through a consumer complaint, or when the device was returned for routine maintenance, or through the rental service. The firm has upgraded the blocking diodes with higher temperature rated diodes, replaced the Lithium coin cell battery, and the software register bit has been changed to denote for subsequent automated testing that the diode upgrade/Lithium coin cell battery replacement has occurred. The firm reported that the device must be returned for the rechargeable NiMH battery replacement around two years of use, and the battery should not be replaced by patients.On 10/29/10, the firm began sending out URGENT NOTICE of VOLUNTARY RECALL letters to their customers. The firm will continue to send out the letters through 2011. The letter states the recall product as RS-4i Sequential Stimulator, Affected Serial Numbers 4i300000 to 4i467119. The customers are informed that ""RS-4i Sequential Stimulators, only those within the affected serial number range indicated above, are susceptible to early expiration of the lithium coin cell battery that provides back-up power to the device memory when the stimulator is powered OFF. Customer experience indicates that the 3V lithium coin cell battery can be depleted as early as one third of its rated life. The RS-4i Stimulator will perform as intended until the lithium coin cell battery is fully depleted. When this happens, the Stimulator will turn OFF and fail to turn ON, even if it has been charged by battery charger connection to a standard electrical wall outlet"".Customers are advised to make a schedule for a free Return and Repair of a RS-4i Sequential Stimulator and should call the Toll Free Service Line at 877-363-5753 (English) or 877-363-5754 (Spanish) from 6AM to 5PM (Pacific Time) Monday-Friday.If the customers have any other questions or to review additional information before scheduling a device .",N/A,297,"166, 131 units",Nationwide Distribution,Terminated,"September 10, 2012",672,297,Battery,Device Operation,Replace,Remove or Replace
Z-0328-2011,56628,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,"Stryker M1 Ambulance cot, Model 6100, Stryker Medical, Kalamazoo, MI.",Stryker Model 6100 M1 Ambulance Cot,2,"November 08, 2010", 2010,Stryker Medical Div. of Stryker Corporation,"The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures.",DESIGN: Device Design,"Stryker Medical sent an Urgent Medical Device Alert letter dated May 15, 2010 to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter stated that there is a possibility for fatigue related failures of certain components of the cot and that a Stryker representative will visit the firm to correct the device. A representative from Stryker field service would contact the customer to perform the device corrections, free of charge.Immediate Action required by the customer:Locate the ambulance cots listed in this notice.Return the enclosed post card to confirm receipt of this notification.If any of the cots listed in the letter were loaned or sold the customer was to forward a copy of the notice to the new users and advise Stryker of their new location.If the customer disposed of any of the affected stretchers and they were no longer in use, customers were to advise Stryker of their obsolescence by providing the serial numbersFor any questions or comments regarding this issue, please call (800) 869-0770, ext. 6902.",Contact the recalling firm for information,7314,"7,314","Worldlwide Distribution - US including AZ, CA, CO, FL, LA, MS, NC, NJ, OH, PA, and TN and the countries of Australia, China, France, Germany, Hong Kong, Italy, Japan, New South Wales, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.",Terminated,"February 07, 2012",456,7314,Not_Computer,N/A,N/A,N/A
Z-0322-2011,56255,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart MRx Defibrillator/MonitorModels: M3535A / M3536A / M3536J / M3536MCThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician",Philips Healthcare HeartStart MRx ,2,"November 08, 2010", 2010,Philips Healthcare Inc.,"Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on:"" Default ECG Lead Behavior"" Synchronized Cardioversion using External Paddles",DESIGN: Labeling Design,"Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification.For questions regarding this recall call (800) 722-9377.",N/A,41119,"41,119 units",Worldwide Distribution - US Nationwide and the countries of: CANADAAFGHANISTANALBANIAARGENTINAARUBAAUSTRALIAAUSTRIAAZERBAIJANBAHRAINBELGIUMBOSNIA&HERZEGOVINA;BRAZILBRUNEI DARUSSALAMBULGARIACHILECHINACOLOMBIACYPRUSCZECH REPUBLICDENMARKECUADOREGYPTESTONIAFINLANDFRANCEGERMANYGREECEGUADELOUPEHONG KONGHUNGARYICELANDINDIAINDONESIAIRELANDISRAELITALYJAPANJORDANKENYAKUWAITLATVIALEBANONLIBYAN ARAB JAMAHIRILITHUANIALUXEMBOURGMACEDONIAMALAYSIAMEXICOMOROCCONAMIBIANETHERLANDSNETHERLANDS ANTILLESNEW CALEDONIANEW ZEALANDNICARAGUANORWAYOMANPAKISTANPALESTINEPANAMAPAPUA NEW GUINEAPERUPHILIPPINESPOLANDPORTUGALPUERTO RICOQATARREUNIONROMANIARUSSIASAUDI ARABIASERBIA&MONTE; NEGROSINGAPORESLOVENIASOUTH AFRICASOUTH KOREASPAINSRI LANKASWEDENSWITZERLANDTAIWANTHAILANDTRINIDAD AND TOBAGOTUNISIATURKEYUGANDAUKRAINEUNITED ARAB EMIRATESUNITED KINGDOMVENEZUELAVIET NAMYEMEN,Terminated,"September 05, 2012",667,41119,Not_Computer,N/A,N/A,N/A
Z-0332-2011,55301,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. Intended Use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed supports patients between 250 and 1000 pounds.",Excel Care Bariatric Bed,2,"November 09, 2010", 2010,"Hill-Rom, Inc.","The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers.",DESIGN: Device Design,"Hill-Rom sent out ""Urgent Medical Device Correction"" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail.If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.",N/A,1406,"1,406 beds both models.","Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates.",Open,N/A,N/A,1406,Not_Computer,N/A,N/A,N/A
Z-0329-2011,55840,"lamp, infrared, therapeutic heating",ILY,Infrared lamp.,Physical Medicine,Physical Medicine,510(k),"Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CAInfrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.",Titan XL,2,"November 09, 2010", 2010,Cutera Inc,"Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.",DESIGN: Device Design,"Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices.For questions contact customer service at (888) 428-8372, ext 5561.",N/A,1344,"1,344 units","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.",Terminated,"December 28, 2010",49,1344,Not_Computer,N/A,N/A,N/A
Z-0330-2011,56800,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"External Compression Device; 1 unit per packageStryker Trauma GmbH;Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.",External Compression Device,2,"November 09, 2010", 2010,Stryker Howmedica Osteonics Corp.,Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.,OTHER/UNDETERMINED: Pending,"Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to:Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation.Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice.A Stryker representative would contact the customer with details for return of the product.For any questions regarding this recall call (201) 972-2100.",N/A,11,11,"Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX",Terminated,"August 21, 2012",651,33,Not_Computer,N/A,N/A,N/A
Z-0334-2011,57024,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 The implantable Medtronic Model 8731SC intrathecal catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port.To deliver parenteral drugs to the intrathecal space. The needle is used to facilitate the placement of the catheter. The needle is inserted percutaneously into the intrathecal. The needle stylet is then removed to confirm the needle placement through observing backflow of cerebrospinal fluid (CSF) through the needle. The needle stylet prevents tissue coring and also minimizes loss of CSF. The spinal segment tip of the catheter is inserted through the needle until the catheter is advanced to the desired location. Once the catheter position is verified through fluoroscopy, the needle is carefully removed and discarded.","Medtronic Intrathecal Catheter, 8731SC ",2,"November 09, 2010", 2010,"Medtronic, Inc. - Neuromodulation",Medtronic is recalling specific lots of Model 8731SC intrathecal catheter kits and Model 8598A intrathecal catheter spinal revision kits because there is the potential that the 11.4 cm introducer needles within these kits may exceed USP requirements for bacterial endotoxin.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Medtronica sent an ""Urgent: Medical Device Recall"" letter, dated September 2010, was sent to medical facilities/customers beginning September 29, 2010. The letter described the issue, identified affected product, requested that unused inventory be segregated and returned to Medtronic Neuromodulation per the enclosed Product Return Instructions form. A Recall Reply Card was also asked to be returned. Additionally an ""Urgent: Medical Device Recall"" letter was addressed to Healthcare Providers/customers to inform them of the recall of the Catheter and Revision Kits, identified patients by means of registration information, Informed them of the issue with the needle inside the kits, and requested they stop using the specific lots and to monitor any patients for symptoms. If you have any questions or comments, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.",Contact the recalling firm for information,1323,1323,"AL, CA, CO, CT, FL, GA, HI, ID. IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, WY. OUS to include: Argentina, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, San Marino, Jordan, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.",Terminated,"December 10, 2011",396,1743,Not_Computer,N/A,N/A,N/A
Z-0339-2011,56973,"stent, carotid",NIM,N/A,N/A,Cardiovascular,N/A,"RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and",RX ACCULINK Carotid Stent System ,2,"November 10, 2010", 2010,Abbott Vascular,The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.,PRODUCTION CONTROLS: Process Control,"Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning anyunused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter.The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular.For questions regarding this recall call (951) 914-3324.",N/A,42,42 units total for all products,"Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI",Terminated,"November 16, 2010",6,42,Not_Computer,N/A,N/A,N/A
Z-0343-2011,56976,"fluorometric method, cpk or isoenzymes",JHX,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer",Stratus(R) CS Rotors,2,"November 10, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.",Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.,PRODUCTION CONTROLS: Process Control,"The recalling firm, SIEMENS, issued an ""Urgent Field Safety Notice"" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers. The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A ""no-charge"" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467.If you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.",N/A,330,330 bags,"Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI, and WV and country of Canada",Terminated,"November 10, 2010",0,330,Not_Computer,N/A,N/A,N/A
Z-0341-2011,56751,"apparatus, autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(k),"The box label states: ""ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician"".The ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir.ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a ¶_ inch. suction port and is connected to a vacuum source.ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter.ATF 40 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.",ATF 40 (item 9108491),2,"November 10, 2010", 2010,"Fresenius Kabi, LLC","Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message ""alarm blood flow"" and the CATS device stops in a secure mode.",OTHER/UNDETERMINED: Pending,"Fresenius Kabi sent out a Technical Notification letter dated March 29, 2010, to one distributor located in Ann Arbor, Michigan. The distributor sent the technical notification with a cover letter to each of their customer's that had ordered AT1's, ATF120's and ATF40's over the last year. The letter identified the product, the problem, and the action to be taken. Customers were notified that the autotransfusion prime and / or washing procedure can be continued after alarm blood flow by following Alternative procedures. The Technical Notification informs the distributor about the problem of the AT1 (item #9005101), but also mentions the other two products ATF120 (item #9108501) and ATF40 (item #9108491) which have no known problem.The distributor is advised to contact Fresenius Kabi, LLC for any question regarding the Technical Notification.For questions regarding this recall call (425) 242-2074.",N/A,444,"17, 444 units distributed in US","Worldwide Distribution - USA and the countries of Australia,Austria, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, Phillipines, Portugal, Switzerland, Thailand, UK, and Vietnam.",Terminated,"June 15, 2011",217,1384,Not_Computer,N/A,N/A,N/A
Z-0344-2011,56863,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.",SoftLab/Mic ASCII Addon ,2,"November 10, 2010", 2010,SCC Soft Computer,"When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.",DESIGN: Software Design,"Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.",N/A,31,31,Nationwide Distribution - US and Puerto Rico.,Terminated,"July 17, 2012",615,31,Software,N/A,N/A,N/A
Z-0236-2011,56760,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"VITEK 2 Gram Negative Susceptibility Card, AST-N134, REF 22 319, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.","VITEK 2 Gram Negative Susceptibility Card, ASTN134",1,"November 11, 2010", 2010,Biomerieux Inc,"AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"bioMerieux issued a ""Product Correction Notice"" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the ""Actions Required"" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged ""URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786."" The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz.",Contact the recalling firm for information,10091,"10,069 boxes as of 3/8/11","Worldwide Distribution: USA (all states), and the countries of:SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.",Terminated,"May 08, 2012",544,1859979,Not_Computer,N/A,N/A,N/A
Z-0349-2011,51883,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"ViewSonic 19"" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001.The ViewSonic 19"" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products",19 ViewSonic LCD VG930M Display,2,"November 12, 2010", 2010,"Welch Allyn Protocol, Inc","The 19"" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On May 1, 2009, Welch Allyn Protocol, Inc. sent out recall notification to their consignees in via UPS and US Postal Certified Mail.The letter describes the recalled product as 19"" model VGM930M ViewSonic flat panel LCD display with serial numbers less than QC2082880001. For the Welch Allyn service contract consignees/customers, the firm's Field Service Engineer will replace the LCD monitor for the consignees. The consignees could contact Technical Support at 1-800-289-2501.For the Warranty/non-Warranty contract consignees/customers-For the Welch Allyn service contract consignees, Stericycle Return Management Services (RMS) will manage all recall and recovery initiatives. Consignees/customers can call Welch Allyn Customer Care at 1-800-535-6663 for any questions or concern about this recall.",N/A,637,637 units,"Worldwide distribution: USA including states of: AK, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VT, WI, and WV; and countries including: AUSTRALIA, CANADA, ESTONIA, GERMANY, ICELAND, IRELAND, ITALY, JORDAN, MALAYSIA, POLAND, and RUSSIA.",Terminated,"July 25, 2011",255,637,Hardware,Display/Image,Replace LCD,Remove or Replace
Z-0358-2011,53048,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA;Product is manufactured by Boston Scientific Corporation, Cork, Ireland",Renegade Fiber Braided Microcatheter,2,"November 15, 2010", 2010,Boston Scientific Corporation,"Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.",PRODUCTION CONTROLS: Packaging Process Control,"Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers.Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific.Customers can contact Boston Scientific at 510 624-1734.",Contact the recalling firm for information,N/A,N/A,"Distribution Worldwide, including throughout the US.",Terminated,"February 03, 2011",80,N/A,Not_Computer,N/A,N/A,N/A
Z-0367-2011,55839,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringeThe contents of the package are intended to be used in the delivery of contrast media.",MEDRAD Sterile Disposable Syringe Kit Recall,2,"November 15, 2010", 2010,Medrad Inc,Some kits have a hole in the packaging which could compromise the sterility of the components.,PRODUCTION CONTROLS: Packaging,"MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take.Customers were instructed to identify the product with the affected lot numbers.Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product.Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942.For any questions regarding this recall call (412) 767-2400, ext 6851.",N/A,39448,"39,448 syringe kits","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore.",Terminated,"November 17, 2010",2,39448,Not_Computer,N/A,N/A,N/A
Z-0351-2011,56792,"device, vein stabilization",LBJ,Vein stabilizer.,General Hospital,General Hospital,510(K) Exempt,"Baxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter Extension Set Kit; 7.6"" (19.3 cm), Vol. 1.0 mL, 1 Catheter Extension Set with Luer Activated Device with Silver for IV Access and Male Luer Lock Adapter with Retractable Collar, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 6N8220",Baxter VLINK Luer Activated Device with Vitalshield NonDEHP Catheter Extension Set Kit,3,"November 15, 2010", 2010,Baxter Healthcare Corp.,The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. The device is labeled as nonpyrogenic.,DESIGN: Component Design/Selection,"Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.",N/A,73350,"73,350 units",Nationwide Distribution: Throughout the US.,Terminated,"October 04, 2011",323,172300,Not_Computer,N/A,N/A,N/A
Z-0363-2011,56461,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare Transport Pro¶_ Monitor with the CARESCAPE"" Patient Data Module.",Solar 8000i with Patient Data Module / Transport Pro Monitor,2,"November 15, 2010", 2010,"GE Healthcare, LLC",Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer,DESIGN: Software Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated September 17, 2010 to consignees. The letter was addressed to Hospital Administrator, Head of Biomedical Engineering and Nursing Manager. The letter described the product, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Service representatives will updates all of the affected Transport Pros with PDM that were distributed.Customers may contact GE at 262-548-2731 about this correction.",Contact the recalling firm for information,3256,3256,"Worldwide Distribution: Domestic in the states of AL, AZ, AR, CA,CT, CO, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, and WY, and Internation in the countries of BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY GREECE, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MAURITIUS, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD 7 TOBAGO, and the UNITED KINGDOM.",Terminated,"May 17, 2012",549,3256,Software,Display/Image,Software update,Software Update
Z-0364-2011,56865,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.",SA BASE with SoftLab Version 3.1.4.x.,2,"November 15, 2010", 2010,SCC Soft Computer,"Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated to a patient record.",DESIGN: Software Design,"Clients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.",N/A,40,40,"Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.",Terminated,"July 16, 2012",609,40,Software,Display/Image,Software update,Software Update
Z-0369-2011,56814,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.",GE BrightSpeed CT,2,"November 15, 2010", 2010,"GE Healthcare, LLC",GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.,DESIGN: Software Design,"An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded.If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.",Contact the recalling firm for information,946,946,"Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.",Terminated,"May 15, 2012",547,1014,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0362-2011,56872,"software, blood bank, stand alone products",MMH,Automated blood grouping and antibody test system.,Hematology,Hematology,510(k),"SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.23.1:BK040048 23.2:BK080020 25.0:BK090017The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.","SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.",2,"November 15, 2010", 2010,SCC Soft Computer,"SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient history reports using Patient",DESIGN: Software Design,"SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled ""Risk-to-Health Notification Task Verbiage"" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments.If you have any questions, contact (727) 789-0100.",N/A,30,30,Worldwide distribution: U.S. and country of Canada.,Terminated,"September 05, 2012",660,30,Software,Output/Calculation,Software update,Software Update
Z-0360-2011,56873,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).",SoftID.NET versions 2.0.0.6 2.0.0.19. ,2,"November 15, 2010", 2010,SCC Soft Computer,"SCC Soft Computer issued a Correction for SoftID.NET versions 2.0.0.6 - 2.0.0.19. When using the Cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. All affected clients have been notified.",DESIGN: Software Design,"SCC Soft Computer notified Customers on August 28, 2009, via the proprietary communication software entitled ""Risk-to-Health Notification Task Verbiage"" dated August 17, 2009. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; document a request to load the software, if they wish to receive the correction; document that the Alternative Working Solution will be used by the customers facility until the correction has been taken live.If you have any questions, contact (727) 789-0100.",Contact the recalling firm for information,41,41,"Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.",Terminated,"November 16, 2011",366,41,Software,Output/Calculation,Upgrade,Repair
Z-0361-2011,56940,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ENDOPATH¶_ ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.",ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters,2,"November 15, 2010", 2010,Ethicon Endo-Surgery Inc,"The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time, tissue manipulation, and a change in t",OTHER/UNDETERMINED: Pending,"Ethicon Endo-Surgery issued ""Urgent Device Recall Event 1952"" notification letters dated January 21, 2009 to their customers. They instructed their custormers to immediately discontinue use of the product. They are to complete and fax back the Business Reply Form. Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle. Replacement product should be received within 30-60 days after return.Customers can contact Stericycle concerning this recall at 1-866-861-6921, reference Event 1952.",N/A,4113,"4,113 UNITS","Worldwide Distribution: USA only, in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI. IA. ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.",Terminated,"May 10, 2012",542,4113,Not_Computer,N/A,N/A,N/A
Z-0359-2011,56664,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Power supply boards on Dash 3000, 4000 and 5000 Monitors.GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.","GE Healthcare Dash 3000, 4000 and 5000 patient monitors ",2,"November 15, 2010", 2010,"GE Healthcare, LLC","The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient solder on the power supply board could result in excess EMC emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in a loss of monitoring that could delay recognition of a clinic",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated October 8, 2010, which described the loss of monitoring issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to remove the units from use. Local service representatives will contact firms to schedule installation of replacement power supply boards.GE Healthcare can be contacted at 1-800-558-7044, Option 2, Technical Support, about this correction.",Contact the recalling firm for information,137,137,"Worldwide Distribution: USA in the states of IL, NV, TX, and VA, and the countries of Australia, Brazil, China, Japan, South Korea, and Taiwan.",Terminated,"May 29, 2012",561,137,Battery,Device Operation,Replace boards,Remove or Replace
Z-0386-2011,57052,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.",Perfusion Tubing Set,2,"November 15, 2010", 2010,"Sorin Group USA, Inc.",Defective product packaging may compromise product sterility.,N/A,"Sorin Group sent an ""URGENT: FIELD SAFETY NOTICE"" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible.For further information, contact 1-800-650-2623.",N/A,13,13,"Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.",Terminated,"December 17, 2010",32,3021,Not_Computer,N/A,N/A,N/A
Z-0366-2011,57001,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"BD Phoenix"" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***","BD Phoenix"" Automated Microbiology System ID/AST Panels",2,"November 15, 2010", 2010,Becton Dickinson & Co.,"The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.",PRODUCTION CONTROLS: Packaging Process Control,"BD Diagnostic Systems issued an ""Urgent Product Recall"" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded.For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.",Contact the recalling firm for information,1675,1675 units,"Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.",Terminated,"November 29, 2010",14,1675,Not_Computer,N/A,N/A,N/A
Z-0394-2011,55999,"table, radiographic, stationary top",IXQ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.For use to support and aid in positioning a patient during radiologic and other medical procedures.",CIVCO Rectangular Extension,2,"November 16, 2010", 2010,Med Tec Inc,"Under certain conditions, the extensions can become detached from the main body of the couch.",DESIGN: Device Design,"The recalling firm, CIVCO, issued an 'Urgent Field Safety Notice"" dated June 15, 2010, via overnight mail on June 21, 2010, regarding the first issue for the three extension models. The letter described the product, problem, and actions to be taken by the customers. The customers were instructed to load the patients on the couch from the bottom of the couch and not from the superior end with the extension and do not let patients crawl to the top of the couch with their full upper body weight at the end of the couch; notify others within their organization that may have the extension, and complete and return the enclosed response form via fax: Attention: CIVCO MTL6600 Rectangular Extension at 877-271-2310. The letter informs the customer that they will be receiving a kit to replace the locking tab so that the extension will be less likely to come loose. Once the kit is received, the customers are ask to return the replaced part and sign a confirmation form for their records.CIVCO sent a second ""Urgent Field Safety Notice"" dated July 20, 2010 via overnight mail on July 21, 2010, and by phone on July 22, 2010, regarding the second issue which covered only MTIL6600 regarding the weight being dropped onto the corner of the rectangular extension. The letter described the product, problem and action to be taken by the customers. The customers were instructed to accept a one-piece Universal Couch Top replacement; sign the attached form stating the they will stop using the rectangular extension and return it to CIVCO or sign the form stating they have been advised of the recall and they will exercise the necessary precautions to prevent the event from occurring by always using the thumb screw lock and never allowing the patient to crawl on the couch top or extension, and to notify others within their organization that have the extension. The customer was informed that their current system would be replaced and sent back to the recalling firm. Please contac.",Contact the recalling firm for information,22,22 extensions,"Worldwide distribution: USA including states of: CA, FL, IA OH, and WI; and countires of: United Kingdom, Australia, and Switzerland.",Terminated,"April 17, 2012",518,30,Not_Computer,N/A,N/A,N/A
Z-0365-2011,56867,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5.SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates:4.0.1.0 - 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04, 4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 - 01/25/06, 4.0.1.14 - 03/26/07 4.0.1.15 - 05/02/07, 4.0.1.16 - 08/22/08, 4.0.2.0 - 04/08/05, 4.0.2.1 - 08/13/08, 4.0.2.2 - 06/06/05, 4.0.2.3 - 09/19/05, 4.0.2.4 - 09/19/05, 4.0.2.5 - 09/19/05, 4.0.2.7 - 02/13/06, 4.0.2.8 - 12/12/06, 4.0.2.9 - 02/20/08, 04.2.10 - 08/13/08, 4.0.3.2 - 05/17/06, 4.0.3.3 - 09/18/06, 4.0.3.4 - 09/27/06, 4.0.3.5 - 11/29/06, 4.0.3.6 - 06/22/07, 4.0.3.7 - 03/28/07, 4.0.3.8 - 06/22/07, 4.0.3.9 - 08/03/07,4.0.3.10 - 08/24/07, 4.0.3.11 - 09/24/07, 4.0.3.12 - 03/07/08, 4.0.3.13 - 06/13/08, 4.0.4.2 - 02/22/08, 4.0.4.3 - 05/22/08, 4.0.4.4 - 07/28/08, 4.0.4.5 - 05/04/09.Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.","SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4.",2,"November 16, 2010", 2010,SCC Soft Computer,"Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected.",DESIGN: Software Design,"Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.",Contact the recalling firm for information,49,49,Nationwide Distribution,Terminated,"August 07, 2013",995,49,Software,Output/Calculation,Software update,Software Update
Z-0392-2011,56988,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.",Innova 4100,2,"November 16, 2010", 2010,"GE Healthcare, LLC","GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety.A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the systemcannot be recovered without service intervention.GE Healthcare has obse",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE Healthcare sent an "" Urgent Medical Device Correction"" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information.Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems.For questions regarding this recall call (262) 548-2731.",Contact the recalling firm for information,43,43,"Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN D=FEDERATION, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, ISLAMIC IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE, FINLAND , EGYPT, CHILE, CANADA, BULGARIA, BELGIUM BELARUS, AUSTRALIA.",Terminated,"May 17, 2012",548,408,Not_Computer,N/A,N/A,N/A
Z-0402-2011,56876,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816",Vortex VX Port,2,"November 17, 2010", 2010,"Angiodynamics, INC",Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.,OTHER/UNDETERMINED: Pending,"AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products.Customers can contact AngioDynamics at 1 800 772-6446 about this correction.",Contact the recalling firm for information,6000,6000 units (includes all port systems listed),Nationwide Distribution : Throughout the US.,Terminated,"June 21, 2011",216,6000,Not_Computer,N/A,N/A,N/A
Z-0407-2011,56967,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.",Innova 2121IQ/31311Q Biplane Cardiovascular Imaging System,2,"November 17, 2010", 2010,"GE Healthcare, LLC","GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety.GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power.UPS fluoro ba",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE Healthcare sent an ""Urgent Medical Device Correction"" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.For questions regarding this recall call (262) 548-2731.",N/A,32,32 (2121IQ); 37 (3131IQ),"Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM",Terminated,"January 16, 2014",1156,578,Not_Computer,N/A,N/A,N/A
Z-0399-2011,57005,activated whole blood clotting time,JBP,Activated whole blood clotting time tests.,Hematology,Hematology,510(k),i-STAT ACT Celite Cartridgesin vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.,iSTAT ACT Celite Cartridges,2,"November 17, 2010", 2010,Abbott Point Of Care Inc.,Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.,OTHER/UNDETERMINED: Pending,"Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material.Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned.If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.",No consumer action necessary,49025,"49,025 cartridges.",Worldwide Distribution,Terminated,"August 22, 2012",644,144350,Not_Computer,N/A,N/A,N/A
Z-0398-2011,57029,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8"" SPECT, Model number 4535 600 66661; and 5/8"" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH.Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.",SKYLight Gamma Camera,2,"November 17, 2010", 2010,Philips Medical Systems,"Detector arm assembly may slide to hardware limit, potentially causing impact.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.",N/A,24,24 units,Worldwide Distribution -- USA and the Netherlands.,Terminated,"March 21, 2012",490,24,Not_Computer,N/A,N/A,N/A
Z-0401-2011,57015,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023",Millar MikroTip Disposable Angiographic Catheter (Left Heart),2,"November 17, 2010", 2010,"Millar Instruments, Inc",The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.,PRODUCTION CONTROLS: Packaging Process Control,"Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131.",N/A,12,12 Units,"Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.",Terminated,"February 15, 2011",90,12,Not_Computer,N/A,N/A,N/A
Z-0412-2011,52108,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Philips EasyVision MM workstation with software R10.2 and R11.1The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.",Philips EasyVision MM workstation with software,2,"November 18, 2010", 2010,Philips Medical Systems North America Co. Phillips,Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.,OTHER/UNDETERMINED: Pending,"Philips Medical Systems North America Co. sent an URGENT-Field Safety Notice dated January 30, 2009, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised to ascertain the quality of a hard or soft copy explicity before further distribution to make sure that no part of the tissue is covered by image identification information. Philips will issue the Field Change Order (FCO) 83000129 and release a level on EasyVision MM R10.2 L6 and EasyVision MM R11.1 L3 to resolve the issue.Customers could contact Philips Healthcare Call Center at 1-800-722-9377, #2, #3 and Reference FCO 83000129 for any questions.",N/A,11,11 units in US,"Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX",Terminated,"November 19, 2010",1,11,Software,N/A,Software update,Software Update
Z-0416-2011,56978,"vehicle, motorized 3-wheeled",INI,Motorized three-wheeled vehicle.,Physical Medicine,Physical Medicine,510(k),"Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan.",Rascal LiteWay Scooter Model 224,2,"November 18, 2010", 2010,Electric Mobility Corp,"Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.",DESIGN: Device Design,"The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers.Customers can contact the Rascal Company about this recall at 1-800-662-4548.",N/A,166,166 units,Worldwide Distribution: Throughout the US and Canada,Open,N/A,N/A,653,Not_Computer,N/A,N/A,N/A
Z-0346-2011,56874,"syringe, irrigating (non dental)",KYZ,Irrigating syringe.,General Hospital,General Hospital,510(K) Exempt,"ATM100, LB-AP-M0001Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385. Distributed by Lifebond, P.O. Box 3048 Caesarea Industrial Park 38900, Israel, LP-AP-M0001, LifeSeal SLR Applicator Sterilized by Ethylene Oxide, Manufactured By Micromedics, St Paul, MN 55121-1385 USA.","ATM100, LBAPM0001 Fibrijet, Catalog Number ATM100, Autologous Thrombin Mixer (Blending Connector)",1,"November 18, 2010", 2010,"Micromedics, Inc.","Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches potentially resulting in a non-sterile product which may cause transmission of disease or infection.",PRODUCTION CONTROLS: Packaging Process Control,"Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement.Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.",Contact the recalling firm for information,620,620 (800 pouches),"Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI.FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.",Terminated,"June 21, 2011",215,4880,Not_Computer,N/A,N/A,N/A
Z-0421-2011,57041,"suture, nonabsorbable, synthetic, polyethylene",GAT,Nonabsorbable poly(ethylene terephthalate) surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLECatalog Number; 72202469.Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.",Smith & Nephew ,2,"November 18, 2010", 2010,"Smith & Nephew, Inc. Endoscopy Division",FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.,DESIGN: Device Design,"Smith & Nephew notified customers by an Urgent - Product Recall 1st Notification - Urgent letter sent via Federal Express October 14, 2010. The letter identified the affected product and explained the problem. The letter asked customers to call for a Return Authorization (RA) Number. Customers are to complete the form and return of the affected product along with a copy of the letter to the address provided being sure to reference the RA number. Questions were to be directed to Cindy Burns at 508-261-3655. Consignees out side the US were notified by e-mail.",N/A,130,130 units,"Worldwide Distribution - USA, Dubai, and Great Britain.",Terminated,"May 09, 2012",538,804,Not_Computer,N/A,N/A,N/A
Z-0418-2011,57094,"implant, intragastric for morbid obesity",LTI,N/A,N/A,Gastroenterology/Urology,N/A,"LAP-BAND Adjustable Gastric Band System; Product codes:B-2105 (ACCSS PRT II KIT (0-10CC) US),B-2106 (ACCESS PRT II KIT (0-14CC) US),B-2210 (LP-BND SYS, 9.75, STER, US),B-2215 (LAP-BAND 9.75 W/ACC PRT II US),B-2220 (LP-BND SYS, 10.0, STER, US),B-2225 (LAP-BND 10.0,ACCESS PORT II,US),B-2255 (LAP-BAND VG W/ACS PORT II (US),B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II),B-2265 (LP-BND AP LG SYS, W/ACC PRT II);The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.",LAPBAND Adjustable Gastric Band System,2,"November 18, 2010", 2010,Allergan,"In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling",DESIGN: Process Design,"Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees.The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations.Customers were instructed to follow the Directions for Use for inserting the needle. Customers were instructed to report any malfunction or adverse event related to the device to Allergan Product Support at 1-800-624-4261 ext. 5972 or 1-805-961-5972 and FDA's Medwatch Program (1-800-FDA-1088 or www.fda.gov/medwatch). For questions, consignees were instructed to contact their Allergan field representative or contact Allergan Product Support at 1-800-624-4261.",N/A,152000,"Approx. 152,000","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, AND WY",Terminated,"December 22, 2010",34,152000,Not_Computer,N/A,N/A,N/A
Z-0411-2011,57047,orthopedic stereotaxic instrument,OLO,Stereotaxic instrument.,Neurology,Orthopedic,510(k),"smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.",TRIGEN SURESHOT Distal Targeting System,2,"November 18, 2010", 2010,Smith & Nephew Inc,Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.,OTHER/UNDETERMINED: Pending,"Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.",N/A,445,445 units,"Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.",Terminated,"February 17, 2011",91,445,Software,Device Operation,Software update,Software Update
Z-0414-2011,57039,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management SystemSoftware Version D.00 through D.03.",Philips IntelliVue Clinical Information Portfolio,2,"November 18, 2010", 2010,Philips Healthcare Inc.,Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.,DESIGN: Software Design,"Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the ""Action to be taken by Customer/User"" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.",Contact the recalling firm for information,200,200 units,"Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.",Open,N/A,N/A,200,Software,Device Operation,Software update,Software Update
Z-0425-2011,56380,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Signa OpenSpeed, 0.7T MR Systems (HFO3-5).",Signa OpenSpeed,2,"November 19, 2010", 2010,"GE Healthcare, LLC","If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Consignees were sent on 8/23/10 a GE ""Urgent Medical Device Correction"" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.",No consumer action necessary,176,176,"Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.",Terminated,"July 13, 2012",602,378,Not_Computer,N/A,N/A,N/A
Z-0424-2011,57010,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"BARD¶_ Ventrio¶_ Small Circle Hernia Patch 3.0""Product Code: 0010213Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.",Bard Ventrio,2,"November 19, 2010", 2010,"Davol, Inc., Sub. C. R. Bard, Inc.",Mislabeled: Hernia Patch may be a different size than on the product label,PRODUCTION CONTROLS: Packaging Process Control,"Davol notified accounts by an Urgent: Medical Device Recall letter on 10/15/10 via overnight delivery. The letter stated that the product maybe a different size than indicated on the product label. It also identified the affected product. Accounts are requested to examine their inventory, remove, and return recalled product. Customers are to notify any of their customers that they may have further distributed the affected product to by including a copy of the recall notice. Customers should contact Davol Customer Service 1-800-556-6275 for instructions on how to return the affected product. Customers are also requested to complete and fax back the attached fax sheet to 1-401-825-8753. If there are any additional questions, customers should contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Service Support Department at 1-800-562-0027.",No consumer action necessary,26,26 units,Nationwide Distribution,Terminated,"October 27, 2011",342,406,Not_Computer,N/A,N/A,N/A
Z-0432-2011,49384,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.","Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.",3,"November 22, 2010", 2010,Philips Medical Systems,The affected device may not deliver appropriate defibrillation therapy.,TRAINING: Employee Error,"Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.",N/A,1,1 unit,Nationwide Distribution: to one account in Arkansas.,Terminated,"December 01, 2010",9,1,Not_Computer,N/A,N/A,N/A
Z-0437-2011,56215,"prosthesis, wrist, carpal trapezium",KYI,Wrist joint carpal trapezium polymer prosthesis.,Orthopedic,Orthopedic,510(k),"The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint.The NuGrip is intended to replace the proximal end of the first metacarpal.","Ascension PyroHemiSphere (aka NuGrip), ",2,"November 22, 2010", 2010,"Ascension Orthopedics, Inc",Two different product lots were found to be incorrectly labeled and placed into the incorrect box.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Ascension Orthopedics notified by phone on June 25, 2010 and sent a letter dated July 22, 2010, to all customers. The customers were instructed to return the devices to the firm.Should you have any questions or concerns please feel free to contact (512) 836-5001 ext 1585.",Contact the recalling firm for information,9,9,"Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.",Terminated,"June 30, 2011",220,19,Not_Computer,N/A,N/A,N/A
Z-0430-2011,57098,"implantable pulse generator, pacemaker (non-crt)",LWP,N/A,N/A,Cardiovascular,N/A,"Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.",Medtronic DualChamber External Temporary Pulse Generators Model 5388 ,2,"November 22, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,"A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. The letter described the issue, how it presents, and stated that Medtronic will contact the hospitals to return affected product for servicing. The second letter reiterated that Medtronic would notify customers when FDA approves their design upgrade for returning devices for service. In the interim, hospitals should continue to use normally functioning devices. Cusotmers may contact Medtronic Instruments Technical Service at 800-638-1991 concerning this action.",Contact the recalling firm for information,944,"5,595 ( 2,696 US, 2,899 OUS) EXPANDED: 944 (852 US, 92 OUS)","Worldwide Distribution: throughout USA and territories of Guam and Puerto Rico and to the countries of: Algeria, Argentina, Australia, Austria, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen NO ADDITIONAL COUNTRIES ARE AFFECTED BY THE EXPANSION.",Terminated,"May 29, 2012",554,6539,Hardware,Device Operation,Return for servicing,Remove or Replace
Z-0429-2011,56017,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.",PLAC Test ELISA Kit,2,"November 22, 2010", 2010,"DiaDexus, Inc","The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results",OTHER/UNDETERMINED: Pending,"DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010. Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product.For questions regarding this recall call (650) 246-6477.",Contact the recalling firm for information,239,239 kits,"Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.",Terminated,"January 11, 2011",50,239,Not_Computer,N/A,N/A,N/A
Z-0431-2011,56416,"radioimmunoassay, testosterones and dihydrotestosterone",CDZ,Testosterone test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.",Sex Hormone Binding Blobulin (SHBG) Reagent,2,"November 22, 2010", 2010,Beckman Coulter Inc.,The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be usedwhen calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values and Access Testosterone (ng/mL) values are reported in different default units. The testosterone value (when reported in ng/mL) requires conversion to nmol/L before the FAI % can be calculated.,N/A,"Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter on the week of July 26, 2010 to the affected customers. The letter was dated July 30, 2010, and identified the product, the problem and provided the appropriate equation to recalculate the FAI% values. The customers were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were also asked to complete and return the enclosed response form within 10 days to confirm that they had received the important notification.The customers were instructed to contact Beckman Coulter Technical Support at 1-800-854-3633 in the United States, or contact their local Beckman Coulter Representative if they had any questions regarding the notification.",Contact the recalling firm for information,894,"1,113 Units ( 894 in US & 219 in Canada)","Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada",Terminated,"May 04, 2012",529,1113,Computer,N/A,N/A,N/A
Z-0434-2011,57028,"tape, measuring, rulers and calipers",FTY,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 stripsCatalog Number: 1102-00Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference.",LeMaitre VascuTape Radiopaque Tape,3,"November 22, 2010", 2010,"Lemaitre Vascular, Inc.",Box label (Top Part). Lot and Expiration Date information were switched.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Lemaitre Vascular notified customers by an Urgent: VascuTape Radiopaque Tape Device Field Safety Notice letter on 10/22/10 via USPS with delivery confirmation. The Notice advised users of the incorrect lot and lot number on the outer box and also provided an image of the box and label for ease in identifying the product in their inventory. The letter states that the use and functionality of the device are not affected by the problem; however, if customers feel uncomfortable continuing to use the affected device, they can contact Customer Service for replacement. The firm recommended discarding the outer box of the affected product. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. Accounts can contact customer service at 800-628-9470.",N/A,200,200 units,"Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.",Terminated,"September 15, 2011",297,1940,Not_Computer,N/A,N/A,N/A
Z-0443-2011,56985,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255.To be used for verifying the reportable range of tests on the Cholestech LDX System.",Cholestech LDX Calibration Verification,2,"November 22, 2010", 2010,Biosite Inc Dba Innovacon Inc.,The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.,N/A,"All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.Consignees with questions about the information contained in the notification were instructed to contact:Alere San Diego, Inc.9975 Summers Ridge RoadSan Diego, CA 92121U.S.A.Phone: 877 441 7440FAX: 858 805 8457E-mail: Response.ts@alere.com.",Contact the recalling firm for information,388,388 kits,"Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.",Terminated,"August 01, 2012",618,6529,Not_Computer,N/A,N/A,N/A
Z-0427-2011,56913,"system, perfusion, kidney",KDN,Isolated kidney perfusion and transport system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.",Belzer UW Cold Storage Solution,3,"November 22, 2010", 2010,Preservation Solutions Inc,Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..",Contact the recalling firm for information,55,55 units,"Nationwide Distribution - in US to the states of CA, MO, and PA.",Terminated,"April 02, 2012",497,55,Not_Computer,N/A,N/A,N/A
Z-0448-2011,55200,"radioimmunoassay, estradiol",CHP,Estradiol test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Immunoassay Systems Estradiol, Part Number: 33540Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.",Access Immunoassay Systems Estradiol,2,"November 23, 2010", 2010,Beckman Coulter Inc.,The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.,OTHER/UNDETERMINED: Pending,"A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs.The following product replacement contacts were provided:In the United States, please contact Client Services at 1-800-526-3821.In Canada, please contact Customer Service at 1-800-463-7828.Outside the United States and Canada, contact your local Beckman Coulter Representative.Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.",Contact the recalling firm for information,20209,"20,209 units (5475 in US)","Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia",Terminated,"May 07, 2012",531,20209,Not_Computer,N/A,N/A,N/A
Z-0444-2011,55889,dental implant surgical tray (kit),OFY,Endosseous dental implant accessories.,Dental,Dental,Enforcement Discretion,"Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.",Zimmer dental,2,"November 23, 2010", 2010,Zimmer Inc.,The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.,DESIGN: Labeling Design,"Zimmer sent out ""Urgent Device Correction"" letters dated 5/18/2010. The consignees were provided with new instructions for use. The letter informed users that the current pre-vacuum cycle of 3 to 18 minutes is not enough time to assure sterility between the lid-kit interface and could lead to cross contamination of multiple patients. The users were informed that a pre-vacuum time of 30 minutes was required to assure sterility.",N/A,158,158,"Distribution Nationwide, to France, and Spain.",Terminated,"May 18, 2011",176,158,Not_Computer,N/A,N/A,N/A
Z-0445-2011,57282,N/A,N/A,N/A,N/A,N/A,N/A,"Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014"" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.",Lumen Biomedical Xtract Aspiration Catheter system,2,"November 23, 2010", 2010,Volcano Corporation,"Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.",DESIGN: Device Design,"Firm initiated recall on 11/03/2010, and sent notifications to its consignees via letter. The firm has requested that consignees provide the notification to all personnel within the organization and letters will be sent directly to known customers on 11/04/2010 by Volcano. Customers have been instructed to cease use and contact customer service to arrange returns, and credit will be issued.",Discard product or return to place of purchase for a full refund or exchange,4724,4724 units,"Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria",Terminated,"December 07, 2011",379,4724,Not_Computer,N/A,N/A,N/A
Z-0446-2011,57008,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"BARD¶_ Mesh Pre-shaped (1.8"" x 4.0""/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects",BARD Mesh Preshaped ,2,"November 23, 2010", 2010,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeled: The labeled BARD¶_ Mesh Pre-shaped product code 0112700 (1.8"" x 4.0""/4.5cm x 10cm), but the contents are the BARD¶_ Mesh Large Pre-shaped product code 0113700 (2.4"" x 5.4""/6.0cm x 13.7cm).",PRODUCTION CONTROLS: Process Control,"Davol issued an ""URGENT MEDICAL DEVICE RECALL"" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please contact Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Service Support Department at 1-800-562-0027.",No consumer action necessary,144,144 units,Nationwide distribution,Terminated,"October 27, 2011",338,144,Not_Computer,N/A,N/A,N/A
Z-0447-2011,57048,"system, x-ray, mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),"Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers:9732719,9733346,81-700-00027, 81-700-00027R, 81700-00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERRIntended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.",Medtronic Navigation OArm Imaging System,2,"November 23, 2010", 2010,"Medtronic Navigation, Inc.",Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM¶_¶_ Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy,PRODUCTION CONTROLS: Equipment Maintenance,"Medtronic Navigation sent all consignees/customers an ""Urgent Field Safety Notice"" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or 720-890-3200.",Contact the recalling firm for information,244,244 units,"Worldwide distribution: USA including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, and WI; and countries including: Canada, Austria, Australia, Belgium, Brazil, Libya, South Africa, India, Japan, Singapore South Korea, Haiti, Kuwait, Saudi Arabia, Turkey, UAE, Germany, Netherlands, Great Britain, Italy, Poland, Netherlands, Spain,Sweden, and Switzerland.",Terminated,"June 04, 2012",559,244,Not_Computer,N/A,N/A,N/A
Z-0456-2011,55178,"electrode, ion based, enzymatic, creatinine",CGL,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.",iSTAT CREA Cartridge Blood Gas Panel,2,"November 24, 2010", 2010,Abbott Point of Care Inc.,The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.,OTHER/UNDETERMINED: Pending,"Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. Abbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.",N/A,34525,34525 cartridges,Worldwide Distribution: Throughout USA and Canada.,Terminated,"September 22, 2011",302,34525,Not_Computer,N/A,N/A,N/A
Z-0458-2011,55604,"radioimmunoassay, free thyroxine",CEC,Free thyroxine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.",The Dimension FT4L Flex reagent cartridge ,2,"November 24, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.",OTHER/UNDETERMINED: Pending,"Siemens issued an ""Urgent Field Safety Notice"" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250.",N/A,1520,1520,"Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.",Terminated,"March 19, 2013",846,14037,Not_Computer,N/A,N/A,N/A
Z-0449-2011,56345,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789,To deliver x-ray radiation for therapeutic treatment of cancer.Product is manufactured and distributed by Siemens Medical Solutions, Concord, CA",ARTISTE Linear Accelerator,2,"November 24, 2010", 2010,"Siemens Medical Solutions USA, Inc","The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a potential for injury.",OTHER/UNDETERMINED: Pending,"Siemens sent an Urgent Medical Device Correction letter to all on January 27, 2010, via phone, Fax, certified mail and/or delivery via Siemens Customer Service Group to all its direct consignees, informing them of the affected products, the problem, and provided instructions on the recall.Consigneees were to be contacted by an ARTISTE Service Representative for an appointment for corrective action. Consignees were instructed to include Customer Safety Advisory Notice in their ARTISTE System Owner Manual.For questions regarding this recall call (925) 246-8407.",N/A,106,106,"Worldwide Distribution - USA including CA, DE, FL, LA, MA, MI, MO, NC, NE, NJ, OH, PA, TN, UT, WI, AND WV and Egypt, Germany, Japan, Lebanon, Malaysia, New Zealand, Poland, Russia, Spain, Sweden, and Turkey",Terminated,"April 12, 2011",139,106,Not_Computer,N/A,N/A,N/A
Z-0452-2011,56912,dura substitute,GXQ,Dura substitute.,Neurology,Neurology,510(k),"DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches.Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USADuraGen XS is indicated as a dural substitute for repair of dura matter.","DuraGen XS"" Dural Regeneration Matrix",2,"November 24, 2010", 2010,Integra LifeSciences Corp.,Test results no longer support a 3 year shelf life.,OTHER/UNDETERMINED: Pending,"Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3.Customers were instructed to fill out and return the enclosed ""Recall Acknowledgement and Return Form"" indicating whether or not they possessed any of the affected product.For any questions related to this recall call 1-800-654-2873 and selection option 1.",N/A,571,571,"Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.",Terminated,"April 23, 2012",516,2766,Not_Computer,N/A,N/A,N/A
Z-0457-2011,56147,"ventilator, continuous, minimal ventilatory support,facility use",MNT,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.",Respironics V60 Ventilator,2,"November 24, 2010", 2010,Respironics California Inc,"Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.",DESIGN: Device Design,"Phililps Healthcare issued an Urgent Medical Device Field Correction letter dated July 2, 2010 concerning the RespironicsV60 Ventilator issue. Customers will be contacted by US Field Service Technicians and international distributors to schedule and perform inspections and replacement of the affected component. The unit may continue to be used pending completion of the field inspection.Customers may contact Respironics US Customer Service about this action at 1 800 345 6443, option #5, then option #1.",Contact the recalling firm for information,504,504,"Worldwide Distribution: Throughout the US and Puerto Rico,, and to the countries of: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Kenya, Kuwait, Libya, Malaysia, Oman, Netherlands, Norway, the United Kingdom, Saudi Arabia, and Spain.",Terminated,"December 01, 2010",7,504,Hardware,Physical Safety Hazards,Replace component,Remove or Replace
Z-0428-2011,57166,"catheter, thrombus retriever",NRY,Percutaneous catheter.,Cardiovascular,Neurology,510(k),"Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.",Penumbra System Reperfusion Catheter 032,1,"November 24, 2010", 2010,Penumbra Inc.,"Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.",PRODUCTION CONTROLS: Process Control,"Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days.Customers can contact Penumbra at 1 510 748-3223 concerning this action.",Contact your health professional,61,61,"Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.",Terminated,"June 01, 2011",189,61,Not_Computer,N/A,N/A,N/A
Z-0462-2011,57142,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Signa¶_ Excite"" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.","Signa Excite"" 1.5 T Magnetic Resonance Systems, GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.",2,"November 24, 2010", 2010,"GE Healthcare, LLC","Signa¶_ MR Excite"" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences.",DESIGN: Software Design,"GE Healthcare issued an ""Urgent Medical Device Correction"" letter dated April 21, 2009. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Field Engineers will contact customers to schedule a field modification of the affected products to address this issue.Customers can contact GE Healthcare at 262 521-6100 about this issue.",N/A,1464,1464,"Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and South Africa.",Open,N/A,N/A,1464,Software,Display/Image,Software update,Software Update
Z-0455-2011,56012,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x;Model Numbers: H48/H83.",Varian brand Eclipse/VARiS Vision,2,"November 24, 2010", 2010,Varian Medical Systems Oncology Systems,Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record.,DESIGN: Software Design,"On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***.",N/A,2417,2417 units***12-20-12 AMENDED TO: 49 units***,Nationwide and Worldwide,Terminated,"February 24, 2012",457,2417,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0481-2011,50117,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"T2 Ankle Arthrodesis System Nail and Nut Adapter;Stryker Trauma GmbH, Germany;Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ",T2 Ankle Arthrodesis System Nail and Nut Adapter,2,"November 26, 2010", 2010,Stryker Howmedica Osteonics Corp.,"The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.",DESIGN: Process Design,"Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product.Stryker can be contacted about this issue at 201 831-5118.",N/A,8,8 sets,Nationwide Distribution: To one location in New Jersey.,Terminated,"November 22, 2013",1092,8,Not_Computer,N/A,N/A,N/A
Z-0482-2011,55760,intracranial neurovascular stent,NJE,N/A,N/A,Neurology,HDE - Humanitarian Device Exemption,"Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA",Neuroform 3 Microdelivery Stent System,2,"November 26, 2010", 2010,Boston Scientific Corporation,"The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used.",PRODUCTION CONTROLS: Process Control,"Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form.Customers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall.",N/A,638,638 units,"Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary, India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.",Terminated,"November 26, 2010",0,638,Not_Computer,N/A,N/A,N/A
Z-0479-2011,52100,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),"Product's marketing brochure is labeled in part: ""Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS"". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.",Philips Easy Diagnost Eleva Conventional R/F system,2,"November 26, 2010", 2010,Philips Medical Systems North America Co. Phillips,"Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.",DESIGN: Software Design,"Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. Consignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference ""FC0 70600030"" with any communication.",N/A,314,314 units,"Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. Devices are not distributed to any foreign consignees.",Terminated,"December 30, 2010",34,314,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0469-2011,52040,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"The product's marketing brochure states: ""1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems"".The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of the affected system is labeled as 4522-131-6656x.",ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging ,2,"November 26, 2010", 2010,Philips Medical Systems North America Co. Phillips,Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.,OTHER/UNDETERMINED: Pending,"Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the ""old"" Flex M/Shoulder Coils with a new Flex-M coil.Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.",N/A,389,389 units,"Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VA, WA, WI, WV, WY, and Washington DC. There were no foreign consignees.",Terminated,"January 06, 2011",41,389,Not_Computer,N/A,N/A,N/A
Z-0478-2011,56428,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5).The software is used with the SonoSite NanoMaxx ultrasound system.,NanoMaxx ultrasound system,3,"November 26, 2010", 2010,"Sonosite, Inc.","Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the ""print"" command is selected. As a result, the displayed MI or TI values may be incorrect.",DESIGN: Software Design,"Sonosite issued Urgent Medical Device Correction letters dated August 9, 2010 to consignees. Consignees were advised of the software problem and given directions to verify the software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a free software upgrade.",Contact the recalling firm for information,69,69,"Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.",Terminated,"July 21, 2011",237,69,Software,Output/Calculation,Software update,Software Update
Z-0473-2011,55682,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.,HeartStart FR2 automated external defibrillator (AED),2,"November 26, 2010", 2010,Philips Medical Systems,"Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips Medical Systems issued an Urgent Medical Device Recall letter dated May 28, 2010 identifying the affected device and actions to be taken. Customers were instructed to review their inventory for affected devices. If affected devices are found, the customer should contact Philips to arrange for a replacement device. The customer should also run a battery insertion test. If the device passes the test, the AED may remain in service until a replacement is received. For further information, contact Philips at 1 800 263-3342, option 6.",N/A,1478,"1,478 units","Worldwide Distribution: Throughout the USA, and to the following countries: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIETNAM.",Terminated,"September 13, 2013",1022,16573,Other,N/A,N/A,N/A
Z-0480-2011,57023,"device, gas generating",KZJ,Gas-generating device.,Microbiology,Microbiology,510(K) Exempt,"GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***",GasPak EZ Large Incubation Container,2,"November 26, 2010", 2010,Becton Dickinson & Co.,In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form.BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663.",N/A,496,496 units,"Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,",Terminated,"January 05, 2011",40,496,Not_Computer,N/A,N/A,N/A
Z-0476-2011,57077,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1","Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1",2,"November 26, 2010", 2010,"GE Healthcare, LLC","The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems.If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.",DESIGN: Software Design,"GE Healthcare issued ""Urgent Medical Device Correction"" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129.Customers can contact GE Healthcare about this issue at 800-437-1171.",Contact the recalling firm for information,2514,2514,"Worldwide Distribution: USA in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI,MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY, and to the countries of UNITED KINGDOM, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SOUTH, KOREA, SAUDI ARABIA , PORTUGAL, NEW ZEALAND, NETHERLANDS, KUWAIT, JAPAN, ITALY, GERMANY, FRANCE , CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, VENEZUELA, UNITED ARAB EMIRATES, THAILAND, SWEEDEN, SOUTH AFRICA, SLOVENIA, SINGAPORE, RUSSIA, PHILLIPNES, NORWAY, POLAND, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LUXEMBOURG, LEBANON, JORDAN, JAMAICA, ISRAEL, IRELAND, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUADOPUO, GREECE, GEORGIA, FINLAND, EGYPT, DOMINICAN REPUBLIC, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, BULGARIA, BOTSWANA, and ALGERIA.",Terminated,"June 05, 2012",557,2672,Software,Output/Calculation,Software update,Software Update
Z-0474-2011,57090,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.","Medtronic Sprint Quattro Secure S, model 6935",2,"November 26, 2010", 2010,Medtronic Inc. Cardiac Rhythm Disease Managment,Over--retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads.,DESIGN: Device Design,"Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead.Customers can contact Medtronic Technical Services at 800 723-4636.",Contact the recalling firm for information,154000,"154,000 total","Worldwide Distribution: Throughout the US, including Guam, Puerto Rico, and US Virgin Islands, and to the countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bangladesh, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.",Terminated,"February 04, 2012",435,154000,Not_Computer,N/A,N/A,N/A
Z-0465-2011,57117,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014",Rectal Tubes 22 French/20 French,3,"November 26, 2010", 2010,"C.R. Bard, Inc., Urological Division","The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.",TRAINING: Employee Error,"Bard sent an Urgent Product Recall Notification letter dated October 28, 2010 to the consignee. They were instructed to return any outstanding inventory of the affected product. They were advised to notify their consignees of the recall and to retrieve relevant product from those locations. Affected products received by Bard Medical will be destroyed.BMD can be contacted at 1 770 784-6969 for questions or assistance.",N/A,108,108 eaches,Nationwide Distribution: In the state of Ohio.,Terminated,"March 31, 2011",125,108,Not_Computer,N/A,N/A,N/A
Z-0467-2011,57095,"tap, bone",HWX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021",Modified 5.5 mm Modified Depth Gauge for MaxTorque Screw System,2,"November 26, 2010", 2010,Orthohelix Surgical Designs Inc,The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This,DESIGN: Device Design,"OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.",N/A,N/A,N/A,Nationwide distribution: to the states of GA and MO.,Terminated,"September 06, 2012",650,N/A,Not_Computer,N/A,N/A,N/A
Z-0464-2011,57109,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.",DXG Digitizer,2,"November 26, 2010", 2010,AGFA Corp.,"Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.",OTHER/UNDETERMINED: Pending,"Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.",N/A,1,One unit,Nationside Distribution: to NJ.,Terminated,"December 30, 2010",34,1,Not_Computer,N/A,N/A,N/A
Z-0463-2011,57115,"crown, preformed",ELZ,Preformed crown.,Dental,Dental,510(K) Exempt,"3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek"" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150",3M ESPE Stainless Steel Primary Molar Crowns,3,"November 26, 2010", 2010,3M Company / Medical Division,"Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled.The crown contained within the package is incorrectly labeled; series UL3 crowns are labeled series UR3 and vice versa. The lid of the package correctly identified the product number and lot. This mislabeling could result in placement on the right side of a crown intended for use on the left, and",PRODUCTION CONTROLS: Packaging Process Control,"3M ESPE issued a Device Recall letter dated October 6, 2010 to distributors and dentists. The letter listed the product being recalled including code and lot codes, background information including a picture of the product problem, and the recall procedure. The letter included a template letter to be used by distributors to inform their customers who have received the product. Mislabeled product is to be quarantined and returned to 3M ESPE.3M ESPE can be contacted at 651 733-1110.",Contact the recalling firm for information,9819,9819,"Nationwide Distribution: Throughout USA, including the states of AZ, CA, GA, IL, IN, IA, LA, MA, MN, MO, NV,NJ, NY, NC, PA, TN, TX, WA, and WI.Canada and Dominican Republic",Terminated,"February 04, 2012",435,9819,Not_Computer,N/A,N/A,N/A
Z-0484-2011,56816,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge.The label of the device states: ""HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121"".","Philips HeartStart FR2 AED with Text Display , Model M3861",2,"November 29, 2010", 2010,Philips Medical Systems,"A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 10/5/10, Philips began sending out the Voluntary Medical Device Removal notification letter to their consignees.This letter informs the consignees that Philips Healthcare is conducting a voluntary product removal of a limited number of HeartStartFR2+ automated external defibrillators (AEDs), model numbers M3860A, M3861A, M3849A, and M3841A, manufactured by Philips and shipped between March 2007 and August 2010. The owners of affected AEDs are advised to run a battery insertion test. If it passes, the AED should remain in service until its replacement is received. Philips will be replacing affected units.The consignees can visit the firm's website www.philips.com/FR2AEDAction or contact Philips at 1-800-263-3342 for any information or support concerning the issue.",N/A,169,"11, 158 units","Devices were distributed to hospitals, medical facilities, and distributors through out the US and to foreign consignees. Foreign consignees including countries:Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Ecuador, El Salvador, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Japan, Jordan, Kampuchea, Kenya, Korea, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Malta & Gozo, Mexico, Netherland, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.",Terminated,"September 05, 2013",1011,16281,Not_Computer,N/A,N/A,N/A
Z-0489-2011,56775,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02,CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01,CELL-DYN 4000 Vent Needle, List Number: 02H61-01,CELL-DYN 4000 Accessory Kit, List Number: 01H20-01,CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576,CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101,CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201;Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA",CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly,2,"November 29, 2010", 2010,"Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA","The Vent Needle, which is built into the Vent Head Assembly on the CELL-DYN Sapphire Instrument and which is used directly on the CELL-DYN 4000 Instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.",PRODUCTION CONTROLS: Process Control,"Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.",N/A,N/A,N/A,"Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.",Terminated,"September 01, 2011",276,N/A,Not_Computer,N/A,N/A,N/A
Z-0490-2011,57002,"kit, identification, enterobacteriaceae",JSS,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremiaCatalog Number: KT007,AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit ,2,"November 29, 2010", 2010,"AdvanDx, Inc.",Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal.,DESIGN: Device Design,"AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert.Customers can contact AdvanDx technical support about this action at 1-866-376-0009.",N/A,260,260 units,"Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.",Terminated,"June 06, 2011",189,260,Not_Computer,N/A,N/A,N/A
Z-0493-2011,55119,"instrument, compression",HWN,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN.Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.",Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch,2,"December 01, 2010", 2010,Zimmer Inc.,"The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall.Locate all instruments and quarantine them immediately.Count all affected product in their territory and record the data on theInventory Return Certification Form included with the letter.Fax a copy of the completed Inventory Return Form to:Zimmer, Inc. at (574) 372-4265.Return the recalled product along with the original completed Inventory Return Certification Form to:Zimmer Distribution CenterAttn: Product Service1777 West Center StreetWarsaw, IN 46580For questions customers were instructed to contact their Zimmer Sales Representative.For questions regarding this recall call 1 - (800) 613-6131.",N/A,217,217 all products,"Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,",Terminated,"October 05, 2011",308,217,Not_Computer,N/A,N/A,N/A
Z-0502-2011,56892,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - JapanBaxter Healthcare corporation, Deerfield, IL 60015 USA; Intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions.",Baxter Interlink System MicroInfusion Manifold,2,"December 01, 2010", 2010,Baxter Healthcare Corp.,"If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.",OTHER/UNDETERMINED: Pending,"Baxter sent an ""Urgent Device Correction"" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedures to follow: ""If these devices are connected in series, and the luer connector is tightened, do not twist the manifolds. This may lead to loosening or disconnection, which may cause a leak. Additionally, Baxter recommends checking all connections before starting and during infusion therapy."" The accounts were requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",Contact the recalling firm for information,752965,"752,965 units in US and all lots in Japan",Worldwide Distribution -- United States and Japan.,Terminated,"October 16, 2011",319,752965,Not_Computer,N/A,N/A,N/A
Z-0491-2011,56997,"kit, identification, enterobacteriaceae",JSS,Microorganism differentiation and identification device.,Microbiology,Microbiology,510(K) Exempt,"AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic)Catalog number: KT008EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.",AdvanDx EK/P. aeruginosa PNA FISH,2,"December 01, 2010", 2010,"AdvanDx, Inc.",Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red signal,DESIGN: Device Design,"AdvanDX sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact AdvanDx Technical Support at 1-888-376-0009.",N/A,27,27 kits,"Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark",Terminated,"June 06, 2011",187,27,Not_Computer,N/A,N/A,N/A
Z-0504-2011,57102,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.",VACLOCK Syringe,2,"December 02, 2010", 2010,"Merit Medical Systems, Inc.",Packaging for syringes may have holes which would compromise the sterility of the package contents.,PRODUCTION CONTROLS: Packaging Process Control,"Merit Medical notified product managers of the product recall on October 22, 2010 following a voice mail script. Frequently Asked Questions, Sales Rep Letter, and Recall Notification Forms were then sent.. Sales reps were instructed to contact all of their customers and have them identify and quarantine any unused inventory and either return it to Merit or discard. A response form was to completed by the sales rep and the firm's representative, indicating amount of product quarantined, returned , or destroyed.Also, on 10/22/2010, authorized distributors were contacted by phone, mail, and / or fax. They were also provided a Distributor Letter, FAQs, and Recall Notification Forms instructing them to identify and quarantine any unused inventory and return it to Merit or discard. They were instructed to continue the recall to customers to whom they had shipped the affected Merit product.Additional information is available from Merit at 801-316-4822.",N/A,789,789 units,"Worldwide Distribution: USA including the states of AL, CA, GA, OH, PA, TX, UT, and WA, and to the countires of Japan and UK.",Terminated,"January 18, 2011",47,960,Not_Computer,N/A,N/A,N/A
Z-0397-2011,56048,"reagents,specific,analyte",MVU,Analyte specific reagents.,Pathology,Hematology,510(K) Exempt,"BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA.CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).",CD45 APCH7 ,2,"December 02, 2010", 2010,"BD Biosciences, Systems & Reagents",Incorrect expiration date: product with an expiration date of 03/31/2010 was marked with an incorrect expiration date of 06/30/2010.,PRODUCTION CONTROLS: Labeling Mix-Ups,"A Product Field Action Notification letter, dated November 2009, was sent to customers who purchased the affected device. The letter identified the affected device and explained the reason for recall. Customers were asked to not use the current CD45 APC H-7 lot number 58633 past 2010-03-31 until they receive their new lot of CD45 APC H-7 at no cost to them. Customers were also asked to complete and return the attached fax form. Questions should be directed to BD Customer Support Center at 1-877-232-8995.",Contact the recalling firm for information,87,87 units,"Nationwide Distribution -- CA, WA, NJ, UT, TX and OH.",Terminated,"December 03, 2010",1,87,Not_Computer,N/A,N/A,N/A
Z-0533-2011,57178,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.",Zimmer NexGen LPS Flex Gender,2,"December 02, 2010", 2010,Zimmer Inc.,These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all devices have nonconforming geometry.,DESIGN: Process Design,"The firm sent URGENT DEVICE CORRECTION AND REMOVAL notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by surgeons.",No consumer action necessary,158,158 all sizes of 5764,"US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.",Terminated,"July 27, 2011",237,158,Not_Computer,N/A,N/A,N/A
Z-0537-2011,56818,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATIONThe display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.","XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION",2,"December 03, 2010", 2010,"GE Healthcare, LLC","GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety.Inaccurate protocol setup by the user while using Thyroid Uptake Index application has been identifiedon certain Xeleris workstations. Incorrect protocol setup during clinical data acquisition a",OTHER/UNDETERMINED: Pending,"GE Healthcare sent an ""Urgent Medical Device Correction"" letter dated October 27, 2010, to all consignees. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists and Identifed the product, the problem and the action to be taken by the consignees. Consignees were instructed to replace the original protocol instructions provided with their system with the updated protocol instructions provided with the letter. For any questions consignees were to contact their local GE Healthcare Service Representative or contact the GE Healthcare Call Center:United States or Canada (800) 437-1171Other countries: (262) 896-2890.",Contact the recalling firm for information,6020,6020,"All States in continental USA including DC and PR. Viet Nam, Venezuela, Uruguay, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Sweden, Spain, South Africa, Slovakia, Singapore, Saudi Arabia, Russian Federation, Republic of Korea, Portugal, Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Martinique, Malaysia, Luxembourg, Kuwait, Kenya, Japan, Jamaica, Italy, Israel, Ireland, Indonesia, India, Hungary, Hong Kong, Guadeloupe, Greece, Germany, France, Finland, Ecuador, Dominican Republic, Cyprus, Colombia, China, Canada, Bulgaria, Brazil, Bosnia & Herzegovina, Belgium, Azerbaijan, Austria, Australia, Argentina, Algeria.",Terminated,"August 28, 2012",634,6020,Not_Computer,N/A,N/A,N/A
Z-0538-2011,57111,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta VBH Head FIXThe VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.",Elekta VBH Head FIX,2,"December 03, 2010", 2010,"Elekta, Inc.",The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.,OTHER/UNDETERMINED: Pending,"Elekta, Inc. sent an Important Notice A343 dated October 14, 2010 to all affected consignees. The Notice identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed constantly monitor the patient before and during the treatment. Check the patient's position after every patient movement (e.g. coughing). Advise all appropriate personnel of the content of the notice place a copy of the Notice In the Important Notice Section of the HeadFix User Manual P10103-108.For questions regarding this recallservice.schwabmuenchen@elekta.com.",N/A,34,34 units,"Worldwide Distribution - USA including AZ, CA, CT, FL, GA, IL, KY, MI, MS, NY, NC, OK, OR, RI, TN, TX, VA, WA and the country of Canada",Terminated,"December 28, 2010",25,34,Not_Computer,N/A,N/A,N/A
Z-0540-2011,56047,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Autoimmune EIA ANA Screening Test Kit, 576 Tests,Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.","Autoimmune EIA ANA Screening Test Kit, Model 576AN",2,"December 06, 2010", 2010,Bio-Rad Laboratories Inc,"The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.",OTHER/UNDETERMINED: Pending,"Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available.Bio-Rad can be contacted at 510-724-7000 concerning this recall.",Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.",Terminated,"January 05, 2011",30,N/A,Not_Computer,N/A,N/A,N/A
Z-0544-2011,57069,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"MultiDiagnost Eleva with FD.The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications.",MultiDiagnost Eleva with FD,2,"December 07, 2010", 2010,Philips Medical Systems North America Co. Phillips,"The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.",OTHER/UNDETERMINED: Pending,"Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems.If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.",N/A,5,5 units,"Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.",Terminated,"December 09, 2010",2,50,Hardware,N/A,N/A,N/A
Z-0542-2011,57143,"adaptor, stopcock, manifold, fitting, cardiopulmonary bypass",DTL,"Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.",Cardiovascular,Cardiovascular,510(k),"Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614",Edwards Protection Cannulae Monitoring and Infusion Set,2,"December 07, 2010", 2010,Edwards Lifesciences Llc,Monitoring and Infusion Set connectors may break during manipulation.,PRODUCTION CONTROLS: Process Control,"Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form.Further information is available at 800-424-3278.",Contact the recalling firm for information,322,322 sets,"Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.",Terminated,"May 18, 2011",162,892,Not_Computer,N/A,N/A,N/A
Z-0562-2011,57241,"generator, pulsatile flow, cardiopulmonary bypass",JOR,Cardiopulmonary bypass pulsatile flow generator.,Cardiovascular,Cardiovascular,PMA,"Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.",Sarns 8000 Roller pump ,2,"December 08, 2010", 2010,Terumo Cardiovascular Systems Corporation,The system 8000 roller pumps may fail resulting in a persistent pump stop.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm sent ""URGENT MEDICAL DEVICE CORRECTION"" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORMPlease note that we are not recommending that you stop using the roller pumps for your Sarns system 8000.For any questions, call toll free 800-262-3304 or phone 734-663-4145.",N/A,95,95 roller pumps.,"Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.",Terminated,"October 19, 2011",315,95,Not_Computer,N/A,N/A,N/A
Z-0561-2011,57064,"absorbent, carbon-dioxide",CBL,Carbon dioxide absorbent.,Anesthesiology,Anesthesiology,510(K) Exempt,"Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted or upon moisture loss; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton Sodasorb LF is used for absorption of carbon dioxide in low flow anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, desflurane, sevoflurane and isoflurane.",SODASORB LF PrePaks,2,"December 08, 2010", 2010,Darex Container Products Div of W.R. Grace & Co.,Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers.,PRODUCTION CONTROLS: Packaging Process Control,"Darex/W.R. Grace sent a Customer Notification to their sole direct account of the recall and the account provided Darex/W.R. Grace with lists of their customers who received the recalled products. Darex then sent undated recall letters to those accounts on 10/20-22/10. The accounts were informed of the product, the problem, and the action that should be taken. The accounts were warned not to use Pre-Pak units with missing or illegible expiration dates and/or batch numbers and were requested to examine their inventories of Pre-Pak units, placing all units that had missing or illegible expiration dates and/or batch numbers on hold for destruction and replacement. The accounts were instructed to call W.R. Grace at 1-800-492-7632 to arrange for replacement. The accounts were also requested to complete and return the reply postcard, indicating how much product was destroyed.",Contact the recalling firm for information,8096,"8,096 cartons",Nationwide Distribution,Terminated,"September 21, 2011",287,103638,Not_Computer,N/A,N/A,N/A
Z-0557-2011,57176,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,",Merit Custom Kits,2,"December 08, 2010", 2010,"Merit Medical Systems, Inc.","Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.",DESIGN: Process Design,"Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form.For further information about this recall, contact Merit at 800 356-3748.",Contact the recalling firm for information,1033,1033 units,"Nationwide Distribution in the states of CA, IL, IN, and UT.",Terminated,"March 23, 2012",471,6943,Not_Computer,N/A,N/A,N/A
Z-0584-2011,56250,"radioimmunoassay, parathyroid hormone",CEW,Parathyroid hormone test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Active I-PTH ELISA, Part Number: DSL-10-8000The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.",Active I PTH ELISA,2,"December 09, 2010", 2010,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 99,N/A,"Beckman Coulter sent an Urgent Product Corrective Action Letter to their consignees dated June 18, 2010. The letter identified the product, the problem, and the action to be taken. Consignees were instructed to:(1) Discontinue use of all materials provided with I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372.(2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if their laboratory uses only the Control materials provided with the I-PTH ELISA and IRMA kits.(3) Abnormal elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests.(4) I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372 will no longer be shipped. Due to the calibrator instability recently encountered with DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays, Beckman Coulter has decided to immediately discontinue these two part numbers.Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that they received this important notification.If they have any unused product the were asked to contact the numbers listed below:(1) In the United States, contact Customer Service at 1-800-526-382.1(2) Outside of the United States, consignees were asked to contact their local Beckman Coulter RepresentativeConsignees were told to contact DSL Technical Support Center at 1-800-231-7970 in the United States, or their local Beckman Coulter Representative with any questions.For questions regarding this recall call (714) 961-3634.",Contact the recalling firm for information,3,3 kits,"Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation",Terminated,"May 07, 2012",515,199,Not_Computer,N/A,N/A,N/A
Z-0572-2011,56731,"prosthesis, shoulder, non-constrained, metal/polymer cemented",KWT,Shoulder joint metal/polymer non-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"BIGLIANI/FLATOW¶_ THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer¶_ Trabecular Metal Humeral and/or Zimmer¶_ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. The intramedullary reamer manual surgical instrument is used in the surgical procedure to implant the Zimmer¶_ Trabecular Metal Humeral and Zimmer¶_ Trabecular Metal Reverse Shoulder Systems. The reamer is used to open the mid to distal humeral canal to accept the implant. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. is used to open the mid to distal humeral canal to accept the implant.",BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER ,2,"December 09, 2010", 2010,Zimmer Inc.,"The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer¶_ Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.",DESIGN: Device Design,"Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:a. provide the Dear Surgeon (Urgent Device Correction) letter and revisedsurgical technique directly to surgeons and risk managers at facilities usingthe device orb. provide a list of facilities and surgeons using the TM Humeral and TMReverse shoulder systems to the Zimmer Recall Coordinator, andc. destroy previous versions of the surgical technique, andd. inform users of when the new surgical technique, instrument case, distalreamers, and distal pilots will be shipped to them based on communicationfrom Zimmer, Inc.Handling of returned product:HCPs were notified to return all of the distal pilots in the scope back toZimmer which were to be be destroyed once the recall has been completed. They willalso be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into theBigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified byZimmer Sales Representatives.For questions regarding this recall call (574) 371-8852.",N/A,13093,"13,093 total reamers in distribution.","Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.",Terminated,"September 14, 2012",645,13093,Not_Computer,N/A,N/A,N/A
Z-0577-2011,57157,automated urinalysis system,KQO,Automated urinalysis system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.",Teco Diagnostics Uritek TC101 Urine Analyzer,2,"December 09, 2010", 2010,Teco Diagnostics,"This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified bythe FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di",OTHER/UNDETERMINED: Pending,"Teco Diagnostics initiated an ""Urgent: Medical Device Recall"" letter dated October 14, 2010, with an attached ""Recall Return Response Form"" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required.Consignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return ResponseForm, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.",N/A,2140,"2,140 units total for all products","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.",Terminated,"August 03, 2012",603,2140,Not_Computer,N/A,N/A,N/A
Z-0587-2011,57089,"stopcock, i.v. set",FMG,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6202. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.",Baxter ThreeWay Large Bore Stopcock,2,"December 09, 2010", 2010,Baxter Healthcare Corp.,Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.,DESIGN: Device Design,"Safety Alert letters dated October 28, 2010 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy. The accounts were requested to post the enclosed attachment, which illustrates the correct direction to turn the handle of the stopcock, where the stopcocks/sets are dispensed. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at (847) 270-5457. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 10/27/10, and instructed to notify their customers and ministries of health of the recall.Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",N/A,N/A,N/A,"Worldwide distribution: USA and countries including Puerto Rico, Guam and American Samoa, and internationally to Canada, Bermuda, Jamaica, Guatemala, Panama, Bahrain, United Kingdom, Hungary, Lebanon, Pakistan, Saudi Arabia and New Zealand.",Terminated,"November 01, 2012",693,N/A,Not_Computer,N/A,N/A,N/A
Z-0565-2011,57315,"saline, vascular access flush",NGT,Intravascular catheter.,General Hospital,General Hospital,510(k),"MONOJECT Prefill Heparin Lock Flush Syringe10 Unit Heparin, 3 ml in 12 ml syringeItem code 8881580123",MONOJECT Prefill Heparin Lock Flush Syringe,2,"December 09, 2010", 2010,Covidien LP,The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to adfeedback@coviden.com following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888.",N/A,329520,"329,520","Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda",Open,N/A,N/A,3510660,Not_Computer,N/A,N/A,N/A
Z-0551-2011,57045,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),Dixtal Handheld Pulse Oximetry Model 512 Catalog Number: 9100-00,Dixtal Handheld Pulse Oximetry ,2,"December 09, 2010", 2010,"Dixtal Medical, Inc.",Unit may overestimate Sp02 levels in a high humidity environment.,PRODUCTION CONTROLS: Equipment Maintenance,"Dixtal Medical notified accounts by email on 9/27/10 and followed by hard copy Urgent Product Recall letter, dated September 27, 2010. The letter identified the affected product and stated the reason for the recall. The letter also requested that customers to cease distribution and/or use of the suspect product and to return product for replacement. The attached Confirmation Notification should be completed and returned. Customers are to contact Customer Service: sales@dixtal.com, Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.",N/A,4,4 units,"Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.",Open,N/A,N/A,39,Not_Computer,N/A,N/A,N/A
Z-0604-2011,54143,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF 781-2.",Spinal Concepts polyaxial screwdriver,2,"December 10, 2010", 2010,Zimmer Inc.,"The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.",DESIGN: Device Design,"The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.",No consumer action necessary,27,27,"Worldwide Distribution, including US.",Terminated,"June 01, 2011",173,493,Not_Computer,N/A,N/A,N/A
Z-0589-2011,55977,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.",GE Responder 2000 Defibrillator/Monitor,2,"December 10, 2010", 2010,Cardiac Science Corporation,"Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient's heart rhythm or deliver therapy during a rescue.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Cardiac Science issued a Urgent Medical Device Corrective Action letter dated April 28, 2010 requesting GE Healthcare cease distribution of affected devices and to instruct end users of distributed devices to schedule a service call to have the device corrected. Cardiac will send rework kits no later than June 30, 2010. CSC can be contacted at 44 161 926 0011 to arrange return material authorization and replacement of affected devices.",Contact the recalling firm for information,130,130 units,"Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain.",Terminated,"December 08, 2011",363,130,Hardware,Treatment/Delivery/Therapy,Replace,Remove or Replace
Z-0594-2011,56832,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"FUSO Analyzer 300FAbbott Point of Care, Princeton, NJ 08540Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.",iSTAT Analyzer FUSO Analyzer 300F,2,"December 10, 2010", 2010,Abbott Point Of Care Inc.,"i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.",OTHER/UNDETERMINED: Pending,"Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed.Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action.Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.",N/A,2202,2202,"Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.",Terminated,"January 28, 2013",780,656504,Battery,N/A,N/A,N/A
Z-0588-2011,55571,"lipase-esterase, enzymatic, photometric, lipase",CHI,Lipase test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension LIP Flex Reagent Cartridge, Catalog# DF55A",Dimension LIP Flex Reagent Cartridge,2,"December 10, 2010", 2010,"Siemens Healthcare Diagnostics, Inc.","Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.",OTHER/UNDETERMINED: Pending,"Recalling firm issued ""Urgent Field Safety Notice"", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.",N/A,21171,21171,Nationwide Distribution throughout the US.,Terminated,"August 04, 2011",237,21171,Not_Computer,N/A,N/A,N/A
Z-0592-2011,56864,"drape, surgical",KKX,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Microtek Medical, Inc., Microscope Drape for Zeiss StandardModel/Catalog Number: 70890655Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to protect surgical microscopes from contamination during various procedures.Labeling for the product is as follows: (1.) INNER CARTON LABEL:Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)30748426064206, (17) 150700(10) DA102032, INNER, Rev. C.(2.) PRODUCT LABEL:Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 1, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01) 00748426064205, (17) 150700(10) DA102032, EACH, Rev. D.(3.) CARTON LABEL:Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12/CS, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)50748426084200, (17) 150700(10) DA102032, INNER, Rev. D.","Microtek Medical, Inc., Microscope Drape for Zeiss Standard",2,"December 10, 2010", 2010,"Microtek Medical, Inc.","This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization.",PRODUCTION CONTROLS: Error in Labeling,"On 08/23/10 Microtek Medical, Inc., Jacksonville, Florida notified all of their customers via a telephone call and requested immediate return of the product . The firm followed up with each of the customers by sending out an Urgent: Medical Device Recall letter (written notice), dated September 02,2010, to each on 9/8/10. The letter identified the affected product, stated the reason for the recall, and asked that the product be returned immediately. Customers are to complete and return the enclosed response form. Anyone needing further assistance is asked to contact Elizabeth Jolly, V.P. Legal at 1-888-844-0988.",Contact the recalling firm for information,5,"5 Cases, 12 drapes per case, 60 Drapes total distrubuted",Nationwide Distribution,Terminated,"December 14, 2010",4,5,Not_Computer,N/A,N/A,N/A
Z-0601-2011,57096,"heparin, vascular access flush",NZW,Intravascular catheter.,General Hospital,General Hospital,510(k),"Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe",Heparin I.V. Flush Syringe 1 units/mL,2,"December 10, 2010", 2010,Medefil Incorporated,The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Medefil faxed/emailed the direct accounts on 11/1/10, and sent the accounts a hard copy of the Urgent Product Recall letter, dated 11/1/2010, on 11/2/10. The accounts were informed of Medefil's recall of 18 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0780, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant, Oversulfated Chondroitin Sulfate. The accounts were instructed to stop use of the 18 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact Medefil to arrange for the product to be returned. The accounts were requested to complete and return to Medefil the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.",N/A,339180,"339,180 syringes","Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.",Terminated,"February 13, 2012",430,2919180,Not_Computer,N/A,N/A,N/A
Z-0590-2011,57011,bone marrow collection/transfusion kit,LWE,N/A,N/A,General Hospital,510(k),"Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.",Orthofix Bone Marrow Aspiration Needle,3,"December 10, 2010", 2010,Orthofix Inc,Outer cartons for the product may be labeled with incorrect needle gauge.,OTHER/UNDETERMINED: Pending,"Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061.",Contact the recalling firm for information,274,274,"Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.",Terminated,"February 28, 2011",80,274,Not_Computer,N/A,N/A,N/A
Z-0591-2011,57216,"lamp, surgical",FTD,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.",Surgical Lighting and Panel Monitor Arms,2,"December 10, 2010", 2010,Berchtold Corp.,A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop.,OTHER/UNDETERMINED: Pending,"Berchtold issued a Product Safety Notification letter on November 16, 2009 identifying the affected device and issue prompting the action. Consignees were instructed to:Exercise caution when adjusting the position of the surgical lights or flat panel monitors. While an event is highly unlikely, the likelihood does increase when the spring arm is being repositioned. Identify a specific contact person for their facility to facilitate the communication and field action process with BERCHTOLD. The following action is being planned: To further identify if their units are part of the affected population, determine the supplier serial number identification and specific location for each spring arm in their facility. Report the facility information, supplier spring arm serial numbers and specific location or spring arms to a BERCHTOLD. Detail instructions on serial number identification and the method of reporting to BERCHTOLD will also be provided in a subsequent communication. Once BERCHTOLD has received the serial numbers of their spring arm assembly, customers will be notified whether their particular units are affected and the further required action.Berchtold Corporation can be contacted at 1 800 968 6097 about this action.",N/A,7031,7031 arms,"Worldwide Distribution: Throught the U.S,.and the countries of Canada and Germany",Terminated,"July 06, 2012",574,7031,Not_Computer,N/A,N/A,N/A
Z-0614-2011,51242,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System,Model Number: VH-2000,Product is manufactured and distributed by Maquet Corporation San Jose, CA",Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System ,2,"December 13, 2010", 2010,"CTS, Inc. dba Guidant Cardiac Surgery",Sterility may be compromised by a loss of package integrity.,PRODUCTION CONTROLS: Packaging,"Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form.Maquet can be contacted at 888-880-2874 concerning this recall.",N/A,N/A,N/A,Distribution: Nationwide and Internationally.,Terminated,"January 19, 2011",37,N/A,Not_Computer,N/A,N/A,N/A
Z-0608-2011,55815,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc.Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.",Quest EIA ANA Screen Bulk Kit,2,"December 13, 2010", 2010,Bio-Rad Laboratories Inc,The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.,N/A,"Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to:Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product.Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM.For questions regarding this recall call (510) 724-7000.",N/A,453,453 kits,Nationwide Distribution including FL,Terminated,"January 05, 2011",23,453,Not_Computer,N/A,N/A,N/A
Z-0609-2011,55363,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.",NexGen Complete Knee Solution Stemmed tibial broach impactor,2,"December 13, 2010", 2010,Zimmer Inc.,"The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision surgery.",DESIGN: Device Design,"Zimmer issued ""Urgent Medical Device Safety Alert"" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices.Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.",N/A,10666,"10,666 all products.","Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.",Terminated,"September 12, 2012",639,10666,Not_Computer,N/A,N/A,N/A
Z-0613-2011,56386,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test,Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.",BioRad brand Meridian ANA Screen ELISA Test Kit,2,"December 13, 2010", 2010,Bio-Rad Laboratories Inc,False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .,OTHER/UNDETERMINED: Pending,"Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form.Bio-Rad can be contacted at 510 724-7000 concerning this recall.",N/A,N/A,N/A,Nationwide Distribution: to Meridian Diagnostics in Ohio.,Terminated,"January 10, 2011",28,N/A,Not_Computer,N/A,N/A,N/A
Z-0607-2011,56752,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N;Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260;UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access ClinicalSystemsThe Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.",Access/DxI Immunoassay System,2,"December 13, 2010", 2010,Beckman Coulter Inc.,"This recall was initiated because Beckman Coulter has received reports of erroneous test results being reportedas a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these casesboth false positive and false negative results are possible, depending upon the assay configuration.",N/A,"Beckman Coulter, Inc. sent two (2) Product Corrective Action (PCA) letters (Access letter and DxI letter) with attached Customer Response form the week of August 09, 2010 to the affected customers. The letters were dated August 13, 2010, and identified the product, the problem, and the action to be taken by the customers. The letter reminded customers that it is critical that they load reagent packs according to the procedure provided in their Access or Access 2Operators Guide, Instructions for Use, or Help system. A copy of the procedure was included with the letter. Customers were reminded that all operators should be properly trained on these important procedures andunderstand the impact on reported results if these procedures are not followed.Customers were instructed to share this information with their laboratory staff, and retain this notification as part of their laboratory Quality System documentation. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Supportat 1-800-854-3633, option 1 in the United States or Canada.",Contact the recalling firm for information,9571,9571 units (instruments),Nationwide Distribution & Canada,Terminated,"July 11, 2012",576,9571,Not_Computer,N/A,N/A,N/A
Z-0615-2011,57214,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).",Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE,2,"December 13, 2010", 2010,"Endocare, Division Of Healthtronics",Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe).,N/A,"Healthronics issued an Urgent Device Recall letter dated November 2, 2010 to consignees. The letter described the product mislabeling, and requested customers to examine their inventory, quarantine all affected product, and complete and return the verfication section of the letter to the firm. A return authorization number and prepaid return label were provide to facilitate return and replacement.Healthronics can be contacted at 877 367-4873 concerning this recall.",Contact the recalling firm for information,33,33 Units,"Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.",Open,N/A,N/A,33,Not_Computer,N/A,N/A,N/A
Z-0611-2011,56849,"bed, patient rotation, powered",IKZ,Powered patient rotation bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"RotoProne Therapy System, Model 209500, Device List Number E232632Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.",RotoProne Therapy System,2,"December 13, 2010", 2010,"KCI USA, Inc.","Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.",OTHER/UNDETERMINED: Pending,"KCI USA, Inc. sent an URGENT - Medical Device Safety Alert letter, dated September 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the cusotmer. Customers were instructed to have a practiced back-up plan, such as a plan for the manual proning of patients in the event that clinical circumstances dictate the need for more immediate prone therapy. For questions, customers in the US should call KCI's Technical Support Center at 1-800-275-4524, option 5. For customers outside the US they should contact their local sales representative. Customers should contact their accounts with affected product and advise them of the safety notice.",N/A,240,240 units,"Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia",Terminated,"March 21, 2011",98,240,Not_Computer,N/A,N/A,N/A
Z-0612-2011,56126,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.","BioRad Laboratories Autoimmune EIA ANA Screening kit, 96 test",3,"December 13, 2010", 2010,Bio-Rad Laboratories Inc,Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..,N/A,"Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.",N/A,37,37 units,"Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri.Product delivered to 11 consignees only in the US.",Open,N/A,N/A,37,Not_Computer,N/A,N/A,N/A
Z-0618-2011,53182,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico",Stryker Titanium Intraline Anchor,2,"December 14, 2010", 2010,Stryker Endoscopy,"Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records.Stryker can be contacted at 408 754-2000 about this recall.",N/A,447,447 units,Nationwide Distribution: to one distributor in NJ.,Terminated,"December 14, 2010",0,447,Not_Computer,N/A,N/A,N/A
Z-0620-2011,57370,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.",Spacelabs Medical Flat Panel Display,2,"December 14, 2010", 2010,"Spacelabs Healthcare, Llc","The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.",OTHER/UNDETERMINED: Pending,"Spacelabs Healthcare sent an URGENT: MEDICAL DEVICE RECALL Spacelabs Medical Flat Panel Power Supply PNs: 010-1619-00 & 010-1655-00 letter dated March 20, 2009 to US consignees. On March 27, 2009, Spacelabs sent the same recall letter with translation option to their international consignees.The letter stated the firm would be sending a replacement power supply. While waiting for the replacement of the power supply, Spacelabs Medical recommended their consignees brief the staff on the possibility of the display going blank to help prevent any adverse event from happening. The consignees were advised to dispose the old power supply per their premise protocol or local regulations. The consignees from US can contact Spacelabs Medical at 1-800-522-7025, #2 for Technical Support , and consignees outside the United States can call 1-425-657-7200 x5089 for any questions about the recall.",N/A,2877,2877 units in US and 731 units outside US,"Worldwide Distribution: USA in the following states: AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY, and including the following countries: AUSTRALIA, AUSTRIA, CANADA, Caribbean, CZECH REPUBLIC, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED KINGDOM, and VENEZUELA.",Terminated,"June 13, 2011",181,2877,Battery,Display/Image,Replace power supply,Remove or Replace
Z-0619-2011,57304,template,HWT,Template for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.",InterOp Acetabular System hooded trial insert,2,"December 14, 2010", 2010,Zimmer Inc.,Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.,TRAINING: Employee Error,"Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall.",N/A,3,3,"Worldwide Distribution: US in the states of KS and UT, and the country of Canada.",Terminated,"May 23, 2011",160,3,Not_Computer,N/A,N/A,N/A
Z-0617-2011,57223,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require sterility and others may not. However, it is possible that patient contamination could occur if a non-sterile Button Probe is used in clinical applications where aseptic technique is required. The device's labeled in part: "" TRAXTAL PERCUNAV...(1) Button Probe Right hand version, 25mm...Traxtal Inc...49 Spadina Avenue, Suite 310 Toronto, ON Canada M5V 2J1...Made In Canada...www.traxtal.com...STERILE...For use with Traxtal's PercuNav system only. Do not use if package is opened or damaged. Dispose of safely after single use to avoid risk of infection...Rx only...Use immediately after opening unit package. Store at room temperature"".",PercuNav MP008RB Button Probe ,2,"December 14, 2010", 2010,Philips Healthcare Inc.,"The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.",OTHER/UNDETERMINED: Pending,"On 11/10/10, Philips issued URGENT - Medical Device Recall notification letters dated November 10, 2010 to their consignees.Consignees are advised to examine their inventory of MP008R-B Button Probes to confirm the probe tip cover is properly placed over the tip of the probe. They should discard any Button Probes that have been confirmed to have the protective probe tip cover removed from the Button Probe tip. Consignees are also reminded to follow the MP008R-B Button Probe and PercuNav Instructions for Use prior to using the device. Do not use the probe if the unit package is damaged, broken or soiled.The firm's representative will contact the consignees to confirm quantities and Lot Codes of MP008R-B Button Probes that the firm may have examined or discarded. The firm estimates replacement probes will be available in the first quarter of 2011.Consignees can contact Philips Customer Service at 800 722-9377 and reference the FCO 79500189.",N/A,25,25 units,"Nationwide Distribution: in the states of FL, IL, MA, NE, NY, SC, and VA. There are no foreign consignees and US government consignees.",Terminated,"August 15, 2011",244,25,Not_Computer,N/A,N/A,N/A
Z-0621-2011,57269,surgeon's gloves,KGO,Surgeon's glove.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5¶_, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri LankaIntended use: Surgical Gloves",PowderFree Latex Surgical Gloves,2,"December 15, 2010", 2010,Ansell Healthcare Products LLC,open package seams on sterile gloves,OTHER/UNDETERMINED: Pending,"The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: infofrance@eu.ansell.com.",N/A,4000,4000 units,International distribution only: France and Germany,Terminated,"November 28, 2011",348,4000,Not_Computer,N/A,N/A,N/A
Z-0689-2011,55861,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy, Finland.",Inion CPS,2,"December 16, 2010", 2010,Stryker Craniomaxillofacial Division,Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.,OTHER/UNDETERMINED: Pending,"Stryker issued an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned.Stryker can be contacted about this action at 877-534-2464 (option ""Regulatory Affairs"", reference Product Field Action #2009-445).",N/A,N/A,N/A,Nationwide Distribution: Throughout the US,Terminated,"June 06, 2012",538,N/A,Not_Computer,N/A,N/A,N/A
Z-0624-2011,56659,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL",Cmax Surgical Table,2,"December 16, 2010", 2010,Steris Corporation,Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad.,OTHER/UNDETERMINED: Pending,"Steris issued Urgent Field Correction Notice letters dated August 26, 2010 to each affected consignee notifying them of the voluntary field correction. A Steris Representative will contact customers to arrange for STERIS to upgrade the software in the table.For further information about this corrective action, contact Steris at 1 800 333-8828.",Contact the recalling firm for information,1635,"1,635 tables","Worldwide Distribution: USA in the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan.",Terminated,"September 27, 2012",651,1635,Software,Physical Safety Hazards,Software update,Software Update
Z-0627-2011,56716,intracranial neurovascular stent,NJE,N/A,N/A,Neurology,HDE - Humanitarian Device Exemption,"Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CAIndicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.",Wingspan Stent System,2,"December 16, 2010", 2010,Boston Scientific Corporation,Products may not meet radial force specifications.,PRODUCTION CONTROLS: Process Control,"Recall initiated August 25, 2010. ""Urgent Medical Device Recall - Immediate Action Required"" notifications, dated 25 August 2010, were delivered by FedEx where possible, and by personal delivery assigned to sales representatives. The letter identified the affected product and the reason for recall. The letter stated that further distribution or use of any remaining product should cease immediately. Customers were asked to read the enclosed instructions and told that their local Sales Rep could answer any questions that they may have regarding the recall.",N/A,10,10 units,"International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.",Terminated,"December 17, 2010",1,10,Not_Computer,N/A,N/A,N/A
Z-0629-2011,56757,"calibrators, drug specific",DLJ,Clinical toxicology calibrator.,Toxicology,Toxicology,510(k),"ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.",ARCHITECT iVancomycin Reagent ,2,"December 16, 2010", 2010,Abbott Laboratories,The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.,OTHER/UNDETERMINED: Pending,"Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result:1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a microcentrifuge tube for centrifugation at 150,000-300,000 g-minutes, following centrifugation guidelines in the chart in the letter.2. Prior to testing, transfer the serum or plasma to a sample cup or secondary tube for testing. Care must be taken to transfer only the clarified specimen and not the lipemic material or pellet.The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. On September 15, 2010, Abbott discovered that the calculation for the determination of RCF (xg) given in the September 13, 2010 letter was incorrect. Incorrect Calculation previously provided: Relative Centrifugal Force (RCF) = 0.0000118 x rotational radius in centimeters x RPM2 Correct Calculation within revised letter: Relative Centrifugal Force (RCF) = 0.00001118 x rotational radius in centimeters x RPM2 Abbott stopped distribution of the previous letter and initiated redistribution of the revised letter to all impacted customers, globally, on September 15, 2010. Additionally, all customers which had already received the initial letter were sent a cover letter identifying the error.Customers can contact Abbott at 1-877-422688 about this action.",N/A,2411,"2,411 kits","Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam.",Terminated,"June 22, 2011",188,2411,Not_Computer,N/A,N/A,N/A
Z-0625-2011,56957,wearable automated external defibrillator,MVK,N/A,N/A,Cardiovascular,N/A,Model 4000 Monitor component of the LifeVest Wearable Defibrillator,LifeVest Wearable Defibrillator,2,"December 16, 2010", 2010,Zoll Lifecor Corporation,"The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.",OTHER/UNDETERMINED: Pending,Zoll Life Vest contacted patients that are expected to be in the device more than 60 days by letter and phone to arrange replacement monitors. Instructions for the return of the recalled monitor accompany the replacement monitor The firm will also contact the prescribing physician via telephone for long-term use patients to inform the physician of this voluntary recall and to assist in contacting any patients the firm was unable to reach by telephone.Zoll Life Vest can be contacted at 1-800-543-3267 about this recall.,Contact the recalling firm for information,494,494 units,"Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.",Terminated,"July 05, 2012",567,494,Hardware,Treatment/Delivery/Therapy,Replace monitor,Remove or Replace
Z-0623-2011,56679,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC.Venous blood collection tubes.","Vacuette 2 ml Lithium Heparin, Collection Tube",2,"December 16, 2010", 2010,"Greiner Bio-One North America, Inc.",Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.,OTHER/UNDETERMINED: Pending,Greiner Bio-One instructed customers to stop distribution and to complete an attached Product Disposition form and return it via fax to Greiner Bio-One. They were further instructed to destroy any product they may have. Distributors were instructed provide a list of their customers that have received the affected item via Excel file so that they can be notified of the recall.,N/A,18,"18 cases (total 21,600 pieces)","Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.",Terminated,"May 15, 2012",516,18,Not_Computer,N/A,N/A,N/A
Z-0626-2011,57112,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¶_g¶_ "" GPS"" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¶_g¶_ "" GPS"" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.","Protg ""GPS"" SelfExpanding Biliary Stent System",2,"December 16, 2010", 2010,"Ev3, Inc.","Mislabeled size: Specific Prot¶_g¶_ GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Prot¶_g¶_ GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Prot¶_g¶_ GPS stent but actually contai",PRODUCTION CONTROLS: Packaging Process Control,"ev3 issued a ""Medical Device Recall"" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product.ev3 can be reached at 800 716-6700 concerning this recall.",Contact the recalling firm for information,30,30,"Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.",Terminated,"March 29, 2012",469,30,Not_Computer,N/A,N/A,N/A
Z-0606-2011,57104,"aid, surgical, viscoelastic",LZP,Intraocular fluid.,Ophthalmic,Ophthalmic,N/A,"Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. RxFor Intraocular UseREF 585304Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.",BD 1 OVD Sodium Hyaluronate,2,"December 16, 2010", 2010,Becton Dickinson and Company,Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.,DESIGN: Component Design/Selection,"Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows:Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement.Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.",N/A,72278,72278 units,Nationwide Distribution,Terminated,"February 16, 2012",427,72278,Not_Computer,N/A,N/A,N/A
Z-0622-2011,56855,"pack, hot or cold, disposable",IMD,Hot or cold disposable pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609",ThermaCare Menstrual 8 Hour Heat Wraps,2,"December 16, 2010", 2010,Pfizer Global,"The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.",PRODUCTION CONTROLS: Packaging Process Control,"Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.",Contact the recalling firm for information,192000,192000 cartons (3 wraps per carton),Nationwide Distribution: Throughout the U.S. and Puerto Rico.,Terminated,"September 16, 2011",274,192000,Not_Computer,N/A,N/A,N/A
Z-0616-2011,57290,"separator, automated, blood cell and plasma, therapeutic",LKN,N/A,N/A,Gastroenterology/Urology,510(k),"Fresenius Red Blood Cell Set, Catalog Number 9007601.The product is labeled in part: ""RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands"".Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.",Fresenius Red Blood Cell Set (RBC),1,"December 16, 2010", 2010,"Fresenius Kabi, LLC",Potential for patient hematocrit dropped to levels lower than expected post-treatment.,N/A,"On October 21, 2010, Fresenius Kabi, LLC in Redmond, WA sent a ""Field Safety Corrective Action"" Letter dated October 18, 2010 to their US Consignees/Customers. On October 22, 2010, the firm followed up with their customers by telephone call.The letter informed the consignees/customers that the Red Blood Cell (RBC) exchange sets for use on the AS104 Blood Cell Separation Device are being recalled.The consignees/customers were advised to examine their stock and determine if they have any affected products on hand. They were instructed to discontinue distributing, using, dispensing the affected products, and return the product to Fresenius Kabi, LLC, 8635 154th Avenue, NE, Redmond, WA 98052.The consignees/customers were also instructed to notify their sub-account customers if the products were further distributed and to complete the Product Recall Response Form and fax it back to 425-242-2101. TIf you have any further questions concerning the recall, please contact the Quality Assurance Manager at 800-909-3872.",N/A,255,255 units.,"Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.",Terminated,"October 05, 2011",293,255,Not_Computer,N/A,N/A,N/A
Z-0711-2011,57230,"enzymatic esterase--oxidase, cholesterol",CHH,Cholesterol (total) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Genzyme Diagnostics Total Serum Cholesterol Kit, IVDCatalog Number: 225-26Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.","Genzyme Diagnostics Total Serum Cholesterol Kit,",3,"December 16, 2010", 2010,"Diagnostic Chemicals, Ltd.",Cholesterol Reagent bottles labels reversed for R1 and R2,PRODUCTION CONTROLS: Labeling Mix-Ups,"Genzyme Diagnostics P.E.I. Inc. sent an ""IMPORTANT PRODUCT FIELD CORRECTION"" letter dated November 10, 2010, via Federal Express to customers. The letter described the label error and requested that the reagents not be interchanged with another reagent lot. The firm ask that the customers complete and return the attached IMPORTANT PRODUCT FIELD CORRECTION confirmation of notification via fax at 902-628-6504. Contact a Genzyme Diagnostics Technical Services Representative at 1-800-565-0265, if you require further information, or if you have any questions.",Contact the recalling firm for information,30,30 kits,"Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.",Terminated,"September 19, 2011",277,30,Not_Computer,N/A,N/A,N/A
Z-0713-2011,57220,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN Intended for total shoulder replacement in a reverse configuration.",Biomet Compehensive Reverse Shoulder ,2,"December 16, 2010", 2010,"Biomet, Inc.",The firm received complaints regarding fracturing of the device.,N/A,"The firm sent ""URGENT MEDICAL DEVICE RECALL NOTICE"" dated 9/13/2010 to their distributors and customers. The letters stated the reason for the recall and what may happen as a result of the fracture of the device. The notices stated that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet. Customers should follow the instructions on the ""FAX Back Response Form."" If the affected product was further distributed, hospital personnel must be notified of the recall via the enclosed ""Dear Biomet Customer"" notice. The firm sent ""URGENT MEDICAL DEVICE RECALL NOTICES' to implanting surgeons. These letters informed the surgeons of the recall and instructed them to continue to monitor the patient for fracture of the device.Customers are to confirm receipt of the notice by calling 800-348-9500 ext 3755 or 3983. Questions should be directed to 574-371-3755 or 574-372-3983.",No consumer action necessary,45,45 both products,"Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.",Terminated,"July 27, 2011",223,45,Not_Computer,N/A,N/A,N/A
Z-0628-2011,57281,endoscope and/or accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.",ASP Automatic Endoscope Reprocessor (AER),2,"December 16, 2010", 2010,Advanced Sterilization Products,"The recall was initiated because Advanced Sterilization Products (ASP) received three customerreports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of apossible temperature monitoring system malfunction. This recall communication advised consignees that if high-leveldisinfectants are exposed to elevated temperatures, fumes may occur and resul",N/A,"Advanced Sterilization Products sent an URGENT: PRODUCT CORRECTION letter dated February 19, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall communication was initiated with ASP forwarding a ""Urgent: Product Correction"" letter with attached customer fax-back response form to the affected customers. Customers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435.If customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.",N/A,1881,"1,881 units (1514 in US)","Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador,Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan,Venezuela, Croatia, and Bulgaria.",Terminated,"July 30, 2013",957,1881,Not_Computer,N/A,N/A,N/A
Z-0714-2011,57236,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA.Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",CyberKnife Robotic Radiosurgery System,2,"December 16, 2010", 2010,Accuray Inc,"If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.",OTHER/UNDETERMINED: Pending,"Accuray Inc., sent an ""URGENT DEVICE CORRECTION"" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: customersupport@accuray.com.",No consumer action necessary,219,219 units,"USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.",Terminated,"April 01, 2011",106,219,Other,N/A,N/A,Other
Z-0007-2011,54154,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802.The expected usage of this product is to generate head and whole body CT images of human subjects.,HiSpeed X/i Computed Tomography ,2,"December 17, 2010", 2010,"GE Medical Systems, LLC",It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE Healthcare will bring customer systems into compliance with 21 CFR by having a GE Healthcare field service representative, who will perform a field corrective action, visit each customer site. This will be carried out via a Field Modification Instruction planned to be released in October 2009 and planned to be completed by February 2010. Additionally, all forward production operator consoles are manufactured so as to comply with 21 CFR and to include a manufacturing check for appropriate labeling.",N/A,45,45 units (13 Nationwide),"Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.",Terminated,"May 16, 2012",516,45,Not_Computer,N/A,N/A,N/A
Z-0717-2011,57311,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),Axiom Luminos dRFIntended use: solid state x-ray imager (flat panel/digital imager),Axiom Luminos dRF,2,"December 17, 2010", 2010,"Siemens Medical Solutions USA, Inc",patient leg can be pinched,OTHER/UNDETERMINED: Pending,"SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners.If you have any questions, please contact +1-888-826-9702.",N/A,24,24 units,"Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.",Terminated,"September 29, 2012",652,24,Not_Computer,N/A,N/A,N/A
Z-0716-2011,57242,"material, tooth shade, resin",EBF,Tooth shade resin material.,Dental,Dental,510(k),"SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494.SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495.SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499.Revolution is a flowable light cure hybrid resin restorative.",Kerr Revolution Formula 2 Flowable Light Cure Composite,2,"December 17, 2010", 2010,"Patterson Dental Supply, Inc.","Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product.",OTHER/UNDETERMINED: Pending,"Consignees were sent a Patterson Dental ""Urgent Device Recall"" letter dated October 15, 2010. The letter was addressed to ""Valued Customer"". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.",Contact the recalling firm for information,3204,"3,204 packages",Nationwide Distribution -- Including DC except VT.,Terminated,"September 11, 2012",634,3204,Not_Computer,N/A,N/A,N/A
Z-0718-2011,57312,"system, x-ray, mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),Mobilett XP Hybrid/Digital/CRIntended use: mobile x-ray system,Mobilett XP Hybrid/Digital/CR,2,"December 17, 2010", 2010,"Siemens Medical Solutions USA, Inc",battery fuse,OTHER/UNDETERMINED: Pending,"SIEMENS released a field update dated October 25, 2010, via SP011/10/S to the representatives. The update described issue and corrective action plan. The representatives are to visit each account to upgrade the systems with a new battery fuse and a new holder.If you have any questions regarding this report, please contact Quality Engineer by phone 610-448-3237 or email: meredith.adams@siemens.com and Director, Product complaints & Field Support by phone 610-448-4634 or email: josephine.mcbride@siemens.com.",N/A,170,170 units,"Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.",Terminated,"September 29, 2012",652,170,Battery,N/A,Repair,Repair
Z-0715-2011,57277,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027.Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.",Polaris Spectra System Control Unit,2,"December 17, 2010", 2010,"Medtronic Navigation, Inc",Electronic surgical navigation aid may lose tracking ability or stop working.,DESIGN: Component Design/Selection,"Customers were notified by a Product Correction Notification letter on 11/05/2010. The letter advised customers of the affected product, the potential problem, and the description of the correction. Customers were told that a Medtronic rep will visit them to install a replacement control unit. Further information is available at 800-595-9709 or 720-890-3200.",No consumer action necessary,48,48 devices,"Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.",Terminated,"May 03, 2011",137,48,Other,N/A,N/A,N/A
Z-0797-2011,57219,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Vital, Vitrea fX and Vitrea Enterprise Suite fXModel number: Vitrea fX 2.1, fX 3.0, and fX 3.1Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.","Vital, Vitrea fX and Vitrea Enterprise Suite fX",2,"December 21, 2010", 2010,"Vital Images, Inc.","Vital Images Inc., reported that a software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto ROI templates enabled.",DESIGN: Software Design,"Vital Images, Inc sent a Vital ""Urgent Software Update Alert"" letter dated 14 October 2010 to all Consignees/Customers. The letter described the product and problem. They advised, until new software is installed, that the customers can avoid obtaining incorrect values by tuning off ROI templates prior to selecting the batch option from the right click menu in the CT Brain Analysis application; and recommended that the customers re-examine any ROI perfusion values that were previously generated using automatic collage batching with ROI templates.Please direct any questions or comments to Customer Support at support@vitalimages.com or at 1-800-208-3005. Any help needed to install this software update can also be directed to Customer Support.",Contact the recalling firm for information,182,182,"Worldwide distribution: USA including states of: AL, AZ, AR, CA, CO, FL, GA, IA, KY, LA, MD, MA, MI, MN, MO, MT, NY, NJ, ND, OH, PA, PR, TN, TX, WA, WI, and WY, and countries of: CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, and JORDAN.CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, JORDAN.",Terminated,"May 15, 2012",511,182,Software,Output/Calculation,Software update,Software Update
Z-0794-2011,57351,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit.Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.",ACHIEVA 3.0T and Panorama 1T,2,"December 21, 2010", 2010,Philips Medical Systems North America Co. Phillips,The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site.The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and reference FCO 78100296 with any communication.",N/A,3,3 units,"Nationwide Distribution -- IL, MI, and MD.",Terminated,"December 28, 2010",7,3,Not_Computer,N/A,N/A,N/A
Z-0796-2011,57349,"implant, cochlear",MCM,N/A,N/A,Ear Nose & Throat,N/A,"Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02HThe Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.",Advanced Bionics HiRes 90K Cochlear Implant device ,2,"December 21, 2010", 2010,Advanced Bionics Corporation,"The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.",N/A,"Advanced Bionics (AB) Personal contacted all centers with known surgeries about the recall by telephone on November 22, 2010, and sent Blastfax to affected surgeons and clinicians.AB forwarding a Press Release on November 23, 2010 to the Business Wire News Trak. The firm also faxed Health Care Provider letters to the affected Health Care Providers and placed a Patient notification letter on the AB website on November 23, 2010. Health Care Provider letters were FedEx'ed November 24, 2010 to the affected Health Care Providers. Patient Letters were sent via FedEx'ed beginning Monday November 29th and 30th to approx. 10,500 patients. A Recall Acknowledgement Form was included for each recipient to sign as proof that the notification has been read.The press release & recall letter informed the patients/consignees of the reason for recall, the product affected and the potential hazard involved. The Health Care Provider letter also requested providers with recipient under their care who reports pain, overly loud sounds, or sudden shock sensations while the implant is powered to follow these steps:1. Advise them to remove the external equipment immediately,2. Schedule an appointment to complete standard troubleshooting steps listed in the AB Sound Processor User Guide,3. If standard troubleshooting does not resolve the issue, please contact Advanced Bionics for additional troubleshooting steps that may assist in determining the presence of recall problem, 4. If your evaluation of the patient's condition suggests that the implant exhibits this problem, device explantation and replacement is advised. In addition, the Health Care Provider letter informed providers that if AB records show that you have any unregistered implants in their possession, a list of serial numbers has been provided for devices that must be returned to Advanced Bionics. If no unregistered implants have been identified, no list will be enclosed. The Patient letter also .",N/A,82,82 units,"Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.",Terminated,"March 23, 2012",458,414,Not_Computer,N/A,N/A,N/A
Z-0719-2011,57291,"urinometer, electrical",EXS,Urine flow or volume measuring system.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Bard¶_ CritiCore¶_ Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014.Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter",Bard CritiCore,3,"December 21, 2010", 2010,"C.R. Bard, Inc., Urological Division",Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.,OTHER/UNDETERMINED: Pending,"Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.",Contact the recalling firm for information,234,234 units,"Worldwide Distribution -- U.S., Netherlands, and Japan.",Terminated,"February 02, 2012",408,234,Software,Output/Calculation,Software update,Software Update
Z-0507-2011,57376,surveying laser product,REP,N/A,N/A,N/A,N/A,"Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator. Amstech Incorporated, Alpharetta, GA 30022.Targeting, detecting heated areas, searches.",Aimshot HeatSeeker ,2,"December 22, 2010", 2010,Amstech Incorporated,"Product contains infra red laser, which can pose a potential hazard to users who unknowingly shine the beam into people's eyes.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Firm sent a letter dated August 5, 2010 to customers stating that a recall was being conducted on the AimSHOT HeatSeeker and specified model. The letter stated the reason for the recall and that the firm has redesigned the HeatSeeker and removed the infra red laser feature. The letter also asks customers to check their inventory and return the affected products to the firm. The firm states that they will send customers their new model and pay for the shipping. Questions should be directed towards 770-840-8039.",Contact the recalling firm for information,N/A,All units,Nationwide Distribution,Terminated,"November 09, 2011",322,N/A,Not_Computer,N/A,N/A,N/A
Z-0802-2011,57209,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"klinoPORT, AC powered Operating Table",klinoPORT,2,"December 22, 2010", 2010,Kreuzer Gmbh & Co. KG,The motorized adjustable pendant arm may suddenly descend to its lowest position.,OTHER/UNDETERMINED: Pending,"Consignees were notified by a Warning Notice on/about 10/26/2010. Medical facilities were instructed to adjust the pendant arm to the lowest height position and disable the motor and to place the accompanying warning label on the pendant. They will, therefore, not be able to adjust the height of the pendant until corrective action is developed and completed. TRUMPF Medical Systems, Inc. will receive corrective action repair kits by 11/12/2010.",Contact the recalling firm for information,15,15 units,"Nationwide Distribution -- CT, MA, and MO.",Terminated,"March 20, 2012",454,15,Not_Computer,N/A,N/A,N/A
Z-0801-2011,57210,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical",Turon Pegged Glenoid Drill Guide,2,"December 22, 2010", 2010,"Encore Medical, Lp",Complaints of fracturing were reported for affected trial products.,DESIGN: Device Design,Encore Medical notified consignees by letter on 11/5/2010.,Contact the recalling firm for information,34,34 units,"TX, FL, SC, GA",Terminated,"April 05, 2011",104,578,Not_Computer,N/A,N/A,N/A
Z-0790-2011,56965,"system, balloon, intra-aortic and control",DSP,Intra-aortic balloon and control system,Cardiovascular,Cardiovascular,510(k),"Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc.Model: IAB-05830-U",Ultra 8 IAB ,1,"December 23, 2010", 2010,"Arrow International, Inc., Division of Teleflex Medical Inc.","SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.",DESIGN: Component Design/Selection,Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.,N/A,5289,5289 units,"Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.",Open,N/A,N/A,44548,Not_Computer,N/A,N/A,N/A
Z-0789-2011,57335,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030080150, AB14W035120150, AB14W035040150, AB14W030120150, AB14W025120150, AB14W040080150, AB14W040120150, AB14W040210150, AB14W030150150, AB14W025210150, AB14W020150150, AB14W025040150, AB14W040150150, AB14W035080150, AB14W020210150, AB14W035210150, AB14W025150150, AB14W030210150, AB14W035150150, AB14W040080090, Intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.This device is an over the wire (OTW) 0.014"" coaxial lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter shaft and the balloon has a hydrophilic coating. The manifold includes a lumen marked ""THRU"". This is the central lumen of the catheter that terminates at the distal tip. This lumen is used to pass the catheter over a guide wire with a maximum outer diameter of 0.014"". The lumen marked ""BALLOON"" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. The 210mm balloon contains two additional radiopaque marker bands that denote the middle of the balloon body.",ev3 NanoCross 0.14 OTW PTA Dilatation Catheter,1,"December 23, 2010", 2010,"Ev3, Inc.","ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in material separation and potential embolization.",PRODUCTION CONTROLS: Process Control,"A Medical Device Recall letter addressed to Risk Managers, dated 11/10/2010, was sent to hospitals beginning 11/12/2010. The letter identified the affected devices, described the issue and requested that affected devices be located and removed from use. ev3 sales representatives will contact customers to arrange return of all unused devices. A credit or replacement will be provided for any unused devices. Questions regarding this issue may be directed towards Customer Service at 800-716-6700.",Contact the recalling firm for information,4962,"4,962 (3,858 US; 1,104 OUS)","Worldwide Distribution -- USA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MALTA, NETHERLANDS, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SYRIA, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM,",Terminated,"May 17, 2011",145,4962,Not_Computer,N/A,N/A,N/A
Z-0816-2011,56972,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"BD Vacutainer Push Button collection Set;Non-Pyrogenic, Sterile, Rx only;23 G x 3/4 x 12"" (0.6 x 19 mm x 305 mm)Becton Dickinson & Co., Franklin Lakes, NJ, USAIntended use: Blood collection",BD Vacutainer Push Button collection Set,2,"December 27, 2010", 2010,Becton Dickinson & Company,There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.,PRODUCTION CONTROLS: Process Control,"BD Diagnostics sent ""RECALL NOTIFICATION"" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.",N/A,4223200,"4,223,200",Nationwide Distribution,Terminated,"June 06, 2012",527,4223200,Not_Computer,N/A,N/A,N/A
Z-0819-2011,56894,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non SterileProduct Code: 2883-90-420The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.",Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set,2,"December 27, 2010", 2010,"DePuy Spine, Inc.",The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy,DESIGN: Labeling Design,"Depuy Spine issued an ""URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION"" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.",Contact the recalling firm for information,237,237 units,"Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.",Terminated,"April 15, 2011",109,441,Not_Computer,N/A,N/A,N/A
Z-0808-2011,56846,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL.Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA",AdVance Male Sling System,2,"December 27, 2010", 2010,"American Medical Systems, Inc.",American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.,DESIGN: Packaging Design/Selection,"Consignees were sent an AMS ""Urgent Product Recall"" letter dated September 7, 2010. The letter described the problem and the product involved. They requested consignees to return any existing stock product and to return the Product Recall Acknowledgement form enclosed. Customers may request a credit or a full refund or also, arrange for replenishment of AdVance product. Questions regarding the recall should be directed towards AMS Customer Service at 1-800-328-3881.",Contact the recalling firm for information,7069,"7,069","Worldwide Distribution -- All states in the Continental USA including DC and Puerto Rico and countries of ARGENTINA, AUSTRIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, GERMANY, ESTONIA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, CROATIA, IRELAND, ISRAEL, INDIA, ITALY, REPUBLIC OF KOREA, LEBANON, MOROCCO, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, RUSSIAN FEDERATION SAUDI ARABIA, SWEDEN SINGAPORE, SLOVENIA, THAILAND, TURKEY, TAIWAN, VENEZUELA, and SOUTH AFRICA.",Terminated,"June 28, 2012",549,7069,Not_Computer,N/A,N/A,N/A
Z-0820-2011,55976,"prosthesis, testicular",FAF,Testicular prosthesis.,Gastroenterology/Urology,Gastroenterology/Urology,N/A,"Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark.Catalogue Number Description Part Number450-1323 Extra Small 520600450-1325 Small 520610450-1327 Medium 520630450-1329 Large 520650The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.",Saline Filled Testicular Prosthesis,2,"December 27, 2010", 2010,"Coloplast Manufacturing US, LLC","On April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled Testicular Prosthesis is considered mislabeled. This is solely due to a difference in expiration dates between the Terumo Butterfly Needle included in the kit and the testicular implant. The needle has a 3yr expiration date & the Saline Testicularhas a 5yr expiration date.",MISBRANDING: Labeling False and Misleading,"The recall will extend to field personnel who have control of all SFTP Systems. The product is ordered by the customer (physician and/or hospital) directly from a field sales representative who ships the device to them or drops it off in person.Coloplast sent all Field Personnel an email on April 30, 2010, with a copy of a letter dated April 30, 2010 and a follow-up letter dated May 1, 2010. The letters described the problem and the product involved in the recall. The letters included a list of Corrections Required. This included the field personnel receiving a stock of sterile Butterfly Needles based on their home consignment inventory to be provided for use with all Saline Testicular Implants; Copies of customer letters to be provided with each replacement needle; Changes in all Saline Testicular orders, and Field personnel to administer the details of the correction and make the direct customer contacts. For questions, contact the Customer Service/Field Inventory Representative at 612-337-7859 or email: usbam@coloplast.com.",Contact the recalling firm for information,1018,1018,"Worldwide distribution: USA including states of AL, AK, AZ, AR, CO, CT, CA, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI,MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT and WA; and countries of Australia, Canada, Hong Kong and Latin America (Chile, Columbia, Ecuador and Venezuela).",Terminated,"December 17, 2011",355,1018,Not_Computer,N/A,N/A,N/A
Z-0815-2011,57292,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;","CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H",2,"December 27, 2010", 2010,Stryker Howmedica Osteonics Corp.,"The CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach Handle may fracture in two pieces along the width of the body under the striking plate. This may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.",N/A,"Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue.In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.",N/A,459,459 units,"Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.",Open,N/A,N/A,459,Not_Computer,N/A,N/A,N/A
Z-0807-2011,57274,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"ACL ELITE PRO Coagulation Analyzer, PN 00001000311Coagulation testing.",ACL ELITEPRO,2,"December 27, 2010", 2010,Instrumentation Laboratory Co.,Sporadically lowered APTT results were observed with the PT/APTT Test Groups.,DESIGN: Device Design,"On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.",N/A,379,"379 in use in USA & Canada, 24 in distribution channel subject to recall","Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK.",Terminated,"August 23, 2013",970,466,Not_Computer,N/A,N/A,N/A
Z-0813-2011,57348,"gas-machine, anesthesia",BSZ,Gas machine for anesthesia or analgesia.,Anesthesiology,Anesthesiology,510(k),"Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed ""shot bold"" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously..The product is labeled in part: ""BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018"".",Blease Sirius Anaesthesia Systems,2,"December 27, 2010", 2010,"Spacelabs Healthcare, Llc","Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems.",OTHER/UNDETERMINED: Pending,"Spacelabs Healthcare issued an URGENT MEDICAL DEVICE CORRECTION letter dated June 25, 2009 to the two consignees in the US. Spacelabs Healthcare UK notified consignees outside the US.The consignees were advised to brief their staff about the issue and test the Anesthesia Systems in advance of a procedure. If there is an issue with turning on a vaporizer in the left hand position, simply move the vaporizer to the right hand position.The firm contacted their consignees for a schedule to replace the flowmeter mouldings. The US consignees can contact Spacelabs Healthcare Representatives at 425-657-7200 ext. 5089 about this recall. Foreign consignees can contact Spoacelabs at 44 1494 784422.",N/A,5,5 units to US consignees and 36 units Internationally.,"Worldwide Distribution: US in the states of LA and SD, and internationally by Spacelabs Healthcare, Ltd in the countries of China, Czech Republic, Hong Kong, India, Poland, Saudi Arabia, Singapore, and the United Kingdom.",Terminated,"December 28, 2010",1,5,Not_Computer,N/A,N/A,N/A
Z-0814-2011,57337,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ThomoTherapy Hi-Art SystemIntended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.",HiArt System,2,"December 27, 2010", 2010,TomoTherapy Incorporated,TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.,DESIGN: Software Design,"Consignees were sent a TomoTherapy ""Urgent Field Safety Notice"" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone.",No consumer action necessary,40,40 (21US; 19 OUS),"Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELGIUM",Terminated,"February 04, 2012",404,40,Software,N/A,N/A,N/A
Z-0811-2011,57317,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI.Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.",Expect Endoscopic Ultrasound Aspiration Needle,2,"December 27, 2010", 2010,Boston Scientific Corporation,The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.,OTHER/UNDETERMINED: Pending,"""Urgent Medical Device Recall - Immediate Action Required"" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory.",Contact the recalling firm for information,567,567 all products.,Worldwide Distribution -- US and Canada.,Terminated,"August 03, 2011",219,567,Not_Computer,N/A,N/A,N/A
Z-0831-2011,51260,"wheelchair, mechanical",IOR,Mechanical wheelchair.,Physical Medicine,Physical Medicine,510(k),"Manual Wheelchairs with Transit System Option,Model: Quickie LXI (EILXI),Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.",Manual Wheelchairs with Transit System Option,2,"December 28, 2010", 2010,Sunrise Medical Inc,The stabilizer bar was inadvertently omitted during the manufacturing process.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.",N/A,23,23,Worldwide Distribution -- United States and Canada.,Terminated,"January 03, 2011",6,23,Not_Computer,N/A,N/A,N/A
Z-0830-2011,53183,"bougie, esophageal, and gastrointestinal, gastro-urology",FAT,Esophageal dilator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.",Stryker Infravision Esophageal Kit,2,"December 28, 2010", 2010,Stryker Endoscopy,The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.,DESIGN: Device Design,"Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.",N/A,2985,2985 units,"Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.",Terminated,"January 03, 2011",6,2985,Not_Computer,N/A,N/A,N/A
Z-0825-2011,54147,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico","End Cutter Shaver Blade FSeries, 4.0 mm",2,"December 28, 2010", 2010,Stryker Endoscopy,"Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.",DESIGN: Device Design,"Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker.Stryker can be contacted concerning this recall at 408 754-2124.",N/A,295,295 units,"Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.",Terminated,"January 03, 2011",6,295,Not_Computer,N/A,N/A,N/A
Z-0823-2011,56245,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada.Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.",Reliance EPS Endoscope Processing System,3,"December 28, 2010", 2010,Steris Corporation,Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.,OTHER/UNDETERMINED: Pending,"Steris issued an ""Urgent Field Correction Notice"" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043.",N/A,936,936,"Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.",Terminated,"September 27, 2012",639,936,Not_Computer,N/A,N/A,N/A
Z-0822-2011,56170,N/A,N/A,N/A,N/A,N/A,N/A,BD Beaver Slit Blade 3.0mm StraightPart Number: 375521The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.,BD Beaver Slit Blade 3.0mm Straight,2,"December 28, 2010", 2010,Bd Medical Systems,Blades may contain defects at the blade tip or cutting edge.,N/A,"BD Medical notified customers via letter dated 6/24/10 to discontinue use of product and remove from inventory. Customers were instructed to complete the customer response form and fax to BD Medical. BD Medical was to contact customers upon receipt of the customer response form to arrange for replacement.Unused product was to be returned to:BD MedicalOphthalmic SystemsAttn: WT-12582411 Waverly Oaks RoadBuilding 2, Suite 229Watham, Massachusetts 02452-8402For questions regarding this recall call 1-781-906-7952.",N/A,524,524 pieces,Nationwide Distribution,Terminated,"June 29, 2012",549,524,Not_Computer,N/A,N/A,N/A
Z-0821-2011,56774,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA",Varian Trilogy System with RapidArc,2,"December 28, 2010", 2010,Varian Medical Systems Inc.,"The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.",DESIGN: Software Design,"Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display ""RapidArc"" or ""VMAT"" under Treatment Type during dose delivery, discontinue use of the device and call Varian service.Varian Service Help Desk can be contacted at 1-888-827-4265.",N/A,N/A,N/A,"Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.",Terminated,"July 18, 2011",202,N/A,Software,N/A,N/A,N/A
Z-0829-2011,57273,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK.This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.",Offset reamer brushing angled,2,"December 28, 2010", 2010,"Biomet, Inc.",The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient.,OTHER/UNDETERMINED: Pending,"The firm, BIOMET, sent a ""FIELD SAFETY NOTICES"" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached ""FAX BACK RESPONSE FORM"" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, Bridgend, CF31 3XA. The customers were also instructed to inform all in their organization who are using or ordering the products and send a copy to the organization to which potentially affected products may have been transferred.If you have any questions regarding this communication, please contact the Quality Manager at +44 (0) 1656 655221 or email: david.broderick@biomet.com.",N/A,16,16 units,"International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark",Terminated,"January 19, 2011",22,16,Not_Computer,N/A,N/A,N/A
Z-0828-2011,57286,extractor,HWB,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.",CLP Instrumentation Removal Hook,2,"December 28, 2010", 2010,"Encore Medical, Lp","Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.",OTHER/UNDETERMINED: Pending,"DJO issued an Urgent Recall Notice letter dated November 10, 2010 to consignees identifying the affected devices and requesting return of all affected devices for replacement. Customers are also requested to complete and return an enclosed Recall Response Form.Customers can contact David Harris of DJO at 512 834-6330 with questions about this recall.",N/A,27,27 Units,"Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.",Terminated,"April 25, 2011",118,27,Not_Computer,N/A,N/A,N/A
Z-0826-2011,57289,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system.Siemens Medical Solutions USA, Inc.Business Unit Ultrasound1230 Shorebird WayMountain View, CA 94043Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.",4Z1c matrix array transducer ,2,"December 28, 2010", 2010,"Siemens Medical Solutions USA, Inc.",There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.,OTHER/UNDETERMINED: Pending,"SIEMENS issued a filed correction in the form of a ""Customer Safety Advisory Notification"" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware.If you have any questions, please contact (650) 969-9112 or (800) 422-8766.",N/A,2196,196 units both Transducer and ACUSon SC2000,"Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.",Terminated,"October 04, 2011",280,2196,Not_Computer,N/A,N/A,N/A
Z-0824-2011,57341,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN.A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimmer Natural Nail system.",Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long,2,"December 28, 2010", 2010,Zimmer Inc.,The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen without the use of excessive force.,TRAINING: Employee Error,"The firm sent Correction and Removal Notification Immediate Response Required letters via email to consignees. The letter identified the affected product and the reason for the recall. The letters also discussed the clinical implications and required actions. Customers are to complete the inventory certification form and user facility documentation form. Each of the affected accounts will be provided with a new instrument, manufactured with the correct lumen diameter and will secure and return the affected instruments per the attached notification, along with the completed inventory certification form. If any further information is needed, customers are to contact Aimee Wood at 574-372-4463.",Contact the recalling firm for information,34,34,"Worldwide Distribution -- USA, including states of MI, NJ, MS, OR, KS, TN, A, UT, and CA and countries of Belgium and Germany, Spain, Italy, Greece, France, UK, and Switzerland.",Terminated,"September 16, 2011",262,34,Not_Computer,N/A,N/A,N/A
Z-0834-2011,56763,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CAThe XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.",GreenLight MoXy Fiber Optic,2,"December 29, 2010", 2010,AMS Innovative Center - San Jose,"Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing",N/A,"American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel.For questions regarding this recall call 847-855-6270.",N/A,77,77 units,"Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.",Terminated,"January 03, 2011",5,77,Not_Computer,N/A,N/A,N/A
Z-0836-2011,56024,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CATreatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.",FastPlan Versions 5.5 and 5.5.1,2,"December 29, 2010", 2010,Varian Medical Systems Oncology Systems,"Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.",DESIGN: Device Design,"Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated.Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated.Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan.For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager.Phone: USA and Canada - 1-888-VARIANS (888-827-4265) Europe -+41 41 749 8844E-mail: North America: support-america@varian.com Australia/New Zealand: support-anz@varian.com Europe: support-emea@varian.com South East Asia: seasia.apps.helpdesk@varian.com China/Asia: china.apps.helpdesk@varian.com Japan: Japan.Apps.Helpdesk@varian.com Latin America: soporte.al@varian.comInternet: Oncology Systems customer site - www.myvarian.com Varian Medical System public site - www.varian.com.",N/A,218,218 units,"Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan",Terminated,"February 24, 2012",422,218,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-0833-2011,57196,"pump, portable, aspiration (manual or powered)",BTA,Powered suction pump.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.",Care E Vac 3 Portable Suction,2,"December 29, 2010", 2010,Ohio Medical Corporation,"The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.",N/A,"Ohio Medical sent Urgent Medical Device Correction Notification letters dated November 4, 2010, to all affected customers on November 8, 2010. The letters identified the product, the problems, and the action to be taken by the customer.Customers were instructed to take the affected product out of service, remove diode 14, and replace the foot screw contained therein. Customers were instructed to visit the micro-sites established for these repair procedures for step-by-step instructions on performing the repairs. Accounts with questions after viewing the video demonstration were directed to the Ohio Medical technical assistance line at 224-430-1522. Customers were asked to complete the attached Customer Acknowledgment Form and return the form to the Quality Assurance Department at (fax) 1.847.855.6304, or e-mail to:Complaints@OhioMedical.com, or mail to:Ohio Medical CorproationQuality Assurance1111 Lakeside DriveGurnee, Illinois 60031.For questions regarding this recall call 847-855-6270.",Contact the recalling firm for information,4183,"4,183 units","Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.",Terminated,"March 16, 2012",443,4183,Hardware,Physical Safety Hazards,Repair,Repair
Z-0832-2011,57254,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),Urethral Warmer System Model number FPRCH3001The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.,Urethral Warmer System,2,"December 29, 2010", 2010,Galil Medical,"This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali",N/A,"Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to:"" Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. "" Immediately discontinue use and quarantine the affected product. "" Contact Customer Service Department at 800-828-7341 to arrange for replacement. "" Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. "" If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.",Contact the recalling firm for information,4,4,"Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.",Terminated,"December 10, 2011",346,4,Not_Computer,N/A,N/A,N/A
Z-0835-2011,57110,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),Mammography KeypadRadiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to apply hot keys from a keypad versus a keyboard.,Mammography Keypad,3,"December 29, 2010", 2010,AGFA Corp.,Product did not receive UL Certification,OTHER/UNDETERMINED: Pending,"AGFA sent an Urgent Safety Notice letter dated October 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to unplug existing keypad(s) including USB cable. Plug in loaner Keypad(s). Print out the Fed Ex shipping label that they received via the e-mail notification. Use that label to ship their existing keypad(s) and their corresponding USB cables to the manufacturer. The manufacturer would perform the upgrades and return the keypad(s) along with the USB cables.Upon receipt of the original keypad(s) customers would also receive another e-mail notification with a shipping label so that they may return the loaner keypad(s) to AGFA HealthCare. Customers were to distribute this information to all those who need to be aware of it, and complete the feedback form as soon as possible and return it to AGFA HealthCare.For questions regarding this recall call 838-342-3989..",N/A,26,26 units,"Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada",Terminated,"February 01, 2011",34,26,Not_Computer,N/A,N/A,N/A
Z-0845-2011,57192,"device, neurovascular embolization",HCG,Neurovascular embolization device.,Neurology,Neurology,510(k),"Micrus Endovascular Microcoil Delivery System;The Micrus¶_ Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA",Micrus Endovascular Microcoil Delivery System;,2,"January 03, 2011", 2011,"Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131",The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.,OTHER/UNDETERMINED: Pending,"Micrus Endovascular Corp sent Urgent: Medical Device Recall Letters dated October 21, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine inventory (including consignment) and quarantine the product to prevent it from being used or shipped. If the product was further distributed, customers were to notify their customers by sending a copy of the recall letter and were instructed to work with all customers to ensure that all product was returned and that pre-use protocol was followed.The response form was to be completed and returned indicating the number of devices that had been used (or shipped if distributor) and the number that would be returned. Customers were to call the Micrus Customer Service Department at 1-888-550-4129 from 8:00 am to 5:00 Pacific time for arrange for a Return Authorization number and replacement. Recall letters also stressed the importance of always following the pre-use protocol and inspecting the device immediately prior to use. Additionally, connector functionality should be verified and instructions were provided.Questions or concerns should be directed to Micrus Customer Service at 1-888-4120.Consignees who did not respond to the initial recall notification after 15 days were notified again by letter. A third letter was sent after another 15 days if there was still no response.",N/A,6755,6755,"Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom",Terminated,"January 11, 2011",8,6755,Not_Computer,N/A,N/A,N/A
Z-0846-2011,54638,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321.Labeling on the device reads in part: ""***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***"".Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.",NeuViz Dual Series Computed Tomography Scanner System,2,"January 04, 2011", 2011,"Philips And Neusoft Medical Systems Co., Ltd.",Potential for the CT patient table top to become detached from the carrier due to missing washers.,OTHER/UNDETERMINED: Pending,"Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees.The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury.Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at nms-service@neusoft.com or Service Support Department at helpdesk@neusoft.com for questions about this recall.",N/A,26,26 devices,Nationwide Distribution including NC,Terminated,"April 15, 2011",101,26,Not_Computer,N/A,N/A,N/A
Z-0745-2011,56400,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),HiSpeed LX/l (2200997-2),HiSpeed LX/l ,2,"January 04, 2011", 2011,"GE Healthcare, LLC",A defect with the hardware and software displaying the incorrect dose data.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.",N/A,102,102 total in US,Nationwide Distribution,Open,N/A,N/A,102,Other,N/A,N/A,N/A
Z-0847-2011,56829,"camera, surgical and accessories",KQM,Surgical camera and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"The Power Cord Reel is labeled as follows:REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY.These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialtiesMANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.",Linvatec Power Cord Reel Catalog Number:,2,"January 04, 2011", 2011,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid",DESIGN: Component Design/Selection,"ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form.Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062.For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail Custserv1@Invatec.com.",No consumer action necessary,77,77 ea,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.",Terminated,"March 22, 2012",443,1761,Not_Computer,N/A,N/A,N/A
Z-0842-2011,57271,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018"" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020",AngioSculpt PTA Scoring Balloon Catheter ,1,"January 04, 2011", 2011,AngioScore Inc.,Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.,DESIGN: Component Design/Selection,"Medical Device Recall notifications were sent to all domestic consignees on Nov 16, 2010 by overnight mail. Foreign distributors, other than Japan, were sent recall letters by e-mail or international overnight delivery on November 16, 2010. The Japanese distributor received notification and notified their customers on November 10, 2010.",N/A,17682,"17682 units, all sizes and lots","Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom",Terminated,"October 04, 2011",273,17682,Not_Computer,N/A,N/A,N/A
Z-0854-2011,57179,"clamp, uterine",HGC,Obstetric-gynecologic general manual instrument.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(K) Exempt,Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.,Boston Scientific brand Matrix2 2D Standard SR Coils.,2,"January 05, 2011", 2011,"Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538",The product appears to have premature degradation of the PGLA coating on the Matrix Coil.,PRODUCTION CONTROLS: Process Control,"US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.",N/A,77364,"77,364 total units","Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.",Terminated,"January 27, 2012",387,77364,Not_Computer,N/A,N/A,N/A
Z-0852-2011,57352,"stent, ureteral",FAD,Ureteral stent.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.",Universa Soft Ureteral Stent,2,"January 05, 2011", 2011,Vance Products Incorporated,The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.,PRODUCTION CONTROLS: Labeling Mix-Ups,The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.,No consumer action necessary,25,25 units,"Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.",Terminated,"July 27, 2011",203,25,Not_Computer,N/A,N/A,N/A
Z-0864-2011,55541,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014"" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection and placement of a 0.014 (0.36 mm) Over the Wire (OTW) guide wire into peripheral vessels. Specification Developer: Medtronic, Minneapolis, MN. Manufactured by: Accellent, Laconia NHThe Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intra-luminal cross-sectional ultrasound image of the area of interest to facilitate placement of guide wires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.",Pioneer Plus Catheter PPlus 120,2,"January 06, 2011", 2011,Medtronic CardioVascular,Needles may fail to retract and thus cause injury.,N/A,"Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative.",N/A,1080,"1,080 units","Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain",Terminated,"January 06, 2011",0,1080,Not_Computer,N/A,N/A,N/A
Z-0865-2011,57457,"catheter,intravascular,therapeutic,long-term greater than 30 days",LJS,"Percutaneous, implanted, long-term intravascular catheter.",General Hospital,General Hospital,510(k),"Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116.The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.",Groshong PICC ,2,"January 06, 2011", 2011,Bard Access Systems,Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.,TRAINING: Employee Error,"BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.",Contact the recalling firm for information,195,195 units,"Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.",Terminated,"May 04, 2011",118,195,Not_Computer,N/A,N/A,N/A
Z-0883-2011,57416,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI.The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.",Terumo Advanced Perfusion System 1,2,"January 07, 2011", 2011,Terumo Cardiovascular Systems Corporation,The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.The firm identified a fai,N/A,"Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule.Customers were to review the Medical Device Correction.Assure that all user were aware of the notice.Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call 1-800-521-2818.",Contact the recalling firm for information,221,221 devices,"Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam",Terminated,"April 17, 2012",466,729,Not_Computer,N/A,N/A,N/A
Z-0867-2011,54651,"system, digital image communications, radiological",LMD,Medical image communications device.,Radiology,Radiology,510(K) Exempt,"Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.",Stryker Digital Capture Pro 2,2,"January 07, 2011", 2011,Stryker Endoscopy,"Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how pictures or videos are captured using SDC Pro",DESIGN: Software Design,"Stryker Endocoscopy sent an URGENT: Device Correction letter dated December 11, 2009, to the OR Supervisor/Risk Manager and all Stryker Sales Representatives. The letter identified the product, the problem, and the action to be taken by the Sales Representatives. Sales Representatives were to identify affected accounts. Go to customer accounts and install the upgrade for each affected unit. Upon completion of the upgrade, the sales rep was to sign the acknowledgment form indicating that all of their affected accounts received the appropriate software fix and mail to Stryker Endoscopy or fax both sides of the postcard to 408-754-8378 or scan in both sides of the postcard and email to sdcpro2recall@stryker.com.For questions regarding this recall call 408-754-2738 or 408-754-2000.",N/A,3070,3070 units,"Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Africa, Australia, Brazil, Cnanda, China, France, Germany, Hong Kong, Iberia, Italy, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Puerto Rico, Scandinavia, Singapore, Switzerland, Thailand, and the UK",Terminated,"January 08, 2011",1,3070,Software,Output/Calculation,Software update,Software Update
Z-0885-2011,54685,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),Boston Scientific Guider Softip TM XF Guide CatheterCatheter is intended to facilitate the placement of interventional devices into the neurovascular system.,Guide Catheter,2,"January 07, 2011", 2011,Boston Scientific Corporation,Complaint about product quality: degradation of polymer portion of the distal section of the catheter.,MISBRANDING: Labeling False and Misleading,"Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to Joe.Nesci@beci.com.",Contact the recalling firm for information,94296,"94,296 units","Worldwide. US Domestic including US Federal Government, and foreign countries.",Terminated,"December 19, 2011",346,94296,Not_Computer,N/A,N/A,N/A
Z-0871-2011,56388,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific brand Synchro2 0.14"" Guide Wire, 300 cm, Soft Pre Shaped;Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.",Boston Scientific Synchro 2 Guidewire,2,"January 07, 2011", 2011,Boston Scientific Corporation,"The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.",PRODUCTION CONTROLS: Packaging Process Control,"Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of and segregate the affected product. Complete and return the Reply Verification Tracking Form even if they did not have any affected product. Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1. E-mail or Fax the completed and signed Reply Verification Tracking Form to email Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475.PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to:Boston Scientific CorporationUS Distribution CenterBoston Scientific Marina BayCustomer Fulfillment Center500 Commander Shea Blvd.Quincy, Massachusetts 02171RGA: ____________For questions regarding this recall call (510) 624-2563.",N/A,49,"36, 049 total units - all sizes","Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.",Terminated,"January 10, 2011",3,36049,Not_Computer,N/A,N/A,N/A
Z-0866-2011,57418,"catheter, irrigation",GBX,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Merit One Step Centesis Drainage CatheterIntended for the percutaneous drainage of fluids,Merit One Step Centesis Drainage Catheter,2,"January 07, 2011", 2011,"Merit Medical Systems, Inc.",The catheter's valved hub may fail resulting in an inability to drain fluid.,DESIGN: Device Design,"Merit Medical Systems, Inc. sent a Product Safety Notice letter dated November 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to provide a copy of the Safety Notice form to their applicable customers. Advise them to immediately stop using the affected product and to discard it.Customers were asked to complete and sign the Safety Notice forms and fax them to 1-801-208-3378 and send the original Safety Notice Form with both signatures via Federal Express 2nd day air to:Customer ServiceMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095-2416entirety and faxed them For questions regarding this recall call 801-316-4929 or Customer Service at 801-208-4365.",N/A,20863,"20,863","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, AND WV and the countries of Canada, Finland, Germany, Netherlands, Singapore, Sweden, Switzerland, and the UK",Terminated,"March 23, 2012",441,20863,Not_Computer,N/A,N/A,N/A
Z-0884-2011,56986,"cable, transducer and electrode, patient, (including connector)",DSA,Patient transducer and electrode cable (including connector).,Cardiovascular,Cardiovascular,510(k),"CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CTThis product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions",CARTO 3 System Interface Cable,2,"January 07, 2011", 2011,"Biosense Webster, Inc.","When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.",DESIGN: Device Design,"Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form.For questions regarding this recall call Biosense Webster at 909 839-8874.",Contact the recalling firm for information,1692,1692,"Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.",Terminated,"May 07, 2012",486,1692,Not_Computer,N/A,N/A,N/A
Z-0886-2011,56347,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.","Varian brand Cseries Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X,",2,"January 08, 2011", 2011,Varian Medical Systems Oncology Systems,The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.,OTHER/UNDETERMINED: Pending,"Varian sent a Customer Technical Bulletin letter to all affected users on May 27, 2010, and was also posted to Varian's customer support site: http://www.MyVarian.com. The letter identified the product, the problem, and provided instructions on the recall. Customers were instructed to return the proof of notification (via completed ""Proof of Notification Form or appropriate Postal system certified receipt of delivery to Varian. For questions regarding this recall call 650-483-3153.",N/A,N/A,N/A,"Worldwide Distribution - USA including CA, TX, IL, GA, NJ, and NV and the countries of Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK",Terminated,"December 23, 2011",349,N/A,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0888-2011,51217,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).",Optical Guidance Platform,2,"January 10, 2011", 2011,Varian Medical Systems Oncology Systems,Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.,DESIGN: Device Design,"Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations.",Contact the recalling firm for information,3,3 units,Product was distributed to 3 consignees in Florida and Wisconsin.,Terminated,"February 24, 2012",410,3,Not_Computer,N/A,N/A,N/A
Z-0891-2011,54146,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.",4D Integrated Treatment Console,2,"January 10, 2011", 2011,Varian Medical Systems Oncology Systems,"Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.",DESIGN: Device Design,"The firm, Varian Medical Systems, sent a Product Notification Letter/Field Safety Letter entitled ""URGENT MEDICAL DEVICE CORRECTION"" dated October 16, 2009, to all affected customers. The letter described the product, problem, actions to be taken by the customers and Varian. The customers were instructed to use caution when creating CBCT imaging field and limit use of the 'select all' button when acquiring treatment parameters; review departmental policies and procedures regarding the acquisition of any gantry angle at the 4D ITC, and advise the appropriate personnel of this letter. The firm, Varian, recommended that only vertical, longitudinal and lateral couch parameters are acquired when creating a CBCT field at the 4D ITC; notified all affected customers of this document, and will correct this issue in a future release of the 4D ITC software. If owners of $D ITC, version 8.0.12 and higher, have any questions regarding this product notification letter, please contact Varian Medical Systems Help Desk at 1-888-VARIANS (888-827-4265) for USA and Canada, +41 41 749 8844 or support-emea@varian.com for Europe;Emails for North American: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com and Latin American: soporte.al@varian.com, and Internets for Oncology Systems- www.myvarian.com and Varian Medical Systems- www.varian.com.",Contact the recalling firm for information,3629,3629,"Worldwide distribution: USA and countries including: Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia.",Terminated,"July 20, 2011",191,3629,Software,Device Operation,Software update,Software Update
Z-0890-2011,56326,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA.Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.",CyberKnife Treatment Planning System,2,"January 10, 2011", 2011,Accuray Inc,Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.,N/A,"Accuray sent an ""URGENT DEVICE CORRECTION"" letter dated July 6, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to assure the LINAC cover is secure following reattachment and adhere to and follow the instructions included in the letter. Note: A new design is being developed, and will be distributed to user base once available.If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non-USA) or customersupport@accuray.com.",N/A,207,207 units,"Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.",Open,N/A,N/A,207,Not_Computer,N/A,N/A,N/A
Z-0887-2011,57338,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN.The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.",Zimmer TiTLE2 Polyaxial Spinal System,2,"January 10, 2011", 2011,Zimmer Inc.,"There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. There could be a delay in surgery to remove the ball plunger. If the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal.",OTHER/UNDETERMINED: Pending,"Zimmer sent an URGENT MEDICAL DEVICE RECALL LETTER dated October 21, 2010, to all affected customers. The letter identified the product, the problem, the action to be taken by the customer.Customers were instructed to:Inspect their inventory, stop using the device, and place it in quarantine. Contact Zimmer Customer Service at 1-800-774-6368 to obtain a return authorization number. Complete the Inventory Return Certification form and fax a copy to (952) 837-6958, or scan and email to qualitycompliance@zimmer.com.Return the recalled product along with the original completed Return Certification Form to:Zimmer Spine, Inc.Attn: RA Receiving5301 Riata Park Ct.Austin, Texas 78727For questions regarding this recall call Zimmer Spine Customer Service at 1-866-774-6368. .",N/A,68,68,"Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.",Terminated,"October 12, 2011",275,68,Not_Computer,N/A,N/A,N/A
Z-0843-2011,57293,"set, tubing, blood, with and without anti-regurgitation valve",FJK,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing SetP/N: 03-2695-9,Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set,1,"January 10, 2011", 2011,"Fresenius Medical Care Holdings, Inc.",Hemodialysis Blood tubing Sets may develop kinking of the arterial line.,N/A,"Fresenius Medical issued recall notification dated 11/19/10, ""URGENT RECALL FMCNA Combiset¶_ BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)"", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.",N/A,24,"190,080 units (7920 cases x 24 units)",Distribution Nationwide and Canada,Terminated,"November 03, 2012",663,56,Not_Computer,N/A,N/A,N/A
Z-0889-2011,57414,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assemblyThe TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.,TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly,2,"January 10, 2011", 2011,"Cardiac Assist, Inc",Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed ""CAUTION: DO NOT USE"" sticker(s) and quarantine to prevent usage.Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.",N/A,164,164,"Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.",Terminated,"December 01, 2011",325,164,Not_Computer,N/A,N/A,N/A
Z-0837-2011,57099,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets",B. Braun Outlook,1,"January 10, 2011", 2011,"B Braun Medical, Inc","Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.",DESIGN: Component Design/Selection,"B. Braun Medical Inc. notified consignee by letter on August 24, 2010.",N/A,2107,"2,107 Pumps (582 Pumps to Winchester)",Virginia and New York,Open,N/A,N/A,2107,Software,Alarm/Message,Notification,Safety Notice/Insructions
Z-0853-2011,53047,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),"RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA.Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.","RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurgery System",2,"January 11, 2011", 2011,Accuray Inc,Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.,DESIGN: Device Design,Consignees were notified verbally about the issue when an inspection was scheduled.,N/A,26,26,"Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.",Terminated,"January 12, 2011",1,26,Not_Computer,N/A,N/A,N/A
Z-0892-2011,56350,N/A,N/A,N/A,N/A,N/A,N/A,"Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator,Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.","Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,",2,"January 11, 2011", 2011,Varian Medical Systems Oncology Systems,"There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.",OTHER/UNDETERMINED: Pending,"Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take.Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin.Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure.Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately.Pay special attention to the ""Recommendations based on wear measurements"" table.Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB.For questions regarding this recall call (650) 424-5731.",N/A,N/A,N/A,"Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.",Terminated,"February 24, 2012",409,N/A,Not_Computer,N/A,N/A,N/A
Z-0894-2011,57463,phlebotomy blood collection kit,OFM,Impedance phlebograph.,Cardiovascular,Cardiovascular,Enforcement Discretion,"Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020.The kits are used by blood centers to draw blood.",Monoject Prefill Advanced,2,"January 11, 2011", 2011,"Continental Medical Labs,Inc","Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to their distributors. Continental Medical Labs,Inc telephoned on 12/06/2010 and later sent a letter dated December 7, 2010, with an enclosed copy of the recall notice. The letters were addressed to McCormick Medical Distribution, Inc and to Medico Mart, Inc. The letter described the problem and product affected. Advised consignees to inform all their customers to return the product as well as the distribution information as soon as possible so CML could notify Covidien for replacements.For questions regarding this recall call (262) 723-6715, ext. 313.",No consumer action necessary,30,"30 cases, 30 kits per case",Nationwide Distribution including WA and WI,Terminated,"July 05, 2012",541,30,Not_Computer,N/A,N/A,N/A
Z-0899-2011,51401,"catheter, ventricular, general & plastic surgery",GBS,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CAProduct is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.",Concentric 7F Balloon Guide Catheter ,2,"January 12, 2011", 2011,Concentric Medical Inc,Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to examine their inventory and identify any affected product.Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices.For questions regarding this recall call 877-471-0076.",N/A,36,36 units affected.,"Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland",Terminated,"January 13, 2011",1,36,Not_Computer,N/A,N/A,N/A
Z-0897-2011,51274,"table, powered",INQ,Powered table.,Physical Medicine,Physical Medicine,510(K) Exempt,"Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system,Model Number: 4535 602 50851, Catalog Number: 882350,Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.",Precedence SPECT/CT System Upper Patient Pallet,2,"January 12, 2011", 2011,Phillips Nuclear Medicine,"A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm, Philips Healthcare, sent an ""Urgent - Field Safety Notice"" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet.If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.",N/A,2,2 units,International distribution only: Mexico and Saudi Arabia.,Terminated,"January 13, 2011",1,2,Not_Computer,N/A,N/A,N/A
Z-0896-2011,54718,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),Acuson Antares Ultrasound SystemDiagnostic Ultrasound system,Ultrasound System,2,"January 12, 2011", 2011,"Siemens Medical Solutions USA, Inc.",Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.,DESIGN: Software Design,"Field notification in the form of a Customer Safety Advisory Notice was initiated on 09/30/2009 by the firm, and the notice was mailed to all affected customersSiemens sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter on September 30, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconnect and reconnect the V5Ms transducer between uses until their local Customer Service Engineer installs the software update to their system. For any questions customers were to contact their local service support person.For questions regarding this recall call 650-694-5398.",N/A,452,452,"Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Croatia, India, Indonesia, Italy, Jordan, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.",Terminated,"June 18, 2012",523,452,Software,Physical Safety Hazards,Instructions on reconnecting the transducer,Safety Notice/Insructions
Z-0898-2011,57218,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703.Permits venous access to the central circulation.,ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter,2,"January 12, 2011", 2011,Arrow International Inc,"One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.",N/A,1150,1150 units,International Distribution Only -- Argentina and Columbia.,Terminated,"September 29, 2012",626,1150,Not_Computer,N/A,N/A,N/A
Z-0895-2011,57462,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Disc Space DistractorLabel states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.",IBD Disc Space Distractor,2,"January 12, 2011", 2011,Stryker Spine,Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.,N/A,"Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product.Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370.Return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance,Stryker Spine 6 Pearl CourtAllendale, New Jersey 07401For questions regarding this recall call 201-760-8206.",Contact the recalling firm for information,21,21 units,"Nationwide Distribution including AZ, FL, MA, NY, PA, and TX",Terminated,"November 14, 2012",672,21,Not_Computer,N/A,N/A,N/A
Z-0900-2011,57436,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Horizon Cardiology ECG ManagementThis is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.",Horizon Cardiology ECG Management,2,"January 13, 2011", 2011,McKesson Provider Technologies - Medical Imaging Group,"When importing ECG files from Mortara ECG carts using DICOM interface, the Horizon Cardiology ECG Management System does not display the amplitudes of the waveform properly.",DESIGN: Device Design,"McKesson Medical sent an advisory notice letter dated June 16, 2010, to all affected customers. Advisory notice ADV01646 was distributed to 13 affected clinical sites from August 30, 2010 to September 28, 2010. The letters identified the product that is affected, the circumstances under which patient safety issue may occur, the risk, and the immediate actions that need to be taken along with a temporary fix. Customers were instructed to use the ECG cart printout to verify results of procedures acquired by Mortara ECG carts. Users should be aware of the problem when referrring to past ECG procedures and when performing a visual comparison with ECG procedures acquired by Mortara ECG carts.Customers should disable the Glasgow Serial Comparison for ECG procedures.McKesson Support would contact the customer to coordinate the deployment of the software update on all the affected applications and Horizon Cardiology client applications. For any questions regarding this recall, customers should call the Customer Support department at 1-866-777-0202 and speak to their Support Manager.",N/A,16,16 units,"Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.",Terminated,"August 17, 2012",582,16,Software,Display/Image,Software update,Software Update
Z-0904-2011,52716,"microscope, surgical",EPT,Surgical microscope and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, GermanyMedical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. Product Quantity Distributed (Int) 2540 units",VISU 200,2,"January 14, 2011", 2011,Carl Zeiss Meditec Inc,Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery.Verify the position of the retinal protection filter and inform their staff of the customizable feature. Verify that the correct filter was in place. Customers were asked to complete the acknowledgement form indicating receipt of the alert. Sign and return the form to:Carl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope.For any questions customers should call (925) 557-4422.",N/A,2540,2540 units,Worldwide Distribution including USA (nationwide) and the UK,Terminated,"February 09, 2011",26,2540,Not_Computer,N/A,N/A,N/A
Z-0901-2011,57377,"ventilator, high frequency",LSZ,N/A,N/A,Anesthesiology,N/A,"One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.",Life Pulse High Frequency Ventilator,2,"January 14, 2011", 2011,"Bunnell, Inc.",Product software coding error may compromise patient safety.,DESIGN: Software Design,"Customers were notified by an ""Urgent: Medical Device Recall or Correction"" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade.",Contact the recalling firm for information,660,660 total,"Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.",Terminated,"April 17, 2012",459,660,Software,Physical Safety Hazards,Return/Update,Remove or Replace
Z-0903-2011,57021,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company.Used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.",PROCEED Surgical Mesh,2,"January 14, 2011", 2011,"Ethicon, Inc.",There is a potential for delamination in one lot of Proceed surgical mesh.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Ethicon sent Urgent Voluntary Product Recall letters via Fed Ex on October 18, 2010. The letters described the issue with the affected product and instructed customers not to use it. They are to immediately remove the recalled product from their inventory and return it according to the instructions provided. A reply card is attached and must be filled out and returned to Stericycle whether or not the customer has product in their possession. Separate correspondence has been sent to end customers stating that if they have purchased the recalled product through a distributor, to return the product directly to Stericycle. Replacement product will be provided at no additional charge for all recalled product.",N/A,87,87 products,Worldwide Distribution,Open,N/A,N/A,87,Not_Computer,N/A,N/A,N/A
Z-0908-2011,51550,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CAA Radiation therapy device.",CyberKnife System Robotic Radiosurgery System,2,"January 18, 2011", 2011,Accuray Inc,The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.,DESIGN: Device Design,"Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.",Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan",Terminated,"January 19, 2011",1,N/A,Not_Computer,N/A,N/A,N/A
Z-0910-2011,53778,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.","CSeries Clinac, Trilogy and Novalis Tx",2,"January 18, 2011", 2011,Varian Medical Systems Oncology Systems,"Product may deliver radiation treatment to areas larger than intended,to healthy tissue.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.",N/A,5208,5208 units,Worldwide Distribution,Terminated,"February 24, 2012",402,5208,Not_Computer,N/A,N/A,N/A
Z-0912-2011,56624,"tourniquet, pneumatic",KCY,Pneumatic tourniquet.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF 5920-011-000, Rx only.Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity.",SmartPump Tourniquet Pump,2,"January 18, 2011", 2011,Stryker Instruments Div. of Stryker Corporation,"This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded sction of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this fa",DESIGN: Component Design/Selection,"Stryker Instruments sent an Urgent - Medical Device Recall Notification letter dated April 13, 2010, to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Stryker notified customers again on May 24, 2010, and again on September 14, 2010, via email, fax, or telephone.Customers were instructed to locate the units and visually inspect each affected cord. Remove the affected cord and dispose of it using their healthcare facilities disposal procedure. If the cord did not show signs of damage, the unit could remain in service until a replacement cord was available. Customers were to return the enclosed business reply form to confirm receipt of the notification letter and identify how many affected units were currently in their inventory. Stryker instruments would send out replacement cords.If the customer loaned or sold any of the units listed in the notification, the customer was to forward a copy of the notice to the new users and advise Stryker of the new user's name and their new location. If products were disposed of and were no longer in use, the customer was to advise Stryker of their obsolescence by providing them with their serial numbers. For questions regarding this recall call 800-800-4236, ext 3808 or ext 3584 Monday -Friday 8am-5pm (EST).",N/A,N/A,N/A,"Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England.",Terminated,"May 16, 2011",118,N/A,Not_Computer,N/A,N/A,N/A
Z-0920-2011,57535,"gown, surgical",FYA,Surgical apparel.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.",Kimberly Clark Ultra Surgical Gown,2,"January 18, 2011", 2011,Kimberly-Clark Corporation,Product was not properly sterilized.,N/A,"Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm'sRecall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.",N/A,200,200 cases (32 units per case),"Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.",Terminated,"July 27, 2011",190,240,Not_Computer,N/A,N/A,N/A
Z-0911-2011,56772,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System",Varian Eclipse,2,"January 18, 2011", 2011,"Varian Medical Systems, Palo Alto, CA","Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose.",DESIGN: Software Design,"Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected users on August 6, 2010. Letters were also sent to Varian Sales, Marketing and Service organizations to inform them of the recall.",Contact the recalling firm for information,7019,7019,Worldwide Distribution.,Terminated,"July 21, 2011",184,7019,Software,Device Operation,Software update,Software Update
Z-0907-2011,56773,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA;Intended to deliver x-ray radiation for therapeutic treatment of cancer.ARTISTE with 160 MLC,Part No.8139789,ONCOR AG with 160 MLC,Part No.5863472ONCOR Impression Plus with 160 MLC,Part No.5857912,ONCOR Expression with 160 MLC,Part No.7360204,ONCOR Expression with 160 MLC,Part No.7360717,PRIMUS HI with HPD,Part No. 4504200,MEVATRON M2 / PRIMUS Mid-Energy / HPD,Part No.1940035,MEVATRON 6323-2 / HPD,Part No.19244500,MEVATRON K2 / HPD,Part No.1940753,MEVATRON PRIMART / HPD,Part No.5500371,MEVATRON 77 / HPD,Part No.5659503,MEVATRON M 7400 / 7440 (MEX) / HPD,Part No.5672977,MEVATRON M 6700 (MX) / HPD,Part No.5693908,MEVATRON M 6730 / HPD,Part No.5694005,MEVATRON M 7140 / HPD,Part No.5694104,MEVATRON M 7400 / HPD,Part No.5694153,MEVATRON M 7445 / HPD (MEX),Part No.5694203,MEVATRON K 7467 / HPD,Part No.5694252,MEVATRON K 7767 / HPD,Part No.5694302,MEVATRON K 8067 / HPD,Part No.5694401,MEVATRON M 6300 (MX) / HPD,Part No.8317000,MEVATRON M 6730/6740 (MEX) / HPD,Part No.8319758,MEVATRON MD (MD, MDX) / HPD,Part No.8319808,MEVATRON KD / HPD,Part No.8319857,MEVATRON MDX / HPD,Part No.8496200,MEVATRON KD-2 / HPD,Part No.8515520,MEVATRON M3 6300 / HPD,Part No.9401316,MEVATRON M2 6700 / HPD,Part No.9401407,MEVATRON M2 6740 / HPD,Part No.9401506,MEVATRON KDS / HPD,Part No.941522,MEVATRON MD-2 / HPD,Part No.9401654,MEVATRON MDX 2 / HPD,Part No.9401746,MEVATRON KDS-2 / HPD,Part No.9411588,MEVATRON KD-2 / HPD,Part No.9822685,MEVATRON KDS-2 / HPD,Part No.9822693","ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators",2,"January 18, 2011", 2011,"Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510",The potential safety issue with the 160MLC or the HPD collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. The potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged.,N/A,"Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist.",N/A,1167,1167,Worldwide Distribution.,Terminated,"January 31, 2012",378,1167,Not_Computer,N/A,N/A,N/A
Z-0906-2011,56871,"carrier, sponge, endoscopic",FGS,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system.Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.",InfraVision IR Illuminator Console,2,"January 18, 2011", 2011,Stryker Endoscopy,Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Stryker Endoscopy, sent an ""Urgent: Device Correction"" letter dated September 28, 2010, t o all consignees/customers via a Fed Ex Mailer that included notification letter, acknowledgment receipts and updated instructions for use. International Stryker sites received product advisory notification. Stryker reps at those sites are responsible for notifying customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to discard any old IFUs from the InfraVision Console and ensure that they only use InfraVision compatible scopes; read the newly updated IFU provided with the letter; and complete and sign the enclosed ""acknowledgement of receipt"" form and fax to (408) 754-8378 or scan in or email to infravision@stryker.com. Note: Not returning the ""acknowledgement of receipt"" card will result in additional notices.Please contact your local Stryker sales representative to obtain information on scopes that are specific to the InfraVision system.If you have any questions, please contact us at 1-800-624-4422 or email at infravision@stryker.com.",N/A,861,861 units.,"Worldwide distribution: USA and countries including: Australia, Africa, Brazil, Canada, China, France, Greece, India, Italy, Korea, Latin America Mexico, New Zealand, Portugal, Romania, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.",Terminated,"February 09, 2011",22,861,Not_Computer,N/A,N/A,N/A
Z-0919-2011,54229,"system, pressure measurement, intermittent",JFC,Intermittent pressure measurement system.,Physical Medicine,Physical Medicine,510(K) Exempt,"Product labeling of the X3 Display reads in part:""XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada"".Product labeling of the X3 PRO reads in part:""XSENSOR Technology Corporation***X3 PRO***REF:XBOM-004 PID: CMUHUB00 S***R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada"".Pressure mapping and surface assessment for seats, seat backs, and beds. XSENSOR pressure imaging systems, also known as pressure mapping systems, are a valuable tool in helping clinicians prevent and manage pressure ulcers. Clinicians, nurses, and rehabilitation specialists use XSENSOR pressure imaging systems to help prevent pressure ulcers through improved surface selection and patient positioning on wheelchairs and hospital beds.",Pressure Imaging System,2,"January 18, 2011", 2011,Xsensor Technology Corporation,The plastic enclosures for the X3 Display and X3 PRO Pressure Mapping System has a UL94 HB flammability rating while the medical equipment specification UL 60601-1 requires V-2 rated plastic for electronic enclosures.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"On July 6, 2009, Xsensor sent an ""URGENT: MEDICAL DEVICE RECALL"" notifications to their consignees/customers.The consignees/customers were informed that the incorrect material of the plastic enclosures was used. The incorrect plastic had a UL94 HB flammability rating while the medical equipment specification UL 60601-1 required V-2 rated plastic for electronic enclosures. The firm provided prepaid shipping box to consignees/customers with instructions for returning the components. The components were refurbished and returned to consignees for free of charge.For further information please contact XSENSORs Customer Support at 1-866-927-5222.",N/A,33,33 units of X3 Display and 2 units of X3 Pro,"Devices were distributed to one distributor, medical facilities, and rehab centers through out the US, including following states:AL, AR, AZ, CA, CO, FL, GA, IA, IL, KS, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, and WI.",Terminated,"January 31, 2011",13,33,Not_Computer,N/A,N/A,N/A
Z-0918-2011,57068,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system.The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.",Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system,2,"January 18, 2011", 2011,Philips Medical Systems North America Co. Phillips,Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registered in the DI will be overwritten with an image of a later patient.,OTHER/UNDETERMINED: Pending,"On March 6, 2009, Philips sent an ""URGENT-Device Correction Easy Diagnost Eleva, MultiDiagnost Eleva, and OmniDiagnost Eleva with DI Rel. 2 systems notification"" to their consignees/customers.The consignees/customers are advised that before diagnosing images, always check the stored (Digital Image, Viewform or PACS) or printed images to ensure that these represent the data and images captured from the examination of the respective patient. Do not use images if they do not represent the patient that was examined. Consignees will be contacted by Philips to schedule a software upgrade of their units.The consignees can contact Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference ""FCO 70800070"" with any questions about this recall.",N/A,13,13 units,"Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.",Terminated,"June 16, 2011",149,95,Software,N/A,N/A,N/A
Z-0923-2011,50074,"alpha-1 microglobulin, antigen, antiserum, control",MGA,Alpha-globulin immunological test system.,Immunology,Immunology,510(K) Exempt,"K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: ""K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA..."".",KASSAY Alpha1 Microglobulin Reagent,3,"January 19, 2011", 2011,"Kamiya Biomedical Company, LLC",Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.,TRAINING: Employee Error,"Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed.For questions regarding this recall call 1-800-222-0342.",Contact the recalling firm for information,5,5 kits,Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.,Terminated,"January 20, 2011",1,5,Not_Computer,N/A,N/A,N/A
Z-0922-2011,56356,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072.240-099-001,240-099-001K,240-099-011,240-099-011K,240-099-020,240-099-020K,240-099-050,240-099-072,Product is manufactured and distributed by Stryker EndoscopySan Jose, CAThe product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.",Electrical Power Cord,2,"January 19, 2011", 2011,Stryker Endoscopy,"The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused.",DESIGN: Device Design,"Stryker Endoscopy sent an URGENT: Device Recall letter dated April 16, 2010, to Stryker Sales reps and all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Locate the affected units.Visually inspect each cord for damage.If the cord has bent or cracked prongs the unit should be taken out of service immediately. The customer was instructed to call a Regulatory Affairs Recall Representative at (408) 754-2738 for further instruction. If the cord did not show signs of damage, it could remain in service.An acknowledgement form was included to document confirmation of receipt of the letter. Upon completion of the power cord inspection, customers were to sign the acknowledgement form indicating that all of their units were inspected. Customers were asked to mail the form to Stryker Endoscopy or fax to (408) 754-8378 or scan the card and email to PowerCord@stryker.com.For questions regarding this recall call the Stryker RA/QA Department at (408) 754-2738 or (800) 435-0220, Reference RA 2010-034.",N/A,7371,7371,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, MY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Canada, Chile, China, India, Korea, Mexico, Singapore, Taiwan and Latin America.",Terminated,"January 19, 2011",0,7371,Battery,N/A,N/A,N/A
Z-0925-2011,57573,"catheter, biliary, diagnostic",FGE,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.",Cholangioscopy Access Balloon,2,"January 19, 2011", 2011,Cook Endoscopy,Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.,OTHER/UNDETERMINED: Pending,"The firm, Cook Medical, sent an ""URGENT: PRODUCT RECALL"" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use CustomerRelationsNA@cookmedical.com or call toll free at 1-800-457-4500, press 4 then enter extension 2146.",N/A,103,103 units (total for both units under recall),"Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..",Terminated,"August 04, 2011",197,104,Not_Computer,N/A,N/A,N/A
Z-0928-2011,56931,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker CorporationThe A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.",Scorpio Fixed Femoral A/P Sizing Guide,2,"January 19, 2011", 2011,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the ""Sizing Guide"") to disassociate from the main body of the instrument.",DESIGN: Component Design/Selection,"Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.",N/A,6,six units,"Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.",Terminated,"July 31, 2013",924,243,Not_Computer,N/A,N/A,N/A
Z-0924-2011,56859,"table, surgical with orthopedic accessories, ac-powered",JEA,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.",ProFx 6850,2,"January 20, 2011", 2011,Mizuho Orthopedic Systems Inc,"Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.",N/A,"All customers will be contacted to arrange for removal and shipping arrangements. Verification will be done by the Repair and Verification instructions for the leg spars, via registered letters.*******UPDATED INFO---The firm sent another notification letter---dated 12/22/10---which states in part: ""****The upgrade involves the correction of your 6850 PROfx¶_ spars (6850-2100) at your facility by a Qualified Technician. The spars shall be upgraded to remove the 6850-2123, Drive Bracket, Spar Push Rod and replace it with the 6850-2170, Drive Bracket, Spar Push Rod. Upon completion of the upgrade, the 6850-2123, Drive Bracket, Spar Push rod shall be returned to Mizuho OSI for processing. *******.",Contact the recalling firm for information,17,17 units,Worldwide Distribution -- USA & Germany.,Terminated,"May 17, 2011",117,17,Not_Computer,N/A,N/A,N/A
Z-0929-2011,56403,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT CG8+ Cartridge;pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVDAbbott Point of CareThe test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.",iSTAT CG8 Cartridge,2,"January 20, 2011", 2011,Abbott Point of Care Inc.,Two cartridge lots were identified that may generate falsely elevated PCO2 results.,OTHER/UNDETERMINED: Pending,"Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them.For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.",Contact the recalling firm for information,55350,55350 total cartridges,"Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of Oman and Turkey.",Terminated,"December 05, 2011",319,55350,Not_Computer,N/A,N/A,N/A
Z-0936-2011,57572,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),Super Arrow-Flex(R) PSI SetIntended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures,Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set,2,"January 21, 2011", 2011,Arrow International Inc,"Packaging may have been compromised, and sterility of product cannot be guaranteed.",OTHER/UNDETERMINED: Unknown/Undetermined by the firm,"The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an ""Urgent Field Safety Notice"" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer.If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.",N/A,320,320 units,"International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.",Open,N/A,N/A,320,Not_Computer,N/A,N/A,N/A
Z-0931-2011,57515,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161",Colleague CX Volumetric Infusion Pump,2,"January 21, 2011", 2011,Baxter Healthcare Corp.,"While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.",TRAINING: Employee Error,"Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost.For questions regarding this recall call (800) 437-5176.",Contact the recalling firm for information,1,1 pump,Texas,Terminated,"May 13, 2011",112,1,Not_Computer,N/A,N/A,N/A
Z-0933-2011,57334,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063For delivery of intravenous solutions, drug solutions, enteral feedings and blood.",Baxter FloGard 6201 Volumetric Infusion Pump,2,"January 21, 2011", 2011,Baxter Healthcare Corp.,The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.,PRODUCTION CONTROLS: Process Control,"The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may choose to send the pump to Baxter for testing.If you have any questions regarding this information, please contact Vice President, Quality, GIS at 847-270-5507.",N/A,1,1 pump,Nationwide distribution: WA only,Terminated,"March 16, 2011",54,1,Hardware,Physical Safety Hazards,Replace/Return,Remove or Replace
Z-0932-2011,57527,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"4D Integrated Treatment Console (4DITC);All versions up to and including 8.8.17Varian Medial Systems, Palo Alto, CADesigned to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.",4D Integrated Treatment Console (4DITC),2,"January 21, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present.",DESIGN: Software Design,"Urgent Medical Device Correction/Field Safety notification letters were distributed to all affected users, and to Varian Sales, Marketing and Service Organizations on December 14, 2010 by certified mail. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters described the issue and recommended user actions along with Varian's actions. Users are to use caution when acquiring actual couch positions for any plan. In addition, each plan should be reviewed for quality assurance purposes in accordance to set departmental or organizational policies. The firm updated the procedure and enclosed a copy with the letter. It was also posted to the customer support site. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.",N/A,4188,4188,Worldwide Distribution.,Terminated,"July 22, 2011",182,4188,Software,Treatment/Delivery/Therapy,Procedure update,Other
Z-0934-2011,57612,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),"Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packetsIntended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Brand names: 1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; 2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.; 3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.; 4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. 10-8917, Net Wt. 2 oz, Cat. No. 10-8946, Net Wt. 5 g, Triad Plus Cat. No. 11-8344, 3 g., Cat. No. 11-8472, 5 grams, Cat. No. 10-8919, Net Wt. 4 oz, Cat. No. 10-8500, Net Wt. 4 oz; 5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.; 6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.; 7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.",Sterile Lubricating Jelly,2,"January 21, 2011", 2011,"H & P Industries, Inc. dba Triad Group",Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products.,PRODUCTION CONTROLS: Process Control,"The firm, Triad Group, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated December 22, 2010, to all customers via US Postal Service certified. The letter described the issue, identified affected product as that which contained a lot number beginning with the digits 7, 8, 9, or 0, and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; notify their customers at once if the recalled product was further distributed, and complete and return the enclosed Recall Acknowledgement form via fax at 262-538-2947 or mail along with the recalled product to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Hartland, WI 53029.If you have any questions, please call Triad Group Customer Service Monday thru Friday, between the hours of 8:30 a.m. and 4:00 p.m. Central Time at 262-538-2900 ext 2761.",Contact the recalling firm for information,453787,"453,787 cases","Worldwide distribution: USA including states of: CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MY, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI and Puerto Rico; and countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates.",Terminated,"June 11, 2012",507,453787,Not_Computer,N/A,N/A,N/A
Z-0935-2011,57516,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161.Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.",Colleague CX and CXE Infusion Pumps,2,"January 21, 2011", 2011,Baxter Healthcare Corp.,The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.,TRAINING: Employee Error,"Baxter telephoned the two customers on December 1, 2010, informing them that that a post repair test was not performed correctly on their Colleague pumps (serial numbers 12070599CC and 17086323CP) during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost.*** Baxter expanded the recall to include twelve additional pumps on June 22, 2011 by telephone calls to the affected accounts. The recall strategy remains the same as the December 1, 2010 instructions. ****.",N/A,14,14 pumps,"Nationwide Distribution -- Arizona, Indiana, *** California, Iowa, New Jersey, Ohio, Virginia and West Virginia***.",Terminated,"January 20, 2012",364,14,Not_Computer,N/A,N/A,N/A
Z-0938-2011,50791,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CAIntended use: Catheter for use in surgery.",Crosser 14S Catheter,2,"January 24, 2011", 2011,Flowcardia Inc.,"Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.",TRAINING: Employee Error,"The firm, FlowCardia, Inc., sent an ""URGENT! Medical Device Recall"" letter dated January 9, 2009 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to return the product to FlowCardia, at the firms expense, for replacement and Confirm that this product has been used by completing and returning the attached fax document via fax to 408-616-0053. The customers were ask to please make an attempt to contact the customer service representatives, Operations specialist at 888-456-7286 or Vice President, Clinical, Quality & Regulatory Affairs at 408-617-0352 x302, within the next 30 days. Note: FlowCardia Sales, Clinical and Customer support will send notification via certified mail or traceable courier and track response.If you have any questions or need any additional information email (dmichaels@flowcardia.com) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.",N/A,35,35 units,"Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.",Terminated,"January 25, 2011",1,35,Not_Computer,N/A,N/A,N/A
Z-0937-2011,56804,"pacemaker, cardiac, external transcutaneous (non-invasive)",DRO,External transcutaneous cardiac pacemaker (noninvasive).,Cardiovascular,Cardiovascular,510(k),Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series.Designed for use in and out of the hospital.,Welch Allyn PIC 50 Portable Intensive Care System,2,"January 24, 2011", 2011,"Welch Allyn Protocol, Inc",Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.,OTHER/UNDETERMINED: Pending,"On 9/17/10, Welch Allyn began sending out the Important Product Alert letter to all their direct consignees. On 9/24/2010, the firm sent out the letters to their distributors.The Product Alert letter informs the consignees of a low potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail.The consignees are advised to follow the instruction in the PIC 50 user's manual requiring routine shift equipment checks daily or at each shift change to minimize the likelihood of the malfunction from occurring. The checks ensure that the PIC 50 and its component (including the screen display) are fully operation and undamaged.The letter further states ""our analysis indicates that routinely doing such checks will likely lead to discovery of this malfunction as it occurs, and thus timely maintenance and repair"".The distributors are advised to communicate this Product Alert to their customers if the devices were further distributed. For customers in US and Canada, distributors are advised to provide the electronic Excel file with customer's name, address, serial number and part number to WA2221@Stericycle.com. For customers in other countries, they are advised to provide information to PIC50Product Alert@welchallyn.comConsignees can call Welch Allyn at 800-289-2500 for any questions during normal business hours.",N/A,3606,2002 units to US consignees and 1604 units to foreign consignees,"Worldwide Distribution -- US, including states: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and countries ofAustralia, Austria, Belgium, Canada, China, Columbia, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Mexico, Oman, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Yemen.",Terminated,"July 25, 2011",182,3606,Other,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-0947-2011,57470,"lavage, jet",FQH,Jet lavage.,General Hospital,General Hospital,510(K) Exempt,"The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.",InterPulse Handpiece Set With Suction Tubing,2,"January 25, 2011", 2011,Stryker Instruments Division of Stryker Corporation,"There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.",PRODUCTION CONTROLS: Packaging Process Control,"Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.For questions regarding this recall call (269) 323-7700.",Contact your health professional,490,490,"Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.",Terminated,"June 06, 2011",132,3187,Not_Computer,N/A,N/A,N/A
Z-0955-2011,57380,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTCThe Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.",UniCP Compression Plate System ,2,"January 25, 2011", 2011,Integra LifeSciences Corp.,Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The sterilization parameters noted in the Uni-Comp IFU were incorrect. It is noted that the sterilization recommendations in the UNI-Comp IFU in which the Exposure,OTHER/UNDETERMINED: Pending,"The firm, Integra, contacted the Sales Representatives on November 8, 2010 via telephone conference calls. Integra also sent a ""URGENT: PRODUCT RECALL NOTIFICATION"" letter dated November 9, 2010 all customers via FedEx overnight delivery. The letter described the product, problem and the action to be taken by the customers and the firm. The customers were instructed to immediately examine their inventory, QUARANTINE THE PRODUCT, and complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via mail: Integra LifeSciences Corporation, Attn: Sandy Yates, 311 Enterprise Drive, Plainsboro, NJ 08536, fax to (609)-275-5363 or Scan and email to sandra.yates@integralife.com. The firm will have a Integra LifeSciences Corporation Sales Representative contact the customer to assist them in retrieving and returning their Uni-CP Compression Plate System to Integra. Integra will also ship replacement Uni-CP Compression Plate (Uni-CPII and Large Uni-Clip) Systems back to the customers as soon as possible at no charge.Should you have any additional questions, contact the Director of Marketing, Hindfoot-Extremity Reconstruction or your regional managers at 513-533-7929, 609-275-0500 or toll free at 800-654-2873.",Contact the recalling firm for information,67,Sixty seven (67) Kits,"Nationwide distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.",Terminated,"November 18, 2011",297,67,Not_Computer,N/A,N/A,N/A
Z-0954-2011,57498,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.",LigaSure Blunt Tip Laparoscopic Sealer/Divider,2,"January 25, 2011", 2011,Covidien LP,"During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.",N/A,"The firm, Covidien, sent a ""URGENT: PRODUCT RECALL"" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307.To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1.Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).",Contact the recalling firm for information,25009,"25,009 units","Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.",Terminated,"March 27, 2012",427,25009,Not_Computer,N/A,N/A,N/A
Z-0939-2011,57630,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027",Linemaster Wireless Footswitch,2,"January 25, 2011", 2011,"Sound Surgical Technologies, LLC","Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.",PRODUCTION CONTROLS: Process Control,"Customers were notified by e-mail with an Advisory Notice on 12/21/2010. The Notice identified the affected product and described the issue. The Notice also explained what the potential hazard involved along with a mechanism to eliminate the potential hazard. Sound Surgical would arrange a service call to implement the correction at the firm's expense. If customers experience this potential failure, they are to contact Sound Surgical Technologies at 1-888-677-8765 or 1-888-471-4777.",N/A,27,27 units,"Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .",Terminated,"February 08, 2011",14,27,I/O,N/A,N/A,N/A
Z-0966-2011,57708,"catheter, urological",KOD,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.",Koyle Diaper Stent.,2,"January 25, 2011", 2011,Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN,The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.,PRODUCTION CONTROLS: Packaging Process Control,The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.,Contact the recalling firm for information,25,25 stents,"CA, CT",Terminated,"January 31, 2011",6,25,Not_Computer,N/A,N/A,N/A
Z-0967-2011,57188,N/A,N/A,N/A,N/A,N/A,N/A,"StaXx¶_ XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H)Catalog number: 11-1525The StaXx¶_ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx¶_ XD System is the CapSure¶_ PS Spine System.",Spine Wave,2,"January 26, 2011", 2011,Spine Wave Inc,Package Insert Incorrect,PRODUCTION CONTROLS: Packaging Process Control,"Spine Wave notified each affected customer on October 22,2010, via telephone of the product, the issue and action they should take. Customers were asked to segregate the product from other products and immediately return to Spine Wave.For questions regarding this recall call 203-944-9494.",N/A,12,12 units,"Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York",Terminated,"March 15, 2011",48,12,Not_Computer,N/A,N/A,N/A
Z-0959-2011,57609,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.",S5 Mast Roller Pump System 85,2,"January 26, 2011", 2011,"Sorin Group USA, Inc.","Touch screen may become unresponsive, inhibiting user input.",N/A,"All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.",Contact the recalling firm for information,11,11 units,Worldwide Distribution.,Terminated,"July 13, 2012",534,6671,I/O,N/A,N/A,N/A
Z-0968-2011,57231,"blade, saw, general & plastic surgery, surgical",GFA,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI.The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.",Sternal Saw II Sterile Blades,2,"January 26, 2011", 2011,Terumo Cardiovascular Systems Corporation,The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.,DESIGN: Labeling Design,"Terumo Cardiovascular Systems Corporation firm sent out an 'URGENT MEDICAL DEVICE CORRECTION: SAFETY ADVISORY"" letter dated October 20, 2010, to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Safety Advisory, assure that all users were aware of the notice, and confirm receipt of the Safety Advisory by faxing the attached Customer Response Form to the fax number on the form. For questions regarding this recall call 1-800-521-2818.",N/A,4265,"42,650 units, 4265 boxes of 10 each","US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.",Terminated,"December 14, 2011",322,4265,Not_Computer,N/A,N/A,N/A
Z-0973-2011,53198,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811.Intended use: The EPT-1000xp Cardiac Ablation Controllers and Foot Switch are indicated for use in cardiac ablation procedures with standard and high power BSC cardiac ablation Catheters.","RF Ablation System Foot Switch, used with the EPT1000 RF Generator",2,"January 27, 2011", 2011,Boston Scientific Corp,Product malfunction causes inadvertent delivery of energy.,DESIGN: Component Design/Selection,"The firm, Boston Scientific, sent an ""URGENT: Medical Device Recall"" letter dated January 14, 2009, with attached recall instructions to all customers. The letter described the product, problem, and the action to be taken by the customers. The customers were instructed to complete and return the Reply Verification Tracking Form and Obtain an RGA via fax to 408-957-6204; and return the recalled product using BSC Federal Express Number 1-809-4713-2 via second day delivery to Boston Scientific Corporation, Distribution Center, 500 Commander Shea Blvd., Quincy, MA 02171. Boston Scientific Corporation sales representatives will contact each customer.If you have any questions, please contact 408-935-4952 or email: wareb@bsci.com.",N/A,1044,1044 units,Worldwide distribution,Terminated,"January 27, 2011",0,1044,Not_Computer,N/A,N/A,N/A
Z-0974-2011,54350,"airway, oropharyngeal, anesthesiology",CAE,Oropharyngeal airway.,Anesthesiology,Anesthesiology,510(K) Exempt,"KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.Airway management by providing a patent airway to allow patient ventilation.","KING LT D Size 3, 100002 Oropharyngeal Airway",2,"January 27, 2011", 2011,King Systems Corp.,"King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for ""airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat",MISBRANDING: Labeling False and Misleading,"On October 29, 2009, the firm, Kings System, sent a ""Urgent - Product Correction"" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications.Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197.For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.",N/A,25000,"25,000 all products","Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.",Terminated,"August 16, 2012",567,25000,Not_Computer,N/A,N/A,N/A
Z-0987-2011,57501,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Physiological Monitoring, Patient MonitorM31250 Information Center Local DatabaseReleases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers.The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.","Physiological Monitoring, Patient Monitor",2,"January 27, 2011", 2011,Philips Healthcare Inc.,"Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.",DESIGN: Device Design,"Philips notified all affected customers with an Urgent Medical Device Correction notification letter dated December 17, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to observe their system for any of the described symptoms. If they experience intermittent audio or there is no sound from their PAS-210 speaker while it is not connected to another audible alarm annunciation system, customers were instructed to remove the speaker from use and contact their local Philips service representative. Customers were advised not to rely exclusively on the audible alarm system for patient monitoring, the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.ACTIONS PLANNED BY PHILIPSPhilips will replace affected speaker assemblies free of charge.A Philips Healthcare representative would contact the customer when the replacement was available. Field Service Engineers will remove and replace defective speakers to correct the problem. The defective speakers will be returned to vendor (Beach Wire) to be discarded. This correction will be done free of charge for customers.",Contact the recalling firm for information,1071,1071,"Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA WI, WV, WY, and Canada",Open,N/A,N/A,1071,I/O,Alarm/Message,Replace components,Remove or Replace
Z-0972-2011,57051,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Bio Med Devices Disposable Pediatric Breathing Circuit, One SetCatalog Number: 4040LC5 foot /15mm corrugated EVA hoseIntended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators",Bio Med Devices,2,"January 27, 2011", 2011,Biomed Devices,Breathing circuit may disconnect between the adapter adjacent tubing cuff,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"The firm,Bio Med Devices, sent a ""URGENT MEDICAL DEVICE RECALL"" letter dated October 18, 2010 via fax to the customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to immediately examine their stock for the affected lots, if found, discontinue distributing and using the product and promptly return via UPS #025106 to Bio-Med Devices 61 Soundview Rd, Guilford, CT 06437, Attention: 4040LC Recall Return. The customers were also instructed to immediately contact their accounts, if the product was further distributed , advise them of the recall situation and have their outstanding product returned, and to complete and return the RETURN FAX-IMMEDIATE RESPONSE REQUIRED form via fax to 203-458-0440. Note: Bio-Med informed the customers that they will credit the return product; however, they only plan to replace the product in an emergency situation, because they have very few of the 3/8"" x 15mm adapters left and are looking to discontinue the 4040LC due to the discontinuance of this product by the manufacturer.If you have any questions, please contact (203) 458-0202 x 217.",Contact the recalling firm for information,15,15 cases (20/cs),"Nationwide distribution: OH, WI.",Open,N/A,N/A,16,Hardware,N/A,Return,Remove or Replace
Z-0970-2011,57703,N/A,N/A,N/A,N/A,N/A,N/A,"RLSense, Restless Legs Sensor, Proto6, Rev-J FirmwareRLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.",RL Sense,2,"January 27, 2011", 2011,Sleep Modus,Device had no 510(k) clearance prior to patient use.,OTHER/UNDETERMINED: Pending,"Sleep Modus, Inc. notified consignees by e-mail on 9/15/2010 and 10/7/2010. The e-mail identified the product, the problem, and the action to be taken. Customers were instructed to let them know if they experienced any of the issues identified in the e-mail. For questions call 214-405-4055.",N/A,110,110 devices (2 per kit),Nationwide Distribution including Texas,Terminated,"January 31, 2011",4,110,Not_Computer,N/A,N/A,N/A
Z-0991-2011,57522,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9"", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614.The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters",EndoPlege,2,"January 28, 2011", 2011,Edwards Lifesciences Llc,Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.,DESIGN: Component Design/Selection,"The firm, Edwards Lifesciences, sent an ""URGENT PRODUCT RECALL - ACTION REQUIRED"" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.",No consumer action necessary,3427,"3,427 kits",Nationwide Distribution,Terminated,"October 27, 2011",272,3517,Not_Computer,N/A,N/A,N/A
Z-0941-2011,57540,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis.",Catheter introducer,1,"January 28, 2011", 2011,"Merit Medical Systems, Inc.","Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Merit Medical Systems, Inc., issued an ""Urgent Product Recall Notice"" dated December 17, 2010, and contacted all customers (sales reps and authorized distributors) via email, phone and/or fax. The notice described the product, problem and action to be taken by the customers (Sales reps/Distributors). The customers were instructed to contact all their customers to identify, quarantine and return all unused inventory and extend the recall to any of their customers who may have received the affected products. The customers were instructed to complete and return the Manufacturer RECALL NOTIFICATION and Product Retrieval Form via fax to 1-801-208-3378 and send original to: the Manager, Customer Service, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, UT 84095-2416.Questions should be directed to the Senior Product Manager at 801-208-4344 or the Manager, Customer Service at 801-208-4365.",N/A,378,378 units,Nationwide Distribution,Terminated,"July 11, 2011",164,378,Not_Computer,N/A,N/A,N/A
Z-1001-2011,56354,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand C Series Clinic¶_s (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room. Intended use: The Trilogy Mx"" System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. 7/9/2013 - UPDATE: Determined that the correction only applied to C3 users, not C1 and C2 users.",Varian brand C Series Clinics,2,"January 31, 2011", 2011,Varian Medical Systems Oncology Systems,A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.,DESIGN: Device Design,"The firm, Varian Medical Systems, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated December 1, 2009 via Federal Express to consignees/customers. The letter described the product, problem and actions to be taken by the customers and the firm. The customers were instructed to perform a verification of field symmetry on electron beam energies to determine the threshold and report any field symmetry issues to their local Varian service office for attention. The firm, Varian, is developing new functionality to detect the symptoms of this component failure condition under all conditions of electron beam operations and asserting a beam interlock if it is detected. Note: Varian indicated until the solution can be developed, they will conduct an audit of installed Clinacs to identify those the suspect ""blue"" electron beam balance potentiometers installed, and will execute a program of prophylactic replacement of these potentiometers.If you require further clarification, please contact your local Varian Customer Support District or Regional Manager at phone: USA and Canada-1-888-VARIANS (888-827-4265); Europe- +41 41 749-8844 or email support-emea@varian.com; North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: seasia.apps.helpdes@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America: soporte.al@varian.com; Internet: Oncology Systems - www.myvarian.com; Varian Medical Systems -www.varian.com.",Contact the recalling firm for information,4411,4411,"USA and countries including: Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bolivia, Brazil, Canada, Chile,, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France,French Polynesia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lebanan, Luxembourg, Maca, Macedonia, Malaysia, Martinique, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan,, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea,, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay..",Terminated,"March 14, 2012",408,4411,Hardware,Device Operation,Instructions,Safety Notice/Insructions
Z-0990-2011,56963,"scalpel, one-piece",GDX,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.",Southmedic/Personna Safety Scalpel,2,"January 31, 2011", 2011,"Southmedic, Inc.",Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.,PRODUCTION CONTROLS: Packaging Process Control,"On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.",N/A,1330,1330 cases all products,"Worldwide Distribution -- USA, including states of TX, MO, NJ, LA, IL, NY, KY, PA, VA, WA, CA, MA, MD, IN, NV, TN, NC, AZ, IA, WI, UT, NE, GA, FL, MN, ME, OH, SD, and KS and countries of Australia and Canada.",Terminated,"May 18, 2011",107,1330,Not_Computer,N/A,N/A,N/A
Z-1005-2011,53780,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA.Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.",Acuson Antares PE ,2,"February 01, 2011", 2011,"Siemens Medical Solutions USA, Inc.","ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm's Customer Safety Advisory notice was mailed to all affected customers. The letter describes when the malfunction occurs and the potential risk. It also recommended that users collect corresponding evidence with spectral waveforms that would confirm or deny findings based on ECG, in order to avoid potential risks for misdiagnosis. The firm planned to exchange the faulty hardware component in the system. Customers would be contacted to schedule for the hardware exchange. Questions regarding this issue should be directed to the local service support person.",Contact the recalling firm for information,67,67 units total,Worldwide Distribution,Terminated,"March 29, 2011",56,67,Hardware,Output/Calculation,Replace component,Remove or Replace
Z-1008-2011,54535,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",CyberKnife Treatment Planning System,2,"February 01, 2011", 2011,Accuray Inc,"If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.",TRAINING: Employee Error,"The firm, Accuray, sent an ""URGENT DEVICE CORRECTION"" letter dated December 29, 2009, to all customers. The letter described the product, problem, and action to be taken by the customers. The customers were instructed to verify correctness of the CT number to relative electron density and Mass Density Calibration curves. Note: A patch is being developed to address this issue. Accuray Customer Support will contact the customers regarding further resolution.If you have any questions or concerns regarding this issue, please contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.",N/A,71,71 units are subject to this action,"Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China.",Terminated,"February 11, 2011",10,71,Software,Output/Calculation,Software update,Software Update
Z-1002-2011,56357,"bougie, esophageal, and gastrointestinal, gastro-urology",FAT,Esophageal dilator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560",Stryker Infravision,2,"February 01, 2011", 2011,Stryker Endoscopy,The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.,DESIGN: Device Design,"On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.",N/A,4125,4125,"Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).",Terminated,"February 01, 2011",0,4125,Not_Computer,N/A,N/A,N/A
Z-1003-2011,56349,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA","Varian brand CSeries Clinacs and Acuity, Exact Couch Top",2,"February 01, 2011", 2011,Varian Medical Systems Oncology Systems,The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Varian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office.For questions regarding this recall call 650-483-3153.",N/A,13,13,Worldwide Distribution - Japan only,Terminated,"December 23, 2011",325,13,Not_Computer,N/A,N/A,N/A
Z-0940-2011,56868,"clamp, vascular",DXC,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJIntended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.",Marquet Heartstring II Proximal Seal System,1,"February 01, 2011", 2011,"Maquet Cardiovascular, LLC","Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.",DESIGN: Process Design,"The firm, MAQUET Getinge Group, sent an ""URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED"" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874.If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.",Contact the recalling firm for information,1630,1630,"Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel",Terminated,"June 21, 2011",140,1630,Not_Computer,N/A,N/A,N/A
Z-1004-2011,56759,"system, imaging, optical coherence tomography (oct)",NQQ,Ultrasonic pulsed echo imaging system.,Radiology,General & Plastic Surgery,510(k),"Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).",Optovue iVue,2,"February 01, 2011", 2011,Optovue Inc.,Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.,DESIGN: Software Design (Manufacturing Process),"Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.",N/A,22,22 devices in the US.,Nationwide,Terminated,"February 08, 2011",7,22,Not_Computer,N/A,N/A,N/A
Z-1009-2011,57576,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"AutoSuture SURGIPRO Polyproylene Mesh Clear 3"" x 5"" SterileREF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in multiple designs, including multi-filament and open weave. All designs are knitted in such a fashion as to provide bi-directional elasticity, while allowing the mesh to be cut to any shape without unraveling.Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a non-absorbable mesh during and after wound healing.",autosuture,2,"February 01, 2011", 2011,Covidien LP,Sterility compromised due to breach in sterile barrier,PRODUCTION CONTROLS: Packaging Process Control,"Covidien notified customers via letter dated November 15, 2010. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to examine inventory and return the affected lot to Field Returns Department, 195 McDermott Road, North Haven, CT 06473. For questions regarding this recall call 203-492-8091.",N/A,132,132 units,"Worldwide Distribution - USA including CA, CT, FL, HI, IL, IN, KS, MA, MD, MI, MN, NC, NJ, NY, OH, PA, SC, TX, and WI and the countries of Canada and Italy",Terminated,"January 10, 2013",709,132,Not_Computer,N/A,N/A,N/A
Z-1010-2011,57595,powered laser surgical instrument with microbeam\fractional output,ONG,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Fraxel re:store¶_ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store¶_ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.",Fraxel re:store Dual Laser System,2,"February 01, 2011", 2011,"Solta Medical, Inc.",The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.,DESIGN: Software Design,"The firm, Solta Medical, issued three ""DEVICE CORRECTION"" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further.If you have any questions, please call Solta Product Support at (510) 259-7291.",N/A,352,352 units,"Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam",Terminated,"November 14, 2011",286,352,Software,Physical Safety Hazards,Software update,Software Update
Z-1017-2011,57661,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Port Dressing Tray, Reorder DT12885, Sterile, Centurion Medical Products Corp. Williamston, MI. Intended use: Vascular access port kit",Port Dressing Tray,2,"February 01, 2011", 2011,Centurion Medical Products,"The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed ""that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)"".",OTHER/UNDETERMINED: Pending,"The firm, Covidien, sent an ""URGENT PRODUCT RECALL"" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor.Should you have any medical questions concerning this recall, please call 508-261-6393.For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.",Contact the recalling firm for information,2250,2250 kits.,"Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.",Terminated,"February 16, 2011",15,4290,Not_Computer,N/A,N/A,N/A
Z-1012-2011,57259,anesthesia conduction kit,CAZ,Anesthesia conduction kit.,Anesthesiology,Anesthesiology,Enforcement Discretion,"Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) CatheterIntended use: Permits acccess to epidural space, Epidural Anesthesia Kit",Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) Catheter,2,"February 01, 2011", 2011,Arrow International Inc,Sterility may be compromised.,TRAINING: Employee Error,"The firm, Arrow International, issued an ""URGENT MEDICAL DEVICE RECALL"" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935.If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.",Contact the recalling firm for information,2320,2320,Nationwide Distribution: USA states including IL and LA.,Terminated,"July 05, 2012",520,2320,Not_Computer,N/A,N/A,N/A
Z-1022-2011,53014,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"PEAK brand PlasmaBlade EXT, Tissue Dissection Device,Catalogue Number: PS215-040;Product is manufactured and distributed by PEAK Surgical, Palo Alto, CAThe PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.",PEAK,2,"February 02, 2011", 2011,Peak Surgical,A customer reported that a patient suffered a burn while using the device.,N/A,"Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall.",Contact the recalling firm for information,493,493 units,"Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland",Terminated,"April 21, 2011",78,493,Not_Computer,N/A,N/A,N/A
Z-1023-2011,54658,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1.For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",CyberKnife Robotic Radiosurgery System Device,2,"February 02, 2011", 2011,Accuray Inc,"When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.",DESIGN: Software Design,"The firm, Accuray, sent an ""URGENT DEVICE CORRECTION"" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer regarding further resolutions.If you have any questions or concerns regarding this issue, contact Accuray Customer Support at +1-877-668-8667(USA) or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.",Contact the recalling firm for information,99,99 units,"Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.",Terminated,"February 11, 2011",9,99,Software,Output/Calculation,Software update,Software Update
Z-1021-2011,56923,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Vital Connect 4.0 & 4.1, radiological image processing softwareA Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.",Vital Connect ,2,"February 02, 2011", 2011,"Vital Images, Inc.","There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data",DESIGN: Software Design,"The firm, Vital Images, Inc,., sent a ""Urgent Software Alert"" letter dated August 23, 2010 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to not use the PET/CT fusion functionality until the software updates are provided and to re-examine any past results. If you have any questions or comments, contact Customer Support at support@vitalimages.com or at 1-800-208-3005.",N/A,178,178,"Worldwide Distribution: USA including states of: AK, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, PA, SC, TN, TX VA, WV, WI, and WY; and countries of: AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, and ITALY.AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, ITALY.",Terminated,"November 06, 2012",643,178,Software,Display/Image,Software update,Software Update
Z-1026-2011,57555,"accessories, solution, ultrasonic cleaners for lenses",LYL,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"Up&Up; Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.",Up&Up; Multipurpose Solution ,2,"February 02, 2011", 2011,Bausch & Lomb Inc,There is a potential for some packages to not meet sterility requirements.,OTHER/UNDETERMINED: Pending,"On December 8, 2010, Target was visited by FDA/PHI-DO and was informed on the violation. The Target customers that received lot GH0078 were requested to return all affected product directly to the Bausch & Lomb Greenville, SC Distribution Center. Bausch and Lomb sent an Urgent Voluntary Medical Device Recall to all first consignees who were shipped the affected lot GH0066 of Renu Fresh Multipurpose Solution on/about December 22, 2010. Since Target customers had already been notified previously regarding lot GH0078, this lot number was not included in the subsequent recall notification. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, 2670 Executive Drive, Indianapolis, IN 46241. Stericycle is conducting this recall under the control of Bausch & Lomb.For questions abut the recall process contact Stericycle, Inc. at 1-888-345-8316.For questions regarding this recall call 1-800-828-6974.",N/A,12,"67,296 12 oz Bottles (33,648 twin packs)","Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil",Terminated,"September 04, 2012",580,14,Not_Computer,N/A,N/A,N/A
Z-1024-2011,57464,"laryngoscope, rigid",CCW,Rigid laryngoscope.,Anesthesiology,Anesthesiology,510(K) Exempt,"Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112.Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.",Greenlight II laryngeal scope handle and cartridge,2,"February 02, 2011", 2011,Vital Signs Colorado Inc.,Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.,DESIGN: Device Design,"Healthcare Systems sent an URGENT MEDICAL DEVICE CORRECTION letter dated December 20, 2010, to all affected consignees advising them of the possible problem and giving them interim safety instructions until new battery cartridges were available. Customers were instructed to complete and return the Confirmation Form which was included with the letter.For information regarding this recall call 973-956-5300.",N/A,2202,2202 units,"Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, MA, MN, MO, NH, NJ, NY, OH, OK, SC, TN, TX, WA, and WV and the countries of Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK",Terminated,"July 01, 2011",149,2202,Not_Computer,N/A,N/A,N/A
Z-1020-2011,56392,"multi-analyte controls, all kinds (assayed)",JJY,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),i-STAT Level 2 Control Value Assignment SheetsHuman Consumption,iSTAT Level 2 Control,2,"February 02, 2011", 2011,Abbott Point of Care Inc.,"Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.",OTHER/UNDETERMINED: Pending,"Abbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on 8/3/2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. The Business Reply card is to be completed and returned to Abbott. Questions or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1.",N/A,8293,8293 Value sheets worldwide,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.",Terminated,"September 28, 2011",238,8293,Other,N/A,Manual update,Other
Z-1011-2011,57275,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.",ABL90 FLEX Blood Analyzer ,2,"February 02, 2011", 2011,Radiometer America Inc,"Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample ""fails"" the next result will inherit the patient data from the previous result.",DESIGN: Software Design,"On 11/16/10 the firm sent Medical Device Field Correction letters to their customers. The letter states that all systems will be upgraded and until each system is upgraded, they instructed their customer to ""always query for patient ID prior to introducing the sample."" They also instruct each customer to complete the ""Fax Return Form"" acknowledging receipt of the letter. If customers have questions regarding the letter or the upgrade, they should contact Technical Support at 1-800-736-0600 Opt 4.",N/A,432,432 units,"Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.",Terminated,"May 09, 2012",462,432,Software,Output/Calculation,Software update,Software Update
Z-1030-2011,57570,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),Precise Treatment TableThe Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.,Precise Table,2,"February 03, 2011", 2011,"Elekta, Inc.",Possible error in the table longitudinal position.,OTHER/UNDETERMINED: Pending,"Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout. Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites. For questions regarding this recall call 770-670-2548.",N/A,597,597 units,Nationwide Distribution and Puerto Rico,Terminated,"August 09, 2012",553,597,Not_Computer,N/A,N/A,N/A
Z-1031-2011,57571,"unit, cryosurgical, accessories",GEH,Cryosurgical unit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ.Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Presice has the following specific indications: "" Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia ""BPH""); "" Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); "" Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.); "" Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); "" General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma); * ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); "" Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); * Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Presice system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.",Presice Cryosurgiclal system,2,"February 03, 2011", 2011,"Galil Medical, Inc.","This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction",DESIGN: Device Design,"Galil Medical sent an ""Urgent Medical Device Correction"" letter dated December, 30, 2010, to all affected consignees. The letter described the product, the problem involved, and the action to be taken by the consignee. Consignees were instructed to make sure the locking mechanism on the Precise and Seednet MRI Systems were in the ""locked"" position when a needle is inserted into the manifold. Gently pull on the black plug to ensure needle is secure in locking mechanism. Apply the enclosed alert sticker on the bottom of the distribution panel and the bottom of the system monitor of the Precise System and on the side of the mobile unit itnerface panel and the top of the system monitor of the Seednet MRI System. Consignees were asked to take a picture of the alert sticker after it has been applied to the appropriate location on their Presice or Seednet MRI System(s) and e-mail to yoni.kadosh@galilmedical.com. Consignees were instructed to complete and return the enclosed form as soon as possible.For questions regarding this recall call Customer Service at (877) 639-2796.problem involved.",Contact the recalling firm for information,63,63,"Worldwide Distribution - USA including CA, CT, FL, GA, MA, MD, MN, MO, NC, NY, OH, PA, SC, TN, TX, VA, and WA and the countries of CANADA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, ISRAEL, ITALY, KOREA, NETHERLANDS, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, CHINA, and JAPAN.CANADA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, ISRAEL, ITALY, KOREA, NETHERLANDS, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, CHINA, JAPAN.",Terminated,"March 27, 2012",418,85,Computer,N/A,N/A,N/A
Z-1033-2011,57650,"pump, infusion, pca",MEA,Infusion pump.,General Hospital,General Hospital,510(k),"Smiths Medical, CADD¶_-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.",CADDSolis,2,"February 03, 2011", 2011,"Smiths Medical ASD, Inc.","Reports of the Cassette Lock mechanism on certain CADD¶_-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Smiths Medical, sent an ""URGENT MEDICAL DEVICE CORRECTION NOTICE"" dated January 13, 2011 to all consignees/customers. The notice described the product, problem, and action to be taken by the customers. The customers were instructed to have their Pumps undergo a correction which consist of removal and reattachment of the Cassette Latch handle using a new adhesive process. The customers were also instructed to remove the Pump from service if unable to remove cassette (or administration set); to inspect their inventory and identify Pumps; prepare a plan for correction of these Pumps; complete and return the attached CONFIRMATION FORM via fax to 1-800-237-8033 or by email to CADDDSolis_CassetteLock@smiths-medical.com, and if they have distributed the affected product to other persons or facilities, promptly forward this notice to the recipients. If you should have any questions regarding this information, please contact Smith Medical at 1-866-216-8806.",Contact the recalling firm for information,2903,2903 (2539 US; 364 OUS),"Worldwide Distribution: USA including states of: AK, AZ, C, CO, DC, FL, GA, ID IL, MA, MI, MN, MO, MT, NE, NH, NM, NY, NC, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WI, and WY; and countries including: Australia, Austria, Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Luxembourg, New Zealand, Qatar, Saudi Arabia, Switzerland and The Netherlands.",Terminated,"April 17, 2012",439,2903,Not_Computer,N/A,N/A,N/A
Z-1037-2011,57721,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),"Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.Intended use: Kit components to be used during Intermittent Urinary Catheterizations.",Irrigation Kit,2,"February 03, 2011", 2011,Apogee Medical,This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.,OTHER/UNDETERMINED: Pending,"The firm, TRIAD Group, sent a ""Urgent Medical Device Recall"" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return the recalled product to the wholesaler who would then return the product to Apogee Medical. Non-responders to the recall notice will be contacted on a weekly basis.Should you have any questions regarding this notification, please call the Regulatory Affairs/Quality Assurance Manager at (919) 435-5409.",N/A,1.0,see line 1.,"Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.",Terminated,"February 28, 2012",390,4454544,Not_Computer,N/A,N/A,N/A
Z-1028-2011,57504,"monitor, breathing frequency",BZQ,Breathing frequency monitor.,Anesthesiology,Anesthesiology,510(k),ThermiSense model 5700-A5The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study,ThermiSense model 5700A5,2,"February 03, 2011", 2011,"Salter Laboratories, Division of Regulatory Affairs","The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.",TRAINING: Employee Error,"Salter Laboratories, Inc. sent an URGENT PRODUCT RECALL LETTER dated December 20, 2010, to all affected customers. The letter identfied the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for this product and lot number. Contact Salter to arrange for the return of the product. Complete the attached reply form, confirming receipt of the letter, and fax it back to Salter Labs at 1-800-628-4690.For questions regarding this recall call 661-854-3166.",N/A,41,41 units,"Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,",Terminated,"June 06, 2011",123,41,Not_Computer,N/A,N/A,N/A
Z-1029-2011,55087,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines.Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.,SEQUENCER for Mosaiq ,2,"February 04, 2011", 2011,Impac Medical Systems Inc,Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.,DESIGN: Software Design,"A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.",N/A,40,40,"Worldwide Distribution -- US, Canada, Germany, and France.",Terminated,"April 06, 2011",61,40,Software,Device Operation,Software update,Software Update
Z-0993-2011,57507,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CAThe Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.",Arstasls One Access System,1,"February 04, 2011", 2011,"Arstasis, Inc",Device has the potential to fracture and sheath separation during use.,DESIGN: Device Design,"The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com.If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.",N/A,330,330 units,Worldwide Distribution,Terminated,"February 16, 2011",12,330,Not_Computer,N/A,N/A,N/A
Z-1042-2011,57549,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO.Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.",Vertex Max Drill Tube,2,"February 04, 2011", 2011,"Medtronic Navigation, Inc",Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.,DESIGN: Component Design/Selection,Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.,Contact the recalling firm for information,15,15 devices,"Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.",Terminated,"May 04, 2011",89,15,Not_Computer,N/A,N/A,N/A
Z-1019-2011,57558,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"PCR Eleva. The marketing brochure is labeled in parts: ""Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V"".Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.",PCR Eleva,2,"February 04, 2011", 2011,Philips Medical Systems North America Co. Phillips,"There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.",DESIGN: Software Design,"On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees.The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected.The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue.All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference ""FCO 73200029"" with any questions.",Contact the recalling firm for information,686,686 units,"Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.",Terminated,"August 25, 2011",202,686,Software,Output/Calculation,Software update,Software Update
Z-1046-2011,56448,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Omnifit M/S PSL Porous Coated Acetabular Shell 40MM;Stryker Orthopaedics,Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.",Omnifit M/S PSL Porous Coated Acetabular Shell ,2,"February 07, 2011", 2011,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.,DESIGN: Device Design,"The firm, Stryker Orthopaedics, sent an ""URGENT PRODUCT RECALL"" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.",N/A,N/A,N/A,"Worldwide distribution: USA including states of: AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA , and WI; and countries including: China, Hong Kong and Korea.",Terminated,"November 09, 2012",641,N/A,Not_Computer,N/A,N/A,N/A
Z-0945-2011,57193,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010.Head and whole body X-ray computed tomography applications.,GE Healthcare Discovery RX (16 slice) PET/CT System,2,"February 07, 2011", 2011,"GE Healthcare, LLC","Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the diffe",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.",Contact the recalling firm for information,1450,1450 units total in US,Worldwide Distribution,Terminated,"July 13, 2012",522,1450,Not_Computer,N/A,N/A,N/A
Z-1064-2011,53054,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA.Intended use: medical charged-particle radiation therapy system",Linear Medical Accelerator ARTISTE MV system,2,"February 08, 2011", 2011,"Siemens Medical Solutions USA, Inc","Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.",DESIGN: Software Design,"The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation.If you have any questions, call 1-925-602-8157.",N/A,151,151 units,"Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.",Terminated,"April 12, 2011",63,151,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1063-2011,57531,"needle, aspiration and injection, disposable",GAA,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI.The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.",Inrad sample master aspiration biopsy needle ,2,"February 08, 2011", 2011,"Inrad, Inc",This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.,N/A,"The firm, Inrad Inc., sent an ""URGENT FIELD CORRECTION"" notice dated December 20, 2010 to its customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to immediately examine their inventory for the affected product. If the recalled product was in stock, the customers were told to removed the affected product from the carton and dispose of carton; to disregard carton label expiration date and reference the expiration date appearing on the pouch label only, and to complete, sign and return the attached ""Carton Expiration Date"" INFORMATION FORM via fax to 616-301-779 or mail to Inrad Inc., ATTN: Director RA/QA, 4375 Donker Court SE, Kentwood, MI 49512.If you have any additional questions about this action, please call 800-558-4647 extension 102.",Contact the recalling firm for information,250,250,"Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.",Terminated,"February 09, 2011",1,250,Not_Computer,N/A,N/A,N/A
Z-1045-2011,57610,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian High Energy Linear Accelerator:Varian Medical Systems, Palo Alto, CA 94304Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",Varian High Energy Linear Accelerator,2,"February 08, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.",PRODUCTION CONTROLS: Process Control,"An Urgent Medical Device Correction letter was sent to all affected users with a description of the problem and user corrective action steps. Letters were sent on 12/10/2010. Users are to immediately investigate any unusual noises coming from the affected product and report them to whoever is responsible for servicing the device. For customers that do have a service contract with Varian, Varian service will perform an inspection of the counterweight bolts as part of the regular Periodic Maintenance Inspection procedure. Customers are to advice the appropriate personnel of the contents of the letter. For further clarification, customers can contact their local Varian Customer Support Services Manager.",No consumer action necessary,1882,1882,Worldwide Distribution.,Terminated,"August 02, 2011",175,1882,Not_Computer,N/A,N/A,N/A
Z-1000-2011,57524,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;","Abbott Diabetes Care, ReliOn Ultima ",1,"February 09, 2011", 2011,"Abbott Diabetes Care, Inc.","Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.",PRODUCTION CONTROLS: Process Control,"On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.",N/A,359,"359 total lots, 1,000,000 strips per lot",Products were released for distribution in US and Puerto Rico.,Terminated,"October 25, 2011",258,359,Not_Computer,N/A,N/A,N/A
Z-1065-2011,57333,immunohistochemistry reagents and kits,NJT,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(K) Exempt,"Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800;Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom.Intended for immunohistochemistry on paraffin-embedded tissue sections.",Bond Polymer Refine Detection,2,"February 09, 2011", 2011,"Leica Microsystems, Inc.","Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of ""weak staining"" due to the DAB Part B component, which may give a false negative result.",OTHER/UNDETERMINED: Pending,"Leica Microsystems sent Medical Device Field Correction letters dated 11/16/10 to the affected users of the Bond Polymer Refine Detection System, DS9800 via first class mail on the same date, informing them that they may experience instances of ""weak staining"" due to the DAB Part B component in the affected lots, which may give a false negative result. The users were requested to test their DS9800 System prior to use to rule out that the DAB Part B components have been affected, using the enclosed testing protocol. If their system is affected, the users were instructed not to use it and contact Leica Technical Assistance Center for a replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.",N/A,653,653 units,Worldwide Distribution -- USA and Canada.,Terminated,"October 17, 2011",250,653,Not_Computer,N/A,N/A,N/A
Z-1066-2011,57321,"nadh oxidation/nad reduction, alt/sgpt",CKA,Alanine amino transferase (ALT/SGPT) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is manufactured and distributed by Abaxis, Incorporated, Union City, CA The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¶_contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.",Piccolo Comprehensive Metabolic Panel,2,"February 09, 2011", 2011,"Abaxis, Incorporated",Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.,OTHER/UNDETERMINED: Pending,"The firm, Abaxis Inc., sent an ""URGENT PRODUCT RECALL NOTICE"" dated November 19, 2010, to all customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory of the lot for boxes #0665 or higher; if found, to discontinue use; contact Abaxis for immediate replacement; complete and return the enclosed PRODUCT RECALL RESPONSE form to Abaxis Technical Support via fax at 1-877-349-2087, and ensure that their laboratory staff is informed of this recall notice.If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, or at medtechsupport@abaxis.com.",N/A,797,797 units,Worldwide distribution: USA and countries of: Kowloon and Germany.,Terminated,"August 23, 2011",195,797,Not_Computer,N/A,N/A,N/A
Z-1067-2011,57676,N/A,N/A,N/A,N/A,N/A,N/A,Fujinon Endoscope Series;Model # EPX-4400 and EPX-4400HD.Digital processing of images from endoscope.,"EPX4400, EPX4400HDVideo Processor",2,"February 09, 2011", 2011,Fujinon Inc,The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under the premarket notification/510k process.,PREMARKET APPROVAL: No Marketing Application,"Fujinon sent an Urgent Medical Device Corrective Action Letter, dated 1/7/2011, via overnight mail to all consignees. The letter advises users that the FICE feature should no longer be used and that a Fujinon Field Service Engineer will be coming to physically disable the FICE feature on the processor. Instructions labeled as Attachment B are provided to assist in ceasing use of the FICE function. Attachment A is provided for frequently asked questions. Customers are to complete the Response/Acknowledgement Form and either fax it or email back to the firm. If there are additional questions, customers can call 800-385-4666 or email products.fice.@fujinon.com.",Contact the recalling firm for information,783,783 units,Nationwide Distribution,Terminated,"June 04, 2012",481,783,Not_Computer,N/A,N/A,N/A
Z-1081-2011,56391,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Centurion Medical Products PICC Line Kit CV12880, Sterile.",Centurion Medical Products ,2,"February 09, 2011", 2011,Centurion Medical Products,The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.,Contact the recalling firm for information,60,60,Nationwide distribution.,Terminated,"February 09, 2011",0,4160,Not_Computer,N/A,N/A,N/A
Z-1094-2011,57202,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902;Product is distributed byAbbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, ILIntended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.",CELLDYN Emerald ,2,"February 10, 2011", 2011,Abbott Laboratories,"There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is ""No Memory Available"" and has the potential for delay in generating patient results.",OTHER/UNDETERMINED: Pending,"The firm, Abbott Laboratories, sent a ""Product Correction"" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument.If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.",N/A,N/A,N/A,"Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.",Terminated,"June 07, 2011",117,N/A,Hardware,Device Operation,Install a new printer driver,Other
Z-1061-2011,57651,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic SynchroMedimplantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps",Medtronic SynchroMed implantable drug pump ,1,"February 10, 2011", 2011,"Medtronic, Inc. - Neuromodulation","This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed¶_ II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum",OTHER/UNDETERMINED: Pending,"The firm, Medtronic, sent an ""Urgent Medical Device Correction Cover "" letter dated January 2011 to all customers. Enclosed with each letter, an ""Urgent Medical Device Correction Important Clinical Information about Pocket Fills"" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication.Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT. UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a.",N/A,91369,"91,369 total for all devices.","Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, FAROE ISLANDS, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTI LES, NORWAY, PANAMA, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAN MARINO, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VATICAN CITY.",Open,N/A,N/A,91369,Not_Computer,N/A,N/A,N/A
Z-1222-2011,56860,"cutter, surgical",FZT,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey.Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.",HEARTSTRING Aortic Cutter 4.3 mm,2,"February 11, 2011", 2011,Maquet Cardiovascular,"Pouch integrity may be compromised, resulting in loss of sterility.",PRODUCTION CONTROLS: Process Control,"Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be exchanged with other unaffected HEARTSTRING Aortic Cutter 4.3 MM devices. Customers are to contact their local MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874 to arrange for an exchange and if they have any questions.",Contact the recalling firm for information,395,395 units,"Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.",Terminated,"June 21, 2011",130,395,Not_Computer,N/A,N/A,N/A
Z-1220-2011,57733,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED).",TotalCare AC powered adjustable hospital bed,2,"February 11, 2011", 2011,"Hill-Rom, Inc.",The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.,DESIGN: Software Design,"The firm, Hill-Rom, sent a ""URGENT MEDICAL DEVICE CORRECTION"" letter dated January 19, 2011, along with a software upgrade (USB stick/flash drive) with instructions, to all affected customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to requests that facility service personnel immediately upgrade their software; complete and return the Customer Response Form via fax to 812-931-2410 or mail to: Hill-Rom Company, 1069 State Route 46 E, Batesville, IN 47006, Attn: MOD Coordinator J12 and forward a copy of this notice to any other facility personnel. Note: The customer can request that Hill-Rom technicians complete the software upgrade.If you have any questions concerning this Urgent Medical Device Correction, please contact Hill-Rom Technical Support at 800-445-3720.",N/A,905,905 beds.,"Worldwide distribution: USA and countries including: AUSTRALIA, BRAZIL, CANADA, CHINA, EGYPT, GERMANY, GREECE, ITALY, JAPAN, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, OMAN, POLAND, QATAR, SAUDI ARABIA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, VENEZUELA, and YEMEN.",Terminated,"September 26, 2012",593,945,Software,Output/Calculation,Software update,Software Update
Z-1093-2011,57405,"instrument, coagulation",KQG,Coagulation instrument.,Hematology,Hematology,510(k),"Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests.Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.",Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT),2,"February 11, 2011", 2011,International Technidyne Corp.,"Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.",PRODUCTION CONTROLS: Process Control,"ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail techsupport@itcmed.com.",Contact the recalling firm for information,265,265 boxes (95 ACT Tubes per box),Worldwide Distribution,Terminated,"August 22, 2012",558,265,Not_Computer,N/A,N/A,N/A
Z-1224-2011,57597,"pump, breast, powered",HGX,Powered breast pump.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged;h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.",Pump in Style Advanced Breast Pump,3,"February 11, 2011", 2011,Medela Inc,"The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"This firm, Medela, sent an ""Important Device Recall"" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns.com to expedite shipment of a replacement unit. Questions about the recall process were directed to Medela Customer Service at 1-800-435-8316 or e-mail at medelareturns@medela.com.Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelareturns.com on January 11, 2011.",Contact the recalling firm for information,11154,"11,154 units","Nationwide, including Puerto Rico",Terminated,"May 21, 2012",465,11154,Hardware,Device Operation,Replace device,Remove or Replace
Z-1219-2011,57730,"heart-valve, allograft",MIE,N/A,N/A,Cardiovascular,Contact ODE,Pulmonary Valve & Conduit SGUsed in heart surgery,SynerGraft CryoValve,2,"February 11, 2011", 2011,"CryoLife, Inc.",A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.,N/A,"The firm, Cryolife, sent an ""Urgent-Human Tissue Recall"" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received.If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.",N/A,1,One,Nationwide distribution: USA state of: MI,Terminated,"November 01, 2011",263,1,Not_Computer,N/A,N/A,N/A
Z-1095-2011,57660,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. One single unit to a package.Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement.",Triathlon Femoral Distal Fixation Peg,2,"February 11, 2011", 2011,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).,EXPIRATION DATING: Incorrect or No Expiration Date,"The firm, Stryker, sent a ""UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL"" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430.If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team at (201) 831-5028.",N/A,15,15 units,Nationwide distribution.,Terminated,"October 03, 2012",600,15,Not_Computer,N/A,N/A,N/A
Z-1232-2011,57505,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.","Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long",2,"February 14, 2011", 2011,Stryker Instruments Division of Stryker Corporation,"Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.",PRODUCTION CONTROLS: Packaging,"The firm, Stryker, sent a ""MEDICAL DEVICE RECALL NOTIFICATION"" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer.Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer.For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or kathleen.kelly.smith@stryker.com.",N/A,N/A,N/A,"Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.",Terminated,"April 13, 2011",58,N/A,Not_Computer,N/A,N/A,N/A
Z-1231-2011,57550,"instrument, shunt system implantation",GYK,Shunt system implantation instrument.,Neurology,Neurology,510(k),"Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USADesigned to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.",Integra Peritoneal Introducer Sheaths,2,"February 14, 2011", 2011,Integra LifeSciences Corp.,Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Integra Life Sciences sent an Urgent Product Recall letter dated December 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine any of the affected product. Contact Integra Customer Service at (800) 654-2873, select option 2 to arrange for product returns. Customers were asked to complete the attached ""Recall Acknowledgement and Return Form"" indicating the current status of quantities of affected product in their inventory. For questions call (609) 936-2237.",Contact the recalling firm for information,95,95 units,"Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.",Terminated,"May 07, 2012",448,95,Not_Computer,N/A,N/A,N/A
Z-1225-2011,57679,"adaptor, stopcock, manifold, fitting, cardiopulmonary bypass",DTL,"Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.",Cardiovascular,Cardiovascular,510(k),"Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00.","YGlide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)",2,"February 14, 2011", 2011,Thomas Medical Products Inc,Compromised sterility/weak or open seals.,PRODUCTION CONTROLS: Packaging Process Control,GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.,N/A,28679,"28,679 for all products",Distribution Nationwide USA and Germany.,Terminated,"August 08, 2012",541,28679,Not_Computer,N/A,N/A,N/A
Z-1230-2011,57735,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI.The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures.",VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM,2,"February 14, 2011", 2011,Terumo Cardiovascular Systems Corporation,The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the complaints were beyond their product life,OTHER/UNDETERMINED: Pending,"Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE CORRECTION letter dated January 10, 2011, to Operating room managers. The letter informed the customers of the Bipolar cord product life of 50 uses. The letter states that the IFU for the bipolar cord is being updated to include the information regarding the limit of 50 uses and sterlization cycles. The letter recommends that user keep a sterile back up bi-polar cord in a convienent place during endoscopic vein harvesting procedures. The firm provided a tracking sheet in each package to help users track the number of sterlization cycles for the cord. Customers were instructed to review the Medical Device Correction notice, assure that all users were aware of the notice, and confirm receipt of the communicaiton by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call Terumo CVS Customer Service at 1-800-521-2818.",No consumer action necessary,2782,2782 cords,"Worldwide Distribution - United States including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, , NY, MO, MS, MT, NC, NE, NH, NJ, NM, OH, OK, OR, PA, SC, TN, TX, VA, WI, AND WV and the countries of Chile, Hong Kong, Malaysia, United Arab Emirates, Belgium, Japan, Korea, The Phillipines, Singapore, Taiwan, Thailand, Germany, and United Kingdom.",Terminated,"July 13, 2011",149,2782,Not_Computer,N/A,N/A,N/A
Z-1223-2011,57607,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Leksell GammaPlan, Model 5.34.Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.",Leksell GammaPlan,2,"February 14, 2011", 2011,"Elekta, Inc.",Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.,OTHER/UNDETERMINED: Pending,"Product bulletin Leksell GammaPlan - ""Leksell GammaPlan version 5.34"" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - ""Potential issue using flipped angiographic images"" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visualization requirements and listed recommendations.",Contact the recalling firm for information,272,272 units,Worldwide Distribution,Terminated,"March 02, 2011",16,272,Other,N/A,N/A,Other
Z-1229-2011,56058,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230;Product is manufactured and distributed by AMS Solutions,San Jose, CAThe GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.",AMS GreenLight PV Surgical Laser System,2,"February 14, 2011", 2011,AMS Innovative Center - San Jose,"A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.",OTHER/UNDETERMINED: Pending,"AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to CustomerCare@ammd.com.",Contact the recalling firm for information,242000,"~242,000 units",Worldwide Distribution including US,Terminated,"February 14, 2011",0,242000,Not_Computer,N/A,N/A,N/A
Z-1258-2011,51399,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA.Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are intended for use in the home and in professional settings to monitor blood glucose levels.",FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Strips,2,"February 15, 2011", 2011,"Abbott Diabetes Care, Inc.",Product dispositioned for destruction was potentially diverted to end users.,OTHER/UNDETERMINED: Pending,"The firm, Abbott Diabetes Care (ADC), will be posting notification on its Abbott Diabetes Care website. Also, the firm issued an ""IMPORTANT: MEDICAL DEVICE NOTIFICATION"" letter dated March 13, 2009, to customers ( registered users of Free Style, Free Style Flash, FreeStyle Freedom or Free Style Navigator). For foreign consignees/customers, the firm has issued communication worldwide. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please check the lot number on the test strip carton or vial for the affected product number; if found, discontinue use and call the ADC Customer Care line at: 1-800-310-1500 and the ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent.If you have any questions, please call ADC Customer Care line at 1-800-310-1500.",N/A,1860,1860 units,"The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consignees.",Terminated,"February 15, 2011",0,1860,Not_Computer,N/A,N/A,N/A
Z-1259-2011,54746,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick GuideIntended use: Measurement of Hemoglobin A1c in human whole blood.",BioRad Variant II Turbo Link Hemoglobin Testing System,2,"February 15, 2011", 2011,Bio-Rad Laboratories Inc,The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Bio-Rad Laboratories, Inc., sent an ""URGENT: MEDICAL DEVICE CORRECTION"" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.",N/A,27,27,"Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.",Terminated,"March 03, 2011",16,27,Not_Computer,N/A,N/A,N/A
Z-1249-2011,56182,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX","CSeries Clinac, Trilogy and Novalis Tx",2,"February 15, 2011", 2011,Varian Medical Systems Oncology Systems,Position errors may result in misdelivery of radiation.,DESIGN: Device Design,"Varian sent Urgent Medical Device Correction letters on June 23, 2010 by Federal Express to all customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***Field Safety notification including customer distribution lists, was e-mailed to Varian international Customer Support Managers. Managers will translate to local language if necessary, notify sites by appropriate methods.",N/A,5741,5741 units,Worldwide distribution.,Terminated,"May 03, 2011",77,5741,Not_Computer,N/A,N/A,N/A
Z-1248-2011,57485,"unit, x-ray, extraoral with timer",EHD,Extraoral source x-ray system.,Dental,Radiology,510(k),"Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA",Gendex eXpert DC Intraoral XRay System,2,"February 15, 2011", 2011,Gendex Dental Systems,The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.,DESIGN: Component Design/Selection,"Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.",N/A,5,5 units,California,Terminated,"February 15, 2011",0,5,Not_Computer,N/A,N/A,N/A
Z-1246-2011,57587,"tube, orthodontic",DZD,Orthodontic appliance and accessories.,Dental,Dental,510(K) Exempt,"ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each);ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each;ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O;ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each;ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each;ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each;ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.",ClassOne Orthodontics Buccal SS Tubes ,2,"February 15, 2011", 2011,Ortho Organizers Inc,Products were mis-labeled as nickel free.,N/A,"An Urgent: Product Recall Notice letter, dated November 1, 2010 was sent to consignees at the distribution level who received recalled products. Consignees were instructed to do the following:1) Carry out a physical count of current inventory and record this data on the business reply card provided with this notice. Return the enclosed Reply Card with the amount remaining inventory to Ortho Organizers, Inc., Carlsbad, CA 92008 within 10 days of receipt of this notification.2) Immediately cease distribution/use of this product and remove from your shelves.3) Notify all of your retail customers with the Urgent: Product Recall Notice (Retail Level) letter who purchased the affected item numbers from you that the affected items are stainless steel and contain nickel.4) Contact your sales representative to return any unused items. Return any unused product within 30 days. Please clearly mark the return carton Recall Material Enclosed. Ortho Organizers shall accept any product covered by this recall and credit your account for all product and shipping costs.",N/A,1300,1300,"Worldwide Distribution -- USA, including states of CA, CO, IL, LA, MI, MN, PA & TX and countries of CA (Canada), BE (Belgium), NO (Norway), and CO (Columbia).",Terminated,"April 27, 2011",71,1300,Not_Computer,N/A,N/A,N/A
Z-1254-2011,57592,"bed, flotation therapy, powered",IOQ,Powered flotation therapy bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"Flexicair¶_ MC3 (Model number: M4000) Low Airloss Therapy UnitsFor use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.",Flexicair MC3 ,2,"February 15, 2011", 2011,"Hill-Rom Manufacturing, Inc.",Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.,OTHER/UNDETERMINED: Pending,"Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients.For questions regarding this recall call 800-445-3720.",N/A,45,42 Flexicair MC3 units,"Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA",Terminated,"November 01, 2011",259,46,Not_Computer,N/A,N/A,N/A
Z-1256-2011,57626,"mask, oxygen",BYG,Oxygen mask.,Anesthesiology,Anesthesiology,510(K) Exempt,"Oxygen Masks- Labeling as follows:MADA, Inc.Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREXAerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. RESPIREXNebulizer Kits w/Aerosol MaskAdult7 ft. (2.1m) Aerosol TubingManufactured for PSS World Medical Inc.Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; Unomedical, Inc., Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient UseMADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient UseMADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient UseMADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient UseUnomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, Adult with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eVal","MADA, Hospilak, respirex, Trianim, McKesson, optimist, portex, medichoice",2,"February 15, 2011", 2011,Convatec Inc.,"Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Unomedical, Inc issued recall letters with attached return response forms dated January 7, 2011 via UPS. The letters request the customer stop use and quarantine product. The recall response form is to be completed and returned to Unomedical.The letters/return response form were also sent out in Spanish.Another recall letter was sent dated February 16, 2011 to capture additional lots that werent included in the initial letter.",N/A,1113200,1113200 pcs.,"Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, UnitedArab Emirates, Russia, Australia, New Zealand,Japan and Vietnam.",Terminated,"February 27, 2013",743,2692300,Not_Computer,N/A,N/A,N/A
Z-1068-2011,57580,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.",ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters,2,"February 15, 2011", 2011,Ethicon Endo-Surgery Inc,The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.,OTHER/UNDETERMINED: Pending,"Ethicon Endo-Surgery issued ""Urgent Expanded Device Recall Event 1981"" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. They are to complete and fax back the Business Reply Form, Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle, Replacement product should be received within 30-60 days after return, Customers can contact Stericycle concerning this recall at 1-888-365-4680, reference Event 1981.",N/A,29403,"29,403 units","Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.",Terminated,"February 15, 2013",731,29538,Not_Computer,N/A,N/A,N/A
Z-1257-2011,57499,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner,Toshiba AQUILION ONE ,2,"February 15, 2011", 2011,Toshiba American Medical Systems Inc,Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.,DESIGN: Software Design,"Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.",Contact the recalling firm for information,44,44 units distributed between 09/2007 - 07/2010,Nationwide distribution.,Terminated,"April 20, 2012",430,44,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1247-2011,57665,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MANThe Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted.",Mantis Tap Sleeve,2,"February 15, 2011", 2011,Stryker Spine,"Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / PEI tube interface. This can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.",OTHER/UNDETERMINED: Pending,"Stryker Spine sent an Urgent Product Recall letter dated January 07, 2011, to Stryker Spine sales branches and agencies where affected product was distributed. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify the product.Reconcile any Mantis Tap Sleeves with the catalog and lot numbers referenced in the letter. Complete the Customer Response Form with distribution sheet provided to assist with product reconcilation. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370.Customers were to retrieve and return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court, Allendale, New Jersey 07401. For questions call 201-760-8180.",N/A,25,25 units,"Nationwide Distribution including MA, MN, and PA.",Open,N/A,N/A,25,Not_Computer,N/A,N/A,N/A
Z-1251-2011,57604,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.",Elekta Leksell Stereotactic System ,2,"February 15, 2011", 2011,"Elekta, Inc.","New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.",DESIGN: Labeling Design,"Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt.",N/A,379,379 units,Nationwide,Terminated,"February 17, 2011",2,379,Not_Computer,N/A,N/A,N/A
Z-1252-2011,57731,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Synergy XVIIntended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",Medical linear accelerator (with patient imaging),2,"February 15, 2011", 2011,"Elekta, Inc.",Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.,OTHER/UNDETERMINED: Pending,"The firm, Elekta Limited, sent an ""Important Notice A344"" dated January 5, 2011 to all consignees/customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to follow any instructions or recommendations covered in the notice. The notice provides suggestions on how to check and prevent this situation from occurring; it instructs the User to file the document in the Important Notice section of the appropriate User Manual; to complete a FlexMap Check each time they acquire a new FlexMap and amend their local procedures to include the FlexMap Check and complete and return the Important Notice Confirmation of Receipt via Fax to: Field Support Administration, Elekta Limited, Linac House, Fleming Way Crawley, West Sussex, RH10 9RR UK +44 (0)1293 654401.If you have any questions, contact Elekta Limited at +44 (0)1293 654200 or www.elekta.com.",N/A,223,223 units,Nationwide distribution.,Terminated,"April 07, 2011",51,223,Other,N/A,N/A,Other
Z-1250-2011,57159,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes..","Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0",2,"February 15, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0:1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris.3. Wrong marking of Early and Late result series on display in Bra",DESIGN: Software Design,"The firm, GE Healthcare, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system.If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.",Contact the recalling firm for information,6046,6046,"Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, LUXEMBOURG, LEBANON, MALY ASIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SPAIN, SOUTH AFRICA, SOUTH KOREA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, and VIET NAM.",Terminated,"October 16, 2012",609,6046,Software,Output/Calculation,Software update,Software Update
Z-1245-2011,57379,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results.",GE Centricity Laboratory ,2,"February 15, 2011", 2011,Ge Healthcare It,"The GE Centricity Laboratory System Software has safety issues with the ""Telephone List"" function, the ""Anatomic Pathology"" application, and the Instrument Interface IO module that may impact patient safety.",DESIGN: Software Design,"GE Healthcare, sent ""Urgent Medical Device Correction"" letters dated December 12, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the product, the problem, and the action to be taken by the customer. The letters provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.",Contact the recalling firm for information,26,26 units,"Worldwide Distribution -- USA, including AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OR, TN, VA, and WI, , and internationally to the countries of Australia, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.",Terminated,"July 15, 2011",150,26,Software,Physical Safety Hazards,Software update,Software Update
Z-1334-2011,50094,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"S T-Bone Plate;M T-Compression Plate;Manufactured and Distributed by Stryker Lebinger GmbH & Co.Freiburg, Germany.The Profyle System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screws techniques, joint fusion, corrective osteotomies, and the treatment of fractures",S TBone Plate; M TCompression Plate;,2,"February 16, 2011", 2011,Stryker Howmedica Osteonics Corp.,"A package labeled as a S T-Bone Plate, Catalog Number 57-05260, Lot Code G4M00F1576, may actually contain a M T-Compression Plate, Catalog Number 57-10250, Lot Code G4N00F1584 and vice versa.",DESIGN: Process Design,"Stryker Orthopedics sent an Important Market Withdrawal letter dated May 26, 2006, by Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to examine their inventory, including their hospital consignment location, to identify the product.If the affected product remained in its original packaging, customers were instructed to retrieve all of the affected product lots and return it to their branch or agency warehouse for reconcillation.Reconcile all product on the attached Product Accountability Form and fax a copy of the form to 201-831-6069 within 5 days of receipt of the notice.Customers were asked to return the affected product via Inter-Org Transfer and ship to Product Surveillance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, USA 07430-2104. Customers were also instructed to contact their Stryker Orthopaedics Customer Service representataive to re-order the product that they were returning.For questions regarding this recall call (201) 831-5825.",N/A,21,21,Nationwide Distribution,Open,N/A,N/A,21,Not_Computer,N/A,N/A,N/A
Z-1320-2011,57295,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"WalkMed Infusion Triton 90"" 20 drop IV Administration Set with Needlefree Y-siteItem # T090-000VIntended use: Intravascular Administration Set",WalkMed Infusion Triton 90,2,"February 16, 2011", 2011,"Churchill Medical Systems, Inc.",Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"The firm, Churchill Medical/Vygon, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced.If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.",N/A,12150,12150 units,"Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.",Terminated,"May 01, 2012",440,61251,Not_Computer,N/A,N/A,N/A
Z-1341-2011,57454,activated whole blood clotting time,JBP,Activated whole blood clotting time tests.,Hematology,Hematology,510(k),"Celite ACT CartridgeCartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.",Celite ACT Cartridge,2,"February 16, 2011", 2011,Abbott Point Of Care Inc.,Celite ACT cartridges have increased numbers of values outside the accepted allowable error.,DESIGN: Device Design,"On behalf of Abbott, Genco Pharmaceutical Services sent an ""URGENT RECALL NOTICE"" dated November 2010, on December 3, 2010 via Fedex to all consignees/customers. Abbott sent out notification packages to foreign consignees/customers on December 3, 2010. The notice described the product, problem and action to be taken by customers. The firm recommended that customers use cartridges within 12 hours of removal from refrigerated storage based on the instructions provided with the product. The customers were instructed to complete and return the Business Reply cards to acknowledge receipt of the communication and provide the letter to any customers that have recieved the product. If you have any additional questions, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care Representative.On February 27, 2012 Abbott sent an Important Product Information letter via Fed Ex to inform customers that i-Stat Celite ACT cartridges manufactured from the beginning of 2012 can now be stored for two weeks at room temperature as indicated on the cartridge box. Foreign consignees were notified on 2/28/2012. Users are instructed to complete business reply cards to acknowledge receipt of the communication and provide the letter to any customers that have received the product. Any additional questions can be answered by contacting 8003668020 option 1.",N/A,1164275,1164275 cartridges,Worldwide distribution.,Terminated,"July 16, 2013",881,1164275,Not_Computer,N/A,N/A,N/A
Z-1308-2011,57318,"appliance, fixation, nail/blade/plate combination, single component",KTW,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.",Synthes Spiral Blade Component of the Synthes Modular Blade Plate System,2,"February 16, 2011", 2011,"Synthes USA (HQ), Inc.",Potential for out of specification star grind teeth.,OTHER/UNDETERMINED: Pending,"Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the recalled product to:Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.For questions regarding this recall call 1-800-620-7025, x 6883.",N/A,N/A,N/A,"Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1335-2011,57792,"marker, ocular",HMR,Ophthalmic surgical marker.,Ophthalmic,Ophthalmic,510(K) Exempt,"Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.",Oasis Corneal Ink Stamp Sterile,2,"February 16, 2011", 2011,"Aspen Surgical Products, Inc.",Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.,DESIGN: Component Design/Selection,Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers.The firm does not intend to continue manufacturing or distributing the product.,N/A,77850,"77,850","Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.",Terminated,"October 07, 2011",233,77850,Not_Computer,N/A,N/A,N/A
Z-1365-2011,57544,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO.A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.",Electrosurgical generator.,2,"February 17, 2011", 2011,ConMed Electrosurgery,Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.,DESIGN: Device Design,"ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.",N/A,442,442 units,"Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.",Terminated,"August 01, 2011",165,2323,Other,N/A,N/A,N/A
Z-1348-2011,57287,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660.Central venous catheterization kit,CENTRAL VENOUS CATHETERIZATION KIT,2,"February 17, 2011", 2011,Arrow International Inc,Sterility may be compromised.,OTHER/UNDETERMINED: Pending,"Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product.If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935.If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service.Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to:Arrow International, Inc.312 Commerce PlaceAheboro, NC 27203Attn: Asheboro Quality Assurance Manager.For any questions regarding this recall call 800-523-8446.",N/A,40260,"40,260","Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.",Terminated,"September 29, 2012",590,963380,Not_Computer,N/A,N/A,N/A
Z-1342-2011,56387,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA.Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).",VARIANT II TURBO Hemoglobin A1c Program ,3,"February 17, 2011", 2011,Bio-Rad Laboratories Inc,"The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.",N/A,"Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.",N/A,48,48 units,Worldwide Distribution -- USA and Italy.,Terminated,"March 04, 2011",15,48,Not_Computer,N/A,N/A,N/A
Z-1370-2011,57850,"instruments, surgical, cardiovascular",DWS,Cardiovascular surgical instruments.,Cardiovascular,Cardiovascular,510(K) Exempt,"MitraXs"" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium.Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.","MitraXs"" Self Adjusting Atrial Retractor",2,"February 17, 2011", 2011,St. Jude Medical Cardiovascular Division,St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008.They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may,PRODUCTION CONTROLS: Process Control,"The firm, St. Jude Medical, sent an ""Urgent Medical Device Recall Notice"" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product.If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.",Contact the recalling firm for information,450,450,"Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.",Terminated,"May 31, 2012",469,450,Not_Computer,N/A,N/A,N/A
Z-1374-2011,56394,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67,Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.670070-1721: Version 3.671 0070-1662: Version 3.67, US version;0070-1668; IVersion 3.67 International versionProduct is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CAThe WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX¶_ STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.",AMO brand WaveScan WaveFront System,2,"February 18, 2011", 2011,"AMO Manufacturing USA, LLC","The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result.",DESIGN: Software Design,"Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer.Customers were asked to take the following actions:Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530.For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com.For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.",N/A,N/A,N/A,"Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.",Terminated,"June 22, 2012",490,N/A,Other,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1373-2011,57502,"unit, x-ray, extraoral with timer",EHD,Extraoral source x-ray system.,Dental,Radiology,510(k),"Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international)The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.",Orthoralix 8500 DDE Panoramic Dental XRay System,2,"February 18, 2011", 2011,Gendex Dental Systems,"The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units manufactured between 12/4/09 and 5/16/10 had functioning AEC buttons, but their manuals stated they were disabled. Units intended for International distribution bet",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Gendex sent a recall letter to their accounts on December 21, 2010, stating that the AEC button on the control panel was a non-functional feature that becomes illuminated upon activation and that Gendex would send them a kit to correct this issue and inactivate the button. A second letter was sent to the accounts on January 31, 2011, explaining that a corrective kit was no longer necessary, letting them know if the AEC feature was active or inactive for their system, and providing them with the appropriate user manual addendum for their system.Customers were asked to complete and return the required Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com.For questions regarding this recall call 800-323-8029.",N/A,574,574 systems,"Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, and WI and the countries of Australia, Canada, Germany, New Zealand, Taiwan, and Vietnam.",Terminated,"November 09, 2011",264,574,Not_Computer,N/A,N/A,N/A
Z-1260-2011,57567,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25.Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.",Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device ,2,"February 18, 2011", 2011,"Ethicon, Inc.",The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.,N/A,"Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.",N/A,4110,"4,110",Worldwide Distribution -- USA and Canada.,Terminated,"November 07, 2012",628,4110,Not_Computer,N/A,N/A,N/A
Z-1372-2011,57736,"electrode, electrodcardiograph, multi-function",MLN,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI.The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.",Medstorm Adult Radiolucent Electrode ,2,"February 18, 2011", 2011,"Heart Sync, Inc","The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, "" Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air. ",PRODUCTION CONTROLS: Packaging,"Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would send replacement product as soon as they were notified.Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope.For any questions regarding this recall call 734-213-5530.",No consumer action necessary,300,300,"Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada",Terminated,"July 13, 2011",145,300,Not_Computer,N/A,N/A,N/A
Z-1378-2011,57666,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician.",InfusO.R. ,3,"February 18, 2011", 2011,Baxter Healthcare Corp.,"Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures .53 inches ¶_.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum",OTHER/UNDETERMINED: Pending,"Safety Alert letters dated January 11, 2011 were mailed via first class mail to the InfusOR direct accounts, to the attention of the Director of Biomedical Engineering, the Director of Anesthesia and the Director of Materials Management, on the same date, informing them that over-the-counter Energizer C size alkaline batteries should not be used with the InfusO.R. Pumps (Product codes 2L3100, 2L3100R, 2L3100R, 2L3100U, 2L3100N, 6461500 and 6461500R). That particular battery incorporates a feature that may inhibit electrical contact and affect the ability of the pump to power-up. The accounts were requested to check their inventory of InfusO.R. Pumps for the presence of over-the-counter Energizer C size alkaline batteries. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.*** Baxter expanded the scope of their action to include the Mini-Infuser System and sent Urgent Device Correction letters dated 3/4/11 via First Class mail to all InfusOR and Mini-Infuser customers who had purchased either of the affected product lines. The letters informed the accounts that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The accounts were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future refer.",N/A,39725,"39,725 pumps",Nationwide Distribution,Terminated,"August 27, 2012",556,39725,Battery,Device Operation,Instructions,Safety Notice/Insructions
Z-1376-2011,57270,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.",GE Healthcare Discovery MR450 1.5T,2,"February 18, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety.The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the grad",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE Healthcare sent an ""Urgent Medical Device Correction"" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information.Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures.Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.",No consumer action necessary,11,11,"Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.",Terminated,"February 04, 2012",351,104,Not_Computer,N/A,N/A,N/A
Z-1392-2011,53691,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufactured by Siemens Medical Solutions, Mountain View, CA.Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary or secondary ultrasound echo data. The V5Ms is a multi frequency, multiplane, phased sector array transducer. It can be introduced into the esophagus to obtain images of the heart structure.",V5M TEE Transducer,2,"February 22, 2011", 2011,"Siemens Medical Solutions USA, Inc.","If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.",DESIGN: Software Design,"Siemens sent a Customer Safety Advisory Notification letter on August 28, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their local Customer Service Engineer would install a software update as soon as it becomes available. Customers were instructed to pass the Customer Safety Advisory Notification letter to all who need to be aware of these issues until the corrective action is completed. For questions regarding this recall call 650-969-9112 or 800-422-8766.",Contact the recalling firm for information,97,97 units,"Worldwide Distribution - USA (nationwide) and internationally to Canada, China, Czech Republic, Denmark, Germany, Great Britian, Hong Kong, Indonesia, Italy, Japan, Norway, Poland, Portugal, Russian Federation, Singapore, South Korea, Taiwan, and Turkmenistan.",Terminated,"March 29, 2011",35,97,Software,Physical Safety Hazards,Software update,Software Update
Z-1390-2011,56670,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only.The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.",GMD UNIVERSAL URINARY INCONTINENCE SLING ,2,"February 22, 2011", 2011,Generic Medical Devices,Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.,DESIGN: Component Design/Selection,"The firm, GMD, issued an ""URGENT MEDICAL DEVICE RECALL"" letter dated February 14, 2011 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed not to use any GMD Model 1010 Universal Slings remaining in their inventory; return any Model 1010 slings in their possession to the Distributors or GMD; notify their customers to whom they shipped Model 1010s of this voluntary recall and request them to return any Model 1010 slings in their possession to them; and return all Model 1010 inventories to GMD using the attached Recalled Model 1010 Return Form. Note: Full credit in the amount of the returned products purchase price will be issued for all sterile, unexpired product returned to GMD.Contact the GMD Product Performance Senior Manager, at phone: (253) 853 3512 or email: 1010recall@gmd-us.com, if you have any questions/issues related to this recall.",N/A,1711,approximately 1711,"Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.",Terminated,"September 24, 2012",580,1711,Not_Computer,N/A,N/A,N/A
Z-1393-2011,56367,"sterilization wrap containers, trays, cassettes & other accessories",KCT,Sterilization wrap.,General Hospital,General Hospital,510(k),Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332.Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.,Tyvek SelfSeal Pouch with STERRAD Chemical Indicator ,2,"February 22, 2011", 2011,Advanced Sterilization Products,"The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.",PRODUCTION CONTROLS: Process Control,"Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.",No consumer action necessary,470,470,"Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.",Terminated,"March 14, 2012",386,470,Not_Computer,N/A,N/A,N/A
Z-1395-2011,57715,"antigens, all groups, streptococcus spp.",GTY,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.,SP Brand Strep A Cassette,2,"February 22, 2011", 2011,Biosite Inc Dba Innovacon Inc.,"The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product hasdemonstrated an elevated Incidence of non-specific binding, potentially causing false positive results. A falsepositive test result could lead to the administration of antibiotics that are unnecessary. This exposes the",N/A,"The firm, Alere San Diego, sent a ""URGENT MEDICAL DEVICE RECALL"" letter dated January 17, 2011. The letter described the product, problem and action to be taken by customers. The customers were instructed to: (1) Immediately discontinue use of the affected lot (if applicable) and inventory remaining full or partial kits at their site (if applicable);(2) Destroy any remaining inventory of this lot and document destruction per their site requirements (if applicable);(3) Complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of this notice and to receive replacement of their remaining inventory of this lot (if applicable). The customers were ask to please return the form even if they have no remaining inventory or do not have any involved product in order to confirm receipt of this notification; and (4) to please ensure that all users of the device have received a copy of this Urgent Medical Device Recall.Customers with questions about the information contained in the notice were instructed to contact Technical Services at 888-246.7483, option 2 or by e-mail attechservices@alere.com.",N/A,814,"814 kits/24,420 devices",Nationwide distribution,Terminated,"June 26, 2012",490,814,Not_Computer,N/A,N/A,N/A
Z-1386-2011,57790,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.",AUTOMIX 33/AS,2,"February 22, 2011", 2011,Baxter Healthcare Corp.,The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.,OTHER/UNDETERMINED: Pending,"Baxter Healthcare Corp. sent Urgent Device Correction letters dated January 27, 2011, via first class mail to all affected customers. informing personnel that use Automix compounders to exercise care when entering data, and verify the accuracy of the keypad response. The accounts were requested to convey this information to all users of the Automix compounders, emphasizing the need to verify data accuracy each time the keypad is used. The accounts were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667.After determining the root cause of the incorrect keypad responses, Baxter issued a follow-up correction letter on 4/27/11 outlining the recommended work practices to reduce fluid penetration into the Automix compounder keypad/control module.",N/A,950,950 units,"Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.",Terminated,"February 16, 2012",359,5160,Computer,N/A,N/A,N/A
Z-1387-2011,57700,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"Masimo HemoglobinPronto-7 with Rainbow 40 Technology foreasy-to-use spot-check testing of hemoglobin (SpHb),SpO2, pulse rate, and perfusion indexPronto-7 rainbow 4D Reusable Sensors are an accessory to the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter. The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument) with Masimo Rainbow SET Technology is developed to simultaneously and non-invasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The instrument has a single on/off button and an interactive touchscreen for administering tests along with user selectable options.",Pulse Oximeter,2,"February 22, 2011", 2011,Masimo Corporation,"Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement.",DESIGN: Process Design,"Masimo sent an Urgent Voluntary Medical Device Recall letter dated December 21, 2010, to all affected customers via FexEx on December 23, 2010. The Urgent Voluntary Recall Notice provides instructions on the actions that the customers and field personnel must take to correct the issue.Customers were instructed to choose any of the three options below. Option 1 would ensure accurate results are achieved when using the Pronto-7 rainbow 4D Reusable Sensor with the Pronto-7 Spot Check Pulse CO-Oximeter. (1) Option 1: Prior to performing an SpHb measurement, wait at least seven (7) minutes with the patient's finger inserted inside the Pronto-7 rainbow 4D Reusable Sensor. The seven minute wait will help ensure that the actual finger temperature and the sensor temperature are close to equalized.Masimo is working to quickly develop a revision to the Pronto-7 rainbow 4D Reusable Sensor that will address this issue and plan to have it available in early 2011. We will contact you when the new revision of the sensor becomes available to replace the current sensor;(2) Option 2: Return only the Pronto-7 rainbow 4D Reusable Sensor and request a loaner Pronto device with rainbow DCI sensor (part numbers 9167 and 2646) to be utilized until the new version of the sensor is available for use with the Pronto-7. Please let us know if you wish to try the Pronto or see the product brochure for Pronto. We will contact you when the new revision of the sensor becomes available;(3) Option 3: In addition, the Pronto-7 rainbow 4D Reusable Sensor and the Pronto-7 Spot Check Pulse CO-Oximeter may be returned for a refund.Customers were also instructed to complete the Tracking/Verification Form provided with the recall notice and fax it to Masimo at: 1-949-297-7499.",Contact the recalling firm for information,497,497,"Worldwide Distribution - Nationwide in the US and worldwide to Argentina, Austria, Bahrain, Belgium, Benin, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebaron, Libyan Arab, Jamahiriya, Malaysia, Malta, Mauritius, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United kingdom",Terminated,"March 26, 2013",763,497,Not_Computer,N/A,N/A,N/A
Z-1389-2011,57245,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England.The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.",SROM distal femoral cutting block guide ,2,"February 22, 2011", 2011,"Depuy Orthopaedics, Inc.",The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED block size.,DESIGN: Device Design,"The firm, DePuy, sent an ""URGENT INFORMATION - DEVICE CORRECTION"" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011.If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482.On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.",Contact the recalling firm for information,219,219,"Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.",Terminated,"December 03, 2012",650,448,Not_Computer,N/A,N/A,N/A
Z-1394-2011,57082,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.",Maquet Heart Lung Machine HL20,2,"February 22, 2011", 2011,"Maquet Cardiovascular Us Sales, Llc",A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,Maquet hand delivered a letter to the consignee on 10/4/2010.,N/A,4,4 units,One hospital in New York City,Terminated,"August 11, 2011",170,4,Not_Computer,N/A,N/A,N/A
Z-1391-2011,57805,"apparatus, autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(k),Haemonetics cardioPAT Cardiovascular - autotransfusion SystemCatalog Number: 02050-US,Haemonetics cardioPAT ,2,"February 22, 2011", 2011,Haemonetics Corporation,"Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.",PRODUCTION CONTROLS: Process Control,"Haemonetics issued a Field Correction Notice on 1/25/11 . with the Air Leak Detection addendum and index be inserted into the appropriate document, applied to all cardioPAT@ devices on site. The serial number for each cardioPAT device on site should be recorded on the attached acknowledgementand the completed acknowledgement should be returned to your Haemonetics Sales Consultant. A Haemonetics Sales Consultant will train on the content of these items and insert them into the Operator Manuals.",N/A,309,309 units,"Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.",Terminated,"January 14, 2013",692,309,Not_Computer,N/A,N/A,N/A
Z-1401-2011,57781,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),MAGNETOM VerioNuclear magnetic resonance imaging,MAGNETOM Verio,2,"February 23, 2011", 2011,"Siemens Medical Solutions USA, Inc",On some systems the gradient cable connections did not meet firm's specifications after installation,OTHER/UNDETERMINED: Pending,"Siemens Medical Solutions USA, Inc sent customers a letter on January 10, 2011 notifying them of an Update Instruction and informing them that recalling firm would preventatively check the gradient cable connections of all systems. For questions regarding this recall call 610-219-6300.",Contact the recalling firm for information,92,92,"Nationwide Distribution including AK, AZ, CA, CT, FL, HI, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NV, OH, OK, OR, PA, RI, TN, TX, VA, WI, and WV",Terminated,"September 25, 2012",580,92,Not_Computer,N/A,N/A,N/A
Z-1421-2011,57775,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOSSystem, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)","AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS",2,"February 23, 2011", 2011,"Siemens Medical Solutions USA, Inc",Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing,OTHER/UNDETERMINED: Pending,"Siemens Medical Solutions USA, Inc issued a Customer Safety Advisory Notice via Update Instruction XP005/10/S to affected customers. This letter informs customers of the potential malfunction and of possible danger for patients, users or other persons. A future Update Instruction will be released for the replacement of the tilt buttons on all OPTI Grip handles. Customers were instructed to forward the safety notice to any new owners of this device and to provide Siemens Medical with names of the new customers. For any questions regarding this recall call 610-448-3237.",N/A,1323,1323,"Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.",Terminated,"July 16, 2013",874,1323,Not_Computer,N/A,N/A,N/A
Z-1157-2011,57663,"catheter,intravascular,therapeutic,short-term less than 30 days",FOZ,Intravascular catheter.,General Hospital,General Hospital,510(k),"Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-SDLMY-401J-ABRM-IHI-FST, G48047, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.","Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane",1,"February 23, 2011", 2011,"Cook, Inc.","Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.",N/A,51473,"51,473 total kits/trays","Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.",Terminated,"June 21, 2011",118,51473,Not_Computer,N/A,N/A,N/A
Z-1400-2011,57818,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Integra Radionics HRAIM Intubation Head Ring AssemblyRef: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation used for precise spatial localization and treatment of physiologic targets for stereotactic neurosurgical procedures such as craniotomies, biopsies, functional neurosurgery, and radiation therapy. Head Rings are delivered to the user non-sterile, and are reusable.",Integra Radionics,2,"February 23, 2011", 2011,Integra LifeSciences Corp.,Overall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach,PRODUCTION CONTROLS: Manufacturing Material Removal,"Integra sent a Medical Device Field Corrective Action letter dated January 12, 2011, to all affected customers via Federal Express. Integra Sales Specialists were provided with the replacement part and written instructions on how to replace the affected intubation hoops from customer inventory identified in the traceability report. Upon completion of the field correction each sales specialist was instructed to return the affected hoop along with a completed copy the Recall Acknowledgement and Return Form. If additional information is required contact me at (609) 936-2485 or james.tillman@integraJife.com.",N/A,8,8 units,"Worldwide Distribution - USA, Canada, and Australia",Terminated,"April 04, 2011",40,8,Not_Computer,N/A,N/A,N/A
Z-1399-2011,57431,hepatitis viral b dna detection,MKT,N/A,N/A,Microbiology,N/A,"Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USAThe Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.",Abbott RealTime HBV Assay,3,"February 23, 2011", 2011,Abbott Molecular,Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.,OTHER/UNDETERMINED: Pending,"Abbott Molecular sent a Field Advisory Notice letter to all RealTime HIV-1, CT/NG and HBV assay customers on December 20, 2010, informing them that internal testing identified the potential of under filled and over filled enzyme vials which may result in obtaining less than the total number of tests per kit as described in the package insert. The customers were told that specimens that meet acceptance criteria, per the product labeling are not affected by the situation and are considered valid results, and that the issue has no impact on results for those runs that generate valid results. Any questions were directed to Abbott Technical Support at 1-800-553-7042, Option 2.",N/A,N/A,N/A,Nationwide Distribution,Terminated,"November 19, 2012",635,N/A,Not_Computer,N/A,N/A,N/A
Z-1396-2011,57861,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company.Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.",Comfort Sling Plus Model 300,2,"February 23, 2011", 2011,"Hill-Rom, Inc.","Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.",N/A,"The firm sent an URGENT MEDICAL DEVICE RECALL notice dated 02/09/2011 to Facility Risk Manager/Facility Administrators. The letter Identified the affected product, explained the recall situation, and asked firms to check their facility for the affected serial numbers. Consignees were asked to return the recalled products, and a replacement sling would be sent to them. Customers can contact Hill-Rom Technical Support at 800-445-3720, if they have any questions concerning this matter.",N/A,10,10 units,"Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.",Terminated,"October 07, 2011",226,10,Not_Computer,N/A,N/A,N/A
Z-1424-2011,57084,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"1) Signa Lx ( K962061Signa Horizon Cx)The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.",Signa Lx ,2,"February 24, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety.If the gradient cables are inadvertently swapped while servicing the gradients, and the Service Engineerdoes not perform the geometry check as required in the service procedure, images m",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On November 9, 2010, the firm, GE Healthcare, sent an ""Urgent Medical Device Correction"" letter dated November 5, 2010 to all Consignees/Customers. The letter described the product, problem and action to be taken by the firm. GE instructed the customers to contact their local GEHC support Engineer, if they have any questions about the image orientation, or the procedures for geometry checks on thier system. Additionally, a GE Healthcare representative will install a device, which will reduce the potiential for the gradient cables to be swapped.Contact your local GEHC Support Engineer if you have any questions concerning this notification or phone: 262-548-2731.",Contact the recalling firm for information,3105,3105,"Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.",Terminated,"July 03, 2012",495,8937,Not_Computer,N/A,N/A,N/A
Z-1434-2011,57821,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Cardiovascular Review StationThe IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.",CRS,2,"February 24, 2011", 2011,AGFA Corp.,Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.,OTHER/UNDETERMINED: Pending,"The firm, AGFA Healthcare, sent a ""Safety Notice"" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades.If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754.",Contact the recalling firm for information,107,107,Worldwide distribution: USA and country of: Canada,Terminated,"March 29, 2011",33,107,Software,Output/Calculation,Software update,Software Update
Z-1422-2011,57704,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789;Intended use: To deliver x-ray radiation for therapeutic treatment of cancer.Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany",ARTISTE MV with Artiste Digital Linear Accelerators,2,"February 24, 2011", 2011,"Siemens Medical Solutions USA, Inc., Concord, CA","The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.",OTHER/UNDETERMINED: Pending,"The firm, Siemens, issued a ""Customer Information"" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' .If you any questions, please call 925-246-8407.",N/A,20,20 units,Worldwide distribution.,Terminated,"June 30, 2011",126,20,Not_Computer,N/A,N/A,N/A
Z-1423-2011,57629,"generator, oxygen, portable",CAW,Portable oxygen generator.,Anesthesiology,Anesthesiology,510(k),"HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184.The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.",HomeFill Oxygen Compressor IOH200 Homefill,2,"February 24, 2011", 2011,Invacare Corporation,"Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor failure/shutdown or to cause the motor",OTHER/UNDETERMINED: Pending,"The firm, INVACARE Corp., sent an ""URGENT PRODUCT RECALL: IOH 200 Homefill Recall"" letter dated January 10, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to ""immediately examine their inventory and quarantine product subject to recall. In addition, if they may have further distributed this product, please identify their customers and notify them at once of this product recall."" The customers were also instructed to complete and return an enclosed response form. Note: All product is to be return to the recalling firm.If you have any questions, contact the Manager, Regulatory Affairs at (440) 329-6356.",Contact the recalling firm for information,62,62 Compressors,"Nationwide distribution: USA including states of: FL, GA, KY, LA, MO, NC, NE, NJ and SC.",Terminated,"November 21, 2011",270,62,Not_Computer,N/A,N/A,N/A
Z-1402-2011,57487,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000.It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.",STRYKER NAVIGATION SYSTEM iNtellect Cranial Software ,2,"February 25, 2011", 2011,Stryker Instruments Division of Stryker Corporation,"When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.",DESIGN: Software Design,"Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification.2) Distribute this notification to all departments affected.3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form.Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update.5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location.6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers.Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.",Contact your health professional,1155,"1,155 total","Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.",Terminated,"June 01, 2011",96,1155,Software,Display/Image,Software update,Software Update
Z-1439-2011,57829,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Curlin Infusion Administration Set, REF 340-4111, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.",Infusion Administration Set,2,"February 25, 2011", 2011,"Zevex International, Inc.",Defect in tubing may trigger false Air-In-Line warning.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, MOOG, sent an ""Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall"" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return.If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided.If you have any questions, contact MOOG Customer Service at 800-970-2337.",N/A,240,"17,120 units (US), 240 units (INTL)","Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.",Terminated,"September 27, 2011",214,629950,Not_Computer,N/A,N/A,N/A
Z-1435-2011,57820,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX CV Results Manager/Results Manager Administration ToolThe IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO","RM, RMAT",2,"February 25, 2011", 2011,AGFA Corp.,User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.,OTHER/UNDETERMINED: Pending,"The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that have formulas. Note: Technical Support ran diagnostic scripts for each customer and documented in GSC cases for each consignee/customer.If you have any questions, contact Agfa Healthcare at (949) 830-4959.",N/A,6,6 devices,"Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.",Terminated,"October 13, 2011",230,6,Software,Output/Calculation,Notification,Safety Notice/Insructions
Z-0893-2011,54768,upc reader (bar code reader),RFZ,N/A,N/A,N/A,N/A,Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System.The system is intended to be used only with test cuvettes that are available from ITC.,Hemochron Signature Elite Whole Blood Microcoagulation System,2,"March 01, 2011", 2011,International Technidyne Corp.,There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.",N/A,1640,"1640 units (1303 US, 337 foreign)","Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.",Terminated,"September 25, 2012",574,1640,Not_Computer,N/A,N/A,N/A
Z-1457-2011,57402,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842",QuickVue OneStep hCG Urine,2,"March 01, 2011", 2011,Quidel Corporation,"The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and testcassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.",N/A,"Quidel Corporation initiated an ""Urgent Medical Device Recall"" letter on November 23, 2010, with an attached ""Distributor Recall Notification Form"" to the affected distributor consignees notifying them of this issue and requesting return of all kits from the affected lot. Quidel is further requesting that distributor consignees notify end-users of the issue and request return of kit boxes containing the H. pylori pouched cassettes. The recall notices sent to the distributors were sent via US Postal, certified, with return receipt.The consignees were instructed to:(1) Locate kits with the affected lot number and immediately remove the kits from your existinginventory and place them into a quarantine location, (2) Contact Quidel Corporation for instructions on how to return the kits and obtain replacement product.Quidel Technical Support(800) 874-1517, Monday-Friday, 7am - 5pm PST,(3) Fax the enclosed Inventory Form to Quidel at (858) 431-3522. Indicate the total number of kits currently on hand with lot number 706842 or if you do not have any kits of this lot numberremaining in inventory.",N/A,3624,"3624 kits = 90,600 tests total","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, HI, IL, KS, KY, MA, MD, MN, NC, NJ, NM, NV, OK, OR, PA, TN, TX, UT, VA, and WA and Canada.",Terminated,"June 26, 2012",483,3624,Not_Computer,N/A,N/A,N/A
Z-1458-2011,57561,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"The Panorama HFO system has the Traceable Item Identification (12NC):9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO).9896 030 19641-SW R 2.5.39896 030 19861-SW R 2.6.19896 030 19862-SW R 2.6.19896 030 19863-SW R 2.6.3",Panorama HFO,2,"March 01, 2011", 2011,Philips Medical Systems North America Co. Phillips,"In the ExamCard MobiFlex the Patient Position is ""Prone"" which must be ""Supine"". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a risk of wrong treatment or the need of additional X-RAY during treatment.",OTHER/UNDETERMINED: Pending,"Philips began sendng out the URGENT-Device Correction Notice letter dated February 5, 2010, ro all affected consignees on February 10, 2010. The consignees were advised to change the patient position from ""Prone"" immediately to ""Supine"" and store the corrected ExamCard in the hospital database if they use the ExamCard, MobiFlex dual Injection.Consignees were instructed to call Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and also reference ""FCO 78100318"" with any communication.",Contact the recalling firm for information,82,82 units,"Nationwide Distribution including the following states: AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV.AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV. There was no foreign consignees.",Terminated,"August 10, 2011",162,82,Not_Computer,N/A,N/A,N/A
Z-1472-2011,57514,"control material, blood circulating epithelial cancer cell",NRS,Hematology quality control mixture.,Hematology,Hematology,510(k),"Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003",Cell Search CTC Control Kit,3,"March 01, 2011", 2011,"Veridex, LLC",There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.,PRODUCTION CONTROLS: Process Control,"Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.",Contact the recalling firm for information,122,"122 US, 28 International","Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.",Open,N/A,N/A,122,Not_Computer,N/A,N/A,N/A
Z-1459-2011,57560,hepatitis viral b dna detection,MKT,N/A,N/A,Microbiology,PMA,COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD;COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD,COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 CEIVD,2,"March 01, 2011", 2011,"Roche Molecular Systems, Inc.",There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test on the COBAS AmpliPrep instrument.,DESIGN: Software Design (Manufacturing Process),"Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete.For questions regarding this recall call 908-253-7569.",N/A,22212,"93 kits to US; 22,119 kits to foreign","Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom",Terminated,"August 27, 2012",545,22212,Not_Computer,N/A,N/A,N/A
Z-0286-2011,56922,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System.For head, whole body X-ray Computed Tomography applications.",BrightSpeed Excel/Edge/Elite Select Computed Tomography XRay System,2,"March 01, 2011", 2011,"GE Healthcare, LLC",Failure to properly document the CTDI in the Technical Reference or User Manual.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an ""Important Electronic Product Radiation Warning"" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.",N/A,103,103 units,Nationwide Distribution,Terminated,"December 05, 2013",1010,103,Not_Computer,N/A,N/A,N/A
Z-1495-2011,53690,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA.EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions.",PhD System EIA/IFAversion 2.1A software,2,"March 02, 2011", 2011,Bio-Rad Laboratories Inc,Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"BIO-RAD sent an URGENT: MEDICAL DEVICE CORRECTION letter dated September 29, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their customer records to identify all PhD System customers that are using version 2.1A of the EIA/IFA Software and Methods CD-ROM.Customers who are not running competitive immunoassays on the PhD System may continue using the 2.1A software.Customers who run competitive immunoassays must revert to software version 2.0B.Customers were instructed to translate if necessary and add local contact information to the customer letter and distribute to all PhD System customers that are using 2.1A of the EIA/IFA Software and Methods CD-ROM. A Customer Medical Device Correction Response Form must be collected from each customer to ensure that they have received this important communication. Once forms have been collected from all applicable customers, they should be faxed to Bio-Rad CSD Regulatory Affairs Department along with the completed Subsidiary Medical Device Correction Response Form.For questions regarding this recall call 510-741-3954.",N/A,262,262 units,"Worldwide Distribution - USA including AL, CA, CO, CT, DC, FL, IL, MA, MD, MN, MO, MS, MT, NC, NY, OH, PA, SD, TN, TX, UT, and VT and the countries of Australia, New Zealand, Singapore, China, France, Sweden, and Canada",Terminated,"March 11, 2011",9,262,Software,Output/Calculation,Revert to a previous version,Software Update
Z-1479-2011,56385,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests,Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA.Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.",Autoimmune EIA ANA Screening Kit,2,"March 02, 2011", 2011,Bio-Rad Laboratories Inc,The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.",N/A,2109,"2,109 bulk packs","Nationwide Distribution -- New York, US.",Terminated,"March 11, 2011",9,2109,Not_Computer,N/A,N/A,N/A
Z-1477-2011,57427,"test, epithelial ovarian tumor-associated antigen (ca125)",LTK,Tumor-associated antigen immunological test system.,Immunology,Immunology,510(k),ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows:Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit,ADVIA Centaur CA 125 II ,2,"March 02, 2011", 2011,"Siemens Healthcare Diagnostics, Inc",Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal,PRODUCTION CONTROLS: Process Control,"Siemens Healthcare Diagnostics on 12 /14/10 issued Urgent Device Recall notice via Federal Express to accounts. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Device Recall notice directs customers to immediately discontinue the use of ADVIA Centaur CA 125 II assay kits that contain CA 125 II reagent lot 144. It also recommends that patient results obtained with this reagent lot be reviewed. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Technical questions, please contact the Technical Solutions Center at 1-877-229-3711.",N/A,2960,2960 units,"Worldwide distribution, including USA, Canada, Argentina, Austria, Belgium, China, Denmark, France, Germany, Great Britain, Greece, India, Italy, Japan, Korea, Lavitia, Lithuania, Malyasia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Switzerland, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Czech Republic, Taiwan, Turkey, Uganda, and Venezuela",Terminated,"April 12, 2013",772,2960,Not_Computer,N/A,N/A,N/A
Z-1478-2011,55293,"antinuclear antibody, antigen, control",LKJ,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.","DiaSorin ETIANA Screen Kit, 96 Test",2,"March 02, 2011", 2011,Bio-Rad Laboratories Inc,Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.,Contact the recalling firm for information,999,999 kits,"Foreign Only:One distributor, DiaSorin S.R.I. in Italy.No wholesalers.No retailers.No domestic distribution, No Federal Government sales/distribution centers.",Terminated,"March 11, 2011",9,999,Not_Computer,N/A,N/A,N/A
Z-1473-2011,57083,N/A,N/A,N/A,N/A,N/A,N/A,"GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph",AdvantageSim MD,2,"March 02, 2011", 2011,"GE Healthcare, LLC",GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected.,DESIGN: Software Design,"GE Healthcare sent an ""Urgent Medical Device Correction"" letter dated November 23, 2010. The letter was addressed to Hospital Administrators / Risk mangers, Oncology Department Managers / Radiation Oncologists, & Radiation Physicists / Dosimetrists / Therapists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.For any questions or concerns regarding this recall, please call one of thefollowing phone numbers:United States: 800 437 1171Japan: 0120 - 055 - 919For other countries, please contact your local GE Healthcare Service Representative.",Contact the recalling firm for information,1531,1531,"Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, PAKISTAN, NOWAY, NIGERIA, NETHERLANDS, MEXICO, MALAYSIA, LITHUANIA, LATVIA, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, ECUADOR, DOMINICA REPUBLIC, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BRAZIL BELGIUM, AUSTRIA, AUSTRALIA.",Terminated,"August 03, 2012",520,1531,Other,N/A,N/A,Other
Z-1476-2011,57692,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),PrecisePLAN Treatment Planning SystemTo plan multiple beam radiation therapy treatments.,PrecisePLAN Treatment Planning System,2,"March 02, 2011", 2011,"Elekta, Inc.",PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.,OTHER/UNDETERMINED: Pending,"Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .",N/A,277,277 units,"Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan,",Terminated,"April 21, 2011",50,277,Not_Computer,N/A,N/A,N/A
Z-1474-2011,57419,"motor, drill, electric",HBC,Electric cranial drill motor.,Neurology,Neurology,510(k),"Aesculap MicroSpeed Uni Control Box, Part #GD670Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery.",MicroSpeed Uni Motor System,2,"March 02, 2011", 2011,Aesculap Inc,Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.,DESIGN: Software Design,"AESCULAP sent an IMPORTANT CORRECTION NOTICE letter dated November 22, 2010, to all affected consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to not use the motors for thread cutting and removal of screws.If any unusual reactions of any cutting tools were observed consignees should check to ensure that the motor is not running in the opposite direction.If any error message is displayed, consigness were instructed to not use the motor.Consignees were also instructed to check both directions of running before use and do not use a motor which produces an error message in one direction. Aesculap would be providing all customers with a software update to the MicroSpeed Uni control box either by the unit being returned to Aesculap for update or by firm representative doing the upgrade on site at their facility.For questions regarding this recall call 800-258-1946 x5254 or 800-258-1946 x5267.",Contact the recalling firm for information,91,91 units,"Worldwide Distribution - USA including CA, CO, DE, FL, GA, IN, LA, MO, NC, NJ, OK, PA, TN, TX, and VA and the country of Canada.",Terminated,"July 05, 2012",491,91,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1475-2011,57100,spinal vertebral body replacement device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306.Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.",Vu aPOD Intervertebral Body Fusion Device,2,"March 02, 2011", 2011,Integra LifeSciences Corp.,"The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a""POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.",TRAINING: Employee Error,"On 10/19/2010 the firm sent ""URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.",N/A,2163,"2,163 pieces","Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.",Terminated,"September 19, 2012",567,2163,Not_Computer,N/A,N/A,N/A
Z-1497-2011,57884,"tape and bandage, adhesive",KGX,Medical adhesive tape and adhesive bandage.,General Hospital,General & Plastic Surgery,N/A,"High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.",Dermabond Topical Skin Adhesive,2,"March 02, 2011", 2011,"Ethicon, Inc.",Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.,OTHER/UNDETERMINED: Unknown/Undetermined by the firm,"Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.",N/A,725722,"725,722 each (total)","Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, ireland, Israel, italy, Japan, Korea, Lithuania, Luxembourg, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Palestine, Puerto Rico, Reunion, Russia, Senegal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Ukraine, and Venezuela.",Terminated,"November 07, 2012",616,1451494,Not_Computer,N/A,N/A,N/A
Z-1494-2011,54620,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.",FassierDuval Telescopic IM System,2,"March 02, 2011", 2011,Pega Medical Inc.,"Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.",PRODUCTION CONTROLS: Process Control,"On 01/29/2010, Pega Medical began contacting their consignees by e-mail and telephone.Pega Medical followed up with their consignees by sending out the replacement components along with the explanation letter. The subject on the letter is Notice for 3.2 mm and 4.0 mm Male Drivers of the Fassier-Duval IM Telescopic System.The consignees were informed that there could be a structural weakness in some of the Male Driver instruments. This problem has been detected on the 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. Consignees can contact Pega Medical at 450-688-5144 x 242.",N/A,4,4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm) distributed in US.,"Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.",Terminated,"March 26, 2011",24,4,Not_Computer,N/A,N/A,N/A
Z-1493-2011,57827,"electrode, electrocardiograph",DRX,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.","Neotrode, Softrade, TruLink",2,"March 02, 2011", 2011,ConMed Corporation,Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.",N/A,9009000,"9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wire","Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.",Open,N/A,N/A,9009000,Not_Computer,N/A,N/A,N/A
Z-1379-2011,57566,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm RectangleCatalog #: 1161015",XenMatrix Surgical Graft,1,"March 02, 2011", 2011,"Davol, Inc., Sub. C. R. Bard, Inc.","Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.",PRODUCTION CONTROLS: Process Control,Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753.,N/A,1456,1456 units,Nationwide,Terminated,"October 31, 2013",974,5227,Not_Computer,N/A,N/A,N/A
Z-1518-2011,57552,"device, monitoring, intracranial pressure",GWM,Intracranial pressure monitoring device.,Neurology,Neurology,510(k),"LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA.Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.",LICOX CMP Tissue Oxygen Monitor,2,"March 03, 2011", 2011,Integra LifeSciences Corp.,Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached ""Recall Acknowledgement and Return Form"" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.",N/A,26,26 units,Worldwide Distribution,Terminated,"November 05, 2012",613,26,Not_Computer,N/A,N/A,N/A
Z-1522-2011,56660,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, noninvasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.",ApexPro Telemetry System ,2,"March 03, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in annunciation of audible alarms when used in combo mode, and may result in thedelay of treatment of a cardiac event.",DESIGN: Software Design,"GE sent an ""Urgent Medical Device Correction"" letter dated December 29, 2010. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Product Correction, Safety Instruction and Contact Information.Customers were instructed to contact Technical Support or their local Service Representative with any questions regarding this medical device.For any questions regarding this recall call 262-573-4122.",Contact the recalling firm for information,2346,2346,"Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT,NE, NJ, NM, NY, NC, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY. and the UNITED KINGDOM, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH KOREA, RUSSIA, NORWAY, NEW ZEALAND, NETHERLANDS, MALAYSIA, JAPAN, ITALY, ISRAEL, IRELAND, GERMANY, FRANCE, FINLAND, DENMARK, CUBA, CHINA, CANADA, AUSTRIA, AUSTRALIA, POLAND.",Terminated,"May 29, 2012",453,2346,Other,Alarm/Message,N/A,Other
Z-1521-2011,57847,powered laser surgical instrument,GEX,Laser surgical instrument for use in general and plastic surgery and in dermatology.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.",VariLase WireFiber,2,"March 03, 2011", 2011,"Vascular Solutions, Inc.","Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896.Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur during patient procedure and has the p",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Vascular Solutions sent an ""Urgent Medical Device Recall"" letter dated January 10, 2011. The letter described the issue and the product affected. Advised consignees to immediately check their inventory , place affected product in a secure location, and to complete and return the Customer Inventory Form.For questions regarding this recall call 763-656-4210.",Contact the recalling firm for information,41,41,"Nationwide Distribution - USA including CT, MA, MN, NY, VA",Terminated,"May 03, 2012",427,41,Not_Computer,N/A,N/A,N/A
Z-1498-2011,57303,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"SSH-880CV Aplio Artida; System, Diagnostic Ultrasound","SSH880CV Aplio Artida; System, Diagnostic Ultrasound",2,"March 03, 2011", 2011,Toshiba American Medical Systems Inc,Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.,DESIGN: Software Design,Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter to consignees via USPS return receipt mail. The letter contained a return reply form that is to be faxed to TAMS at 877-349-3054 as proof of notification.Customers were instructed to share the information with all users and reviewing radiologists as well as clinical engineering or biomedical group at their facility.For questions regarding this recall call 800-421-1968 or 800-521-1968.,N/A,40,40 units,"Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.",Terminated,"May 02, 2012",426,40,Software,N/A,Instructions,Safety Notice/Insructions
Z-1520-2011,57841,"cannula, manipulator/injector, uterine",LKF,N/A,N/A,Obstetrics/Gynecology,510(k),"VCare¶_ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5"" x 12"" 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. The ConMed VCARE¶_ Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.","VCare, Standard/Small/Large Cervical Cup",3,"March 03, 2011", 2011,ConMed Corporation,"Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare¶_ Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare¶_",DESIGN: Device Design,"ConMed Corporation sent a communication to provide its direct consignees with important supplemental information concerning the Instructions for Use (IFU) for the VCARE¶_ Vaginal-Cervical Ahluwalia's Retractor-Elevator uterine manipulators. The direct consignees were instructed to place a copy of the enclosed Instructions for Use, Part No. 14071 (Rev. A), with any inventory in your possession with an expiration date prior to August 2011 (2011-08) and replace any other Instructions for Use in thier possession. A copy of the enclosed Instructions for Use is already packaged with all devices bearing later expiration dates. Any inventory in their consignees possession with an expiration date prior to January 2011 (2011-01) is expired and should not be used. If the devices were further distributed to other facilities or distributors, or their consignees are a distributor, they were instructed to forward this information as appropriate to any known users of these devices.For questions regarding this recall call 315-624-3225. --- The IFU Warning changes are as follows: A new warning statement # 6 asks the user to verify the presence of all the components of the device upon removal of the VCARE¶_ device from the patient. Although the prior IFU contained warnings about verifying that all components of the device were properly removed following use during surgery, the new statement expands the earlier, briefer statement. 6. Upon removing VCARE, the surgeon should visually inspect the VCARE device, and the patient, to make sure that the entire VCARE device was properly removed and that no components or fragments of these components were retained in the patient. There are 5 parts/components to the VCARE Cervical Elevator Retractor. These are: 1) the balloon; 2) the forward ""cervical"" cup; 3) the back or vaginal cup; 4) the locking assembly with thumb screw; 5) the metal shaft and handle with balloon inflation valve. --- A new warning statement # 10 further addresses.",N/A,31028,"31,028 VCare¶_ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices","Worldwide Distribution - USA including NY, TX, CA, IA, AZ, PA, IN, and KS and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada.",Terminated,"August 30, 2012",546,31028,Not_Computer,N/A,N/A,N/A
Z-1501-2011,57702,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.,Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105,2,"March 03, 2011", 2011,Applied Medical Resources Corp,"Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage.",DESIGN: Process Design,"Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product.Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.",Contact the recalling firm for information,2843,"2,843 units for all products","Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.",Terminated,"March 09, 2011",6,2843,Not_Computer,N/A,N/A,N/A
Z-1562-2011,54551,"ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine",JNB,Phenylalanine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA",Quantase Neonatal Elution Buffer,2,"March 04, 2011", 2011,Bio-Rad Laboratories Inc,"Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.",OTHER/UNDETERMINED: Pending,"Direct accounts were notified by phone, followed by fax (domestic). Urgent Device Recall notification letters were sent out on January 26, 2010 to subsidiary along with a Bio-Rad customer form to be send to each customer. The letters identified the affected product and explained the reason for the recall. Customers were asked to examine their inventory and quarantine the affected lots listed. In addition, they are to complete and return the enclosed response form according to the instructions provided. Customers are contact their regional Bio-Rad office for Elution Buffer replacement.",Contact the recalling firm for information,714,714,"Worldwide Distribution -- USA, including states of MI and MN and Bio-Rad facilities in Italy, France, Czech Republic, Canada, Argentina, Panama, United Kingdom, Hong Kong, China, Canada, Singapore, India, South Korea, Brazil, and Sweden.",Terminated,"March 17, 2011",13,714,Not_Computer,N/A,N/A,N/A
Z-1523-2011,56344,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.",Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Conn,2,"March 04, 2011", 2011,"Siemens Medical Solutions USA, Inc","A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.",OTHER/UNDETERMINED: Pending,"Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, ""Safety Advisory Letter.For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist.For questions regarding this recall call 925-602-8157.",N/A,N/A,N/A,"Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.",Terminated,"March 09, 2012",371,N/A,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-1559-2011,57500,"unit, x-ray, extraoral with timer",EHD,Extraoral source x-ray system.,Dental,Radiology,510(k),"Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USAThe wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16"", or to a wall supported by steel studs.",Wall Mounting Plate,2,"March 04, 2011", 2011,Gendex Dental Systems,The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Gendex, sent an ""URGENT MEDICAL DEVICE FIELD CORRECTION"" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: regulatory.affairs@gendex.com and contact Gendex Customer Service at 1-800-323-8029.If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or regulatory.affairs@gendex.com.",N/A,34,34 wall plates,"Worldwide distribution: USA and countries including: Australia, Canada and Germany.",Terminated,"August 14, 2012",529,34,Not_Computer,N/A,N/A,N/A
Z-1539-2011,57605,reamer,HTO,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Bell Drive Warsaw IN.The product is used to prepare the femoral canal for stem implantation.",Cylindrical Reamer ,2,"March 04, 2011", 2011,"Biomet, Inc.","The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.",N/A,"The firm, BIOMET, sent an"" URGENT MEDICAL DEVICE RECALL NOTICE"" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683.Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.",N/A,51,51 all products,"Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.",Terminated,"October 01, 2012",577,51,Not_Computer,N/A,N/A,N/A
Z-1548-2011,57563,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"The LIFEPAK12 Defibrillator/Monitor.The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.",LIFEPAK 12 Defibrillator/MonitorAC Power Adapter,2,"March 04, 2011", 2011,"Physio Control, Inc.","L1FEPAK 12 Operating Instructions that describethe process for disconnecting the device from AC (wall) power are not always being followed. When theinstructions are not followed and the Power ON button is pushed within 2 seconds after disconnectingthe device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.",PRODUCTION CONTROLS: Environmental Control,"Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicator illuminates, it's important to be aware that turning the device off, then back on again, will reset the device and restore full functionality.The complete copy of the current LIFEPAK 12 Operating Instructions can be downloaded from the company's website at www.physio-control.com/products/ defibrillators, Select LIFEPAK 12, Select Documents.The consignees can call the firm's Technical Support Team at 1-800-442-1142, option 5, between 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.",N/A,180,"39, 180 units (17168 units internationally and 22012 units in US)","Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries:ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.",Terminated,"April 05, 2012",398,39180,Battery,Device Operation,Advice,Safety Notice/Insructions
Z-1556-2011,57693,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),PrecisePLAN Treatment Planning SystemIntended use: To plan multiple beam radiation therapy treatments.,PrecisePLAN Treatment Planning System,2,"March 04, 2011", 2011,"Elekta, Inc.","When using the 'Beam Edit"" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.",OTHER/UNDETERMINED: Pending,"The firm, Elekta, sent an ""Important Notice A312"" titled ""Unintentional Modification of a locked fraction group in PrecisePLAN"" dated February 5, 2008 to all affected customers. The notice described the product, problem and action to be taken. The customers were instructed to use care when using the ""Make Opposed"" function and when changing the Fraction Group of a beam. The customers were also advised to review the final plan and any locked fraction groups to make sure the planned beam arrangement is what was intended. Note: A Field Change Order 540 073 ""All PrecisePLAN 2.15 users"" was issued on September 30, 2008 to all customers.If you have any questions, call 770-670-2548 or +44(0)1293 654400.",N/A,282,282 units,Worldwide distribution: USA and country of: Mexico.,Terminated,"April 07, 2011",34,282,Not_Computer,N/A,N/A,N/A
Z-1549-2011,57589,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8;Philips Medical SystemsAn imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.",Precedence ,2,"March 04, 2011", 2011,Philips Medical Systems,Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.,OTHER/UNDETERMINED: Pending,"Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.",Contact the recalling firm for information,540,"540 units, all varieties",Worldwide Distribution,Terminated,"April 02, 2012",395,540,Not_Computer,N/A,N/A,N/A
Z-1555-2011,57688,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.","Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2",2,"March 04, 2011", 2011,"Elekta, Inc.",Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.,OTHER/UNDETERMINED: Pending,"The firm, Elekta, sent an ""Important Notice A302"" dated August 23, 2007 titled ""Update to iCom Tables for Desktop Pro when used with Third Party R&V; Systems"",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro.If you any questions related to this issue, please contact your local Elekta, third party R&V; system representative or Elekta Limited at +44 (0)1293 654200.",N/A,229,229 units,Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.,Terminated,"April 07, 2011",34,229,Not_Computer,N/A,N/A,N/A
Z-1525-2011,57854,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, Sterile EO, Wright, Arlington, TN USAUsed in the repair of tendons and ligaments","TI ANCHOR 2.5MM W / 20 SUTURE, GFORCE (R) SUTURE ANCHOR, ",2,"March 04, 2011", 2011,Wright Medical Technology Inc,Driver may break during use.,OTHER/UNDETERMINED: Pending,"Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630.For questions regarding this recall call 901-867-4788.",Contact the recalling firm for information,45,45 units,"Nationwide Distribution including FL, NC, OH, IL, IN",Terminated,"July 11, 2011",129,55,Not_Computer,N/A,N/A,N/A
Z-1526-2011,57851,N/A,N/A,N/A,N/A,N/A,N/A,"Fresenius 2008T Hemodialysis MachinePart Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUSPart Number 190713, 2008T Hemodialysis System with CDXPart Number 190766, 2008T Hemodialysis System with biBagThe Fresenius 2008T is indicated for acute and chronic dialysis therapy.",Fresenius 2008T Hemodialysis Machine,2,"March 04, 2011", 2011,"Fresenius Medical Care Holdings, Inc.",Cursor on the dialysis screen may disappear and not respond to user input,DESIGN: Device Design,"Fresenius Medical Care contacted customers by mailing a Customer Notification letter ""Urgent correction FMNCA Model 2008T Hemodialysis Machine"" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.",N/A,1268,1268 units,Worldwide Distribution - USA and Canada,Terminated,"July 08, 2013",857,1268,Other,N/A,N/A,Other
Z-1557-2011,58008,"accessories, soft lens products",LPN,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060.Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses",AquaRefresh,3,"March 04, 2011", 2011,Marietta Vision,"Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.",OTHER/UNDETERMINED: Pending,"John Patterson, President of Marietta Vision called each optical retailer on February 21, 2011, and told them of the misbranding issue in regards to country of origin. In addition, an Urgent Product Recall letter was sent to each account on February 23, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their AquaRefresh inventory for lot number KD005, and discontinue distribution of the samples immediately and to return any outstanding stock to Marietta Vision for exchange. Marietta Vision would return the misbranded product back to the Mexican factory at their expense to have the product packaging corrected. If they elect not to do so, Marietta Vision would have the product disposed of.Customers were instructed to fax the enclosed form back to Marietta Vision at 678-797-1099.For questions regarding this recall call 866-300-6257.",Contact the recalling firm for information,502,500/2 fl.oz. Bottles,"Nationwide Distribution including AR, AZ, CA and TX.",Terminated,"November 03, 2011",244,500,Not_Computer,N/A,N/A,N/A
Z-1561-2011,57974,"patch, pledget and intracardiac, petp, ptfe, polypropylene",DXZ,"Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.",Cardiovascular,Cardiovascular,510(k),Pulmonary Hemi-Artery SGUsed in heart surgery,SynerGraft CryoPatch Pulmonary HemiArtery SG,2,"March 04, 2011", 2011,"CryoLife, Inc.",Staphylococcus aureus (not methicillin resistant) identified in companion tissue.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary.The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification.For any questions the physician was advised to call 770-419-3355.",Contact the recalling firm for information,1,One,Nationwide Distribution including AZ & NV,Terminated,"April 24, 2012",417,1,Not_Computer,N/A,N/A,N/A
Z-1554-2011,57988,powder-free guayle rubber examination glove,OIG,Patient examination glove.,General Hospital,General Hospital,510(k),"Medline Industries, Inc. ""Cedar"" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569","Medline Industries, Inc. ""Cedar"" brand Vinyl Economy Exam Glove, PowderFree, Large Size",2,"March 04, 2011", 2011,Medline Industries Inc,"The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to:1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock.3. Fax or email the completed form to Medline. The email address is Recalls@Medline.com or faxed the form to 866-767-1290. Customers with questions regarding the recall were instructed to contact Medline at 1-866-359-1704 or via e-mail at Recalls@Medline.com.",Contact the recalling firm for information,696,"696 cases (696,000 units)","Nationwide Distribution including CA, HI, and NV.",Terminated,"March 19, 2012",381,2796,Not_Computer,N/A,N/A,N/A
Z-1558-2011,57696,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027.The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.",Surgical Navigation System,2,"March 04, 2011", 2011,"Medtronic Navigation, Inc",Position Sensor Unit may generate tracking errors or may stop tracking immediately.,DESIGN: Component Design/Selection,"The firm, Medtronic, sent a ""Product Correction Notification"" letter dated December 22, 2010, to all US Consignees/Customers on December 23, 2010 and foreign Consignees/Customers on December 27, 2010. The letter described the product, problem and actions to be taken. The customer were instructed to discontinue use of the impacted navigation system(s) until a replacement camera (PSU) is installed. A Medtronic Navigation Representative will visit each facility to remove the navigation camera and install a replacement. If you have any questions, contact your Medtronic Navigation Representative or Medtronic Navigation Technical Support services at 1-800-595-9709 or +1-720-890-3200.",N/A,11,"11 (US), 8 (Intnl)","Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa.",Terminated,"March 11, 2011",7,19,I/O,N/A,N/A,N/A
Z-0905-2011,58077,"generator, high-voltage, x-ray, diagnostic",IZO,Diagnostic x-ray high voltage generator.,Radiology,Radiology,510(K) Exempt,BuckyDiagnost general purpose x-ray system with Optimus Generator.General Purpose Diagnostic Radiography.,BuckyDiagnost with Optimus Generator,2,"March 04, 2011", 2011,Philips Healthcare Inc.,Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.",Contact the recalling firm for information,1810,1810 units in the US,Worldwide Distribution,Open,N/A,N/A,1810,Software,Device Operation,Software update,Software Update
Z-1568-2011,56120,"lens, spectacle, non-custom (prescription)",HQG,Prescription spectacle lens.,Ophthalmic,Ophthalmic,510(K) Exempt,"Polycarbonate prescription single vision lenses for use in sport goggles.To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.",Polycarbonate prescription single vision lenses for use in sport goggles.,2,"March 07, 2011", 2011,Luxottica Optical Manufacturing,The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.,OTHER/UNDETERMINED: Pending,"Luxottica Optical Manufacturing sent notification letters on June 30, 2010, to their customers informing them of the problem. Customers were instructed to complete the enclosed Sport Goggle Return Form, and to indicate whether they would like a replacement pair of goggles or a refund.Place the completed Sport Goggle Return Form and their sport goggles (without the sport goggle case) in the envelope provided and return it to the firm via the United States Postal Service. Customers were instructed not to return to the retail store where purchased. If customers were unable to return their sport goggles because they were lost or discarded, customers should complete the appropriate information on the Sport Goggle Return Form, being sure to indicate whether they would like a replacement pair of goggles or a refund, and then sign the form. Place the completed Sport Goggle Return Form in the envelope provided and return it to the firm via the United States Postal Service. For any questions, call 1-877-488-2407. They instructed their customers to return the product for replacement or refund.",N/A,2916,"2,916 individual lenses (1,458 pair of sport goggles)","Worldwide Distribution - USA including the following states: AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV; and the country of Canada.",Terminated,"September 19, 2012",562,2916,Not_Computer,N/A,N/A,N/A
Z-1592-2011,56994,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10",Straumann coDiagnostiX,2,"March 07, 2011", 2011,Straumann Manufacturing Inc.,Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.,DESIGN: Software Design,"Straumann notified accounts of this correction by letter datedSeptember 30, 2010 and delivered via Federal Express Delivery Service. The upgrade is available on-line by logging into the coDiagnostiX system and enabling the automatic upgrade to occur.",Contact the recalling firm for information,20,20 systems,Nationwide,Terminated,"September 19, 2011",196,20,Software,Device Operation,Software update,Software Update
Z-1594-2011,57915,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN.The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.",Arcos Modular Revision System Torque Limiting THandle,2,"March 07, 2011", 2011,"Biomet, Inc.","The firm received two complaints of the tabs on the Torque Limiting T-Handle fracturing during surgery. The firm performed internal testing and found that the tabs may fracture when used in the ""OFF"" or ""locked"" setting for hand-reaming the femoral canal.",DESIGN: Device Design,"Biomet, Inc. made telephone calls to distributor accounts on January 28, 2011, with specific instructions that the Arcos Torque Limiting T-Handle was not to be used in the ""OFF"" position. Distributors were required to use the Arcos Torque Limiting T-Handle on the ""55"" setting for insertion of locking screws and troch bolt. Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated February 21, 2011, to their distributors. The letter stated that the firm was currently manufacturing replacement handles which would be distributed to the field shortly. Consignees were advised to immediately discontinue use of the T-Handle in the ""OFF"" position.Send back the current T-Handle as soon as they receive a replacement.Carefully follow the instructions on the enclosed ""FAX Back Response Form.""Fax a copy of the Response Form to 574-372-1683 prior to return of product.Use priority carrier for shipment.If the product has been further distributed, consignees must notify hospital personnel of this action, via the enclosed ""Dear Bioment Customer"" notice. This letter must be give to hospital personnel responsible for receiving recall notices. Consignees are charged with the location and return of these products. Consignees were instructed to confirm receipt of this notice by calling, 800-348-9500, ext. 3755 or 3983. For any questions call 574-371-3755 or 574-372-3983.",No consumer action necessary,40,40 units,"Worldwide Distribution - USA including the states of CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada.",Terminated,"July 27, 2011",142,40,Not_Computer,N/A,N/A,N/A
Z-1572-2011,57732,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),MOSAIQ Oncology Information SystemIntended Use : Electronic Patient Records Management,MOSAIQ Oncology Information System,2,"March 07, 2011", 2011,"Siemens Medical Solutions USA, Inc",The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.,DESIGN: Software Design (Manufacturing Process),"Sent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.",Contact the recalling firm for information,10,10 units,International Only Distribution -- Germany and Japan,Terminated,"April 19, 2012",409,10,Other,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-1593-2011,57519,"prosthesis, vascular graft, of 6mm and greater diameter",DSY,Vascular graft prosthesis.,Cardiovascular,Cardiovascular,510(k),"Hemashield Finesse Ultra-Thin Knitted Cardiovascular PatchIndicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.",Hemashield Finesse UltraThin Knitted Cardiovascular Patch,2,"March 07, 2011", 2011,"Maquet Cardiovascular, LLC",One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.,N/A,"The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.",N/A,1,one unit,Nationwide distribution: SC only.,Terminated,"September 12, 2012",555,1,Not_Computer,N/A,N/A,N/A
Z-1591-2011,57432,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SBThe device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.",Anchor Tissue Retrieval System TRS175SB,2,"March 07, 2011", 2011,"Anchor Products Company, Inc.",The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.,N/A,"The firm, Anchor, sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers.For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.",No consumer action necessary,2256,"2,256 units","Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.",Terminated,"January 20, 2012",319,91041,Not_Computer,N/A,N/A,N/A
Z-1580-2011,57396,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF 8141-30-115, Depuy Orthopaedics, Inc., Warsaw, IN.",PolyAx Locking Plate System,2,"March 07, 2011", 2011,"Depuy Orthopaedics, Inc.","The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw passes through the plate.",N/A,"Urgent Information - Recall Notice letters, dated November 1, 2010 were sent to customers. The letters described the reason for recall and identified the product affected along with the affected units. The letters also provided clinical guidance and stated that the problem had been corrected and that DePuy was in the process of replenishing its inventory. Hospitals were to determine if any of the recalled components they received were still on hand, and return them immediately to their DePuy Representative or directly to DePuy for credit.",Contact the recalling firm for information,246,246 all products,"Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.",Terminated,"June 27, 2012",478,246,Not_Computer,N/A,N/A,N/A
Z-1569-2011,57314,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),MONOJECT Blood Collection Tubes containing heparin13x100 sodium heparin trace elementItem Code 8881307014,MONOJECT Blood Collection Tubes containing heparin,2,"March 07, 2011", 2011,Covidien LP,The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the product, and return it to the firm. Distributors were instructed to notify their customers. All customers were required to respond to the notice regardless of their remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customers Service questions regarding this recall call 1-800-962-9888 option 1.",N/A,18100,"18,100","Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KS, KY, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, MV, MY, OH, OK, PA, SC, SD, TN, TX, WA, and WI and the country of Canada",Open,N/A,N/A,176100,Not_Computer,N/A,N/A,N/A
Z-1589-2011,57965,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE",InnerVue Diagnostic Scope System,2,"March 07, 2011", 2011,"Biomet, Inc.",The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.,DESIGN: Process Design,"On 2/10/2011, Biomet issued an ""URGENT MEDICAL DEVICE NOTICE"" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.",N/A,264,264,Distribution USA nationwide and to the Netherlands,Terminated,"August 27, 2013",904,607,Not_Computer,N/A,N/A,N/A
Z-1566-2011,57969,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.",Terumo Advanced Perfusion System 1,2,"March 07, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that",DESIGN: Component Design/Selection,"Terumo sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 14, 2011, addressed to Chief of Perfusion, Department of Cardiovascular Surgery or Director of Operationd Room Services. The letter explains the problem with the circuit breakers and hazards of the problem. The letter states that a service technician will visit the facility to install a guard. The service will be performed at the next scheduled preventative maintenance visit for those consignees with a service contract. For customers without a service contract, Terumo CVS will contact the consignees to schedule an appointment for the correction.Customers were instructed to review the Medical Device Correction notice.Assure that all users are aware of the notice.Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions or concerns customers were instructed to contact Terumo CVS Customer Service at 1-800-521-2818.",Contact the recalling firm for information,728,728 devices.,"Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, ME, MI, MO, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and the countries ofCANADA, COLUMBIA, JAPAN, RUSSIA, EGYPT, TURKEY, PAKISTAN, KUWAIT, COSTA RICA, TAIWAN, SAUDI ARABIA, INDIA, SOUTH KOREA, JORDAN, THE PHILLIPINES, INDONESIA, HONDURAS, DOMINICAN REPUBLIC, REPUBLIC OF GEORGIA, HONG KONG, UNITED ARAB EMIRATES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, GERMANY, BELGIUM, MEXICO, THAILAND, VEITNAM, SOUTH AFRICA",Terminated,"March 20, 2012",379,1113,Hardware,Device Operation,Install a guard,Other
Z-1577-2011,57885,"instrument, biopsy",KNW,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.","Remington Medical, Inc. Automatic Cutting Needle",2,"March 07, 2011", 2011,Remington Medical Inc.,There is a potential for the needle hubs to break during use.,DESIGN: Device Design,"Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.",Contact the recalling firm for information,8161,8161 units,U.S. Nationwide,Terminated,"August 12, 2011",158,46878,Not_Computer,N/A,N/A,N/A
Z-1565-2011,57944,"bed, ac-powered adjustable hospital",FNL,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. The TotalCare¶_ Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare¶_ Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare¶_ Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution",Total Care bed,2,"March 07, 2011", 2011,"Hill-Rom, Inc.","Hill-Rom has become aware of a potential issue with some TotalCare¶_ and VersaCare¶_ beds equipped with the integrated P500 Microclimate Management(MCM) therapy surface, and with the VersaCare¶_ P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCMblower may experi",OTHER/UNDETERMINED: Pending,"Hill-Rom sent an ""IMPORTANT MEDICAL DEVICE CORRECTION"" notice dated February 21, 2011, to Facility Risk Manager/Facility Administrators. The letter states that because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate.This issue does not pose a hazard to patients as long as normal patient monitoring is in effect in relation to managing skin temperature and moisture. Customers were instructed to continue to use the product as they normally would. The mattress system would provide an alarm in the event the MCM blower does not operate properly. A Hill-Rom representative would be contacting their facility to make arrangements for correcting the affected MCM blowers. If customers had any questions concerning this request or the procedure as outlined, they were instructed to contact Hill-Rom Technical Support at 800-445-3720.For questions regarding this recall call 812-934-7777.",N/A,740,740 units,"Worldwide Distribution - USA including AL, CA, CO, CT, DC, DE, FL, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WI, and the countries of ARUBA, AUSTRIA, CANADA, FRANCE, GERMANY, LEBANON, PORTUGAL and SAUDI ARABIA",Terminated,"August 06, 2012",518,2465,Not_Computer,N/A,N/A,N/A
Z-1605-2011,57611,"device, spot-film",IXL,Spot-film device.,Radiology,Radiology,Enforcement Discretion,"Philips BV Pulsera, Rel. 2.3, 718095.Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.",Philips BV Pulsera,2,"March 08, 2011", 2011,Philips Medical Systems North America Co. Phillips,The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.,DESIGN: Device Design,"On 01/06/11, Philips sent an URGENT Device Correction Notice, dated 01/05/2011, to their consignees. The consignees were informed that the fixing strap of the Laser Aiming Device Image Intensifier may inadvertently detach when used with BV Libra, BV Endura Rel. 2, and BV Pulsera Rel 2.3 Mobile X-Ray systems. Specifically the draw latch of the fixing strap holding the CBX Laser to the Image Intensified can be accidentally released during a procedure when used with the above Mobile X-Ray systems. While waiting for Philips to implement their corrective action, the consignees are advised to fix the closed latch body of the draw latch to the metal band using a Tie Wrap. Without securing the latch with a Tie Wrap, the device should not be used.The consignees can contact Philips Call Center at 1-800-722-9377, select 5, and reference FCO 71800035 with any questions about this recall.",N/A,214,214 units,"Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington, DC.",Terminated,"February 28, 2012",357,227,Not_Computer,N/A,N/A,N/A
Z-1606-2011,56427,"cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma",OAW,N/A,N/A,Immunology,HDE - Humanitarian Device Exemption,MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests.MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.,MESOMARK,3,"March 08, 2011", 2011,"Fujirebio Diagnostics, Inc.","presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.",OTHER/UNDETERMINED: Pending,"Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight.FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory.Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010.Notify your ordering physician or health care provider as appropriate.For questions regarding this recall call 877-861-7246 or 610-240-3800.",Contact the recalling firm for information,42,42 kits,Nationwide Distribution including UT,Terminated,"July 05, 2012",485,42,Not_Computer,N/A,N/A,N/A
Z-1596-2011,57892,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),Hospira Power cord use on Symbiq One-Channel infuser andSymbiq Two-Channel infuser. Power cord part number: HSP3306-E07.Used on List No. 16026 - Symbiq One Channel infuser;List No. 16027 - Symbiq Two-Channel infuser,Symbiq,2,"March 08, 2011", 2011,Hospira Inc,"Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on Symbiq AC Power cords.",DESIGN: Component Design/Selection,"Hospira Recall notification letters were sent by Federal Express on November 1, 2010.",N/A,32376,"32,376 power cords","Nationwide distribution and to Australia, Canada, and Malaysia.",Terminated,"November 07, 2013",975,32376,Not_Computer,N/A,N/A,N/A
Z-1598-2011,57697,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846",Plum XL Micro/Macro Infusion Pump,2,"March 08, 2011", 2011,Hospira Inc.,"Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.",DESIGN: Labeling Design,"Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. They were also instructed to ensure that all personnel in their facility are following Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventative maintenance, including inspection of the buzzers for leg lifting. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance.The accounts were also requested to complete the attached reply form and return it to Hospira via fax at 1-866-382-4228.",Contact the recalling firm for information,23385,"23,385 pumps","Worldwide distribution, including United States, the U.S. Virgin Islands, Puerto Rico, Argentina, Australia, Bahamas, Bahrain, Barbados, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, EI Salvador, Finland, France, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Mexico, New Zealand, Oman, Panama, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, United Arab Emirates and Venezuela.",Open,N/A,N/A,205689,Not_Computer,N/A,N/A,N/A
Z-1607-2011,57759,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.",CIVCO Latex Free NeoGuard Transducer Cover,2,"March 08, 2011", 2011,Civco Medical Instruments Inc,Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.,DESIGN: Labeling Design,"The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.",N/A,55,31/24-cover boxes,"Nationwide Distribution -- WA, CA, and MO.",Terminated,"July 09, 2013",854,31,Not_Computer,N/A,N/A,N/A
Z-1471-2011,57767,"kit, wound dressing",MCY,Elastic bandage.,General Hospital,General & Plastic Surgery,Enforcement Discretion,"Dressing Change Tray, DT5880A, Sterile, Centurion Medical Products Corp., Williamston, MI.These kits are used for dressing changes.",Dressing Change Tray,1,"March 08, 2011", 2011,Centurion Medical Products Corporation,"The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Centurion Medical Products, sent an ""URGENT PRODUCT RECALL NOTICE"" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility.Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.",N/A,68056,68056 all kits,"Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.",Terminated,"June 21, 2011",105,68056,Not_Computer,N/A,N/A,N/A
Z-1595-2011,57819,"catheter, intravascular occluding, temporary",MJN,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.",Sizing Balloon II,2,"March 08, 2011", 2011,AGA Medical Corporation,"AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.",PRODUCTION CONTROLS: Labeling Mix-Ups,"AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA.For questions regarding this recall call 1-763-531-3175.",Contact the recalling firm for information,54,54,"Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom",Terminated,"March 29, 2012",387,54,Not_Computer,N/A,N/A,N/A
Z-1609-2011,57846,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp.Used for the termination of ventricular tachycardia and ventricular fibrillation.",Phiips Medical Systems,2,"March 08, 2011", 2011,Philips Healthcare Inc.,Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.,DESIGN: Software Design,"Philips Healthcare representatives issued an Urgent Medical Device letter on 2/7/11. Customers are asked to follow the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notification. In this section, customers are given the following instructions: Philips software (SW) version F.01.03 (for M3535A and M3536A) and R.01.00 (for M3536A, English only) corrects this problem.If you have affected product a Philips Service Engineer will contact you to install software version F.01.03 or R.01.00. Until your software is updated your HeartStart MRx monitor/defibrillator can remain in service. If you are using the device in one of the use modes listed under problem description, make sure that operators are aware that even though the EtCO2 and ventilation rate values can display interchangeably (unexpectedly or randomly switch) under either the ventilation rate label or the EtCO2 label, the values themselves can be identified by their color (for example if the ventilation rate label is white, the ventilation value is displayed as white). Customers are to contact their local Philips representative at 1-800-722-9377, if they need further information or support regarding this issue.",N/A,2382,2382 units,"Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA,FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Open,N/A,N/A,2382,Software,Output/Calculation,Software update,Software Update
Z-1610-2011,57936,"collector, ostomy",EXB,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inchThis kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.",Natura Durahesive Convatec Moldable Techonology PostOperative/Surgical System (57mm),3,"March 08, 2011", 2011,Convatec Inc.,"Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.",TRAINING: Employee Error,"Convatec sent a Medical Device Recall letter dated February 1, 2011, via UPS with return response forms attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop distributing and quarantine the recalled lot (0100814).Perform a count of recalled product currently in inventory. Complete the enclosed Recall Response Form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. Ensure that their account number is correctly identified on the attached Recall Response Form. To return the recalled product call the toll free number 1-800-582-6514 to receive an RGA number and instructions on how and where to return the recalled product. If the product has been distributed to wholesalers then customers should forward the letter to them and ask that they follow the Required Actions and return the Recall Response Form to the address listed on the form. Product must be labeled for shipment to: UPS Supply Chain Solutions1920 Outer LoopDock Door #123Louisville, KY 40219For questions regarding this recall call 908-904-2149.",Discard product or return to place of purchase for a full refund or exchange,77,77 market units,"Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.",Terminated,"January 11, 2012",309,77,Not_Computer,N/A,N/A,N/A
Z-1611-2011,58045,N/A,N/A,N/A,N/A,N/A,N/A,"MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment.",MMP 200,2,"March 08, 2011", 2011,Stryker Communications Corp,Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.,PRODUCTION CONTROLS: Process Control,"Stryker notified consignees verbally on January 28, 2011 and by letter dated February 11, 2011.",Contact the recalling firm for information,2,2,"MA, CO",Terminated,"March 30, 2011",22,2,Not_Computer,N/A,N/A,N/A
Z-1608-2011,57211,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18.Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct.The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.",Orthofix Pedicle Screw Spinal System,2,"March 08, 2011", 2011,Orthofix Inc,There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.,OTHER/UNDETERMINED: Pending,"The firm, Orthofix, sent an ""URGENT: PRODUCT RECALL"" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc.The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery.If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: DarlaChew@Orthofix.com.",N/A,166,166 Units,"Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.",Terminated,"April 25, 2011",48,166,Not_Computer,N/A,N/A,N/A
Z-1619-2011,56746,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNCHRON and UniCel Systems and Part Numbers:Synchron LX20, Part Number: 466200,Synchron LX20 PRO, Part Number: 476100,Synchron LXI 725, Part Number: 476501,UniCel DxC 600, Part Number: A10405,UniCel 600 PRO, Part Number: A11810,UniCel DxC 600i, Part Number: A27318,UniCel DxC 800, Part Number: A11816,UniCel DxC 800 PRO, Part Number: A11812,UniCel DxC 880i, Part Number: A59102,UniCel DxC 660i, Part Number: A64871,UniCel DxC 680i, Part Number: A64903,UniCel DxC860i, Part Number: A64935(1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).",GLU Reagent ,2,"March 09, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples.The Impact:(1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient tocause interference with glucose estimation and are a special at-risk population,(2) Other hemolysed samples may be similar",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated August 10, 2010 with an enclosed fax-back Customer Response Form to the customers. The letter provided the customers with an explanation of the problem identified, the impact and an action to be taken. The customers were instructed to run samples using another method/technology and to complete and return the enclosed FAX BACK RESPONSE FORM via fax to (714) 961-4232 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., PO Box 8000, Brea, CA 92822.Firms with questions regarding this Product Corrective Action letter, were instructed to call our Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada http://www.beckmancoulter.com/customersupport/support/default.asp.",N/A,81871,"81,871 units",Worldwide distribution: USA and country: Canada.,Terminated,"October 17, 2013",953,81871,Not_Computer,N/A,N/A,N/A
Z-1613-2011,57831,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.",STAFlex SUBTALAR SCREW,2,"March 09, 2011", 2011,"Biomet, Inc.",The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.,N/A,"The firm sent URGENT MEDICAL DEVICE RECALL NOTICES dated 1/21/2011 to distributors, implanting physicians, and medical facilities. The letter to the distributors and medical facilities states the recalled product should be immediately located and returned to Biomet. In addition, the ""FAX Back Response Form"" should be completed and returned to the number provided. If product has been further distributed, distributors are to contact hospital personnel via the enclosed ""Dear Biomet Customer"" notice. The letter to the implanting physicians informs the physician of the recall and lists the patients that were implanted with the device. The physician letter quotes from the surgical technique ""the implant should also be removed if any postoperative complications occur"". The letter to the implanting physicians does not recommend any action be taken with the devices that are implanted. The notice just makes the surgeons aware of the recall. Distributors and Physicians are to confirm receipt of the letter by contacting 800-348-9500, ext 3755 or 3756. Also, questions related to this matter should be directed to 574-371-3755 or 574-371-3756.",N/A,254,254 all products,Nationwide Distribution.,Terminated,"November 10, 2011",246,254,Not_Computer,N/A,N/A,N/A
Z-1621-2011,56637,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT G3+ Cartridge: PCO2Abbott Point of Care,Princeton, NJ 08540The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.",iSTAT G3 Cartridge,2,"March 10, 2011", 2011,Abbott Point Of Care Inc.,Certain lots of G3+ cartridges may be difficult to fill.,OTHER/UNDETERMINED: Pending,"The firm, Abbott Point of Care, sent a ""Important notice"" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers.If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.",Contact the recalling firm for information,125,"12,675 in US, 125 ROW",Worldwide distribution: USA and country of : Canada.,Terminated,"February 27, 2012",354,12800,Not_Computer,N/A,N/A,N/A
Z-1492-2011,58015,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.Made in Germany Manufactured for and Distributed byRoche Insulin Delivery Systems Inc. Fishers, IN 46037, USAToll Free: 1-800-280-7801Roche Diabetes Care AG3401 Burgdorf, Switzerland",ACCUCHEK FlexLink Plus,1,"March 10, 2011", 2011,Roche Insulin Delivery Systems Inc.,There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.,DESIGN: Device Design,"Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.",No consumer action necessary,1454918,"1,454,918 million worldwide",Worldwide Distribution -- US and Canada.,Terminated,"July 27, 2011",139,1454918,Not_Computer,N/A,N/A,N/A
Z-1438-2011,55432,"dna-reagents, mycobacterium spp.",LQF,Mycobacterium tuberculosisimmunofluorescent reagents.,Microbiology,Microbiology,510(k),"Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.",AccuProbe MYCOBACTERIUM TUBERCULOSIS COMPLEX CULTURE IDENTIFICATION TEST,1,"March 10, 2011", 2011,Gen-Probe Inc,"This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.",PRODUCTION CONTROLS: Process Control,"Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result.With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to technicalsupport@genprobe.com.The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com.",N/A,1293,1293 kits,"Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.",Terminated,"June 08, 2011",90,2659,Not_Computer,N/A,N/A,N/A
Z-1625-2011,54384,"mixer, cement, for clinical use",JDZ,Cement mixer for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA.Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.",KyphX HVR Bone Cement,2,"March 11, 2011", 2011,"Medtronic Spine LLC, formerly Kyphon Inc",Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.,OTHER/UNDETERMINED: Pending,"The firm, Medtronic Spine LLC, sent an ""URGENT DEVICE RECALL NOTICE"" dated November 9, 2009 to the customers. The notice described the product, problem and actions to be taken. The customers were instructed to return the affected lots to Medtronic Spine; to not use any of the affected product that they may have received (Medtronic will replace any affected product in their inventory), the customer should contact their Medtronic Spine sales representative or customer service at [866-959-7466 or for geography] for assistance with replacement product, and complete and return the URGENT DEVICE RECALL NOTICE: Action Required form to Medtronic Spine LLC via fax at (408) 543-6192 or mail to: Medtronic Spine LLC, Attn: Recall Coordinator, 1221 Crossman Avenue, Sunnyvale, CA 94089. If you have any questions about this notification, please do not hesitate to contact Sr. Director, Regulatory Affairs via email: pamela.n.segale@medtronic.com or phone at (408) 548-5235.",N/A,N/A,N/A,"USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.",Terminated,"March 11, 2011",0,N/A,Not_Computer,N/A,N/A,N/A
Z-1627-2011,57506,"system, test, carcinoembryonic antigen",DHX,Tumor-associated antigen immunological test system.,Immunology,Immunology,510(k),"CEA ELISA Kit.BioCheck, Foster City, CA 9440.Quantitative determination of AFP concentration in human serum.",CEA ELISA Kit,2,"March 11, 2011", 2011,BioCheck Inc,Product labels indicate that the products are for IVD use and they do not have an approved 510(k).,PREMARKET APPROVAL: No Marketing Application,"The firm, BioCheck, sent an ""URGENT: DEVICE RECALL"" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: info@biocheck.com or fax to (650-573-1969) immediately.If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).",Contact the recalling firm for information,25000,"estimate 25,000 kits, all varieties",Nationwide distribution.,Terminated,"March 25, 2011",14,25000,Not_Computer,N/A,N/A,N/A
Z-1623-2011,54468,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CAMedical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.",CELLDYN 4000 Automated Hematology Analyzer,2,"March 11, 2011", 2011,Abbott Laboratories,"A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.",OTHER/UNDETERMINED: Pending,"The firm, Abbott Laboratories, sent an ""Urgent Field Safety Notice Product Recall"" letter dated December 28, 2009 to the Customers via Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to destroy any CELL-DYN 4000 Vent Head Spring Assemblies that they have on hand and have not installed; (No action is necessary for assemblies that are currently installed on the CELL-DYN 4000 Analyzer); complete and return the Customer Reply form (even if they do not have the product) via fax to 1-800-777-0051 or email: QAGCO@abbott.comProduce Recall; indicate the number of Vent Head Spring Assemblies destroyed. the number identified will be replaced with Vent Head Spring Assemblies that meet specifications, and to please keep this communication with their CELL-DYN 4000 System Operator's Manual. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S., please contact your local hematology customer support representative.",Contact the recalling firm for information,157,157 assemblies,"Worldwide distribution: USA including states of: CA, CO, FL, GA, KY, NC, NJ, NY, OR, VA, and WV; and countries including: Argentina, Australia, Canada, Germany and Japan.",Terminated,"March 11, 2011",0,157,Not_Computer,N/A,N/A,N/A
Z-1647-2011,56044,"anti-dna antibody (enzyme-labeled), antigen, control",LRM,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests,Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CAThe Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.",EIA AntidsDNA Test Kit,2,"March 14, 2011", 2011,Bio-Rad Laboratories Inc,The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Bio-Rad, sent an ""URGENT: MEDICAL DEVICE RECALL NOTIFICATION"" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.",N/A,N/A,N/A,"Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.",Terminated,"March 15, 2011",1,N/A,Not_Computer,N/A,N/A,N/A
Z-1651-2011,57534,real time nucleic acid amplification system,OOI,Instrumentation for clinical multiplex test systems.,Clinical Chemistry,Clinical Chemistry,510(k),"MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes.",MagNA Pure LC 2.0 Instrument,2,"March 14, 2011", 2011,"Roche Diagnostics Operations, Inc.","If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.",DESIGN: Software Design,"The firm, Roche, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011. If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.",N/A,119,119 devices,"Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.",Terminated,"August 30, 2011",169,119,Software,N/A,N/A,N/A
Z-1649-2011,57914,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.",HiART System ,2,"March 14, 2011", 2011,TomoTherapy Incorporated,It was determined that the Treatment Planning Station (TPS) can potentially under dose.,DESIGN: Software Design,"Consignees were sent a TomoTherapy ""Field Safety Notice Medical Device Correction"" letter dated January 26, 2011. The letter was addressed to ""TomoTherapy Customer"". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this issue. DQA dose measurements should be performed at each unique full fraction dose that will be used for patient treatment, without using DQA scaling.If Customers have any questions they are to contact TomoTherapy Interaction Center by email or phone.",N/A,326,326,"Worldwide Distribution -- US, including States of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of SPAIN, GERMANY, FRANCE, INDIA, KOREA, SWEDEN, ITALY, MALAYSIA, SWITZERLAND, CANADA, UNITED KINGDOM, SINGAPORE, TURKEY, TAIWAN, AUSTRALIA, JAPAN, BELGIUM, CHINA, MEXICO, NETHERLANDS, POLAND, SAUDI ARABIA, and UNITED ARAB EMIRATES.",Open,N/A,N/A,326,Software,N/A,N/A,N/A
Z-1645-2011,57724,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet softwarePlum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software",Plum A3 Triple Channel Infusion Pumps,2,"March 14, 2011", 2011,Hospira Inc.,"Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Hospira, sent ""URGENT DEVICE RECALL"" letters dated February 14, 2011 to their customers on the same date. The letter described the product, problem and action to be taken by the customers. The Customer/Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-888-216-7330.",Contact the recalling firm for information,23020,"23,020 pumps","Worldwide distribution: United States including the U.S. Virgin Islands and Puerto Rico, and countries including: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, United Arab Emirates and Vietnam.",Open,N/A,N/A,167595,Not_Computer,N/A,N/A,N/A
Z-1658-2011,54136,"enzyme immunoassay, fetal fibronectin",LKV,N/A,N/A,Clinical Chemistry,PMA,"Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA.Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in",Rapid fFN for the TLi IQ system (Branded as FullTerm),2,"March 16, 2011", 2011,Cytyc Prenatal Products/Hologic Inc.,"Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.",PREMARKET APPROVAL: No Marketing Application,"The firm, Hologic, sent a ""Important-Product Recall/Correction"" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the ""full term"" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).",N/A,N/A,N/A,Worldwide distribution.,Terminated,"March 16, 2011",0,N/A,Not_Computer,N/A,N/A,N/A
Z-1681-2011,56332,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"SCORPIO CR TIBIAL TRIAL, non sterile, made in the USAHowmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.",SCORPIO CR TIBIAL TRIAL,2,"March 16, 2011", 2011,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024"" (0.6mm).",DESIGN: Process Design,"Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069.For any questions customers were to call 201-972-2100 or 201-831-5028.",N/A,159095,"159,095 units, all types.","Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.",Open,N/A,N/A,159095,Not_Computer,N/A,N/A,N/A
Z-1665-2011,56407,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),TSX-301A: AQUILION ONE SystemAQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.,TSX301A: AQUILION ONE ,2,"March 16, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.",DESIGN: Software Design,"The firm, Toshiba America Medical Systems (TAMS), sent an ""URGENT: MEDICAL DEVICE CORRECTION"" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to raffairs@tams.com.If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.",N/A,43,43 units,"Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.",Terminated,"April 05, 2011",20,43,Software,N/A,N/A,N/A
Z-1675-2011,56415,"table, radiographic, tilting",IXR,Radiologic table.,Radiology,Radiology,510(K) Exempt,Toshiba DUA-450F Kalare Radiographic Tilting Table.,Toshiba DUA450F Kalare Table,2,"March 16, 2011", 2011,Toshiba American Medical Systems Inc,"Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement.",DESIGN: Software Design,"Toshiba America Medical Systems (TAMS) issued Urgent Medical Device Correction notification dated July 8, 2010, to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.",Contact the recalling firm for information,238,238 systems,US Nationwide,Terminated,"April 20, 2012",401,238,Software,N/A,N/A,N/A
Z-1674-2011,57199,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.",Blackstone Medical Inc. Firebird Spinal Fixation System ,2,"March 16, 2011", 2011,Orthofix Inc,There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.,OTHER/UNDETERMINED: Pending,"Orthofix sent an URGENT: PRODUCT RECALL letter dated October 22, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their accounts immediately and advise them of the recall situation and have them return any affected inventory.For any questions customers were instructed to contact their Account Services Representative at 1-888-298-5700.For questions regarding this recall call 214-937-2061.",N/A,27,27 (19 of 77-7630) (8 of 77-8630),"Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.",Terminated,"May 31, 2011",76,27,Not_Computer,N/A,N/A,N/A
Z-1679-2011,57513,"colorimetry, acetaminophen",LDP,Acetaminophen test system.,Toxicology,Toxicology,510(k),"Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.",Roche Acetaminophen Roche/Hitachi,2,"March 16, 2011", 2011,"Roche Diagnostics Operations, Inc.","The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. Low serum concentrations of acetaminophen were included in the study.",OTHER/UNDETERMINED: Pending,"The firm, Roche, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated December 07, 2010 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to be aware that endogenous interferents (i.e., bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen; complete and return the attached UMDC Faxback Form for Acetaminophen Assay via fax to 1-817-868-5343, and file this letter for future reference. The firm ask the customers to please consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. The firm is also updating the product labeling to include information regarding the interference of icteric, hemolytic or lipemic samples.Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have any questions about the information contained in this Urgent Medical Device Correction (UMDC).",Contact the recalling firm for information,8668,"8,668 units",Nationwide distribution.,Terminated,"March 13, 2012",363,8668,Not_Computer,N/A,N/A,N/A
Z-1669-2011,57690,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034.The Brilliance Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",Vertical Brake Hubs of the Computed Tomography XRay Systems ,2,"March 16, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can disengage due to the lack of thread locker on set screws.,OTHER/UNDETERMINED: Pending,"Philips Medical Systems (Cleveland) Inc sent Field Safety Notice to all affected customers on December 10, 2010. The Safety Notices identified the product, the problem, and the action to be taken by the customer. Customers were instructed to monitor their units and if the vertical brake hub malfunctioned to immediately contact the recalling firm. The letter also stated that a Field Service Engineer would visit to perform a brake hub rework on the units. For further information or support customers were to contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center 1-800-722-9377, option 5: Enter Site ID or follow the prompt(s).For questions regarding this recall call 440-483-7672.",N/A,5700,5700 units/vertical brake hubs,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO,CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Afghanistan; Algeria; Angola; Argentina; Australia; Austria; Azerbaijan; Bahamas; Bahrain; Bangladesh; Belgium; Bolivia; Bosnia & Herzegovina; Brazil; Brunei Darussalam; Bulgaria; Cambodia; Canada; Chile; China; Columbia; Costa Rica; Cote d'Ivoire; Croatia; Cyprus; Czech Republic; Denmark; Dominican Republic; Ecuador; Egypt; El Salvador; England; Equatorial Guinea; Finland; France; French Polynesia; Germany; Greece; Hong Kong; Hungary; Iceland; India; Indonesia; Iran; Iraq; Ireland; Israel; Italy; Jamaica; Japan; Jordan; Kazakhstan; Kenya; Kuwait; Latvia; Lebanon; Libyan Arab Jamahiriya; Lithuania; Luxembourg; Madagascar; Malaysia; Malta; Martinique; Mexico; Monaco; Mongolia; Morocco; Mozambique; Namibia; Nepal; Netherlands; Netherlands; Antilles; New Zealand; Nicaragua; Nigeria; Norway; Oman; Pakistan; Panama; Paraguay; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia & Montenegro; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Syrian Arab Republic; Taiwan; Tanzania; Thailand; Tunisia; Turkey; Ukraine; Unidentified KM; United Arab Emirates; United Kingdom; Uzbekistan; Venezuela; Viet am & Yemen.",Terminated,"August 21, 2013",889,5700,Not_Computer,N/A,N/A,N/A
Z-1667-2011,57880,general surgery tray (kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them.The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.",Innovate Esmark Bandages,2,"March 16, 2011", 2011,Cardinal Health,Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Cardinal Health, sent an ""URGENT: PRODUCT RECALL"" letter dated January 28, 2011 to all affected consignees/customers via UPS next day air. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and return the packs/modules to Cardinal Health for destruction; contact the appropriate Customer Service group listed in the letter for return instructions, and complete and return the enclosed Acknowledgment Form via fax to 847-689-9101, regardless of whether or not they have inventory. Should you have any questions, relating to this recall, please feel free to contact Cardinal Health Quality Systems, 800-292-9332.",N/A,4.395,4.395 modules,Nationwide distribution.,Terminated,"September 04, 2012",538,4.395,Not_Computer,N/A,N/A,N/A
Z-1677-2011,57926,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for singlepatient use.,Osteomatrix,2,"March 16, 2011", 2011,"Biostructures, LLC","The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.",OTHER/UNDETERMINED: Pending,An email was sent on 06/15/2010 to the firm's distributors that had products with lot #0809D110 or lot #0307I208 in their possesion. The email was in regards to the distributors' OMG10 granule inventory. The distributors need to return all the recalled granule inventory to be swapped out for new inventory.,Contact the recalling firm for information,248,248 units,"Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.",Terminated,"March 17, 2011",1,248,Not_Computer,N/A,N/A,N/A
Z-1654-2011,57777,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184.",Allura Xper Systems with Velara Generator,2,"March 16, 2011", 2011,Philips Medical Systems North America Co. Phillips,"A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees.The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available).The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system.Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.",N/A,1556,1556 units distributed in US (1452-3107=1556),Devices were distributed through out the US.,Terminated,"February 23, 2012",344,2739,Hardware,Device Operation,Notification,Safety Notice/Insructions
Z-1676-2011,57932,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8",CRS Remote,2,"March 16, 2011", 2011,AGFA Corp.,A discrepancy in the validation testing which resulted in the product not performing as intended.,DESIGN: Device Design,"AGFA sent an ""URGENT SAFETY NOTICE"" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.",Contact the recalling firm for information,1,One,TX,Terminated,"September 15, 2011",183,1,Other,Device Operation,Software update,Software Update
Z-1664-2011,57967,"compressor, cardiac, external",DRM,External cardiac compressor.,Cardiovascular,Cardiovascular,510(k),"LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: ""LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***"".Designed to uninterrupted chest compressions at a consistent rate and depth.",LUCAS 2 Chest Compression System,3,"March 16, 2011", 2011,Jolife AB,LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.,DESIGN: Component Design/Selection,"Medical Device Correction letter, dated February 2011, was sent to customers and states that Jolife AB with the servicing support assistant of Physio-Control is conducting a voluntary upgrade of the LUCAS 2 Chest Compression System with the Serial number range of 30090016 through 30101932.Consignees were advised to keep LUCAS 2 in service and continue to use it in accordance with the Instruction for Use, Section 3.8-Safety Precautions. WARNING-MALFUNCTION. If there are interruptions, or the compressions are not sufficient or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start Manual chest compression.Physio-Control service representative will contact the consignees to schedule a service call to replace the affected battery connector board in the hood of the device. The new connector board will include a new probe design in which current cannot affect the spring.Consignees can contact Physio-Control Technical Support at 1-800-442-1142, #5 between 6 am-4 pm (Pacific Time), Monday-Friday or visit the website www.physio-control-notices.com/LUCAS2. If customers no longer have the affected device or the device location has changed they should contact Physio-Control Technical Support.",Contact the recalling firm for information,1843,1843 units,"Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.",Terminated,"April 24, 2012",405,1843,Other,N/A,N/A,N/A
Z-1673-2011,57747,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020.The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.","Ovation Hip Stem, REF 2010104, Offset Stem Inserter Neutral, NonSterile, Ortho Development",2,"March 16, 2011", 2011,Ortho Development Corporation,Component of total hip arthroplasty may break during surgical procedure.,DESIGN: Process Design,"Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement.For questions regarding this recall call 801-619-3450.",Contact the recalling firm for information,33,33 units,"Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.",Terminated,"November 04, 2011",233,80,Not_Computer,N/A,N/A,N/A
Z-1666-2011,58053,"tubing, pump, cardiopulmonary bypass",DWE,Cardiopulmonary bypass pump tubing.,Cardiovascular,Cardiovascular,510(k),"Labeling on box reads: MAQUET BEQ-HG 0284 3/8"" X 3/8"" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16"" x 3/16"" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units.The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.",MAQUET Bioline Connectors,3,"March 16, 2011", 2011,"Maquet Cardiovascular, LLC",Tubing connectors incorrectly packaged and labeled.,PRODUCTION CONTROLS: Process Control,"The firm, Maquet, sent a ""PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION"" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.",N/A,40,"40 BEQ-HG 0284 3/8"" x 3/8"" Lot 70041098 Connectors",Nationwide distribution: USA state of CA.,Terminated,"September 13, 2012",547,40,Not_Computer,N/A,N/A,N/A
Z-1701-2011,51955,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufactured by Abbott Diagnostics Division, Santa Clara, CaMedical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.",Abbott CELLDYN 3700 Hematology Analyzer CS/SL,2,"March 17, 2011", 2011,Abbott Laboratories,"FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.",DESIGN: Component Design/Selection,"Abbott Laboratories sent Product Correction letters, dated March 22, 2010, to its customers. The letter listed the additional products that are now included in the recall and gave an explanation of the reason for recall. The letter also discussed the safety impact and provided a list of necessary actions for customers. Customers are to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3000 Analyzer. If the fuse is correct, then the steps provided should be followed. If the fuse is incorrect, then customers are to replace the fuse with the correct fuse and follow the instructions provided. Customers are to contact their local Customer Support Representative in the event that they do not have their replacement fuse that was provided with the Accessory Kit. Customers can refer to the Product Information Letter dated April 20, 2010 for additional labeling to assist with the correct fuse replacement. The Customer Reply form should be completed and the letter should be kept with the Operator's Manual. Questions should be directed to Customer Support at 1-877-4ABBOTT.The firm, Abbott Laboratories, sent a ""Product Correction"" letter dated March 27, 2009 to its customers. The letter included a Customer Reply form and CELL-DYN accessory kits to inform new customers of the necessity of replacing fuses correctly. The letter described the product, problem and actions to be taken. The customers were instructed to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3700 System and follow the instructions provided, and complete and return the Customer Reply form via fax to 1-800-777-0051 or e-mail QAGCO@abbott.com, even if they no longer have the instrument. The firm intends to service items in the field. In April 2010, additional labeling was sent to customers providing additional information when replacing fuses..",Contact the recalling firm for information,2961,2961 units,"Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Dominica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand Trinidad and Tobago, Turks & Caicos, Uruguay, and Venezuela.",Terminated,"December 21, 2011",279,10466,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-1698-2011,54665,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories to human waste container systems,CELLDYN,2,"March 17, 2011", 2011,Abbott Laboratories,The use of the device assemblies has been extended to a 6 month useful life.,OTHER/UNDETERMINED: Pending,"The firm, Abbott Laboratories, sent a ""Product Correction"" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or email QAGCO@abbott.com even if they no longer have the instrument.If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S. please contact your local hematology customer support representative.",N/A,874,874,"Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.",Terminated,"March 18, 2011",1,874,Not_Computer,N/A,N/A,N/A
Z-1668-2011,56968,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed byAbbott Diagnostics Division, Santa Clara. CADesigned for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.",CELLDYN Emerald Diluent Reagent,2,"March 17, 2011", 2011,Abbott Laboratories,"The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.",PRODUCTION CONTROLS: Error in Labeling,"Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.",N/A,322,322 units,"Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.",Terminated,"April 07, 2011",21,322,Not_Computer,N/A,N/A,N/A
Z-1700-2011,58075,"splint, nasal",EPP,External nasal splint.,Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1529100***Thermasplint Kit, Small***X5***. ***REF 1529110***Thermasplint Kit, Medium***X5***. ***REF 1529120***Thermasplint Kit, Large***X5***. RECALLED PRODUCT - Front:***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***",Nasal Splint,2,"March 17, 2011", 2011,"Medtronic Xomed, Inc.","Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan",N/A,"Medtronic Xomed, Inc. sent an URGENT PRODUCT SAFETY ADVISORY (PSA) letter dated February 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately discontinue use and dispose of the alcohol prep pad co-packaged in their External Nasal Splint or Thermasplint kits. If there has been further distribution of this item, the Urgent Product Safety Advisory letter should be forwarded to the appropriate recipient. For any questions regarding this recall call 904-279-7532.",No consumer action necessary,8385,"8,385 units (1,677 boxes)","Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.",Terminated,"April 03, 2012",383,34690,Not_Computer,N/A,N/A,N/A
Z-1692-2011,57734,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Liko Sabina II EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.",Liko Sabina II EE Lift,2,"March 17, 2011", 2011,"Hill-Rom, Inc.","The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports, two were injuries in patints during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit.",DESIGN: Device Design,"The firm, Liko, issued two ""URGENT FIELD SAFETY NOTICES"" one dated January 27, 2011 and a follow-up notice dated February 9, 2011 to its consignees/customers. The notices described the product, problem and actions to be taken. The customers were instructed to keep the device in a separate unoccupied area when not in use; use extra care and support when lifting patients with the device; not allow unauthorized persons, especially children, to play around or operate the lift; examine the sling hooks daily to make sure they are secure, and to forward a copy of this notice to any other facility personnel they deem appropriate. The notices state the firm is investigating a design change to mitigate the risk of injuries with the device.If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.",Contact the recalling firm for information,N/A,N/A,"Worldwide distribution: USA including: AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK ,OR, PA, RI, SC, SD, TN ,TX, UT, VA, WA, WI, and WV; and country of: Canada.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-1043-2011,57763,"full field digital,system,x-ray,mammographic",MUE,Full-field digital mammography system.,Radiology,Radiology,510(k),GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL)The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer.,GE SENOGRAPHE ESSENTIAL,2,"March 17, 2011", 2011,"GE Healthcare, LLC",It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,An Important Electronic Product Radiation Warning letter was issued to customers identifying the affected product and describing the defect along with the related hazards. The letter states that there are no actions that are required to be taken on the part of the customer. A GE Healthcare Service Representative will apply the missing rating as necessary and free of charge. Questions or concerns regarding the letter should be directed to 1-800-437-1171 in the US.,N/A,112,112 total,Worldwide Distribution,Terminated,"May 16, 2012",426,112,Not_Computer,N/A,N/A,N/A
Z-1690-2011,57900,"prosthesis, hip, cement restrictor",JDK,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis","DePuy CEMENT RESTRICTOR, Size 5",2,"March 17, 2011", 2011,"Depuy Orthopaedics, Inc.","The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat",TRAINING: Employee Error,"DePuy Orthopaedics sent an URGENT INFORMATION RECALL NOTICE dated January 27, 2011, to DePuy Area Directors, FMDs, Distributors, and Office Managers. The notice identified the product, the problem, and the action to be taken. All territories were required to ensure that all recalled products that remain in customer accounts and field inventory are returned immediately to Warsaw to the attention of Returns. Hospitals that purchased and potentially implanted the now recalled product should be provided appropriate notification of the recall and should complete and return a signed Reconciliation Form(s) within seven business days. If the hospitals have any inventory on hand that is subject to the recall, distributors should remove it or help the hospitals return it for credit. All Reconciliation Forms should be faxed to 574-372-7567.For questions regarding this recall call 574-372-7333.",Contact the recalling firm for information,20,20,"Nationwide distribution including the states of MA, PA, FL, LA, MN, WA, WI, CO, GA, NY, NC and SC and the countries of Canada, Colombia, Ireland and Argentina.",Terminated,"April 23, 2013",768,140,Not_Computer,N/A,N/A,N/A
Z-1705-2011,57970,"airway, oropharyngeal, anesthesiology",CAE,Oropharyngeal airway.,Anesthesiology,Anesthesiology,510(K) Exempt,"KING LT-D, SIZE 3, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, ¶_15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, www.kingsystems.comSize 3: Small adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.",King Systems KLTD Oropharyngeal Airway,2,"March 17, 2011", 2011,King Systems Corp.,"King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be ""inadequately sterilized"" and use of this product may result in ""patient infection"". Because this particular sterile lubricating jelly is packaged in the KING LT-D Kit and KING LTS-D Kit, King Systems is sending a Notice of the Reca",PRODUCTION CONTROLS: Process Control,"The firm, King Systems, sent an ""URGENT PRODUCT RECALL"" letter dated January 14, 2011 to its customers. King Systems sent a follow-up ""URGENT PRODUCT RECALL"" letter dated March 3, 2011 which ""SUPERSEDES"" the January 14, 2011 recall letter with attached instructions to its customers. The letters described the product, problem and actions to be taken by the customers. The customers were instructed to notify all their purchasers of this recall; immediately cease sales and use of the affected products; identify all inventory on hand or returned to them by their customers; REMOVE Triad Group lubricant from King LT-D and LTS-D kits according to King instructions; quarantine the Triad lubricant, re-seal the LT-D and LTS-D kits and destroy Triad lubricant or return to Triad according to King instructions, and complete, sign and return Recall Acknowledgement Form via fax to: 317-776-6827 or email to: triadluberecall@kingsystems.com. King Systems will provide replacement lubricant packs to all customers. Customers with questions regarding product return, replacement, hospital notification or concerning the information requested above, please contact Customer Service at 1-800-642-5464. If you have any regulatory questions about the recall, please contact Director of Quality Assurance and Regulatory Affairs at 1-800-642-5464.",Contact the recalling firm for information,577426,"577,426 airway kits total under recall","Worldwide distribution: USA including: CA,CO, FL, ID, IN, KS, NC, NH, NY, OH, PA, PR, SC, TN, and TX; and Country of: Canada.",Terminated,"February 20, 2013",706,577426,Not_Computer,N/A,N/A,N/A
Z-1704-2011,55617,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.",Stryker Stiletto Electrosurgical Probe (EProbe),2,"March 17, 2011", 2011,Stryker Endoscopy,"The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).",DESIGN: Device Design,"All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at eprobe@stryker.com.",N/A,45,"31, 014 units","Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.",Terminated,"March 18, 2011",1,31014,Not_Computer,N/A,N/A,N/A
Z-1685-2011,56399,"radioimmunoassay, estrone",CGF,Estrone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Estrone Radioimmunoassay (RIA) Kit, DSL-8700.Intended for in vitro diagnostic use.",Estrone Radioimmunoassay (RIA) Kit,2,"March 17, 2011", 2011,Beckman Coulter Inc.,"Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more.",OTHER/UNDETERMINED: Pending,"Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions:*For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications.*For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the light of additional applicable tests, patient's clinical status and clinical history of patient.Beckman Coulter has finalized the process of re-adjusting Estrone calibrators' values assignment to the new internal reference calibrator starting with lot 100403A.If consignees need products for additional tests they were told to follow replacement instructions below:*In the United States, please contact Customer Service at 1-800-526-3821*Outside the United States, contact your local Beckman Coulter Representative.Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They were to also complete and return the enclosed response form within 10 days so the firm can be assured that consignees received the notification.Consignees were instructed to forward any other questions regarding the notification to the DSL Technical Support Center at 1-800-231-7970 in the United States, or contact their local Beckman Coulter Representative.",Contact the recalling firm for information,917,917 units,"Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.",Terminated,"May 04, 2012",414,917,Not_Computer,N/A,N/A,N/A
Z-1733-2011,55146,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.",CELLDYN Emerald Hematology Analyzer System,2,"March 18, 2011", 2011,Abbott Laboratories,Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.,DESIGN: Software Design (Manufacturing Process),"The firm, Abbott, sent two ""Product Correction"" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. The letters described the product, problem and actions to be taken. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-800-777-0051 or email to QAGCO@abbott.com.Should you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 408-567-3403.",N/A,891,891 units,"Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV; and countries including: Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. Eustalius & St. Martin, and Turks & Caicos.",Terminated,"March 18, 2011",0,891,Other,N/A,Software update,Software Update
Z-1722-2011,55875,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000.The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on ""code"" or ""crash"" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices",defibrillator/monitor,2,"March 18, 2011", 2011,"Physio Control, Inc.","A component failure on the AC power supply assembly results in ""NO AC POWER"" operation.A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated.For questions customers were instructed to contact Technical Support at 1-800-442-1142.For questions regarding this recall call 425-867-4000.",N/A,53550,53550 units,"Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnries of ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.",Open,N/A,N/A,53550,Battery,Treatment/Delivery/Therapy,Instructions on cheklists/Power supply update,Safety Notice/Insructions
Z-1727-2011,56962,"filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde",OJZ,N/A,N/A,Orthopedic,HDE - Humanitarian Device Exemption,"Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein)""Catalog numbers: 300-50, 300-55OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.",Stryker Biotech,2,"March 18, 2011", 2011,Stryker Biotech,A change to the Preparation for Use sectionwas identified where 2.5cc was replaced with 2cc-3cc volume and was not approved,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"The firm, Stryker Biotech, sent a ""Medical Device Correction"" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty.If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at PVG@stryker.com.",Contact the recalling firm for information,2861,2861 units,Nationwide distribution.,Terminated,"March 20, 2012",368,2861,Not_Computer,N/A,N/A,N/A
Z-1732-2011,57615,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Stratus(R) CS Acute Care Troponin I TestPak, Troponin I AssayThe Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality.","Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay",2,"March 18, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.",Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.,OTHER/UNDETERMINED: Pending,"The firm, SIEMENS, sent an ""Urgent Field Safety Notice"" letter dated December 2010 to all Stratus(R) CS Instrument customers. The letter described the product, problem and actions to be taken. The customers were instructed to repeat testing of samples with CTNI results above 0.07 ng/mL; discuss content of this letter with their laboratory director regarding the need to review test results reported from CTNI TestPak lots 230200002 or greater; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to Technical Solutions Center at 302-631-8467, and forward this notification to anyone to whom they may have distributed this product.If you have any questions, please contact the Siemens Technical Solutions Center at 800-405-6473.",N/A,11635,11635,"Worldwide distribution: AL, AK, AZ, AR, CA, CO, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.Product was distributed to foreign accounts in Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh,Belgium, Bosnia & Herzegovina, Canada, Canary Islands, Czech Republic, Cyprus, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Indonesia, India, Israel, Ireland, Italy, Japan, Libya, Malaysia, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Arab Emirates.",Terminated,"March 19, 2013",732,11635,Not_Computer,N/A,N/A,N/A
Z-1724-2011,57674,"toothbrush, powered",JEQ,Powered toothbrush.,Dental,Dental,510(K) Exempt,"W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616, Made in China; The toothbrush was sold with a single head and with three heads: a) Rechargeable Power Toothbrush - Model Number 565222, UPC 0 49022 35396 1; b) Rechargeable Power Toothbrush with 3 Replacement Heads: Model Number WIC 472641, UPC 0 49022 49612 5;Intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.",Walgreens Vital Health Rechargeable Toothbrush,2,"March 18, 2011", 2011,"Brushpoint Innovations, Inc.",The power toothbrush may make a loud noise and the battery cap becomes separated from the main body of the toothbrush. The battery cap can become a projectile that could cause potential injury if it comes in contact with the body.,DESIGN: Device Design,"The firm, BrushPoint Innovations, sent a email dated January 7, 2011 notifying their customers of the recall. The email described the product, problem and actions to be taken. The customers were instructed to pull and quarantine the toothbrushes due to potential product quality concerns, and hold their stocks until January 14, 2011, call in the number of toothbrushes quarantined, and then return them to the Walgreen distribution centers. A stop sale was placed on the affected item numbers in their cash register scanners.If you have any questions, call 905-833-5122 or 905-944-1000.",N/A,8100,"8,100 units",Nationwide distribution.,Terminated,"December 16, 2012",639,8100,Not_Computer,N/A,N/A,N/A
Z-1731-2011,57757,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader.Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000.Quantitative, automated, differential cell counters for in vitro diagnostic use.",Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader,2,"March 18, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when thetilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.",N/A,"The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken.Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,4288,4288 units total,"Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya,Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia,Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.",Open,N/A,N/A,4288,Not_Computer,N/A,N/A,N/A
Z-1726-2011,57778,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE",PhD System EIA/IFA Software,2,"March 18, 2011", 2011,"Bio-Rad Laboratories, Inc.","Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "" INVALID"".",OTHER/UNDETERMINED: Pending,"The firm, Bio-Rad, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter.If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.",No consumer action necessary,650,650 units,"Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.",Terminated,"August 17, 2011",152,650,Not_Computer,N/A,N/A,N/A
Z-1041-2011,57784,"full field digital,system,x-ray,mammographic",MUE,Full-field digital mammography system.,Radiology,Radiology,510(k),GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL)The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.,GE SENOGRAPHE ESSENTIAL ,2,"March 18, 2011", 2011,"GE Healthcare, LLC",During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit).,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"The firm plans to repair the defect or to bring product into compliance. The field action is being implemented to inspect the affected units and if found to be missing the certification label, a certification label will be applied. This will be carried out via a Field Modification Instruction planned to be released in March, 2011 with an estimated completion date of July, 2011.",N/A,14,14,Nationwide Distribution,Terminated,"May 16, 2012",425,14,Not_Computer,N/A,N/A,N/A
Z-1737-2011,56639,"test, system, immunoassay, lipoprotein-associated phospholipase a2",NOE,Low-density lipoprotein immunological test system.,Immunology,Immunology,510(k),"diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.",PLAC Test ELISA Kit,2,"March 21, 2011", 2011,"DiaDexus, Inc",Product fails stability tests prior to expiration date.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.",N/A,482,482 units,"Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.",Terminated,"March 21, 2011",0,482,Not_Computer,N/A,N/A,N/A
Z-1736-2011,57443,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Total BhCG (BhCG) Assay Part Number 33500The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.",Access Total BhCG (BhCG) Assay ,2,"March 21, 2011", 2011,Beckman Coulter Inc.,Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range.The role of preanalytical factors in laboratory testing has been described in a variety of published literature.,N/A,"Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:."" Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results."" Follow the sample handling instructions provided in the Access Total ¶_hCG Instruction for Use (IFU)."" Review the enclosed pre-analytical sample handling information bulletins:1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A).2. Sample Handling Makes a Difference (P/N A28226A)."" At the discretion of the laboratory director, any total ¶_hCG result that is questioned due to lack of clinical correlation should be repeated.NOTE: Due to the clinical utility of the Access Total ¶_hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¶_hCG test results. The Access Total ¶_hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician."" Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation."" Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received.If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call1-800-854-3633 in the United States and Canada. Outside the United States and Canada .",N/A,158919,"158,919 units","Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Zambia, Zimbabwe.",Open,N/A,N/A,158919,Not_Computer,N/A,N/A,N/A
Z-1738-2011,57809,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),"TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022a multipurpose system for in vitro coagulation studies",TEG 5000 ,2,"March 21, 2011", 2011,Haemoscope Division of Haemonetics Corp,Haemonetics has received a report of smoke from the unit with a power supply failure.,OTHER/UNDETERMINED: Pending,"Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.",N/A,1155,"1,155 units","Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA",Terminated,"March 12, 2012",357,1155,Battery,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-1735-2011,57232,"microtome, cryostat",IDP,Tissue processing equipment.,Pathology,Pathology,510(K) Exempt,"Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.","Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat",2,"March 21, 2011", 2011,Thermo Fisher Scientific,"Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.",DESIGN: Device Design,"ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.",Contact the recalling firm for information,100,100 units,"Worldwide Distribution - USA including the states of LA, OH, FL, MD, PA, TX, MO, WI, KS, AL, CA, VA, MS, IL, NE, MA, and the countries of Australia, Belgium, China, Czech Republic, Denmark, Estonia, Finnland, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Taiwan, and the UK.",Terminated,"April 02, 2012",378,100,Not_Computer,N/A,N/A,N/A
Z-1739-2011,57366,"enzyme immunoassay, gentamicin",LCD,Gentamicin test system.,Toxicology,Toxicology,510(k),"Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.","Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012",2,"March 21, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.","False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF, and STFR resulting in inappropriate patient treatment.",OTHER/UNDETERMINED: Pending,"Siemens Healthcare Diagnostics, Inc. sent an Urgent Field Safety Notice letter dated November, 2010, to all affected customers. Customers were requested to run GENT on a Dimension Vista(R) system that does not run the listed plasma protein methods. Instructions were provided for disabling methods on the instrument to prevent inadvertently testing Gent along with plasma protein methods.Customers were instructed to :Forward the notification to anyone to whom they may have distributed the product. Complete and return the Field Correction Effectiveness Check Form to Siemens Healthcare Diagnostics at (302) 631-8467.For further information contact Siemens Technical Solutions Center at 1-800-441-9250 or their local Siemens representative.",N/A,N/A,N/A,"Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.",Terminated,"March 19, 2013",729,N/A,Not_Computer,N/A,N/A,N/A
Z-1368-2011,57106,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20.Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.,Philips Healthcare Allura XPER FD10,2,"March 22, 2011", 2011,Philips Medical Systems North America Co. Phillips,"Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended.",N/A,"On 11/5/10, Philips began sending the Electronic Product Radiation Warning notification letter, dated November 4, 2010, to their consignees.The consignees were informed that the middle pedal of the foot switch of the Allura FD10, FD20, CV20 systems, and the Allura Field Extension series does not not always become inactive (sticks) when pedal is released. The function of the middle pedal on the foot switch is freely programmable by the customer. If it is programmed for exposure and if the pedal does not release by itself, the patient will be exposed to X-ray longer than intended.The consignees were advised to check if their footswitch is possibly affected. Footswitch identification 452270000141 is noted. If the pedal does not release by itself press the red emergency stop button on the system.Consignees can call Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 72200189.",Contact the recalling firm for information,4,4 units,"Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.",Terminated,"July 21, 2011",121,11,Not_Computer,N/A,N/A,N/A
Z-1743-2011,56397,"system, test, rheumatoid factor",DHR,Rheumatoid factor immunological test system.,Immunology,Immunology,510(k),"SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.",SYNCHRON System(s) Rheumatoid Factor (RF) Reagent,2,"March 22, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date.,OTHER/UNDETERMINED: Pending,"The firm Beckman Coulter, sent a ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated June 25, 2010 to the consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions:*Discontinue use and discard appropriately Rheumatoid Factor (RF) reagent lot M907325*Contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss reagent replacement options.*Complete and return the FAX BACK RESPONSE FORM via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., Brea, California 92821, Mail Code E2.SE.08Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If consignees/customers forwarded the affected products listed above to another laboratory, then they need to also provide a copy of the Product Corrective Action letter to the laboratory.If they have any questions regarding this Product Corrective Action letter, consignees were told to call Beckman Coulter Customer Support Center (Hotline) at (800) 854-633 in the United States and Canada.",No consumer action necessary,58,58 units,"Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.",Terminated,"July 02, 2012",468,58,Not_Computer,N/A,N/A,N/A
Z-1622-2011,57947,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone.Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.",Optiflux F250NRe Hemodialyzer,2,"March 22, 2011", 2011,"Fresenius Medical Care Holdings, Inc.",There is an increased risk of an internal blood leak.,PRODUCTION CONTROLS: Process Control,"FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.",N/A,38364,"38,364 units",Worldwide Distribution -- USA and Canada.,Terminated,"February 12, 2013",693,38364,Not_Computer,N/A,N/A,N/A
Z-1643-2011,57916,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.",AFFIXUS Lag Screw Drill,2,"March 22, 2011", 2011,"Depuy Orthopaedics, Inc.","The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.",OTHER/UNDETERMINED: Pending,On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.,Contact the recalling firm for information,296,296 units,"Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.",Terminated,"June 27, 2012",463,296,Not_Computer,N/A,N/A,N/A
Z-1744-2011,57937,"test, hepatitis b (b core, be antigen, be antibody, b core igm)",LOM,N/A,N/A,Microbiology,N/A,"ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.",ETIABAUK PLUS ,2,"March 22, 2011", 2011,Diasorin Inc.,"Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co",OTHER/UNDETERMINED: Pending,"The firm, DiaSorin, sent a ""Customer Notification Letter"" dated 19 August, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to destroy all remaining inventory and complete and return the receipt of notification and destruction of product form, found in the bottom portion of the letter, via fax to: (651) 351-5669, ATTN: TECHNICAL SERVICES or mail to: ATTN: TECHNICAL SERVICES, 1951 Northwestern Ave., Stillwater, Minnesota 55082-0285.If you have any questions or concerns, please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.",Contact the recalling firm for information,710,710,"Worldwide distribution: USA including states of: AL, AR, CA, CT, DE, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK OR, PA, TX, VT, VA, WA,and WI; and country of: SOUTH KOREA.",Terminated,"August 16, 2012",513,710,Not_Computer,N/A,N/A,N/A
Z-1723-2011,57960,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Synergy XVI R4.5Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",Elekta Synergy XVI R4.5,2,"March 22, 2011", 2011,"Elekta, Inc.","If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V; system, the XVI information is prioritized and the end of treatment data is never received by the R&V; system.",OTHER/UNDETERMINED: Pending,"Important Notice A341 titled ""Mandatory Upgrade Desktop Pro R7.01 Service Pack and Cancelled Notices"" dated January 26, 2011, is in distribution to all affected customers. Field Change Order 20000501011, ""Service Pack 2 upgrade to Desktop Pro R7.01 Service Pack 1"", dated October 25, 2010 will be utilized by Elekta Service personnel to upgrade the Desktop Pro to include Service Pack 2. The Important Notice letter instructed customers to file the letter in the Important Notice section of the appropriate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their treatment control system. If it is not installed, customers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and should be removed from the User Manual. Customers should direct their questions to their local Elekta representative.",Contact the recalling firm for information,13,13 units,"Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.",Terminated,"May 24, 2011",63,13,Software,Device Operation,Software update,Software Update
Z-1745-2011,52904,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.",ACUSON AcuNav ultrasound catheters,2,"March 23, 2011", 2011,"Siemens Medical Solutions USA, Inc.",Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.,PRODUCTION CONTROLS: Process Control,"Siemens Field correction was initiated on 3/20/2009. A device correction letter was distributed to all affected users, with a description of the problem and its corrective actions. Siemens service personnel will make a site visit.",N/A,21,21 units,Distribution in US and Internationally.,Terminated,"April 01, 2011",9,21,I/O,N/A,N/A,N/A
Z-1746-2011,57824,"dressing, wound and burn, interactive",MGR,N/A,N/A,General & Plastic Surgery,N/A,"Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute",Organogenesis Apligraf,2,"March 23, 2011", 2011,"Organogenesis, Inc.",Product sterility compromised,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis.",N/A,50,50 units,nationwide.,Terminated,"July 28, 2011",127,50,Not_Computer,N/A,N/A,N/A
Z-1748-2011,58137,"system, imaging, gastrointestinal, wireless, capsule",NEZ,Ingestible telemetric gastrointestinal capsule imaging system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).",PillCam Express Delivery Device,2,"March 23, 2011", 2011,Given Imaging Ltd.,"The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.",DESIGN: Device Design,"Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging.",N/A,389,389,"U.S. Nationwide, Canada, Germany Israel and Australia.",Terminated,"December 02, 2011",254,389,Not_Computer,N/A,N/A,N/A
Z-1747-2011,58138,"dressing, wound and burn, interactive",MGR,N/A,N/A,General & Plastic Surgery,N/A,"Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute",Organogenesis Apligraf,2,"March 23, 2011", 2011,"Organogenesis, Inc.",Product sterility may be compromised,PRODUCTION CONTROLS: Packaging Process Control,Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.,N/A,7,7 units,Nationwide.,Terminated,"July 28, 2011",127,7,Not_Computer,N/A,N/A,N/A
Z-1813-2011,57177,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"ASR UNI FEMORAL IMPL SIZE 57, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.Prescription Use, Sterile.The device is part of a system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.",DEPUY ASR XL ACETABULAR CUP SYSTEM (UNI FEMORAL),2,"March 24, 2011", 2011,"Depuy Orthopaedics, Inc.","As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the",DESIGN: Device Design,"DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices. Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts. Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:"" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans."" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging"" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.DePuy representatives were to assist with returns of any remaining inventory.For questions regarding this recall call 574-372-7333.",N/A,N/A,N/A,Worldwide,Terminated,"August 29, 2013",889,N/A,Not_Computer,N/A,N/A,N/A
Z-1818-2011,57946,"immunochemical, thyroglobulin autoantibody",JNL,Thyroid autoantibody immunological test system.,Immunology,Immunology,510(k),"Access Thyroglobulin Antibody II, Part Number: A32898The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.","Access Thyroglobulin Antibody II, Part Number: A32898",2,"March 24, 2011", 2011,Beckman Coulter Inc.,The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The ThyroglobulinAntibody II (TgAbII) reagent lots may produce:(1) Erroneously high TgAb results for both quality co,N/A,"Beckman Coulter sent a Product Corrective Action (PCA) letter on January 26, 2011 via US Postal Service to the affected customers. The letter explained the problem identified and the action to be taken.Customers were instructed to:(1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers identified in the tableabove;(2) If customers obtained questionable thyroglobulin antibody results, or received feedback from clinicians on reported thyroglobulin antibody results using the reagent lot numbers identified above, rerun or request a redraw of the patient sample;(3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they should provide a copy of the letter to them;(4) Complete and return the enclosed response form within 10 days so the firm can be assured that you have received this important notification and are taking appropriate action.For questions regarding the recall communication, customers were told to contact Beckman Coulter Customer SupportCenter:(1) Via our website, http://www.beckmancoulter.com/customersupport/support(2) Via phone, call 1-800-854-3633 in the United States and Canada(3) Outside the United States and Canada please contact your local Beckman Coulter representative.",Contact the recalling firm for information,3658,3658 units (1800 in US),"Worldwide Distribution - USA including AR, CA, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen",Terminated,"May 04, 2012",407,3658,Not_Computer,N/A,N/A,N/A
Z-1819-2011,57962,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269.The Extended Brilliance Workplace¶_¶_ (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).",Extended Brilliance Workstation (EBW),2,"March 24, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"During an FDA inspection on 10/1/2010 the firm was notified by FDA that their field action they initiated in Oct 2009, constituted a recall. The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed f",OTHER/UNDETERMINED: Pending,"Philips sent an URGENT - Field Safety Notice letter dated September 29, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to be aware that the numbers displayed for ""Wall Thickening"" actually represent a reduction in wall thickness from ES to ED.Philips will be providing a sotware update to resolve the issue. For further information or support customers were instructed to contact their local Philips representative:Customer Care Service Center in the U.S. at 1-800-722-9377, option 5:Diagnostic Imaging option 1: CT or their local Philips representative.",N/A,2068,"2,068 units","Worldwide Distribution - USA including the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX , UT, VA, VT, WA, WI, WV & WY and the following countries: ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELGIUM, BRAZIL, BRUSSEL, CANADA, CHILE, CHINA, COLUMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EDUADOR, EGYPT, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LATVIA, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, MIRATES, UNITED KINGDOM, VENEZUELA & YEMEN.",Terminated,"September 21, 2012",547,2068,Software,Output/Calculation,Software update,Software Update
Z-1725-2011,58123,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.",Millar disposable angiographic catheter (Left Heart),1,"March 24, 2011", 2011,"Millar Instruments, Inc",Possibility of epoxy debris particles inside the catheter lumen.,PRODUCTION CONTROLS: Process Control,"The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed.If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.",Contact the recalling firm for information,1080,1080 units,"MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.",Terminated,"June 27, 2011",95,1080,Not_Computer,N/A,N/A,N/A
Z-1820-2011,57564,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance 64 S/N 9089, 9551, 9548.The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.","Brilliance 64 Computed Tomography XRay System Model 728231,",2,"March 24, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.",OTHER/UNDETERMINED: Pending,"Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).",N/A,3,3,"Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany",Terminated,"February 22, 2013",701,3,Software,Device Operation,Instructions to review images accuracy,Safety Notice/Insructions
Z-1823-2011,57455,"cresolphthalein complexone, calcium",CIC,Calcium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN.For the in vitro quantitative determination of calcium in serum, plasma and urine.",Calcium test system,2,"March 25, 2011", 2011,"Roche Diagnostics Operations, Inc.",The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.,OTHER/UNDETERMINED: Pending,"The firm, Roche, sent an ""URGENT MEDICAL DEVICE REMOVAL"" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.",Contact the recalling firm for information,418,"13, 405 units",Nationwide distribution.,Terminated,"September 13, 2011",172,14946,Not_Computer,N/A,N/A,N/A
Z-1822-2011,58002,"joint, knee, external limb component",ISY,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Ossur Total Knee, Model Number: 2100The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.",Ossur Total knee,2,"March 25, 2011", 2011,"Ossur Engineering, Inc","The recall was initiated based on a finding by Ossur that some units of the Total Knee 2100 produced from October 19th, 2010 until January 21st 2011, contained back links that may compromise knee function prematurely.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Ossur initiated a Safety Notice (Voluntary Product Recall) letter on February 11, 2011, via US Postal Service Registered Mail. The recall letter informed the affected customers of the reason for the recall and the product affected.Ossur requested their distributor and providers take the following action: (1) Please identify the users of each of the Total Knee 2100 model devices listed above; (2) Also, please check your inventory and isolate any recalled devices you have on hand but have not fitted on users. Customers were also informed that a representative from Ossur customer service will be contacting them to coordinate replacement of the affected devices.The letters were followed by phone calls placed by a trained Ossur Customer Service Representative to each customer after US distributors provided Ossur with customer contact information.For questions regarding this recall call 517-629-8890.",Contact the recalling firm for information,142,142 units,"Worldwide Distribution - USA including CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA,, and WA and the countries of Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey.",Terminated,"February 29, 2012",341,142,Not_Computer,N/A,N/A,N/A
Z-1821-2011,58017,"catheter, infusion",JCY,Introduction/drainage catheter and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900***For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.",Arthroscopy Outflow/Suction Tubing,2,"March 25, 2011", 2011,Linvatec Corp. dba ConMed Linvatec,"On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.",OTHER/UNDETERMINED: Pending,"Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit.Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office.If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701.If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.",Contact the recalling firm for information,4598,"4,598","Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain.",Terminated,"January 31, 2012",312,4598,Not_Computer,N/A,N/A,N/A
Z-1834-2011,54706,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Coherence Dosimetrist, version 2.2.Intended use: Medical charged-particle radiation therapy system","Coherence Dosimetrist, v 2.2",2,"March 28, 2011", 2011,"Siemens Medical Solutions USA, Inc","A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs at Risk) the user only defines the max. dose. The firms engineering team determined that the software defect was repeatable.",DESIGN: Software Design,Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.,N/A,60,60 units,"Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.",Terminated,"April 06, 2011",9,60,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1832-2011,54842,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Acuson S2000 Ultrasound System with software and imaging.The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.",Acuson,2,"March 28, 2011", 2011,"Siemens Medical Solutions USA, Inc.","""Any 2D measurement performed in Exam Review or offline, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode.""",DESIGN: Software Design,"Siemens Medical Solutions USA, Inc. sent a Consumer Safety Advisory Notification letter on February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the Customer Safety Notice to all those within their organization who need to be aware of the issue until the corrective action was completed. For questions regarding this recall call 650-694-5580.",N/A,1903,1903,"Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Australia, Belgium, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Ecuador, Eguypt, Spain, Finald, France, Great Britian, Germany, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Ireland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lithuania, Mexico, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Slovenia, Slovak Republic, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, Venezeula, Yemen, and South Africa..",Terminated,"June 18, 2012",448,1903,Software,N/A,N/A,N/A
Z-1837-2011,56840,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed;ACUSON S2000: 10041461;S2000 Cardio Option: 10041853;Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CAThe ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.",ACUSON S2000 ultrasound systems ,2,"March 28, 2011", 2011,"Siemens Medical Solutions USA, Inc., Mountain View, CA",There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Siemens Medical Solutions USA, Inc., sent a Customer Safety Advisory Notification letter on August 17, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the notice on to all those within their organization who need to aware of the issue until the corrective action was completed. For questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5993.",N/A,N/A,N/A,"Worldwide Distribution - USA (nationwide)and the countries of Antares distribution includes: United Arab Emirates-AE, Austria-AT, Australia-AU, Azerbaijan-AZ, Brazil-BR, Belarus-BY, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Egypt-EG, Spain-ES, France-FR, Great Britain-GB, Guatemala-GT, Croatia-HR, Hungary-HU, Indonesia-ID, Ireland-IE, India-IN, Italy-IT, Jordan-JO, Japan-JP, South Korea-KR, Moldova-MD, Mexico-MX, Malaysia-MY, Netherlands NL, Norway-NO, New Zealand-NZ, Poland-PL, Portugal-PT, Romania-RO, Serbia-RS, Russian Federation-RU, Saudi Arabia-SA, Sweden-SE, Singapore-SG, Slovak Republic-SK, Suriname-SR, Turkey-TR, Taiwan-TW, Ukraine-UA, United States-US, Uruguay-UY, Uzbekistan-UZ, Venezuela-VE, Vietnam-VN, South Africa-ZA S2000 distribution includes: Austria-AT, Australia-AU, Brazil-BR, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Spain-ES, Finland-FI, France-FR, Great Britain-GB, Hong Kong-HK, Indonesia-ID, India-IN, Italy-IT, Japan-JP, South Korea-KR, Kazakhstan-KZ, Lebanon-LB, Mexico-MX, Norway-NO, Philippines-PH, Poland-PL, Portugal-PT, Romania-RO, Russian Federation-RU, Sweden-SE, Slovak Republic-SK, Turkmenistan-TM, Turkey-TR, Taiwan-TW, United States-US X300 distribution includes: AE (United Arab Emirates) , AL (Albania) , AN (Netherlands Antilles), AO (Angola), AR (Argentina), AT (Austria), AU (Australia), AZ (Azerbaijan), BA (Bosnia-Herzegovina), BD (Bangladesh), BE (Belgium), BG (Bulgaria), BN (Brunei), BO (Bolivia), BR (Brazil), BY (Belarus), CA (Canada), CH (Switzerland), CL (Chile), CN (China), CO (Colombia), CV (Cape Verde), CZ (Czech Republic), DE (Germany), DK (Denmark), DZ (Algeria), EC (Ecuador), EG (Egypt), ES (Spain), ET (Ethiopia), FJ (Fiji), FR (France), GB (United Kingdom), GE (Georgia), GR (Greece), HK (Hong Kong), HN (Honduras), HR (Croatia), HU (Hungary), ID (Indonesia), IE (Ireland), IN (India), IR (Iran), IT (Italy), JO (Jordan), JP (Japan), KE (Kenya), KR (Korea, South), KW (Kuwait), KZ (Kazakhstan), LT (Lithuania), LV (Latvia), LY (Libya), MD (Moldova), ME (Montenegro), MK (Macedonia), MM (Myanmar), MU (Mauritius), MX (Mexico), MY (Malaysia), NG (Nigeria), NI (Nicaragua), NL (Netherlands), NO (Norway), NP (Nepal), NZ (New Zealand), PE (Per¶_), PH (Philippines), PK (Pakistan), PL (Poland), PS (Palestine), PT (Portugal), QA (Qatar), RS (Serbia), RO (Romania), RU (Russia), RW (Rwanda), SA (Saudi Arabia), SC (Seychelles), SE (Sweden), SG (Singapore), SI (Slovenia), SK (Slovakia), SV (El Salvador), SY (Syria), TH (Thailand), TM (Turkmenistan), TN (Tunisia), TR (Turkey), TT (Trinidad/Tobago), TW (Taiwan, ROC), UA (Ukraine), US (United States of America), UY (Uruguay), UZ (Uzbekistan), VE (Venezuela), VN (Viet Nam), YE (Yemen), ZA and (South Africa)",Terminated,"June 18, 2012",448,N/A,Software,N/A,N/A,N/A
Z-1831-2011,57887,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsystem is capable of connectivity with clinical analyzers, a Laboratory Information Systems (LIS), barcode label printers and other third party devices. The TCAutomation is a pre-analytical and post-analytical sample management system. The configuration file enables operational support of the site specific layout and instrument selection. The VITROS 5, 1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric Immunoassay methods.)",enGen TM Laboratory Automation System,2,"March 28, 2011", 2011,Ortho-Clinical Diagnostics,"A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen"" Laboratory Automation System using TCAutomation"" Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification.",N/A,"The firm, Ortho Clinical Diagnostics (OCD), sent an ""URGENT PRODUCT CORRECTION NOTIFICATION"" letter dated January 27, 2011, by Federal Express overnight mail to all customers. Foreign affiliate consignees/customers were notified by email informing them of the issue on the same day. The letter described the problem, product and actions to be taken. The firm also included temporary procedures to help prevent the occurrence of the software anomaly. The customers were instructed to follow the enclosed Procedure to STOP the Automation System and/or Bypass Module; complete and return the attached Confirmation of Receipt - Important Response Required form by February 4, 2011, via fax to: Ortho Clinical Diagnostics, 1-888-557-3759 or 1-585-453-4110, and display this communication near the enGen Laboratory Automation System to ensure compliance by all operators until updated TCAutomation Laboratory Automation System software is installed. A Technical Bulletin will be sent to customers in the near future to be stored with user documentation. Ortho will implement a TCAutomation Laboratory Automation System software change in the near future to resolve this anomaly.If you have any questions regarding this notification, please call Customer Technical Services at 1-800-421-3311 (Options 1, 2).",N/A,63,63 units,"Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.",Open,N/A,N/A,63,Software,Output/Calculation,Software update,Software Update
Z-1833-2011,58025,"guide, surgical, instrument",FZX,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.",VANGUARD MP SLIDEX AP SIZER,2,"March 28, 2011", 2011,"Biomet, Inc.",Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm, Biomet, sent a ""FIELD SAFETY NOTICE"" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: edward.spearpoint@biometeurope.com.",N/A,17,17,"Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.",Terminated,"May 16, 2011",49,17,Not_Computer,N/A,N/A,N/A
Z-1830-2011,57899,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Interventional Pain 6"" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI.The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine","Interventional Pain 6"" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407266",2,"March 28, 2011", 2011,Stryker Instruments Division of Stryker Corporation,The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.,OTHER/UNDETERMINED: Pending,"Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.",Contact your health professional,44,44 units both products,"Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.",Terminated,"June 01, 2011",65,44,Not_Computer,N/A,N/A,N/A
Z-1839-2011,58104,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709.This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.","10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue",3,"March 28, 2011", 2011,"Biosense Webster, Inc.","The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the ""10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue"", catalog number D128709, through the J&J; Gateway (ie, e-IFU website).",OTHER/UNDETERMINED: Pending,"Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated March 16, 2011, to all affected customers (via express mail). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed Acknowledgement Form to confirm that all customers who received the product have been notified accordingly of this concern. If customers have any questions or require additional information, they are to contact their BWI representative and return the Acknowledgement form to:Biosense Webster, Inc.l5715 Arrow HighwayIrwindale, CA 91706Attn: Recall Coordinator - Virgil EllsworthPhone: (909) 839-8500Fax Number: (909) 839-7207.For questions regarding this recall call 909-839-7207.",Contact the recalling firm for information,606,606 units total,"Nationwide Distribution - including GA, KY, NV, WA, PA, and UT",Terminated,"May 07, 2012",406,606,Not_Computer,N/A,N/A,N/A
Z-1835-2011,57857,N/A,N/A,N/A,N/A,N/A,N/A,"Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill);Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide.",Triathlon PKR Peg Drill,2,"March 28, 2011", 2011,Stryker Howmedica Osteonics Corp.,"Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these components occurs, the following potential patient and/or surgeon or surgical staff harms may results.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Stryker sent Urgent Product Recall letters on February 9, 2011, and February 10, 2011, via Fed Ex. to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069.For questions regarding this recall call 201-972-2100.",N/A,13990,5650-4-512- 754 units; 5650-4-536- 880 units,"Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand,",Terminated,"November 18, 2013",966,1634,Not_Computer,N/A,N/A,N/A
Z-1846-2011,55905,abnormal hemoglobin quantitation,GKA,Abnormal hemoglobin assay.,Hematology,Hematology,510(k),"The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CAThe VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.",VARIANT Sickle Cell Short Program ,2,"March 29, 2011", 2011,Bio-Rad Laboratories Inc,The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.,OTHER/UNDETERMINED: Pending,"The firm, Bio-Rad, sent an ""URGENT: MEDICAL DEVICE RECALL NOTIFICATION"" letter dated April 22, 2010, to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and quarantine the product; complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE FORM via fax to: (510) 741-3954, Attn: Bio-Rad CSD Regulatory Affairs, and contact there regional Bio-Rad office for ROM Card replacement. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.",N/A,10,10 units,"Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.",Terminated,"April 07, 2011",9,10,Computer,N/A,N/A,N/A
Z-1852-2011,58028,"container, specimen, non-sterile",NNI,Specimen transport and storage container.,Pathology,General Hospital,510(K) Exempt,"Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.",MediVac Speciment Sock,3,"March 30, 2011", 2011,Cardinal Health Inc,"In one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)",PRODUCTION CONTROLS: Labeling Mix-Ups,"On February 18, 2011 Cardinal Health sent a consignee letter with the following instruction: 1) Quarantine either Catalog Number with the inticated Lot Number.2) Contact the appropiate Customer Service group for return instructions:Hospital - 800-964-5227Federal Government - 800-444-1166Distributirs - 800-635-6021All other customers - 888-444-54403) Return the enclosed acknowledge form via fax to 847-689-9101, even if you do not have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices.4) Notify any customer to whom you may have distributed product affected by this recall.",Contact the recalling firm for information,3360,"3,360 each","Worldwide Distribution - USA including AL, AR, AZ. CA. CO,, CT, DC, DE, FL, GA, HI, IA, ID,IL,IM,KS, KY, LA, MA, MD, ME. MI MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico - and the country of Canada.",Terminated,"October 04, 2011",188,3360,Not_Computer,N/A,N/A,N/A
Z-1850-2011,58105,"chair, dental, without operative unit",NRU,Dental chair and accessories.,Dental,Dental,510(K) Exempt,Pelton & Crane Spirit 3000 dental chair (Model #SP30),Pelton & Crane Spirit 3000 ,2,"March 30, 2011", 2011,Pelton & Crane Company,The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.,PRODUCTION CONTROLS: Process Control,"Pelton & Crane sent an ""Urgent Medical Device Recall"" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.",N/A,9,9 units,"Distribution to USA, Canada, and the Netherlands.",Terminated,"August 16, 2011",139,15,Not_Computer,N/A,N/A,N/A
Z-1845-2011,57613,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CellQuest Pro SW, version 4.0.2. and later;Becton Dickinson, San Jose, CA 95131CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.",CellQuest Pro SW,2,"March 30, 2011", 2011,"BD Biosciences, Systems & Reagents",Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.,DESIGN: Software Design,"Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that ""as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality."" The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.",N/A,4552,4552,Worldwide Distribution,Terminated,"March 31, 2011",1,4552,Software,Device Operation,Software update,Software Update
Z-1817-2011,57004,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000.Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.",115V Blanketroll III Model 233 and 115V CoolBlue Model 2501,2,"March 30, 2011", 2011,Cincinnati Sub-Zero Products Inc,"The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.",MISBRANDING: Labeling False and Misleading,"On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.",N/A,1385,763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01,"Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.",Terminated,"March 08, 2013",709,896,Not_Computer,N/A,N/A,N/A
Z-1847-2011,58066,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"BD Phoenix"" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***The BD Phoenix¶_ Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.","BD Phoenix"" Panel NMIC/ID123, Catalog 448723, ",2,"March 30, 2011", 2011,Becton Dickinson & Co.,In vitro diagnostic test kit is defective and may cause false positive or false negative results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.",N/A,377,377 cartons,"Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.",Terminated,"January 30, 2013",672,377,Not_Computer,N/A,N/A,N/A
Z-1848-2011,57602,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.",HEMOCUE AB GLUCOSE 201 DM ANALYZER,2,"March 30, 2011", 2011,"Hemo Cue, Inc.","Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.",PRODUCTION CONTROLS: Process Control,"Hemocue AB sent Customer Notification ""Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers"" dated October 7, 2010, to customers notifying them of incorrect settings on error codes. The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.",N/A,23,23,"Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.",Terminated,"June 22, 2011",84,102,Software,Alarm/Message,Configuration update,Other
Z-1853-2011,54844,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.,Acuson Antares Utrasound imaging device,2,"March 30, 2011", 2011,"Siemens Medical Solutions USA, Inc.",Image captured from the device may be erroneous.,DESIGN: Software Design,"Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.",N/A,3539,3539,"Worldwide distribution to USA, Andorra, United Arab Emirates, Netherlands Antilles, Angola, Austria, Australia, Azerbaijan, Bosnia, Bangladesh, Belgium, Bahrain, Brunei Darussalam, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, Faroe Islands, France, Great Britain, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Sri Lanka, Lithuania, Latvia, Morocco, Moldova, Mexico, Nicaragua, Netherlands, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Suriname, Thailand, Turkey, Trinidad and Tobago, Taiwan, Ukraine, UA, Uruguay, Venezuela, Vietnam, Yemen, and South Africa.",Terminated,"June 18, 2012",446,3539,Software,Display/Image,Notification,Safety Notice/Insructions
Z-1854-2011,57773,"system, hemoglobin, automated",GKR,Automated hemoglobin system.,Hematology,Hematology,510(k),"HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne CorporationThe Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.",Hgb Pro Professional Hemoglobin Testing system,2,"March 31, 2011", 2011,"ITC-Nexus Dx, Inc.",ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system.,OTHER/UNDETERMINED: Pending,"ITC-Nexus Dx, Inc. sent an Urgent Medical Device Recall letter with return response forms to end users and distributors dated January 21, 2011 via UPS overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they had an of the affected lots.If they have full boxes or loose containers of the affected lots customers were instructed to stop using the product and remove it from inventory.Customers were requested to fill out the return response form and send it back to ITC via fax, email or mail.For questions customers were instructed to call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (International)), Extension 4707 or e-mail techsupport@itcmed.com.",N/A,2500,"2500 containers + 50,563 addtnl containers =53063 containers","Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore",Terminated,"November 02, 2012",582,2500,Not_Computer,N/A,N/A,N/A
Z-1857-2011,57987,"monitor, bed patient",KMI,Bed-patient monitor.,General Hospital,General Hospital,510(K) Exempt,"Stanley Bed-Check 30-Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number.For use in reducing patient falls.","Stanley BedCheck 30Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010",2,"March 31, 2011", 2011,"Stanley Security Solutions, Inc.",The cord could come loose from the mat potentially causing a short to the internal wiring.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm, Stanley Healthcare Solutions, issued an ""Important Technical Bulletin"" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a ""Compliance Notice"" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to obtain a return authorization number and take immediate action to return the units to the firms location in Lincoln, Nebraska. The Compliance Notice informed the customers who had not sent in their units to promptly read the notice and take the necessary steps to respond appropriately for their facility. Additionally, the customers were instructed to complete and return the Bed Check Sensormat Return Form and page 2 of the ""Compliance Notice"" via at 402-475-4281 or mail to: Compliance Engineer, Stanley Security Solutions, Inc., 1550 N. 20th Circle, Lincoln, NE 68503. Follow-up phone calls to nonresponders were made using a phone script. A ""Second Notice Compliance Notice"" dated October 20, 2010 was issued via certified mail to customers asking for immediate response to the previous communication. In addition, a third notice dated October 28, 2010 which was also flagged as ""Second Notice"" was again used asking for a response from the customers.If you have any questions regarding the notice or any action that may need to be taken by you, please contact Quality Manager at 1-800-824-2996 extension 3419 or Compliance Officers at 402-742-9414 or 402-742-9425.",N/A,19997,"19,997 mats",Worldwide distribution: USA and the country of Canada.,Terminated,"March 31, 2011",0,209183,Not_Computer,N/A,N/A,N/A
Z-1862-2011,57852,"gauge, depth",HTJ,Depth gauge for clinical use.,Orthopedic,Orthopedic,510(K) Exempt,"Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique.",Xcelerate Specialty Patella Milling System ,2,"March 31, 2011", 2011,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.,DESIGN: Device Design,"Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer. Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product. Product should be returned to the attention of: Regulatory ComplianceStryker Orthopaedics325 Corporate DriveMahwah, New Jersey, 07430. The orange Product Remediation sticker should be attached to the return, indicating the Product Remediation # RA 2009-296. Mark the outer box with words ""Product Recall.""For questions regarding this recall call (201) 972-2100.",N/A,52,52 units,Nationwide Distribution,Terminated,"October 15, 2012",564,52,Not_Computer,N/A,N/A,N/A
Z-1866-2011,58136,"dressing, wound and burn, occlusive",MGP,N/A,N/A,General & Plastic Surgery,510(k),"HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany",Hydrofilm,3,"April 01, 2011", 2011,"Hartmann USA, Inc","Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no",OTHER/UNDETERMINED: Pending,"Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.",Contact the recalling firm for information,100,100 boxes (10 x 12.5 cm per box),"Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.",Terminated,"August 12, 2011",133,100,Not_Computer,N/A,N/A,N/A
Z-1875-2011,58051,"tape and bandage, adhesive",KGX,Medical adhesive tape and adhesive bandage.,General Hospital,General & Plastic Surgery,510(K) Exempt,"CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7The device is used to cover and protect wounds.",CVS Pharmacy Plastic Sesame Street Adhesive Bandages,2,"April 01, 2011", 2011,Pharmaplast S.A.E.,"The bandages are labeled as sterile, but failed sterility testing.",PRODUCTION CONTROLS: Process Control,"Pharmaplast S.A.E. called the direct account on 2/17/11 and sent a Urgent Medical device recall letter dated 2/21/11 to the direct account via overnight mail, requesting that they examine their inventory for the non-sterile adhesive bandages and quarantine them for return to Pharmaplast via sea freight. The account was instructed to contact their customers concerning the recall and return their stocks of the affected lot, which was done by telephone calls on 2/17/11.For questions regarding this Recall please call 00203-4500264.",Contact the recalling firm for information,5336,"5,336 cases",Nationwide Distribution - Including Illinois.,Terminated,"August 25, 2011",146,5336,Not_Computer,N/A,N/A,N/A
Z-1865-2011,57890,"block, beam-shaping, radiation therapy",IXI,Radiation therapy beam-shaping block.,Radiology,Radiology,510(k),Axxent Flexishield MiniTo shape the beam from a low energy radiation therapy source up to 50kVp.,Axxent Flexishield Mini,1,"April 01, 2011", 2011,Xoft Inc.,"Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.",DESIGN: Device Design,"Xoft, Inc. sent an Urgent Field Removal Action letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and return all units and lots of Flexishield Mini Catalog Number: F5300 in their inventory. Customers were instructed to fill out the attached form and fax to 866-222-3404, then call Customers Service toll free directly at 877-963-8327 to make arrangements to return the product and receive a credit if applicable. Customers were asked to complete and return the form even if they did not have any units to return.For questions regarding this recall call 408-419-2300.",N/A,165,165 units,"Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI.",Terminated,"June 08, 2011",68,165,Not_Computer,N/A,N/A,N/A
Z-1864-2011,57742,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.",Cardiac Marker Control Calibration Verification Set,2,"April 01, 2011", 2011,Abbott Point Of Care Inc.,"Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.",DESIGN: Device Design,"Urgent Recall Notice letters with business reply cards were sent Fed ex on December 17, 2010 to all accounts. International notifications were sent on December 21, 2010. The letter identified the affected product and lot numbers along with a background explanation of the issue. The firm recommends that customers remove the cap from the vial; squeeze the vial 10 times, prior to thawing; replace cap on the vial; and then follow the remaining steps for use as outlines in section 14-12 of the i-STAT 1 System Manual. Customers are to complete and return the Business Reply card to acknowledge receipt of the letter. If the affected product had been further distributed then a copy of the letter should be provided to those customers as well. If additional information is needed, customers should contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or their Abbott Point of Care representative.",Contact the recalling firm for information,557,557 units total,Worldwide Distribution,Terminated,"October 16, 2012",564,557,Not_Computer,N/A,N/A,N/A
Z-1877-2011,57445,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073.Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.",CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5 ,2,"April 04, 2011", 2011,Beckman Coulter Inc.,A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionality.,N/A,"An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions: ACTION/RESOLUTIONFor issue 1: The specimen stability claims should be as follows:- 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube- 24 hours for both % positives and absolute counts for the CD45/56/19/3 tubeFor Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use:- Preparation within 72 hours of collection for the CD45/4/8/3 tube- Preparation within 24 hours of collection for CD45/56/19/3 tubeBeckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation.Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.",N/A,26822,26822 units,"Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay.",Terminated,"June 14, 2012",437,105810,Not_Computer,N/A,N/A,N/A
Z-1883-2011,55554,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination aids in the risk stratification of patients with unstable angina coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.",Access Immunoassay Systems enhanced AccuTnl Reagent ,2,"April 04, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced Access Accu Tnl assay (P/N A 78033):(1) Access Total BhCG (P/N 33500);(2) Access HYPERsensitive hTSH/Fast hTSH (P/N 33820);(3) Access hFSH (P/N 33520).The issue can occur only when the assays are",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated December 16, 2009 to all customers. The letter described the product, problem and actions to be taken. Beckman Coulter instructed the customers to do the following mitigation to reduce the risk of encountering an erroneous result:Systems with multiple reagent pipettors (UniCel Dxl 800 and 600; UniCel DxC 880i, 860i, 680i, and 660i):1. Designate enhanced Access AccuTnl to a different reagent pipettor (s) than Access Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH.2. Discard any open Access Total BhCG, hTSH/Fast hTSH and hFSH reagent packs3. Calibrate Access Total BhCG, hTSH and hFSH using fresh reagent packs4. Run QC following acceptable calibration curves. Proceed with operation following acceptable QC performanceSystems without multiple reagent pipettors (Access, Access 2; SYNCHRON LXi 725, UniCel DxC 600i):1. Discard any open Access Total BhCG, hTSH/Fast hTSH and hFSH reagent packs.2. Calibrate Access Total BhCG, hTSH/Fast hTSH and hFSH using fresh reagent packs3. Run QC following acceptable calibration curves.Ensure that controls and patient samples for Access Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH are not run immediately following enhanced Access AccuTnl controls or patient samples.For example, during routine QC runs, ensure that these assays are requested prior to enhanced Access AccuTnl.4. Proceed with operation following acceptable QC performance.NOTE: An enhanced AccuTnl sample loaded with a system priority of STAT will interrupt routine Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH sample aspiration. Avoid loading enhanced AccuTnl sample aspiration. Avoid loading enhanced AccuTnl samples with a system priority of STAT during aspiration of Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH.Diagnostic test results should be interpreted in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other .",Contact the recalling firm for information,22032,"22,032 kits",Worldwide distribution: USA and country of Canada.,Terminated,"May 07, 2012",399,22032,Not_Computer,N/A,N/A,N/A
Z-1884-2011,52820,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer);Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CAProduct is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.",TEE Transducer V5M,2,"April 04, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's esophagus.",DESIGN: Software Design,"Siemens sent a Customer Safety Advisory Notification letter on April 7, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to pass the notice on to all those within their organization who need to be aware of the issue until the corrective action is completed.For questions regarding this recall call 650-969-9112.",N/A,61,61 units,"Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Great Britain, Hong Kong, Indonesia, India, Italy, South Korea, Norway, Turkmenistan, and Taiwan",Terminated,"April 05, 2011",1,61,Other,N/A,N/A,Other
Z-1879-2011,57810,"airway, oropharyngeal, anesthesiology",CAE,Oropharyngeal airway.,Anesthesiology,Anesthesiology,510(K) Exempt,"King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.",King LT(S)D Oropharyngeal Airway,2,"April 04, 2011", 2011,King Systems Corp.,The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.,OTHER/UNDETERMINED: Pending,"King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form.For questions call 317-776-6823, ext 257.",N/A,143,143 cases of 10 each case,Worldwide Distribution - USA and Canada,Terminated,"June 29, 2012",452,281,Not_Computer,N/A,N/A,N/A
Z-1882-2011,58044,"container, supplementary nitroglycerin",LLC,N/A,N/A,General Hospital,510(k),"iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110; Product is manufactured and distributed by Philips Medical Systems, Foster City, CAViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of ""off-the-shelf"" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images.",iSite PACS with iSite ViewForum Applications,2,"April 04, 2011", 2011,Philips Medical Systems,A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.,DESIGN: Software Design,"Philips sent an Urgent Field Safety Notice letter dated February 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to assure that all colleagues were aware of the problem.When using the Volume Vision software, check the correctness of measurements (graphics and numerical values) prior to saving a captured image containing measurements.Save captured images containing measurements immediately after creating them and before altering the measurements in the original image view.For any subsequent measurements, create a new capture and save it immediately.For further information or support concerning this issues, customers should contact their local Philips representative at +1-877-328-2808.",No consumer action necessary,N/A,N/A,Worldwide Distribution.,Terminated,"August 18, 2011",136,N/A,Software,N/A,N/A,N/A
Z-1880-2011,58013,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone",Surgical Blade,2,"April 04, 2011", 2011,Linvatec Corp. dba ConMed Linvatec,"On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging.",PRODUCTION CONTROLS: Process Control,"Linvatec Corp. dba ConMed sent an Urgent Medical Device Recall Notification letter dated November 30, 2010, by FedEx, email, Fax, etc) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the reply form within 30 days of receipt. Immediately check their facility's inventory for the affected product and lot number. If they had any of the product with lot number 180209. Do Not Use. Segregate and return for credit. If the product was transferred to another facility, customers were to complete the REPLY FORM documenting the transfer of the product and fax the form to 727-319-5701.For questions regarding this recall call 727-319-5701 or 800-535-8536.",Contact the recalling firm for information,415,415,"Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of Canada, and South Africa.",Terminated,"November 09, 2011",219,415,Not_Computer,N/A,N/A,N/A
Z-1896-2011,58011,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),Rusch Irrigation Tray w/Piston Catalogue Number 67890For irrigation according to institutional guidelines.,Rusch Irrigation Tray w/Piston,2,"April 05, 2011", 2011,Teleflex Medical,"The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination.",OTHER/UNDETERMINED: Pending,"the firm,Teleflex Medical, sent two ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letters one dated February 24, 2011 and the other dated March 30, 2011 to all consignees and customers. The letters described the product, problem and actions to be taken. The consignees were instructed to communicate the recall to any of their customers who have received product included within the scope of the field corrective action via the customer letter. The customers were informed in the letter of concerns about potential bacterial contamination of the alcohol prep pads in the affected trays. If contaminated alcohol prep pads are used, there is a potential for infection to occur. The customers were instructed ""that upon opening the affected trays for use, they should discard the prep pads as medical waste"". The customers were also instructed to immediately discontinue use and quarantine any products with the product numbers and lot numbers listed; return the product, and complete and return the Recall Acknowledgement Form, even if they no affected product, via fax to 1-866-804-988, Attn: Customer Service (a customer service representative contact the customer with a Return Goods Authorization number and instructions for the return of the product to Teleflex Medical). If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.",Contact the recalling firm for information,95647,"95,647 eaches (total for both Catalogue Numbers)","Worldwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, MS, MI, MO, MS, NC, NJ, NH, NY, OH, PA, TX, UT, VA, Puerto Rica and the country of: Canada.",Terminated,"April 17, 2012",378,95648,Not_Computer,N/A,N/A,N/A
Z-1893-2011,58009,"camera, surgical and accessories",KQM,Surgical camera and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA***Catalog No ProductVPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCXFor mounting and positioning of flat screen monitors.","Articulating Arm, Secondary Flat Panel",2,"April 05, 2011", 2011,Linvatec Corp. dba ConMed Linvatec,"If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.",DESIGN: Device Design,"An Urgent Service Bulletin Notification was mailed to each ConMed Linvatec customer who received the affected product. The letter identified the affected product and stated the reason for notification. The letter asks customers to review the GCX Corporation Service Bulletins and updated Installation/User Manual. ConMed Linvatec recommends that customers periodically check the VHM Arm to see that it is functioning properly. In addition ""Sudden Movement"" stickers, provided by GCX, were also included to all consignees as part of the mailing. If customers in the US have questions or need technical support, they can contact ConMed Linvatec Endoscopy Customer Service at 888-292-0100 or e-mail Customerserv1@linvatec.com.",N/A,373,373,"Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.",Terminated,"May 17, 2011",42,373,Not_Computer,N/A,N/A,N/A
Z-1894-2011,58109,"knife, ophthalmic",HNN,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,BD Beaver XStar Safety 2.5mm Crescent Knife;REF 378234Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.,"Knife, Opthalmic",2,"April 05, 2011", 2011,Beaver-Visitec International Inc.,Loose blades in the handle of knives due to uncured epoxy.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304.For questions regarding this recall call 781-906-7917.",N/A,1680,"1680 units (1130 domestic, 550 foreign)","Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China",Terminated,"June 14, 2012",436,1680,Not_Computer,N/A,N/A,N/A
Z-1886-2011,58107,"light, surgical, ceiling mounted",FSY,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Harmony LA/LED Monitor Arm Adapter. Model Number: LB61The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting",Harmony LA/LED Arm Adapter,2,"April 05, 2011", 2011,Steris Corporation,The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter,OTHER/UNDETERMINED: Pending,"Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828.For any questions regarding this matter call 440-392-7705.",N/A,14,14 Units,"Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.",Terminated,"March 13, 2013",708,14,Not_Computer,N/A,N/A,N/A
Z-1868-2011,57939,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Curlin 6000 IOD Ambulatory Infusion PumpProvides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.",Ambulatory Infusion Pump,1,"April 05, 2011", 2011,"Zevex International, Inc.",Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.,DESIGN: Software Design,"The firm, MOOG, sent an ""URGENT DEVICE RECALL NOTIFICATION"" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following:1) Identify the affected Pumps:a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days.b) If their pump is not affected by this recall, the pump can be used for its intended purposes.2) Removal of affected Product:a) remove affected products from service and use non-affected pumpb) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patientWARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump.If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.",Contact the recalling firm for information,3407,"3,407 units","Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.",Terminated,"August 06, 2012",489,18306,Software,N/A,N/A,N/A
Z-1900-2011,51497,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Siemens brand ACUSON S2000 Ultrasound System with software versions:VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461;Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CAThe ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.",ACUSON S2000 Ultrasound System ,2,"April 06, 2011", 2011,"Siemens Medical Solutions USA, Inc.",The product has a software problem in which previous patient measurement data gets associated with another patient's image.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, SIEMENS, issued a ""CUSTOMER SAFETY ADVISORY NOTIFICATION"" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.",N/A,N/A,N/A,Worldwide distribution.,Terminated,"April 06, 2011",0,N/A,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-1828-2011,52193,"cabinet x-ray, industrial",RCE,N/A,N/A,N/A,N/A,"Phoenix x/ray nanotom series.Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.",Phoenix x/ray nanotom series,2,"April 06, 2011", 2011,"GE Inspection Technologies, LP","Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"The firm has completed all of the following necessary actions and no further actions have been indicated:A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.",N/A,118,118 units total,Nationwide Distribution,Open,N/A,N/A,118,Not_Computer,N/A,N/A,N/A
Z-1898-2011,54684,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***""Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.",Variant II Turbo,2,"April 06, 2011", 2011,Bio-Rad Laboratories Inc,Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.,PRODUCTION CONTROLS: Process Control,"The firm, Bio-Rad, sent a ""MEDICAL DEVICE CORRECTION"" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following:1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter.2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert.3) Complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to: Bio-Rad CSD Regulatory Affairs Department at (510) 741-3954.If you have any questions, please call 510-724-7000 or contact your regional Bio-Rad office.",Contact the recalling firm for information,51,51 kits (Lot # 70292242; 45 kits( Lot # 70292318),"Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.",Terminated,"June 29, 2011",84,51,Not_Computer,N/A,N/A,N/A
Z-1891-2011,57972,"mask, oxygen",BYG,Oxygen mask.,Anesthesiology,Anesthesiology,510(K) Exempt,"Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.",Universal F2 Anesthesia Breathing Circuit,2,"April 06, 2011", 2011,King Systems Corp.,The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.,OTHER/UNDETERMINED: Pending,"The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.",N/A,416,416 cases of 30 per case 12480 units,"Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.",Terminated,"August 14, 2012",496,2042,Not_Computer,N/A,N/A,N/A
Z-1899-2011,57855,"device, heat-sealing",KSD,Heat-sealing device.,Hematology,Hematology,510(K) Exempt,"2380 MINI Hand-Held Tube Sealer Power Source(including a 23802000 Battery Pack)The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.",Haemonetics 2380 MINI HandHeld Tube Sealer Power Source,2,"April 06, 2011", 2011,Haemonetics Corporation,Battery pack may have exposed wire becoming hot,PRODUCTION CONTROLS: Equipment Maintenance,"The firm, Haemonetics, issued a ""Field Notification: 2380 Sealer battery pack"" letter dated January 28, 2011 to its customers. An international English version of this letter (CL101020-IE) has been released to foreign Distribution countries. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:1) Record the manufacturing date of battery, equipment model, serial number, and photo of the affected battery.2) Report the defect through the Haemonetics PIR system by emailing: sebra2380@haemonetics.com with all of the information listed including the appropriate contact information for their company.3) Recycle or dispose of the nickel-cadmium (NiCad) battery pack in accordance with the local, state, federal, or country specific regulations. Under no circumstances should the battery pack be incinerated as this can cause explosion and personal injury. The operation manual will be updated to provide additional information about the proper installation and removal of the battery. This updated manual will be distributed with new devices upon release.Should you have any questions or concerns regarding this matter, please contact the firm at sebra2380@haemonetics.com.",N/A,50031,"50,031 units","Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.",Terminated,"March 06, 2012",335,50031,Not_Computer,N/A,N/A,N/A
Z-1903-2011,58241,"needle, suturing, disposable",GAB,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILEAfter the Curvtek device is used to drill a ""C"" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.","CURVTEK EYE NEEDLE, 12 MM LARGE",2,"April 06, 2011", 2011,"Biomet, Inc.","The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"The firm, BIOMET, sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" letter dated March 10, 2011 to all customers. The letter described the product, problem and actions to be taken. The letter noted that -Use of a non-sterile Curvtek Eye Needle may lead to patient infection, possibly requiring a revision procedure. The customers were instructed to immediately locate, discontinue use of the product , remove the product from circulation and return the product to Biomet; carefully follow the instructions on the enclosed FAX BACK RESPONSE FORM; complete and return the response form via fax to 574-372-1683 prior to return of product; use priority carrier for shipment, and please confirm receipt of this notice by calling 800-348-9500, extension 3755 or 3756. The firm also informed physicians that had previously utilized the device to monitor patients for infection and provide treatment as appropriate. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8am to 5pm.",No consumer action necessary,35,35,Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.,Terminated,"July 27, 2011",112,35,Not_Computer,N/A,N/A,N/A
Z-1901-2011,58208,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.",Prismaflex,2,"April 06, 2011", 2011,"Gambro Renal Products, Incorporated",Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, GAMBRO Renal Products, sent an ""URGENT - MEDICAL DEVICE RECALL"" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, ""Softkeys won't work."" of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).",N/A,1300,1300 units,Nationwide distribution.,Terminated,"September 01, 2011",148,1300,Other,N/A,Instructions,Safety Notice/Insructions
Z-1904-2011,58099,"compressor, cardiac, external",DRM,External cardiac compressor.,Cardiovascular,Cardiovascular,510(k),"Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.",Zoll Auto Pulse Resuscitation System,3,"April 07, 2011", 2011,"Zoll Circulation, Inc.",Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).,PRODUCTION CONTROLS: Process Control,"The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.",N/A,N/A,not provided,"Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.",Terminated,"April 28, 2011",21,N/A,Battery,Device Operation,Repair,Repair
Z-1905-2011,58112,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARIA versions 8.0 and 8.1Varian Medical Systems, Palo Alto, CA 94304The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.",ARIA versions 8.0 and 8.1,2,"April 07, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.",OTHER/UNDETERMINED: Pending,"Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items.For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265.Europe +41 41 749 8844.",N/A,645,645,"Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, HOng Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithania, Malaysia, Maurtama, Morocco, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.",Terminated,"June 19, 2012",439,645,Computer,N/A,N/A,N/A
Z-1915-2011,56977,"lift, patient, ac-powered",FNG,AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift System, Cascade Transfer, Models 383500-1 (right entry with scale). The firm name on the label is Penner Manufacturing Inc., Aurora, NE.For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.",Penner Patient Transfer/Lift System,2,"April 08, 2011", 2011,Penner Mfg Inc,Incomplete weld on the pillar mounting bracket,TRAINING: Employee Error,"The firm, Penner, sent an undated letter flagged ""Important Safety Inspection: Action Required"" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003.If you have any questions, contact the Quality Assurance Manager at 402-694-5003.",N/A,20,20 lifts,Worldwide distribution: USA and countries including: Canada and Mexico.,Terminated,"April 08, 2011",0,2290475,Not_Computer,N/A,N/A,N/A
Z-1929-2011,57288,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GEThe CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options. The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SpO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.",GE CARESCAPE Monitor B850,2,"April 08, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of potential safety issues associated with the CARESCAPE"" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PSMP), E- MASIMO or E-(P)RE(S)TN modules or Bed-to-bed alarming feature is used.1. When CARESCAPE Monitor B850 is used with the above listed modules, some SpO2 alarms may be delayed or missed.2. Whe",DESIGN: Software Design,"The firm, GE Healthcare, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated February 25, 2011 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the recall product the problem, Safety Issues, Affected Product details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to follow the safety instructions provided in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available.If you have any questions regarding this medical device correction or the identification or affected items please contact Technical Support at 1-800-558-7044, or your local Service Representative.",Contact the recalling firm for information,3817,3817,"Worldwide distribution: USA including states of:AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA,WA, WI, and WV; and countries including: JERUSALEM, UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLAND, MALTA, MALAYSIA, LEBANON, KUWAIT, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CHILE , CANADA, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA.",Terminated,"June 05, 2012",424,3817,Software,Alarm/Message,Software update,Software Update
Z-1925-2011,57866,"enzyme immunoassay, inhibin-a",NDR,Estradiol test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Inhibin A ELISA kit, Part Number: DSL-10-28100-4The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.",Inhibin A ELISA Kit,3,"April 08, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottlesincluded in the kit.,N/A,"Beckman Coulter sent an Urgent Product Corrective Action letter dated December 21, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and discard all remaining inventory. In addition customers were requested to share the information with their laboratory staff and retain the notification as part of their laboratoryQuality System documentation. Customers were instructed to complete and return the enclosed response form within 10 days soBeckman could be assured that customers received this important notification.For product replacement:1. In the United States, please contact Customer Service at 1-800-526-3821, option 1.2. In Canada, please contact Customer Service at 1-800-463-7828.3. Outside of the United States and Canada, contact your local Beckman Coulter representative.Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. For those customers outside the United States and Canada, instructions were given to contact their local Beckman Coulter representative.",N/A,740,740 total units for both products,"Worldwide Distribution - USA including NY, IN, PA, NM, OH, TX, AZ, NC, TN, MI and CT and the countries Denmark, Germany, Spain, Turkey, United Arab Emirates, United Kingdom.",Terminated,"August 31, 2012",511,740,Not_Computer,N/A,N/A,N/A
Z-1907-2011,58006,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816.Siemens Medical Solutions USA, Inc.Business Unit Ultrasound1230 Shorebird Way,Mountain View, CA 94043High-density array transducer for pediatric and fetal echocardiography applications.",8V3c transducer ,2,"April 08, 2011", 2011,"Siemens Medical Solutions USA, Inc.","When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use.",DESIGN: Software Design,A Customer Safety Advisory Notification was initiated on 2/4/2011 and sent via certified mail. The letter identified the affected product and described when the problem occurs along with the associated potential risk. The firm recommends that users not use the 8V3c until the software issue is fixed. The firm is working to release a software update and customers' local Customer Service Engineer will install new software on their system when it is available. Customers should direct their questions to their local service support person. The information in the letter should be shared with all personnel within the organization who need to be aware.,Contact the recalling firm for information,386,386 units,Worldwide Distribution.,Terminated,"October 04, 2011",179,386,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1909-2011,58093,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.",SPIDER Surgical Platform,2,"April 08, 2011", 2011,"Transenterix, Inc",Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.,OTHER/UNDETERMINED: Pending,"TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product toTransEnterix using the enclosed shipping label. Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory.Their sales representative and customer service will work with them to replace the product in full at not cost to them.For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.",Contact the recalling firm for information,305,305 units,"Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA",Terminated,"November 07, 2011",213,397,Not_Computer,N/A,N/A,N/A
Z-1928-2011,58014,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001;Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton MedicalIntended for use in the hospital and institutional environment where healthcare professionals provide patient care.,HamiltonG5 Ventilator ,2,"April 08, 2011", 2011,Hamilton Medical Inc,The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.,DESIGN: Software Design,"A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the ""high tidal volume"" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.",N/A,97,97 units,"Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.",Terminated,"March 21, 2012",348,97,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-1930-2011,58275,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, CARESCAPE Monitor B650The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.",CARESCAPE Monitor B650,2,"April 08, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases.1. When the CARESCAPE Monitor is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectl",DESIGN: Software Design,"The firm, GE Healthcare, sent ""Urgent Medical Device Correction"" letters dated March 23, 2011 to its consignees/customers. The letters were addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letters described the Safety Issues, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. The customers were instructed to follow the safety instructions documented in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available and will contact the customer to schedule the software update.If you have any questions regarding this medical device correction or the identification of affected items, please contact Technical Support at 1-800-558-7044, or your local Service Representative.",No consumer action necessary,1443,1443,"AL, AZ, AR, CA, CO, CT, FL,GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA,PR, SC, TN,TX, UT, VA, WA, WV, WI.UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SWITZERLAND, SWEDEN SLOVENIA, SLOVAKIA, SPAIN, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NORWAY, NORTH KOREA, NEW ZEALAND, NETHERLANDS, MALTA, MALAYSIA, LITHUANIA, LEBANON, KUWAIT, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, DENMARK, ESTONIA, CZECH REPUBLIC, BELGIUM BAHRAIN, COLOMBIA, CHILE CANADA, BRAZIL, AUSTRIA, AUSTRALIA.",Terminated,"February 04, 2012",302,8345,Computer,N/A,N/A,N/A
Z-1927-2011,58143,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Inflow/Outflow Cannula;Qty: 1;distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in endoscopic surgeries. It will be used by orthopedic surgeons in arthroscopic knee and shoulder procedures as well as used in conjunction with the Stryker Flow Control Arthroscopy pump and with all 502-477-xxx scopes. The design included dual scope sheaths made of metal that offer two important features. First, it will separate the inflow irrigation to the operative site from the outflow irrigation out of the operative site. Second, the cannula will have a dual stopcock design that will separately control the inflow and outflow irrigation ports.",Inflow/Outflow Cannula,2,"April 08, 2011", 2011,Stryker Endoscopy,Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.,OTHER/UNDETERMINED: Pending,"The firm, Stryker, issued an ""URGENT: DEVICE CORRECTION"" memo dated March 8, 2011 to all customers. The memo described the product, problem and actions to be taken. The customers were instructed to discard any old Instructions for Use (1000-400-816 rev. A or B) for their Inflow/Outflow Cannual; download the new IFU (1000-400-816 rev. C) from the URL link: http://stryker.com/InflowOutflowCannual; ensure they follow the new cleaning instructions provided in the IFU and complete and return the enclosed ""acknowledgement of receipt"" form and fax to (408) 754-8378 or scan in and email to cannula@stryker.com. Stryker stated in the memo that ""It is important to send the self addressed confirmation forms back to Stryker RAQA"". If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at cannula@stryker.com.",Contact the recalling firm for information,2618,2618 devices,"Worldwide distribution: USA including states of: AL, ALASKA, AK, AR, CA, CO, CT, DC, DE, FL, GA, ID IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: Australia, Canada, China, France, Germany, India, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Switzerland and United Kingdom.",Terminated,"October 04, 2011",179,2618,Not_Computer,N/A,N/A,N/A
Z-1924-2011,57141,"heat-exchanger, cardiopulmonary bypass",DTR,Cardiopulmonary bypass heat exchanger.,Cardiovascular,Cardiovascular,510(k),"Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.",MPS and MPS 2 Consoles,3,"April 08, 2011", 2011,"Quest Medical, Inc",User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.,PRODUCTION CONTROLS: Equipment Maintenance,"Quest Medical Incorporated sent a ""User Update"" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.",N/A,771,771 consoles,"Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy",Terminated,"April 26, 2011",18,771,Not_Computer,N/A,N/A,N/A
Z-1932-2011,54483,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CAThe Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ion¶_exchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-¶_throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.",Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program,2,"April 11, 2011", 2011,Bio-Rad Laboratories Inc,Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"Bio Rad Laboratories, Inc. sent an Urgent Medical Device Correction letter dated December 1, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediatey examine their records to identify all customers who received one of the affected lots.Collect a Customer Medical Device Correction Response Form from every customer.Once forms were received from all applicable customers, complete the following Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or pdf to CSD Recall Coordinator (excluding USSD).For questions regarding this recall call 510-724-7000.",N/A,1099,1099,"Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Taiwan, Singapore, India, China, S. Korea, Hong Kong, France, Sweden, United Kingdom, Italy, Hungary, Germany, Brazil, Mexico and Colombia.",Terminated,"August 30, 2011",141,1099,Not_Computer,N/A,N/A,N/A
Z-1943-2011,57189,"sensor, blood-gas, in-line, cardiopulmonary bypass",DTY,Cardiopulmonary bypass in-line blood gas sensor.,Cardiovascular,Cardiovascular,510(k),"Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.",CDI 101,2,"April 11, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.",DESIGN: Device Design,"On 11/1/2010, Terumo sent ""URGENT MEDICAL DEVICE CORRECTION"" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, the user should verify the accuracy by independent means before treating. The letter included ""Caution"" stickers that were to be applied to the CDI system operators manual.",Contact the recalling firm for information,468,468 monitors,"US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.",Terminated,"April 17, 2012",372,1500,Not_Computer,N/A,N/A,N/A
Z-1938-2011,57952,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"UniCel DxI 800 Access ImmunoassaySystems; Part Number(s): DxI 800: 973100, DxI 800 RemanufacturedA25288, DxI 800 with spot B A71456, DxI 800Reconditioned A25285The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.",UniCel DxI 800 Access Immunoassay Systems,2,"April 11, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patientidentifications when two sample racks advanced into the sample presentation area in one push. The firstrack of the two was not scanned. This is referred to as a ""pushed pair."" If a pushed pair event occurs, results may be associated with the incorrect patient identification.",N/A,"Beckman Coulter sent an Urgent: Field Safety Notice Product Correction letter dated January 26, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:1. To prevent a pushed pair, be sure your sample racks are free of debris prior to use. Do not applyadditional labels to the sample racks. Extra labels can obscure the edges of a sample rack, orobstruct the gap between two racks. Be sure sample labels do not extend beyond the edges of asample rack;2. If a pushed pair occurs on the UniCel DxI system, the system generates a yellow Event Log message- Clear the presentation tray and press ROUTINE button. This Event Log message is associatedwith a variety of common Sample Presentation Unit (SPU) errors. For that reason, you must reviewthe Event Log details to confirm the pushed pair event has not occurred;3. Detach the Appendix included with this notification and store it near your UniCel DxI system. Use theAppendix as a reference if you suspect a pushed pair event has occurred on your system.Beckman Coulter also requested their customers share the recall information with their laboratory staff, and retain pages 1 and 2 of this notification as part of your laboratory Quality System documentation.For questions regarding ththe recall notification, customers were instructed to contact Beckman Coulter Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support, or call1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact theirlocal Beckman Coulter Representative.",Contact the recalling firm for information,2639,2639 units (892 in US),"Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.",Terminated,"June 04, 2012",420,2639,Not_Computer,N/A,N/A,N/A
Z-1933-2011,57953,"bed, hydraulic, adjustable hospital",FNK,Hydraulic adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterprise series hospital beds; Distributed by ArjoHuntleigh, a Branch of Arjo Limited Med AB, Wednesbury, United Kingdom Lifting poles are accessories intended to assist patients in positioning themselves on a hospital bed and the lifting pole is used in conjunction with a strap and handle. The strap and handle hangs from the lifting pole and the patient grasps the handle to pull upon the strap when repositioning themselves",Rolko Adjustable Strap and Handle,2,"April 11, 2011", 2011,"Arjo, Inc. dba ArjoHuntleigh",Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap.,OTHER/UNDETERMINED: Pending,"ArjoHuntleigh sent an Urgent Field Safety Notice to all affected end users via UPS Ground on February 24, 2011. The notice informed the accounts of the potential for the strap retracting mechanism to break during use. The accounts were requested to check their inventory for the presence of adjustable straps and handles procured from ArjoHuntleigh, note if they have a red button on the retractor housing and the affected production dates as explained in the photographs in Figures 1 and 2 in the letter. Any straps and handles found as identified in Figures 1 and 2 should be removed from use and returned to ArjoHuntleigh. Any straps and handles with a yellow button design as shown in Figure 3 are not affected and can continue being used. The accounts were requested to complete and fax or mail the enclosed Customer Response Form to Arjo at 630-576-5012, indicating the number of strap and handles checked and how many were removed from use. Questions were directed to the ArjoHuntleigh Regulatory Department at 1-630-785-4885.",Contact the recalling firm for information,90,90 units,"Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas",Terminated,"June 14, 2011",64,90,Not_Computer,N/A,N/A,N/A
Z-1941-2011,58098,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.",Sensor cables,2,"April 11, 2011", 2011,"GE OEC Medical Systems, Inc",Sensor cables may suffer material degradation when exposed to certain sterilization procedures.,DESIGN: Component Design/Selection,"GE OEC Medical Systems, Inc sent an Urgent Recall Notice dated March 1, 2011, by certified letter on February 24, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if their Transmitter Sensor Cables or Receiver Sensor Cables have been exposed to any STERRAD sterilizer other than STERRAD 1005, discontinue use of these sterilizers for this product. The Transmitter Sensor Cables should be inspected for signs of material degradation.Further information is available at 800-874-7378.",N/A,708,708 cables,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI and WV and the countries of Austria, Canada, China, Denmark, England, France, Germany, Hong Kong, India, Ireland, Italy, Japan, San Salvador, Slovakia, Spain, and Switzerland.",Terminated,"September 09, 2011",151,708,Not_Computer,N/A,N/A,N/A
Z-1945-2011,58163,"radioimmunoassay, free thyroxine",CEC,Free thyroxine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems",Access Free T4 Calibrator,2,"April 11, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment.,OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" (PCA) letter dated November 29, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: ACTION/RESOLUTION:"" Discontinue use of Access Free T4 calibrator lot 014769."" Review historical quality control performance and determine whether any reported patient results were obtained while using a faulty calibration. If results were affected, you will see a shift downward in control recovery that produces out-of-range low QC results."" If patient results were obtained with Access Free T4 calibrator lot number 014769, it is possible they are erroneously low. If any patient results were reported in the period between the time the erroneous calibration with the affected lot was performed and when a different calibrator lot was used, the laboratory should consider advising physicians to whom results were reported so they can evaluate whether diagnosis or treatment decisions should be revisited."" No further orders of Access Free T4 Calibrator lot number 014769 will be shipped. Alternate lots will be provided for current and future replenishment orders or requests.Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed RESPONSE FORM via fax to Beckman Coulter at 786-639-4000. For product replacement:"" In the United States, please contact Client Services at 1-800-526-3821, option 1."" In Canada, please contact Customer Service at 1-800-463-7828."" Outside of the United States and Canada, contact local Beckman Coulter representative.Questions and answers regarding this issue were enclosed for consignee/customer reference. Additional questions, were directed to the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customer.",Contact the recalling firm for information,459,459 units,"Worldwide distribution: USA and countries including: Argentina, Belgium, Bosnia and Herzegovina, Canada, China, Colombia, Czech Republic, French Polynesia, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, Philippines, Russian Federation, South Africa, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Venezuela, and Zambia.",Terminated,"July 11, 2012",457,459,Not_Computer,N/A,N/A,N/A
Z-1961-2011,52928,"transducer, ultrasonic, diagnostic",ITX,Diagnostic ultrasonic transducer.,Radiology,Radiology,510(k),"Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA.The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.",ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transducer,2,"April 12, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.",DESIGN: Software Design,"The firm, SIEMENS, sent a ""Customer Safety Advisory Notification"" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available.Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.",N/A,2591,2591 units,Worldwide distribution.,Terminated,"March 09, 2012",332,2591,Software,Physical Safety Hazards,Instructions to disconnect transducer/Software update,Software Update
Z-1844-2011,58076,"laser, ophthalmic",HQF,Ophthalmic laser.,Ophthalmic,Ophthalmic,510(k),Ellex Solo LT5106-S ophthalmic laser (not sold in USA),Ellex Solo,2,"April 12, 2011", 2011,Ellex Medical Pty Ltd,Unintended laser emission while the user was moving the joystick for targeting.,PRODUCTION CONTROLS: Process Control,"Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.",Contact the recalling firm for information,193,193 units,worldwide distribution,Terminated,"October 02, 2012",539,2335,Not_Computer,N/A,N/A,N/A
Z-1958-2011,58122,"chair, dental, without operative unit",NRU,Dental chair and accessories.,Dental,Dental,510(K) Exempt,"Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane.Part number for the bolt: 022R065Product is labeled in part:DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17.",DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit,2,"April 12, 2011", 2011,Dental Equipment LLC,Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.,PRODUCTION CONTROLS: Process Control,"On 03/08/11, Dental Equipment LLC. started sending out the Medical Device Recall notification letter via USPS 1st class mail to US consignees and Federal Express mail to foreign consignees.The firm also sent a recall notification letter to consignees who only purchased dental accessories such as Rear Mounted Cuspidor with Coverset, Arm Articulating Rear Mounted Cuspidor - Marus Gray, Maxstar Orbit Cuspidor utility W/ Porcelain bowl, and zinc plated bolts.The letter identified the affected dental chair as Marus brand with the following model numbers: DC1490, DC1690, DC1700 and DC1702.The firm's corrective action including the replacement of the affected link arm assembly with a new link arm assembly. The firm's field representative will contact each consignee for an appointment to replace the affected link arm assembly.Consignees can contact the Dental Equipment LLC at 503-537-3617 for any questions.",N/A,66,55 chairs and 11 replacement bolts distributed to US and foreign consignees outside the US.,"Worldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam.",Terminated,"September 21, 2011",162,66,Not_Computer,N/A,N/A,N/A
Z-1959-2011,58110,"system, x-ray, stationary",KPR,Stationary x-ray system.,Radiology,Radiology,510(k),Axiom Aristos FX and FX Plus SystemIntended use: Stationary x-ray system,Siemens Axiom Aristos FX and FX Plus System,2,"April 12, 2011", 2011,"Siemens Medical Solutions USA, Inc","During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect",OTHER/UNDETERMINED: Pending,"The firm, SIEMENS, sent a ""Safety Advisory Notice"" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.",N/A,101,101,"Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.",Terminated,"July 16, 2013",826,101,Not_Computer,N/A,N/A,N/A
Z-1957-2011,58072,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.",Varis Vision RT Chart ,2,"April 12, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.,DESIGN: Software Design,"Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected customers on February 7, 2011.",Contact the recalling firm for information,421,421,Worldwide Distribution.,Terminated,"December 23, 2011",255,421,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-1952-2011,57830,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.,ArthroCare Opus SpeedLock ,2,"April 12, 2011", 2011,ArthroCare Corporation,"During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.",PRODUCTION CONTROLS: Process Control,"On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.",N/A,170,170 units,Product was released for distribution in US.,Terminated,"August 01, 2011",111,170,Not_Computer,N/A,N/A,N/A
Z-1953-2011,57990,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Coulter LH750 AnalyzerThe COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.",COULTER LH750 Analyzer,2,"April 12, 2011", 2011,Beckman Coulter Inc.,"This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greaterthan 2010. The following dates are affected: Run date, Control expiration date, Date of birth(For individuals born in 2011 or later), a",DESIGN: Software Design,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCTION CORRECTION"" letter dated January 31, 2011 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Coulter LH 750 Analyzer, Coulter LH 780 Analyzer, Coulter LH 500 Series System, and Coulter GEN S System. The letter describes the product, problem and actions to be taken. The customers were instructed to work with their US vendor to assess how this affects their laboratory. The actions they choose are dependent on the configuration of their LIS.ACTION FOR ISSUE 1:Use Sample Drawn Date and Date of Birth information available at your LIS in lieu of the analyzer transmitted fields BIRTH and UDATE.Use the current date when the results are received at the LIS in lieu of the transmitted Run Date [DATE]. Print results from the Workstation to keep a copy of the analysis date on the analyzer, if necessary.Use the control expiration date from the analyzer display or printout.ACTION FOR ISSUE 2:If you use the LIS 1G1 transmission format, use the General Information group field names in place of the Retic Parameter group field names to identify each reticulocyte run (see Table in Issue 2 section).Check with your LIS vendor to determine if it is possible to switch to the LH 750 Workstation transmission format. Format requirements are LIS driver specific.For patients with Dates of Birth in 2011 for both Issue 1 and Issue 2, results should be reviewed to determine if decision rules or age-related limits sets were triggered inappropriately.RESOLUTIONThese issues will be corrected in a future software release for the LH Series products. The GEN¶_¶_S product has been discontinued; no software revisions will be forthcoming for the GEN¶_¶_S product line. Customers were also instructed to complete and return the PRODUCT CORRECTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 310B06, 11.",Contact the recalling firm for information,9419,9419 (total units distributed in U.S. & foreign countries),"Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Monaco, Morrocco, Myanmar, Namibia, Netherlands, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Virgin Islands (US).",Terminated,"September 25, 2012",532,9419,Software,Output/Calculation,Software update,Software Update
Z-1934-2011,57450,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Liquid Waste BottleTo store waste material from completed assays.,Liquid Waste Bottle,2,"April 12, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.",N/A,"The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration. New bottles are opaque white in color.Signs of deterioration include:o Any color change to the bottle (yellow, orange or pink)o Crackingo Crazing (spider web cracking)Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i.",No consumer action necessary,7700,7700 units total (3178 in US),"Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.",Terminated,"July 25, 2012",470,7700,Not_Computer,N/A,N/A,N/A
Z-1950-2011,57815,"electrode, electrodcardiograph, multi-function",MLN,Electrocardiograph electrode.,Cardiovascular,Cardiovascular,510(K) Exempt,"Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.",Medstorm Adult Radiolucent LeadsOut Electrode ,2,"April 12, 2011", 2011,"Heart Sync, Inc","The ""leads out"" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.",PRODUCTION CONTROLS: Equipment Maintenance,The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.,N/A,2100,2100 (210 cases of 10 each),Nationwide Distribution,Terminated,"April 13, 2011",1,2150,Not_Computer,N/A,N/A,N/A
Z-1947-2011,57385,"instrument, cranioplasty material forming",HBX,Cranioplasty material forming instrument.,Neurology,Neurology,510(K) Exempt,DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubingProduct Code: 281103Fluid Tissue Management,DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing,2,"April 12, 2011", 2011,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Product sterility may be compromised due to breach in sterile packaging,PRODUCTION CONTROLS: Packaging Process Control,"Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to:DePuy MitekATTN: Recall Coordinator50 Scotland BoulevardBridgewater, MA 02324Record their assigned return material authorization (RMA) number on the outer shipping box.Use the Prepaid Federal Express shipping label for the return of the product.Include a photo copy of the completed business reply form.For questions or concerns call 1-800-382-4682, PROMPT 3.",N/A,7344,7344 units (372 boxes x 24 pieces),"Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.",Terminated,"April 02, 2013",721,149720,Not_Computer,N/A,N/A,N/A
Z-1967-2011,58304,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112.A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set","Container, IV",2,"April 12, 2011", 2011,Baxa Corporation,"TPN bags may leak during filling operation, due to bag manufacturing error.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, BAXA, sent a ""ExactaMix Bag Product Notice"" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following:If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag.If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only.To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292.If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.",Contact the recalling firm for information,336650,"336,650 bags","Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.",Terminated,"March 23, 2012",346,6561200,Not_Computer,N/A,N/A,N/A
Z-1960-2011,58290,"sterilant, medical devices",MED,Liquid chemical sterilants/high level disinfectants.,General Hospital,General Hospital,510(k),"STERIS SYSTEM 1E Liquid Chemical Sterilant Processing SystemThe SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.",SYSTEM 1E liquid chemical sterilant processing system,2,"April 12, 2011", 2011,Steris Corporation Hopkins Facility,"The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco",OTHER/UNDETERMINED: Pending,"The firm, STERIS, Issued an 'Urgent Field Correction Notice' dated March 14, 2011 addressed to their Hospital Administrator, or Manager, and Risk Manager customers on March 18, 2011. The notification letter describes the product subject to field correction and the problem that exists with the language omission present in the printout display and Operator Manual messages which warn of an incomplete or aborted processing cycle. The notification goes on to state that there is no health hazard involved in this error, as the users are still made aware that the processing cycle has not been successfully completed. The notification goes on to remind the user/customers that in case of any incomplete, cancelled or aborted cycle, the users are instructed to process devices in the cycle following the directions contained in the Operator Manual. Lastly, the notification letter informs the user/customers that the company will be installing new software on the recalled systems in order to revise the language on the cycle printout and the display screen warning of a disrupted cycle. It also states that a STERIS Service Representative will be contacting each facility in order to schedule installation of the new software. The notification also provides the customers with a 1-800 telephone number for STERIS Field Service Dispatch, to be used if the customers have questions or want to request additional information. It also provides a local telephone no. 1-440-392-7455, for obtaining additional information from the firm's Director, Div. of Low Temperature Sterilization at: 1-440-392-7455.",N/A,106,106 units,"Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.",Terminated,"March 13, 2013",701,106,Software,Alarm/Message,Software update,Software Update
Z-1906-2011,58175,"device, neurovascular embolization",HCG,Neurovascular embolization device.,Neurology,Neurology,510(k),"Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Microcatheter.","Penumbra brand Penumbra Coil System, Penumbra Coil 400",1,"April 12, 2011", 2011,Penumbra Inc.,The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Penumbra sent an Urgent Voluntary Field Removal Notice dated March 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to immediately inspect all stock of Penumbra Coil 400 and identify product from the Lots.Remove product from these Lots from inventory and place it in quarantine for return to Penumbra Inc. (Do not use product from these Lots).Complete and return the attached product identification/ return form with in 5 business days via fax to +1 510-217-6414.Penumbra employees will contact customer directly to arrange return and replacement of product.For questions call Regulatory Affairs at 510-748-3224 or e-mail RAQA@prenumbrainc.com.",N/A,2082,2082,"Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.",Terminated,"June 06, 2011",55,2082,Not_Computer,N/A,N/A,N/A
Z-1949-2011,58169,"enzyme immunoassay, non-radiolabeled, total thyroxine",KLI,Total thyroxine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lotsThe Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.",Access Total T4 Reagent Kit,2,"April 12, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%)when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range)could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associatedwith pregnancy could result in serious, permanent harm",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an Urgent Product Correction letter dated March 20, 2011, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignees were issued the following instructions:(1) If you suspect pregnant patient results were evaluated at your laboratory using only Total T4 to report thyroid status, consider reviewing Total T4 results reported in the last 9 months. Consult with your Laboratory Medical Director and requesting physician toresolve any concerns you may have regarding previously reported patient results during this time period.(2) Do not use the Access Total T4 assay as the only marker for evaluating pregnant patients for thyroid disorders.(3) Please share this information with your laboratory staff and retain this notification as part ofyour laboratory Quality System documentation. If you have forwarded Access Total T4 reagent kits (Part Number 33800) to another laboratory, please provide a copy of this letter to them.(4) Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.For questions regarding this notice, consignees were instructed to contact Beckman Coulter Customer Support Center.(1) Via our website, http://www.beckmancoulter.com/customersupport/support(2) Via phone, call 1-800-854-3633 in the United States and Canada(3) Outside the United States and Canada please contact your local Beckman Coulter.",N/A,151740,"151,740 units","Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, and Zambia",Terminated,"August 10, 2012",486,151740,Not_Computer,N/A,N/A,N/A
Z-1970-2011,53195,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.",LANTIS Oncology Information System,2,"April 13, 2011", 2011,"Siemens Medical Solutions USA, Inc","When editing the note type of a previously entered note, then reverting to the original type, data may be lost.",DESIGN: Software Design,"Siemens sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to configure their system to lock all new notes automatically.To automatically lock new notes, open eChart Navigator, right mouse click in the notes section, select ""configuration"" and select ""Automatically Lock New Notes.""If the customer chooses not to configure their system to automatically lock new notes, follow at least one of the suggestions listed below:If the customer must edit a note type, use the append feature and document that they are making an edit to the note.Lock all new notes that are entered via eChart Notes. To lock a note manually, after creating the note, right mouse click and select ""Lock,""Access and enter patient notes via eChart Notes until a LANTIS upgrade has been performed at your site.When entering patient notes via eChart Navigator, make sure that you are entering the notes in the correct section.\When entering patient notes via eChart Notes, make sure that the correct note type has been selected.Customers are to keep the Customer Safety Advisory Notice together with their LANTIS 8.30 User Manual where it should remain until the measures defined above are performed. For questions call 1-888-826-9702.",N/A,30,30 affected units,"Worldwide Distribution - USA including DE, WI, TX, TN, NJ, PA, NE, MA, and AL and the countries of South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan.",Terminated,"April 13, 2011",0,30,Not_Computer,N/A,N/A,N/A
Z-1976-2011,57714,"lenses, soft contact, daily wear",LPL,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,N/A,"SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USASoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic",SoftPerm (synergicon A) contact lenses,2,"April 13, 2011", 2011,"CIBA Vision Puerto Rico, Inc.",Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270),OTHER/UNDETERMINED: Pending,"The firm, CIBA Vision, sent two letters of notification to its customers. First letter ""IMPORTANT PRODUCT INFORMATION"" dated June 2010 and the second ""URGENT: Voluntary Product Recall"" dated February 1, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1) complete the requested information on the attached SoftPerm (synergicon A) Lenses Reply Form and drop the form in the mail within 10 business days and 2) If they have any of the recalled SoftPerm (synergicon A) lenses (shipped to you after March 1, 2009) still in their possession, return as follows: Package the product and affix the prepaid UPS return label and ship within 10 business days or mail to CIBA VISION Corporation, c/o Stericycle Pharmaceutical Services, 2670 Executive Drive, Ste. A, Indianapolis, IN 46241, Atth: SoftPerm Recall. CIBA ask customers to please not include other products, lots, kits, packs, or competitor's products with their shipment. In addition, CIBA will issue a credit to the customers account upon receipt of the returned product. Please feel free to contact Stericycle at 877-542-5928 or CIBA VISION Technical Consultation Department at 1-800-241-7468 should you have any questions or concerns.",Contact the recalling firm for information,152,"28, 124","Worldwide distribution: USA (nationwide) including PR; and countries including: Australia, Austria, Argentina, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Dubai (United Arab Emirates), Finland, France, Great Britain, Greece, Hungary, Iceland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Netherlands, Oman, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and Venezuela.",Terminated,"November 30, 2011",231,28124,Not_Computer,N/A,N/A,N/A
Z-1969-2011,56807,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette;Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CASystem Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.",BioRad D10 Hemoglobing Testing System,3,"April 13, 2011", 2011,"Bio-Rad Laboratories, Inc., Hercules, CA",The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.,OTHER/UNDETERMINED: Pending,"The Bio-Rad Laboratories, Inc, sent a Medical Device Correction letter dated 9/8/10, to all affected customers via Federal Express addressing this mislabeling issue, a new Update Kit Floppy Diskette, Lot No. BA02210 has been produced, and Bio-Rad requests that you please destroy the Lot No. AA01815. If you have any questions please contact your regional Bio-Rad office. You may also call (510) 724-7000.",N/A,N/A,N/A,"Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.",Terminated,"June 29, 2011",77,N/A,Not_Computer,N/A,N/A,N/A
Z-1973-2011,58035,"table, radiographic, tilting",IXR,Radiologic table.,Radiology,Radiology,510(K) Exempt,Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246.Used in clinical and hospital settings by trained radiologists.,Rapid Response HUT Table,2,"April 13, 2011", 2011,Medical Positioning Inc,The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.,OTHER/UNDETERMINED: Pending,An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or jhurtig@medicalpositioning.com to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructions were sent to each consignee. The instructions consisted of (1) Rapid Response HUT Motor Replacement Instructions; (2) Control Box Replacement Instructions; and (3) ILD External Power Supply Removal Instructions.,N/A,58,58 total,"Worldwide Distribution -- USA, including Puerto Rico, and Canada.",Terminated,"June 15, 2011",63,58,Not_Computer,N/A,N/A,N/A
Z-1968-2011,58054,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),"Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly.Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.",Presource Custom Sterile Convenience Packs/Modules,2,"April 13, 2011", 2011,Cardinal Health,The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly.,TRAINING: Employee Error,"Cardinal Health issued an URGENT: PRODUCT RECALL letter dated February 28, 2011 to all affected consignees via UPS next day air, informing them that their Presource kit/modules listed in the attached spreadsheet contain a non-sterile petroleum-based lubricating jelly instead of the labeled water-based sterile lubricating jelly. Cardinal instructed the accounts to quarantine the pack/modules with the indicated work order/lot number on the enclosed spreadsheet and contact the appropriate Customer Service group listed in the letter for return instructions. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules being returned. If the product was further distributed, then those customers should also be notified.",Contact the recalling firm for information,4236,"4,236 modules",Nationwide Distribution,Terminated,"April 19, 2012",372,4236,Not_Computer,N/A,N/A,N/A
Z-1972-2011,58022,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405,UniCel DxC 600 PRO Part #: A11810,UniCel DxC 600i Part #: A27318,UniCel DxC 660i Part #: A64871,UniCel DxC 680i Part #: A64903,UniCel DxC 800 Part #: A11816,UniCel DxC 800 PRO Part #: A11812,UniCel DxC 860i Part #: A64935, andUniCel DxC 880i Part #: A59102.",UNICEL DXC SYNCHRON SYSTEMS,2,"April 13, 2011", 2011,Beckman Coulter Inc.,"The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.",N/A,"The recall communication was initiated with Beckman Coulter forwarding a Product Corrective Action Letter (PCA) dated November 16, 2010 to the affected customers. The recall notice explained the reason for recall and asked that customers take the following actions:(1) Customers with a service contract will have hose clamp covers installed by their Field Service Engineer during the next scheduled Preventive Maintenance (PM). A kit can be ordered through their Customer Service Representative if consignees prefer not to wait for the next Preventive Maintenance visit and(2) Customers without a service contract can obtain a kit by contacting their local Customer Service Representative.Customers were also informed that Kit (PN A68986) containing hose clamp covers and installation instructions is available at no charge from their Customer Service Representatives. One kit is required for each DxC system.The following telephone numbers were given for customers to obtain the kits: (800) 526-3821 (United States) and (800) 463-7828 (Canada).Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If any of the affected product was forwarded on to another laboratory they were asked to provide a copy of this letter to them.Questions are to be directed to Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.",N/A,1535,"1,535 units","Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom.",Terminated,"June 28, 2012",442,1535,Not_Computer,N/A,N/A,N/A
Z-1977-2011,58016,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)",UniCel DxH 800 Coulter Cellular Analysis System ,2,"April 13, 2011", 2011,Beckman Coulter Inc.,"There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results.IMPACT:Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.",Contact the recalling firm for information,422,422 units in total (175 in US),"Worldwide distribution: USA (nationwide) and countries including: Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.",Open,N/A,N/A,422,Not_Computer,N/A,N/A,N/A
Z-1982-2011,57776,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.",SmartInfuser PainPump,2,"April 14, 2011", 2011,"Hsmg, Inc. D/b/a Smartinfuser Usa",Elastomeric tube in product's compression unit has the potential to burst following filling.,OTHER/UNDETERMINED: Pending,"Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.",N/A,1483,"1,483 units",Nationwide Distribution,Terminated,"April 25, 2011",11,1851,Not_Computer,N/A,N/A,N/A
Z-1989-2011,58225,"prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer",MBH,Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Posterior Referencing Instrumentation for the NEXGEN¶_ COMPLETE KNEE SOLUTION QUICK-CONNECT HANDLE, REF 00-5901-034-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,INThis instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.",NEXGEN COMPLETE KNEE SOLUTION QUICKCONNECT HANDLE,2,"April 14, 2011", 2011,Zimmer Inc.,The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.,DESIGN: Device Design,"The firm, Zimmer, Inc., sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:Instructions for Handling of Affected Product:1) Stop using the devices and to quarantine immediately2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder3)Ensure they have provided acknowledgement via ""email return receipt"" upon receiving this notification4) Fax copy of completed form to (574) 372-42655) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.Instructions for Health Care Professional Notification1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a ""Dear Doctor"" letter for their surgeons.Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.ADDENDUM INFOThe information listed above was updated to include the additional 5 .",N/A,757,757,"Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.",Terminated,"March 19, 2013",705,9462,Not_Computer,N/A,N/A,N/A
Z-1983-2011,58048,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.",Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift ,2,"April 14, 2011", 2011,"Arjo, Inc. dba ArjoHuntleigh","The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.",DESIGN: Device Design,"ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.",N/A,1246,"1,246 units",Nationwide Distribution,Terminated,"February 16, 2012",308,1246,Hardware,Device Operation,Replace device,Remove or Replace
Z-1980-2011,58288,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Floor Cabinet Part Number: 723335The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)",UniCel DxH 800 Analyzer,2,"April 14, 2011", 2011,Beckman Coulter Inc.,"Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers.IMPACT:There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.",Contact the recalling firm for information,422,422 units in total (175 in US),"Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom",Terminated,"April 02, 2012",354,422,Not_Computer,N/A,N/A,N/A
Z-1984-2011,55910,abnormal hemoglobin quantitation,GKA,Abnormal hemoglobin assay.,Hematology,Hematology,510(k),"VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.",VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack.,3,"April 14, 2011", 2011,Bio-Rad Laboratories Inc,The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.,DESIGN: Software Design (Manufacturing Process),"Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response FormQuestions regarding this recall please call (510) 724-6114.",N/A,658,658 units,"Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.",Terminated,"August 08, 2011",116,658,Other,N/A,N/A,Other
Z-1979-2011,58173,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, SerialNumbers(s): All Serial NumbersThe COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).",COULTER ACT 5diff Autoloader Hematology Analyzer,2,"April 14, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment,or the delivery of",N/A,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTION"" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for RunningManual Samples. For more detailed instructions, please refer to your instrument's Instructions for Use (IFU), part number 624026, Section 8.4 Running Manual (Stat) Samples. An electronic version of the IFU can be found in the instrument's On-Line Help screen as well as the Beckman Coulter web site. For inconsistent data during patient's follow-up, please consider unusual/unanticipated high or elevated platelet levels as possible falsely elevated results due to this failure. An appropriate action for the need to look-back at previous results is at the discretion of the Laboratory Director, given the fact that laboratories have a variety of measures that are employed to ensure the validity of the results. Some of these provisions include delta checks, laboratory protocols for validating results and interaction with physicians.Additionally, the customers were also requested to complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM within ten (10) days via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015, or email to: Regulatory.notifications@beckmancoulter.com.For any questions concerning this notice, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter representative.",Contact the recalling firm for information,1211,"1,211 units","Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland,Taiwan, Tanzania, and Turkey.",Terminated,"July 16, 2012",459,1211,Not_Computer,N/A,N/A,N/A
Z-2000-2011,51504,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, CA.Medical charged-particle radiation therapy system.",LANTIS 6.1 Oncology Information System with MEDOne Module,2,"April 15, 2011", 2011,"Siemens Medical Solutions USA, Inc",The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"On 3/6/2009, a Safety Advisory Letter was distributed to all affected users, with a description of the problem and identifying the affected product. Customers were instructed not to use the LANTIS to calculate Creatine Clearance for any patient under two years of age. Customers should direct their questions with regards to the letter to their local Siemens Service organization. A Siemens Representative will update the systems.",N/A,17,17,Worldwide Distribution,Terminated,"April 15, 2011",0,17,Software,Output/Calculation,Software update,Software Update
Z-1998-2011,56636,cyclosporine,MKW,Cyclosporine test system.,Clinical Chemistry,Toxicology,510(k),"Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants",COBAS INTEGRA Cyclosporine Assay,3,"April 15, 2011", 2011,"Roche Diagnostics Operations, Inc.",The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.,OTHER/UNDETERMINED: Pending,"Roche Diagnostics Corporation sent an Urgent Medical Device Removal letter dated 8/13/2011, by UPS ( signature required ) to the consignees. The letter identified the product, the problem, and the action to be taken by the consignee.Consignees were instructed to discontinue use of affected product upon receipt of replacement product. Consignees were instructed to dispose of the product at their facilities. Therefore, no product returns are anticipated. Questions concerning this recall please call (317) 521-3911.",Contact the recalling firm for information,22,22 kits,"Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.",Terminated,"May 04, 2011",19,22,Not_Computer,N/A,N/A,N/A
Z-1999-2011,58202,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01A stand-alone PC application for administration of medications specific to the GemStar Infuser","GemStar SP Infusion Suite Database, Version 1.0 ",2,"April 15, 2011", 2011,Hospira Inc.,The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, Hospira, sent ""URGENT DEVICE FIELD CORRECTION"" letters dated March 23, 2011 to their customers on the same date. The letter described the product, problem and preventative action to be taken by the customers until the software can be upgraded. The customers were requested to contact Hospira Global Product Safety and Complaints at 1-800-441-4100 to report adverse events, and Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-262-577-6921.For additional information and technical assistance, contact Hospira Advanced knowledge Center at 1-800-241-4002, option 4 (available 24 hours a day/7 days per week).",Contact the recalling firm for information,139,139 units,"Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore",Open,N/A,N/A,139,Software,Device Operation,Software update,Software Update
Z-1873-2011,58134,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Toshiba Infinix-i, INFX-8000VThe expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.",Toshiba Infinixi,2,"April 15, 2011", 2011,Toshiba American Medical Systems Inc,Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.,Contact the recalling firm for information,220,220 units Nationwide,Nationwide Distribution,Terminated,"March 18, 2013",703,220,Computer,N/A,N/A,N/A
Z-2002-2011,58125,"apparatus, suction, single patient use, portable, nonpowered",GCY,"Nonpowered, single patient, portable suction apparatus.",General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA .The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.",Sarns Flexible Weighted Sucker ,2,"April 15, 2011", 2011,Terumo Cardiovascular Systems Corporation,The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting,DESIGN: Labeling Design,"SEE UPDATE BELOW IN ALL CAPS.The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only).If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM.ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED ""URGENT MEDICAL DEVICE RECALL"" THAT STATED ""AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT"" TO THE FIRM.",N/A,11690,"11,690","Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.",Terminated,"December 10, 2012",605,11690,Not_Computer,N/A,N/A,N/A
Z-2022-2011,58041,"electrode, ion specific, sodium",JGS,Sodium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.",iSTAT CHEM 8 Cartridge,2,"April 18, 2011", 2011,Abbott Point Of Care Inc.,"i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.",OTHER/UNDETERMINED: Pending,"The firm, Abbott Point of Care (APOC), sent an ""Urgent Recall Notice"" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the institution with a copy of this letter, and complete and return the business reply card to APOC.If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-336-8020, Option 1 or your Abbott Point of Care representative.",Contact the recalling firm for information,6575,6575 cartirdges,Nationwide distribution.,Terminated,"July 10, 2012",449,6575,Not_Computer,N/A,N/A,N/A
Z-2013-2011,58148,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),"Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USALubricating body orifices.",Water Soluble Lubricant,2,"April 18, 2011", 2011,DeRoyal Processing Center,Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.,PRODUCTION CONTROLS: Process Control,"The firm notified their consignees by a Re: DeRoyal Recall Of Triad Group Lubricating Jelly letter, dated Friday, March 18,2011. The letter discussed the reason for recall and the affected products. The letter asked customers to identify inventory using the attached spreadsheet and quarantine to prevent further use. Customers are to complete the spreadsheet regardless if they have effected product or not. The completed form can be faxed to 865-362-3716 or emailed to recalls@deroyal.com. All affected products should be return to DeRoyal at the address provided. Distributors are to forward a copy of the notice to their end-users. If there are questions or assistance is needed with the recall, Stephanie DeBusk should be contacted at 865-362-1037 or Sharon Cook at 865-362-6157.",Contact the recalling firm for information,323440,"323,440 units",Nationwide Distribution,Open,N/A,N/A,323440,Not_Computer,N/A,N/A,N/A
Z-2021-2011,58080,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"MAGNETOM Avanto, Espree, Trio A Tim System.Nuclear magnetic resonance imaging.","MAGNETOM Avanto, Espree, Trio A Tim System",2,"April 18, 2011", 2011,"Siemens Medical Solutions USA, Inc","Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.",OTHER/UNDETERMINED: Pending,"Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils.Further questions regarding this recall please call (610) 448-3237.",Contact the recalling firm for information,1419,1419,"Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).",Open,N/A,N/A,1419,Not_Computer,N/A,N/A,N/A
Z-2023-2011,55577,"couch, radiation therapy, powered",JAI,Powered radiation therapy patient support assembly.,Radiology,Radiology,510(k),"Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478.The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.",Siemens brand 550 TxT Patient Treatment Table,2,"April 19, 2011", 2011,"Siemens Medical Solutions USA, Inc","Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.",DESIGN: Component Design/Selection,"Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the ""move enable"" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table.Further questions regarding this recall please call (925) 246-8407.",Contact the recalling firm for information,326,326 units,"Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.",Terminated,"March 01, 2012",317,326,Battery,Physical Safety Hazards,Repair,Repair
Z-2027-2011,58276,"instrument, surgical, disposable",KDC,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28For epidural administration of fluids with the Gemstar Pump",Hospira Primary Microbore Gemstar Split Set,2,"April 19, 2011", 2011,Hospira Inc.,There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.,OTHER/UNDETERMINED: Pending,"The firm, Hospira, sent an ""URGENT DEVICE RECALL"" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).",N/A,61150,"61,150 sets","Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.",Terminated,"May 09, 2012",386,147646,Not_Computer,N/A,N/A,N/A
Z-2047-2011,55154,"radioimmunoassay, prolactin (lactogen)",CFT,Prolactin (lactogen) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Active Prolactin ELISA, 96 Wells, DSL-10-4500The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.",Active Prolactin ELISA,2,"April 20, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values.Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio",N/A,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:Action/Resolution:Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product.Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, they were told to contact Technical support at the phone number listed below.Consignees were asked to share this information with their laboratory staff and retain this letter for their Quality System documentation and asked to complete and return the enclosed response form within 10 days via fax to: 786-639-4000 so that Beckman can be assured that they received the notification.If you have any other questions regarding this notification, please contact DSL Technical Support Center at 1-800-231-7970 in the United States and Canada , or contact their local Beckman Coulter Representative.",N/A,30,30 Kits,"Nationwide distribution: USA including states of: FL, GA and NC.",Terminated,"April 27, 2012",373,30,Not_Computer,N/A,N/A,N/A
Z-2045-2011,57750,"reagent, general purpose",LDT,General purpose reagent.,Pathology,Pathology,510(K) Exempt,"IMMAGE¶_ Immunochemistry Systems Wash Solution Part Number: 447060The IMMAGE¶_ Immunochemistry Systems Wash Solution is intended for use with IMMAGE¶_ Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE¶_ Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.",IMMAGE Immunochemistry Systems ,2,"April 20, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed an Immage¶_ Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However, this lot was inadvertently shipped to the U.S. and delivered to five customers.",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage¶_ Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967;package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products.If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.",N/A,9,9 units total in US,"Nationwide distribution: USA including states of : AL, CA, MI and IN.",Terminated,"June 26, 2012",433,9,Not_Computer,N/A,N/A,N/A
Z-2030-2011,57340,"device, monitoring, intracranial pressure",GWM,Intracranial pressure monitoring device.,Neurology,Neurology,510(k),"Codman Metal Disposable ICP KitProduct Code: 80-1190 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures",Codman,2,"April 20, 2011", 2011,"Codman & Shurtleff, Inc.",Packaging defect may compromise sterility of device,DESIGN: Packaging Design/Selection,"The firm, Codman, sent an ""Important Notice Urgent- Voluntary Product Recall Notification"" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return.Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460.Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.",N/A,1671,1671 units,"Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom.",Terminated,"March 14, 2013",694,14792,Not_Computer,N/A,N/A,N/A
Z-2044-2011,58174,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"COULTER¶_ HmX Hematology Analyzerwith AutoloaderPart number: 6605525, 6605526, 6605527The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.",COULTER HmX Hematology Analyzer with Autoloader,2,"April 20, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer.,OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT PRODUCT CORRECTION"" letter dated March 2, 2011, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER¶_ LH 500 Series Analyzer, COULTER¶_ HmX Hematology Analyzer, and COULTER¶_ HmX Hematology Analyzer with Autoloader. The letter described the product, problem and actions to be taken. Customers were informed that the suspect Integrated Circuit Chips have been removed from all systems in inventory and manufacturing.The customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality Systemdocumentation. If customers have forwarded any of the affected product(s) listed on the PCA letter to another laboratory, please provide a copy of the letterto them.The customers were instructed to complete and return the enclosed Response Form within 10 days so Beckman are assured they have received this important communication and are taking appropriate action.The customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States and Canada or contact their local Beckman Coulter Representative.",N/A,288,288 units total (158 in US),"Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.",Terminated,"May 29, 2012",405,288,Not_Computer,N/A,N/A,N/A
Z-2038-2011,57933,"burr, orthopedic",HTT,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424.Intended usage: Cutting and shaping bone including bones of the spine and cranium.",Sterile Bone Cutting Bur,2,"April 20, 2011", 2011,"The Anspach Effort, Inc.","Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. Anspach has not received any complaints related to this problem.",OTHER/UNDETERMINED: Pending,"The firm, Anspach, sent an ""URGENT: Medical Device Product Removal"" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010.2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement.3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate.Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.",N/A,271,271 cutting burs affected,"Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.",Terminated,"August 12, 2011",114,271,Not_Computer,N/A,N/A,N/A
Z-2041-2011,57888,"unit, x-ray, extraoral with timer",EHD,Extraoral source x-ray system.,Dental,Radiology,510(k),"Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.",Orthoralix 9200 DDE Panoramic & Cephalometric Dental XRay System,2,"April 22, 2011", 2011,Gendex Dental Systems,"There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou",OTHER/UNDETERMINED: Pending,"Gendex sent a recall letter to their accounts on February 4, 2011 via first class mail, stating that an anomaly in the Orthoralix firmware can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes. The letter stated that resending the image from the X-Ray system to the PC will correct the issue present in certain images sent during periods of high network traffic. Instructions were provided to download an Appendix to Orthoralix DDE User Manual that explains how to resend the images. If that does not resolve the issue, users were requested to contact Gendex Technical Support at 1-800-323-8029. Customers were asked to complete and return the enclosed Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.",N/A,6835,"Total 6,835 units of all products","Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.",Terminated,"February 15, 2012",299,6835,Software,N/A,N/A,N/A
Z-2058-2011,58324,"prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented",MRA,N/A,N/A,Orthopedic,N/A,"R3 TM CERAMIC ACETABULAR LINER, BIOLOX¶_ FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06",R3 Forte Ceramic Liners,2,"April 22, 2011", 2011,Smith & Nephew Inc,"During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.",TRAINING: Employee Error,"All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall.Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.",N/A,67,67 units,"AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI",Terminated,"February 08, 2012",292,2271,Not_Computer,N/A,N/A,N/A
Z-2051-2011,58231,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"ACUSON S2000 ultrasound systemManufactured by Siemens Medical Solutions USA, Inc.Business Unit Ultrasound,1230 Shorebird WayIntended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications.",Acuson S2000 ultrasound system,2,"April 22, 2011", 2011,"Siemens Medical Solutions USA, Inc.",The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.,DESIGN: Software Design,"Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed. No patient injury has been reported. Further questions regarding this recall please call (650) 694-5398.",N/A,1533,1533 units,"Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC",Terminated,"June 18, 2012",423,1533,Software,Output/Calculation,Software update,Software Update
Z-2061-2011,53053,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795)Product is an ultrasound imaging system intended for General Radiology,Fetal, Abdominal, Intaoperatve, Pediatric, Small parts, Neunatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and peripheral Vascular Applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published with peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. The V5Ms is a multifrequency,multi-plane, phased sector array transducer, which can be introduced into the esophagus to obtain heart structure images. Transesophageal echocardiography is used to obtain unobstructed views of the heart surrounding tissue.",Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 ,2,"April 25, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.",DESIGN: Software Design,"Siemens sent a Customer Safety Advisory Notification letter on July 24, 2009. The letter identified the product, the problem, and the action to be taken by the customer. A software update will be conducted in the field. Until that update occurs, customers were instructed to image without the CW doppler to avoid a system shut down.Customers were instructed to contact their service support person with any questions.For questions regarding this recall call 650-694-5993.",N/A,70,70 units,"Worldwide Distribution - USA including CA, CT, FL, MA, and TX and the countries of United Arab Emirates, Germany, Ecuador, Spain, France, Great Britian, Saudi Arabia, Sweden, Thailand, and South Africa.",Terminated,"April 25, 2011",0,70,Software,Device Operation,Software update,Software Update
Z-2065-2011,53209,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CAMedical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and peripheral vascular applications. The system also provides for measurements of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.",Acuson X300,2,"April 25, 2011", 2011,"Siemens Medical Solutions USA, Inc.",Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.,DESIGN: Software Design,"The firm, Siemens, sent a ""CUSTOMER SAFETY ADVISORY NOTIFICATION"" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge.If you have any questions, contact (650) 969-9112.",N/A,2312,2312 units,"Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kenya, Kosovo, Lativia, Lithuania, Luxembourg, New, Zealand, Nicaragua, Norway, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.",Terminated,"April 25, 2011",0,2312,Software,Display/Image,Software update,Software Update
Z-2060-2011,58261,"light source, fiberoptic, routine",FCW,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Luxtec¶_ MLX 300 Watt Xenon Light Source,Model OOMLX; Surgical/Medical Light SourceThis light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.",Luxtec MLX 300 Watt Xenon Light Source,2,"April 25, 2011", 2011,Integra LifeSciences Corp.,Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Integra notified all customers/distributors via written communication, dated 3/08/2011. On 3/09/11, Integra Sales Representatives and Service Technicians were notified via telephone conference call and provided copies of written communications. Customers were advised to immediately discontinue use of any affected product and to place in a secure area. Note: This defect only applies to MLX units that were repaired between 12/01/2009 and 1/31/2011. This defect does not occur in manufactured units that have not been serviced, nor does it apply to MLX units that were serviced outside of this specific timeframe. Customers with devices already known to require repair and/or servicing will be contacted directly to arrange for the return of their device(s). Additionally, sales specialists were instructed to examine each customer's inventory for those device(s) that may potentially have the jumper-wire and to perform a stand-by test to determine if repair and/or servicing are required.",N/A,159,159 units,"Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden",Open,N/A,N/A,159,Hardware,Device Operation,Replace,Remove or Replace
Z-2062-2011,58320,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471.The User information is labeled in part: ""***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer***This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***"".The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation ""S8-3t"" printed on the connector housing of the transducer.",S83t Micro TEE Transducer,2,"April 25, 2011", 2011,Philips Medical Systems Nederlands,"Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.",OTHER/UNDETERMINED: Pending,"Philips Healthcare began mailing Urgent Medical Device Correction letter on March 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers are being instructed on how to inspect the distal tip for defects that cause image quality degradation, and to plan for epicardial / transthoracic ultrasound imaging as an adjunct to the S8-3t. Customers are also reminded to carefully follow cleaning described under Handling the S8-3t Transducer, of Philips' iE33 System User Information. Customers can call Philips Customer Service at 800-722-9377 and reference to FCO 79500198 for any questions about this recall.",Contact the recalling firm for information,155,155 units,"Worldwide Distribution - USA AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MN, MS, NC, ND, NH, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea Rep, Netherlands, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, and United Kingdom.",Terminated,"February 14, 2012",295,155,Not_Computer,N/A,N/A,N/A
Z-2063-2011,58246,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.",Optical Guidance Platform,2,"April 25, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, Varian, sent an ""URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE"" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check the Calibration timeout on their optical guidance platform. If this exceeds 24 hour, please set the factory default of 16 hours to ensure that the camera will be calibrated daily. The instructions are located in the document. The customers were also instructed to download the most recent version of the Optical Guidance Platform Instructions for Use at www.MyVarian.com or request a copy from their local Varian Customer Support District or Regional Manager. In addition, the customers were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. Varian is preparing a software patch which will be applied to affected units to correct this issue.If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager; USA and Canada -1888-VARIAN5 (888-827-4265) or Europe- +41 41 749 8844.",Contact the recalling firm for information,599,599 units,Worldwide distribution.,Terminated,"June 19, 2012",421,599,Software,Device Operation,Software update,Software Update
Z-2070-2011,57779,"electrode, ion specific, sodium",JGS,Sodium test system.,Clinical Chemistry,Clinical Chemistry,510(k),Synchron¶_ LX I 725The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer and the Access 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.,Unicel DXC and SYNCHRON LX Clinical Systems,2,"April 26, 2011", 2011,Beckman Coulter Inc.,"This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.",PRODUCTION CONTROLS: Environmental Control,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION (PCA)"" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¶_¶_ DxC Clinical SystemsOperating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:-After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them.If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.",N/A,1410,"1,410 units (503 in US)","Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.",Open,N/A,N/A,1410,Computer,N/A,N/A,N/A
Z-2068-2011,58042,osmotic fragility testing,GKE,Osmotic fragility test.,Hematology,Hematology,510(K) Exempt,Advanced Instrument Model 2020 Multi-Sample OsmometerIntended to measure the osmotic pressure of body fluids.,Advanced Instrument Model 2020 MultiSample Osmometer,2,"April 26, 2011", 2011,"Advanced Instruments, Inc.",A poorly soldered power cord may pose a potential electrical shock hazard.,TRAINING: Employee Error,"Advanced Instruments Product Service Department contacted each customer on 1/19/11 via an Urgent Product Recall Notice. The letter identified the reason for recall along with the affected products. The letter provided instructions to safely examine the date code of the AC Power Inlet assembly on the affected product. If customers were unable to perform the inspection or had questions concerning the instructions, they were to contact Advanced Instruments Product Service Manager at 781-471-2147 or via email jorges@aicompanies.com. The attached response forms were to be completed and returned as instructed.",N/A,3,3 units,"Worldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.",Terminated,"December 01, 2011",219,3,Battery,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-2052-2011,57744,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Boston Scientific's LATITUDE Patient Management System:LATITUDE 6.1 Patient Management System WebsiteServer software, Model 6488 for United StatesServer software, Model 6465 for European UnionLATITUDE 6.2 Patient Management System WebsiteServer software, Model 6441 for CanadaServer software, Model 6442 for Australia / New ZealandIntended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.",LATITUDE Patient Management System,2,"April 26, 2011", 2011,Boston Scientific CRM Corp,"Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.",DESIGN: Software Design,"Consignees were sent a Boston Scientific ""LATITUDE¶_ Medical Records Information"" letter dated January 2011. The letter was addressed to ""Dear Doctor"". The letter described the problem and the product involved in the recall.The letter also included the Rate of Occurrence, Action and Further Information sections.",Contact the recalling firm for information,25836,"25,836","Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.",Terminated,"November 15, 2012",569,25836,Other,Output/Calculation,Notification,Safety Notice/Insructions
Z-2059-2011,58209,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371.The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.",PHILIPS MODEL MX 16slice Computed Tomography Scanners,2,"April 26, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inac",OTHER/UNDETERMINED: Pending,"Philips Healthcare issued an 'URGENT- Field Safety Notice MX 16-slice' (dated 3/10/2011) concerning a software issue to customers. The notification informed the firm's users/customers of the potential for inaccurate dimension measurements produced by the MX 16-slice CT scanners when using the Combine Function Viewing Option. Moreover, the letter notified customers of the potential for patient misdiagnosis in the event that inaccurate dimension measurements are used by a physician for reference. The Field Safety Notice described the following: 1) How to identify the affected product; 2) What actions should to be taken by the customers with regard to avoiding the issue -discontinue use of the Combine Viewing Option and instead use the MPR Batch for diagnostic reviews until a planned software upgrade is installed by the recalling firm; and 3) The firm's plans to carry out the installation of a field change order kits to correct the issue.The planned software upgrade is expected to be completed on or before 6 months after the new software is released. If you need any further information or support concerning this issue, pleasecontact your local Philips representative or local Philips Healthcare office.For North America and Canada contact the Customer Care Solutions Center(1-800-722-9377, option 5: Enter Site ID or follow the prompts).",Contact the recalling firm for information,25,25 units were distributed domestically & 168 system units were distributed both domestically & internationally,"Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela",Terminated,"March 01, 2013",675,25,Software,Display/Image,Software update,Software Update
Z-2066-2011,58371,"imager, ultrasonic obstetric-gynecologic",HEM,Obstetric-gynecologic ultrasonic imager.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to Digisonics OB-View/OB-Windows systems.",OBLink release 2.0.7,2,"April 26, 2011", 2011,"Digisonics, Inc",Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report,OTHER/UNDETERMINED: Pending,Digisonics visited consignee in April 2008 as follow-up to complaint.,Contact the recalling firm for information,2,2 units,Nationwide Distribution including OK,Terminated,"May 02, 2011",6,2,Other,N/A,N/A,Other
Z-2049-2011,58135,"system, test, automated, antimicrobial susceptibility, short incubation",LON,Fully automated short-term incubation cycle antimicrobial susceptibility system.,Microbiology,Microbiology,510(k),"VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.","VITEK 2 Gram Negative Susceptibility Card, ASTN183",1,"April 27, 2011", 2011,Biomerieux Inc,"The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BioMerieux sent an Urgent Product Correction Notice (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786,"" letter dated March 30, 2011, via Fed EX on April 4, 2011. to all affected customers. The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Tazobactam (TZP2). The new cards will begin shipping by July 16, 2011, but in the meantime, the cards currently in possession of the customers can be used with specific required actions that need to be followed. Until the TZP redevelopment is completed and a resolution can be implemented, BioMerieux requires their customers to immediately take the following actions: The customers will be required to suppress the TZP2 resistant and susceptible results for Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, and Salmonella enterica and use an alternate method of testing. In addition, the customer is to suppress the TZP2 resistant result only for Klebsiella pneumonia and use an alternate method of testing.The letter provides instructions for configuring the VITEK 2 software to suppress the results from reporting.The instructions contained in the recall notification are to be applied to all current and future product lots that contain TZP2 until further notice.The customer is to complete the enclosed acknowledgement form and return it via FAX to acknowledge receipt of the notification and is requested to file the correction notice with their VITEK 2 Systems permanent records according to their internal policy or procedure.For questions or additional information customers were instructed to call 1-800-682-2666, option 3.In addit.",No consumer action necessary,493,493 boxes as of 3/31/11,There was no U.S. distribution as the cards were for export only to Canada and Sweden.,Terminated,"June 01, 2012",401,3538,Not_Computer,N/A,N/A,N/A
Z-2101-2011,58289,"kit, plastic surgery and accessories",FTN,Plastic surgery kit and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Argon Medical Devices, Arterial Line Kit/1, 18ga x 6"", Part Number 498447, Lot number 99767634Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.","Argon Medical Devices, Arterial Line Kit/1, 18ga x 6",2,"April 27, 2011", 2011,"Argon Medical Devices, Inc",Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.,OTHER/UNDETERMINED: Pending,"Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.",N/A,10,10 units,"Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands",Terminated,"April 24, 2012",363,5780,Not_Computer,N/A,N/A,N/A
Z-2102-2011,58271,"spinal channeling instrument, vertebroplasty",OCJ,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Confidence¶_ Diamond Tip Introducer Needle 11G x 6-InchProduct Code: 2839-03-611The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.",DePuy Spine,2,"April 27, 2011", 2011,"DePuy Spine, Inc.",Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle,PRODUCTION CONTROLS: Packaging Process Control,"The firm, DePuy Spine, sent an ""URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION"" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #.If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.",No consumer action necessary,215,215 units,"Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.",Terminated,"February 20, 2013",665,282,Not_Computer,N/A,N/A,N/A
Z-2082-2011,58291,"epstein-barr virus, other",LSE,Epstein-Barr virus serological reagents.,Microbiology,Microbiology,510(k),"BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200.Product is labeled in part: ""BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547"".BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.",BioPlex 2200 EBV IgG Calibrator Set.,2,"April 27, 2011", 2011,Bio-Rad Laboratories,Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704.,OTHER/UNDETERMINED: Pending,"The firm, Bio-Rad Laboratories, sent an ""Voluntary Field Correction: BioPlex 2200 EBV IgG Calibrator Set, Lot# 46704 for EBV NA-1 Analyte"" letter dated March 16, 2011 domestic customers via Fed-Ex and and to international subsidiaries via e-mail. The letter described the product, problem and actions to be taken. The consignees/customers were informed that Bio-Rad confirmed downward shift in control values for the EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set, Lot # 46704. If this occurs, the customers were instructed to readjust the positive control mean using the procedure presented in the customer notification ""BioPlex 2200 Quality Control Values (L60013402)"". If the re-adjusted mean of the EBV NA-1 controls is within the manufacturer's limit, patient results may be reported. If the new assay positive control mean still does not fall within the manufacturer's limit, the customers were instructed to contact their local Bio-Rad Technical Support and do not report the EBV NA-1 values. The customers were also instructed to complete and return the CUSTOMER RESPONSE FORM via fax to 510-741-5775.If the BioPlex 2200 EBV VCA IgG and EBV EA-D IgG positive and negative control means are within the acceptable QC range, and subsequent passing QC runs are obtained, patient results may be reported for these analytes. Bio-Rad will be manufacturing a new lot of the BioPlex 2200 EBV IgG Calibrator Set which will bring the control values within the manufacturer's limit. It may be necessary to readjust the QC ranges after the consignees receive this new calibrator set lot.Bio-Rad will send their consignees/customers the replacement calibrators and calibrator CDs when available. The consignees/customers were also instructed to discard the calibrator set lot# 46704 in accordance with national and/or local regulations.Customers can call Clinical Diagnostics Group at 510-741-4431 or email to BPD-ProductSupport@bio-rad.com for any questions .",Contact the recalling firm for information,270,270 sets,"Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.",Terminated,"December 22, 2011",239,270,Not_Computer,N/A,N/A,N/A
Z-2067-2011,57912,"system, photopheresis, extracorporeal",LNR,N/A,N/A,Gastroenterology/Urology,N/A,Therakos UVAR XTS Procedural KitsIs indicated for use in the ultraviolet-A (UVA) irradiation.,Therakos UVAR XTS Procedural Kits,2,"April 28, 2011", 2011,Therakos Inc,Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.",N/A,4323,"4,323 kits",Worldwide Distribution,Open,N/A,N/A,4323,Not_Computer,N/A,N/A,N/A
Z-2112-2011,58273,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.",ABL90 FLEX ,2,"April 28, 2011", 2011,Radiometer America Inc,"Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the",DESIGN: Software Design,"The firm, Radiometer America, sent two Urgent ""Medical Device Field Correction"" letters issued on February 4, and on February 24th, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to replace the sensor cassette. In order to prevent this situation from occurring, the firm informed the customers in the recall/correction notification that they intend to upgrade all ABL 90 Flex analyzers to a new software version. The new software will perform a check during a normal system FLUSH in order to allow the analyzer to detect the bias and will notify the customer immediately of this condition and will automatically disable the cassette thus preventing further use. The letter goes on to remind the device customers that until such time as the software upgrade is installed, they should make sure to adhere to the procedures stated in the Reference Manual which call for the replacement of the sensor cassette immediately upon receiving message #1310. The letter further instructs the customer to complete and return the attached FAX RETURN FORM via fax to 440-871-0463. The letter also states that the expected release date for the new software should be sometime in the second half of February 2011. If you have any questions regarding this letter, or the upgrade, please contact Technical Support staff at 1-800-736-0600 Opt 4.",N/A,32,32 units were distributed in the U. S. and 533 units were distributed world-wide,"Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.",Terminated,"May 09, 2012",377,32,Software,Output/Calculation,Replace sensor cassette/Software update,Software Update
Z-2104-2011,58342,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.",Biomet CC IBeam Tibial Plate 75mm,2,"April 28, 2011", 2011,"Biomet, Inc.","The firm is recalling the product due to the product's packaging being labeled ""I-Beam 75mm. Tibial Plate"", but the package actually contains the ""Interlok 67mm. CR Tibial Plate"".",PRODUCTION CONTROLS: Packaging Process Control,"Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.",No consumer action necessary,8,8,"Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands",Terminated,"July 27, 2011",90,8,Not_Computer,N/A,N/A,N/A
Z-2106-2011,58407,"reagent, occult blood",KHE,Occult blood test.,Hematology,Hematology,510(k),"Clearview¶_ iFOB, Clearview¶_ iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number:8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices",Clearview iFOB Complete (30 Test),2,"April 28, 2011", 2011,Alere North Americal,Potential for false negatives test results and negative/faint positive controls,OTHER/UNDETERMINED: Pending,"Alere sent a Voluntary Product Recall letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to indicate zero on the attached Recall Reply Form, sign, and fax to 1-877-877-0147, if they have no remaining product.For any remaining product customers were instructed to discontinue use and indicate the quantity of kits in the attached Recall Reply Form so that the firm can arrange for them to receive credit. Customers were instructed to destroy any affected units at their site. For any further distribution of product, customers will need to be contacted. Physicians and hospitals were advised to retest patients with negative results. Questions relating to this Voluntary Product Recall call 1-877-597-9586.",N/A,6249,6249 kits,Nationwide Distribution,Terminated,"March 07, 2013",679,15543,Not_Computer,N/A,N/A,N/A
Z-2105-2011,58255,"stimulator, nerve, transcutaneous, for pain relief",GZJ,Transcutaneous electrical nerve stimulator for pain relief.,Neurology,Neurology,510(k),"Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc.Alcohol wipe is provided as a cleaning convenience for device electrodes.","InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes ",2,"April 28, 2011", 2011,Neuro Resource Group Inc,Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Triad Group issued a press release on 2/7/2011, and notified consignees by e-mail 3/2/2011. Neuro Resource Group, Inc. ( NRG ) removed the recalled Triad wipes from all kits in house and obtained non recalled wipes from an alternate supplier. For replacement wipes customers may contact NRG customer service at 1-877-314-6500.",Contact the recalling firm for information,57252,"57,252 wipes",Worldwide Distribution,Terminated,"September 23, 2011",148,57252,Not_Computer,N/A,N/A,N/A
Z-2118-2011,53013,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA.The ACUSON Antares is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.",ACUSON Antares System,2,"April 29, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Shock Hazard. The manufacturer failed to set the system power switch to ""ON"" during the line level leakage and high pot current draw testing.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notification letter out on May 15, 2009. Service engineers were to visit each customer to conduct necessary testing.For questions regarding this recall call 650-694-5993.",N/A,1,1 unit,"Worldwide Distribution - USA including CA, IL, MD, NC, OH, and UT and the countries of Australia, China, Denmark, Spain, South Korea, Norway, Poland, Russia and Sweden.",Terminated,"April 29, 2011",0,30,Not_Computer,N/A,N/A,N/A
Z-2017-2011,58188,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb).Abbott Diagnostics Division, Santa Clara, CA 05054Designed for in vitro diagnostic use in clinical laboratories.",Abbott CellDyn 3200 System,2,"April 29, 2011", 2011,Abbott Laboratories,The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.,N/A,"Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.",Contact the recalling firm for information,174,"174 total units, all varieties","Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.",Terminated,"November 22, 2011",207,174,Not_Computer,N/A,N/A,N/A
Z-2122-2011,58482,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.",Baxter FloGard 6201 Volumetric Infusion Pumps,2,"April 29, 2011", 2011,Baxter Healthcare Corp.,Pumps submitted for service may not have been properly serviced before being returned to the customer.,TRAINING: Employee Error,"Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification.",Contact the recalling firm for information,3,3 units,Puerto Rico,Terminated,"April 29, 2011",0,3,Not_Computer,N/A,N/A,N/A
Z-2114-2011,58282,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)",UniCel DxH 800 Coulter Cellular Analysis System,2,"April 29, 2011", 2011,Beckman Coulter Inc.,For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels:The RBC is improperly corrected and not flagged when there is a WBC Pump Failure. IMPACT:Erroneous RBC and/or HCT could affect the interpretation and management of patients at risk with various types of anemias.,OTHER/UNDETERMINED: Pending,"The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue. When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software.Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.",Contact the recalling firm for information,422,422 units in total (175 in US),"Nationwide in the US and worldwide to: Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom",Open,N/A,N/A,422,Software,Alarm/Message,Software update,Software Update
Z-2119-2011,58230,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.",4D Intergrated Treatment Console,2,"April 29, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.",DESIGN: Software Design,"Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers.Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com.This design fix in 4DITC v10.1 or later will be provided to all affected sites.If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager.USA and Canada - 1-888-VARIANS (888-827-4265)Europe - + 41 41 749 8844.",Contact the recalling firm for information,17,17,"Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.",Terminated,"March 30, 2012",336,17,Software,Physical Safety Hazards,Software update,Software Update
Z-2113-2011,58367,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098OB-Windows provides professional reporting and analysis of fetal growth throughout the gestational period, which can help evaluate clinical situations. OB-View provides image management for the user to capture, view, read, and edit images.",DOCTORS REVIEW SYSTEM,2,"April 29, 2011", 2011,"Digisonics, Inc",Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports.,OTHER/UNDETERMINED: Pending,"The firm, Digisonics Inc, notified the affected customers of software release via e-mail on January 24, 2007 and follow-up e-mail on February 7, 2007. The e-mails described the product, problem and the actions taken. The firm was able to trap the error and after this report the developer was able to determine the cause and a new executable was sent and installed at the customers site.If you have any question, please call 800-940-3240 or e-mail: service@digison.net.",Contact the recalling firm for information,128,128,Worldwide distribution: USA (nationwide) and country of Canada.,Terminated,"May 02, 2011",3,128,Software,Output/Calculation,Software update,Software Update
Z-2121-2011,58286,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)",UniCel DxH 800 Coulter Cellular Analysis System ,2,"April 29, 2011", 2011,Beckman Coulter Inc.,RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated.IMPACT:The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact c,OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, issued an ""URGENT: PRODUCT CORRECTIVE ACTION (PCA)"" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following:1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation.2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU).3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS.4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens.5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.Beckman Coulter will make corrections in future version software.Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.",No consumer action necessary,422,422 units in total (175 in US),"Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom",Open,N/A,N/A,422,Software,Output/Calculation,Software update,Software Update
Z-2120-2011,58519,"pulse generator, permanent, implantable",NVZ,N/A,N/A,Cardiovascular,N/A,"Medtronic, Kappa 600KDR600,KDR601,KDR603,KDR606,KDR651,KDR653The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product family, there are varying features, rate responsive pacing, and diagnostic data. Medtronic,Kappa 700KD700,KD701,KD703,KD706,KDR700,KDR700V,KDR701,KDR701PTO,KDR701V,KDR701VIT,KDR703,KDR703V,KDR706,KDR706V,KDR720,KDR721,KDR730,KDR731,KDR733,KVDD700,KVDD701Medtronic,Kappa 800KDR801,KDR803,KDR806Medtronic,Kappa 900KD901,KD903,KD906,KDR901,KDR903,KDR906,KDR921,KDR931,KDR933,KVDD901Medtronic, Enpulse DRE1DR01,E1DR06,E1DR21,E2D01,E2D03,E2DR01,E2DR03,E2DR06,E2DR06J,E2DR21,E2DR21PJ,E2DR31,E2DR31J,E2DR33,E2DR33J,E2VDD01Medtronic, Adapta/Versa/Sensia DRADD01,ADDR01,ADDR03,ADDR06,ADDRL1,ADDRS1,ADVDD01,SED01,SED01N,SEDR01,SEDR01N,SEDRL1,VEDR01Medtronic, ReliaRED01,REDR01,REVDD01(approved in the US but has not been sold in US)Medtronic, Vitatron Extension G and E series DRE50A1,E60A1,G70A1(not sold in the US)",KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS,2,"April 29, 2011", 2011,Medtronic Inc. Cardiac Rhythm Disease Management,"A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices) inappropriately trigger ERI/RRT in the Medtronic Dual Chamber Pacemakers: Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia. This is caused by a random lock-up of the measurement system hardware that may result in an incorrect battery voltage reading of zero. This issue does NOT impact battery lon",DESIGN: Component Design/Selection,"The firm, Medtronic, sent an ""Important: Medical Device Correction"" letter dated April 2011 to its customers. The letter described the product, problem, and actions taken. Medtronic informed the customers that this issue does NOT impact battery longevity and does NOT require device explant. Currently, the device can be reset to normal operation by a Medtronic representative. Reset devices are no more likely to experience a recurrence of this issue. Medtronic is planning to release a programmer software update that will allow the clinician to reset the device. In addition, Medtronic has consolidated their product performance data with the vision of creating a primary reference tool for performance updates.If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.",N/A,1989180,"1,989,180","Worldwide distribution: USA (nationwide) including Guam, Puerto Rico and DC; and countries including: Algeria, Andorra, Anguilla, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Virgin Islands (British).",Terminated,"November 27, 2012",578,1989180,Hardware,Device Operation,Programmer software update,Software Update
Z-2127-2011,58313,"tomography, optical coherence",OBO,Ophthalmoscope.,Ophthalmic,Ophthalmic,510(k),"Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.",Cirrus HDOCT Model 4000 instruments,2,"May 02, 2011", 2011,Carl Zeiss Meditec Inc,"A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient",DESIGN: Software Design,"Carl Zeiss Meditec, Inc. sent an Field Correction Action letter dated March 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letters requested acknowledgement of the letter and a response and the fact that a follow up packet with revised software will be sent to all customers with V 5.0.0 or 5.1.0 software.For questions, please call 1-855-853-9461.",No consumer action necessary,6888,3465 US; 3423 OUS,"Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Boliva, Brazil, Canada, France, Chili, China, Columbia, Denmark, Ecuador,Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Japan, Lebanon, Malaysia, Mexico, New Zealand, Pakistan, Peru, Singapore,South Korea, Spain, Sri Lanka, Taiwan, Uruguay and Venezuela",Terminated,"March 29, 2012",332,6888,Software,N/A,N/A,N/A
Z-2125-2011,58424,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARIA, RT Chart Application v 8.0 through 8.9Varian Medical Systems, Palo Alto, CA.Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment.","ARIA, RT Chart Application v 8.0 through 8.9",2,"May 02, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC.",DESIGN: Software Design,"Varian Medical Systems, Inc. Oncology Systems sent Urgent Medical Device Correction Field Safety Notice letters on March 9, 2011, to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letters identifeid the product, the problem, and the action to be taken by the customer. Customers were instructed to:Manually enter the gantry angel 0.0 when the plan indicates angel 0.0. Manual entry is only allowed to one decimal place, so the range that triggers the issue cannot be created if the keyboard is ued to enter the gantry angel.Users with third party plan sources should verify whether gantry angles with two or more decimal places are supported. If so, customers may be affected by this issue, and should take steps suited to the device.In all cases, the display at the Treatment console is indicative of what direction the gantry will move - users are advised to be especially attentive to these values, particulary when non-zero couch rotation values are used.Users are advised to always run a simulation of the plan, including all plan motions, at the treatment unit prior to first patient treatment. For further clarification customers were insturcted to contact their local Varian Customer Support District Manager. For questions regarding this recall call 650-424-6471.",N/A,612,612 units,"Worldwide Distribution - USA including CA, DC, FL, GA, MD, MN, MS, NY, OH, and TN and the countries of Canada, Australia, Austria, Bahrain, Bagladesh, Belarus, Belgium, Brazil, Columbia, Costa Rica, Cypress, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Luxemborg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tobago, Tunisia, Turkey, Ukraine, Emirates, and the United Kingdom.",Terminated,"March 13, 2012",316,612,Not_Computer,N/A,N/A,N/A
Z-2128-2011,58287,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)",UniCel DxH 800 Coulter Cellular Analysis System ,2,"May 02, 2011", 2011,Beckman Coulter Inc.,"Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, "","") and partial units (decimal, "".""). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid r",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, issued an ""URGENT: PRODUCT CORRECTIVE ACTION (PCA)"" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following:1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation.2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU).3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS.4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens.5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.Beckman Coulter will make corrections in future version software.Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.",Contact the recalling firm for information,422,422 units in total (175 in US),"Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.",Open,N/A,N/A,422,Software,Output/Calculation,Software update,Software Update
Z-2123-2011,58574,"implant, intragastric for morbid obesity",LTI,N/A,N/A,Gastroenterology/Urology,N/A,"Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.",LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM,2,"May 02, 2011", 2011,Allergan,The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile.,N/A,"Allegan sent an Urgent Medical Device Recall letter dated March 21, 2011, to all affected customers. Allergan requested that upon receipt of letter, that the customer check their existing inventory of product for affected lot. Customers were requested to complete Business Reply Card, stating quantity of inventory of affected lot, if any, and return to Allergan Medical. Customer with remaining inventory were instructed to contact Allergan Medical Product Support at 1-800-624-4261, x5972 or 1-805-961-5972 for return and immediate replacement. . Customers will be issued credit for returned product.For questions regarding this recall call 805-319-0589.",Contact the recalling firm for information,1888,1878 x 10-packs,"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, MN, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Australia, Canada, Germany, Great Britian, and the Netherlands",Terminated,"April 06, 2012",340,1878,Not_Computer,N/A,N/A,N/A
Z-2124-2011,58470,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard¶_Ventralex"" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5"",\Catalog #0010302, lot number HUTL1283.The Bard¶_Ventralex"" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is ""Mesh, Surgical, Polymeric"". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material","BardVentralex"" Hernia Patch",2,"May 02, 2011", 2011,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeled: Bard¶_ Medium Ventralex Hernia Patch 6.4cm /2.5"" packaged in a pre-printedcarton identified for a Bard¶_ Ventralex Small Circle 4.3cm /1.7""",PRODUCTION CONTROLS: Labeling Mix-Ups,"Davol sent an Urgent: Medical Device Recall letter on April 11, 2011, via FedeX Priority Overnight to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and remove and return the recalled lot. Distributors were requested to notify their accounts.For questions contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.",No consumer action necessary,146,146 units,"Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV.",Terminated,"October 27, 2011",178,146,Not_Computer,N/A,N/A,N/A
Z-2135-2011,58325,"starter, bone screw",HWD,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE.To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.","Low Profile SelfTapping Bone Screw,",2,"May 03, 2011", 2011,"Biomet, Inc.",One lot of 30 mm screws was switched with one lot of 25 mm screws.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet. Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product. Distributors were instructed to notify all sub-accounts of the recall.Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983.For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.",N/A,100,100,"Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.",Terminated,"February 17, 2012",290,100,Not_Computer,N/A,N/A,N/A
Z-2134-2011,58402,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496.Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx).The data sheet is labeled in part: ""***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria¶_ system interfaces. The SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***"".Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.","Ultraview SL Patient Monitor, Model 91387",2,"May 03, 2011", 2011,"Spacelabs Healthcare, Llc","The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.",OTHER/UNDETERMINED: Pending,"SPACELABS Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use their monitors until they can be upgraded. Customers were recommended to brief their staff about the possibility of losing changes to the alarm settings and to restore them after a power interruption. Field service engineers will contact customers to schedule a mutually agreeable time to come to their hospital and upgrade their affected patient monitors at no cost to the hospital. US Consignees can call 1-800-522-7025, Select 2 for Technical Support. Consignees outside of the US can call 1-425-657-7200 x5089 for any questions about this recall.",N/A,4470,4470 units total (1894 units in US and 2579 units internationally),"Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.",Terminated,"February 15, 2012",288,4470,Hardware,Device Operation,Notification until upgrade,Repair
Z-2133-2011,58278,catheter care tray (kit),OHR,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,Enforcement Discretion,"Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag).Intended usage: Kit components to be used during Intermittent Urinary Catheterizations",Catheter Insertion Kit ,2,"May 03, 2011", 2011,"Apogee Medical, Inc","Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.",OTHER/UNDETERMINED: Pending,"The firm, Apogee Medical LLC, sent an ""Urgent Medical Device Recall"" letter dated March 23, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their inventory; complete and return the enclosed Product Recall Response Form as soon as possible via fax to (919) 570-9611, mail to: Apogee Medical LLC, Youngsville Commerce Center, 90 Weathers Street, Youngsville, MC 27596, or e-mail to: dpeper@apogeemed.com; cease further distribution and return any product that is the subject of this recall to Apogee Medical LLC. All returned product must be labeled with a returned goods authorization label that has been provided with the letter. Apogee will replace returned product upon receipt of the Product Recall Response Form and identified product.In addition, if the customer distributed the product, they are to identify their customer(s) and notify them at once of this product recall. The notification should include a copy of the this recall notification letter and should instruct the customer to return the recalled product so that it can be returned to Apogee.Should you have any questions regarding this notification, please call the Manager Regulatory Affairs/Quality Assurance at (919) 435-5409.",N/A,5503430,"5,503,430 units","Nationwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NJ, NY, OH, OK, TN, TX, VA and WA.",Terminated,"February 28, 2012",301,5503430,Not_Computer,N/A,N/A,N/A
Z-2129-2011,58383,"system, peritoneal, automatic delivery",FKX,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.",HomeChoice and HomeChoice Pro Cyclers,2,"May 03, 2011", 2011,Baxter Healthcare Renal Div,"Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 ""To reduce the risk of bums, electrocution, fire, or injury to persons: Close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves."" Tubing entanglement around the neck may r",OTHER/UNDETERMINED: Pending,"Baxter sent Safety Alert letters dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to consider the following safeguards for at-risk patients on HomeChoice Therapy:Have a caregiver present while the patient is performing therapy.Move the HomeChoice cycler to the foot of the bed, if possible, to minimize the likelihood of entanglement that may lead to asphyxiation.Install bed railings for patients at risk for seizures or falls from bed.Complete the attached customer reply form and fax it to Baxter at t847-270-5457.For questions regarding this recall call 888-736-2543, option 2.",N/A,N/A,N/A,"Worldwide Distribution - USA including AZ, CA, CT, DC, FL, KY, MO, NC, NM, Ny, OH, PA, TN, TX, and VA and the countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovania, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingom, and Venezuela.",Terminated,"March 08, 2012",310,N/A,Not_Computer,N/A,N/A,N/A
Z-2136-2011,58052,"cable, electrode",IKD,Electrode cable.,Physical Medicine,Physical Medicine,510(K) Exempt,"HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/cartonEach kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.","HealthPort BioAnologics Patient Electrode Sensor Test Kit,",2,"May 04, 2011", 2011,"Vermed, Inc.",Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.,OTHER/UNDETERMINED: Pending,"Vermed sent consignee a recall notification letter on February 8, 2011, followed by a phone call and email. The consignee was instructed to respond with a Recall Reply Form via fax and to notify any customers to whom the affected product was further distributed. All recalled alcohol prep pads were to be returned to Triad Group. Firm is replacing Triad alcohol pads in kits with pads from another supplier and has removed Triad from its approved vendor list.For questions regarding this recall call 802-722-9976.",Contact the recalling firm for information,2500,2500 kits total; 500 from each lot except 1000 from Lot 203031,OR,Terminated,"July 25, 2011",82,2500,Not_Computer,N/A,N/A,N/A
Z-2138-2011,58449,"suture, cardiovascular",DTH,N/A,N/A,General & Plastic Surgery,PMA,"SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18""/DS24mm Reverse Cutting Edged Needle.Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.",Sharpoint 40 Nylon Suture,3,"May 04, 2011", 2011,Surgical Specialties Corp,Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.",N/A,2628,"2,628",Class 3 Recall - Worldwide Distribution-- USA and Australia.,Terminated,"August 04, 2011",92,2628,Not_Computer,N/A,N/A,N/A
Z-2137-2011,58166,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.","""NX"" Modality Workstation",2,"May 04, 2011", 2011,AGFA Corp.,"When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.",OTHER/UNDETERMINED: Pending,"AGFA Corp. sent an ""URGENT FIEL SAFETY NOTICE"" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664.For questions regarding this recall call 864-421-1815.",Contact the recalling firm for information,775,775 units,"Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada",Terminated,"March 27, 2012",328,775,Not_Computer,N/A,N/A,N/A
Z-2139-2011,58326,dental implant surgical tray (kit),OFY,Endosseous dental implant accessories.,Dental,Dental,Enforcement Discretion,"***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.",Osseotite Certain Implant(s) & Osseotite Tapered Certain Implant(s),2,"May 04, 2011", 2011,"Biomet 3i, LLC",Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.,OTHER/UNDETERMINED: Pending,"BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454.Customers were instructed to respond with the attached Response Fax or email DomesticComplaints@Biomet.com.If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address:BIOMET 3iRegulatory Compliance Department4555 Riverside DrivePalm Beach Gardens, Florida 33410Incident No. CD117886A replacement implant(s) will be sent to them one the product is returned.For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).",Contact the recalling firm for information,217,217,"Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.",Terminated,"January 25, 2012",266,217,Not_Computer,N/A,N/A,N/A
Z-2149-2011,53211,N/A,N/A,N/A,N/A,N/A,N/A,"4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA.The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.",4Z1c Transducer,2,"May 05, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.",PRODUCTION CONTROLS: Equipment Maintenance,"A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.",N/A,42,42 units,"Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.",Terminated,"May 05, 2011",0,42,Other,Physical Safety Hazards,Software update,Software Update
Z-2146-2011,58181,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJPThe Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.",Baxter Single Day Infusor 2 mL/h System ,2,"May 05, 2011", 2011,Baxter Healthcare Corp.,"Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.",Contact the recalling firm for information,3696,"3,696 units",Worldwide Distribution - USA including AL and the countries of Mexico and Spain,Terminated,"March 12, 2012",312,3696,Not_Computer,N/A,N/A,N/A
Z-2145-2011,58305,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029.The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).",UniCel CxH800 Coulter Cellular Analysis System,2,"May 05, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because the DxH 800 may fail to meet the carryover specification for the WBC Differential (DIFF) when the WBC is greater than 70 X 10 to the 3rd power cells/micro L (70 X 10 to the 9th power cells/L). Beckman Coulter indicated the DIFF% carryover is unlikely to have clinical impact.,N/A,"Beckman Coulter sent a Product Corrective Action (PCA) letter with attached Recall Response Form via US Postal Service on February 11, 2011, to all customers who have the affected instruments. Consignees were informed of the reasons for recall, the products affected and that a resolution for these issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, Consignees were told to contact Beckman Coulter, Customer Service at (800) 526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,566,566 units,"Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines, Germany, Puerto Rico, Greece, Qatar,Hong Kong, Russian Federation, Hungary, Saudi Arabia, India, Singapore, Spain, Israel, taly Sweden, Japan, Switzerland, Korea, Turkey and United Kingdom.",Open,N/A,N/A,566,Not_Computer,N/A,N/A,N/A
Z-2144-2011,58480,"susceptibility test powders, antimycobacterial",MJA,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"BACTEC(tm) MGIT(tm) 2-Tube Spare AST Set Carrier, Bag of 3, Catalog 445946. ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152***The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.",BACTEC(tm) MGIT(tm) 2Tube Spare AST Set Carrier,2,"May 05, 2011", 2011,Becton Dickinson & Co.,In vitro diagnostic device components are mislabeled.,OTHER/UNDETERMINED: Pending,"BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258.For questions regarding this recall call BD Customer Service at 1-800-675-0908.",No consumer action necessary,4123,4123 total labels,"Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.",Terminated,"July 08, 2011",64,4123,Not_Computer,N/A,N/A,N/A
Z-2148-2011,58307,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).",UniCel DxH Coulter Cellular Analysis System,2,"May 05, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.,N/A,"Beckman Coulter sent an Urgent Product Correction letter, dated February 11, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were informed the issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,566,566 units,"Worldwide Distribution - USA including AL, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, and the United Kingdom",Open,N/A,N/A,566,Not_Computer,N/A,N/A,N/A
Z-2147-2011,53051,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA.Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.",ACUSON X300,2,"May 06, 2011", 2011,"Siemens Medical Solutions USA, Inc.","Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.",DESIGN: Software Design,A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be directed to the local service support person.,N/A,154,154 units,"Worldwide Distribution -- Austria, Brazil, China, Columbia, Germany, Denmark, Egypt, Great Britain, Honduras, Ireland, India, Italy Japan, South Korea, Mexico, Malaysia, Peru, Poland, Portugal, Romania, Russia, Sweden, Singapore, Thailand, Turkey, Taiwan, United States, Uruguay, Venezuela, and South Africa.",Terminated,"May 09, 2011",3,154,Software,Treatment/Delivery/Therapy,Sofrware update,Software Update
Z-1971-2011,57383,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.,Precision 500D ,2,"May 06, 2011", 2011,"GE Healthcare, LLC","Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider thanspecified, consequently allowing radiation outside the permitted field without warning to the user. Thisissue manifests with symptoms wherein the user cannot fully close down the lateral blades.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"GE Healthcare sent an Importan Electronic Product Radiation Warning letter to customers. The letter discussed the product defect description and related hazards, affected product details, instructions, and product correction. The firm will send a GE Field Service Representative to visit each affected customer site to inspect and correct all potentially affected units in the field following the instructions in field modification instructions No: 10846.If you have any questions please call 800-437-1171.",No consumer action necessary,440,440 US,Nationwide Distribution,Open,N/A,N/A,440,Not_Computer,N/A,N/A,N/A
Z-2152-2011,57044,"absorbent, carbon-dioxide",CBL,Carbon dioxide absorbent.,Anesthesiology,Anesthesiology,510(K) Exempt,"Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The label shows the product is Manufactured by Allied Healthcare Products Inc., St. Louis, MO.The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications.",Allied Healthcare Products Inc. CarbO2Lime,2,"May 06, 2011", 2011,Allied Healthcare Products Inc,The granules do not absorb as long as expected in the anesthesia machines,OTHER/UNDETERMINED: Pending,"Allied Healthcare Product, Inc. issued recall letters dated August 10, 2011, via certified mail beginning 8/12/10 and/or via e-mail with a read receipt. Letters were issued for both distributors and end-use customers (such as medical facilities or pharmacies) explaining the reason for recall. Distributors were requested to conduct a subrecall using the enclosed customer letter for end users. A response form was included for both distributors and end users to complete to indicate the amount of product to be returned. The customer was instructed to contact the recalling firm for return instructions.For questions regarding this recall call 314-268-1661.",N/A,949,"949 pails, 335/12-canister cases, and 706/12-refill bag cases","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, MS, NC, NE, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Canada and Grenada.",Terminated,"March 28, 2012",327,949,Not_Computer,N/A,N/A,N/A
Z-2131-2011,58567,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Synchron LX20 PRO, Part Number: 476100.Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.",Synchron LX20 PRO,1,"May 06, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.,PRODUCTION CONTROLS: Equipment Maintenance,"The recall communication was initiated on 04/05/2011 with Beckman Coulter forwarding a Product Correction letter with attached customer response form to the affected customers via US Postal Service. The letter informed customers of the products affected, the issue, the impact, and the actions to be taken.Customers were instructed to follow the steps provided in order to address the issues related to microbial contamination; and to complete and return the enclosed response form within 10 days so that receipt of this important information could be confirmed. In addition, the letter requested customers share the information with their laboratory staff and retain the notification as part of your laboratory Quality System documentation.For customers who have any questions regarding this update, the letter indicated to contact Customer Support Center Call Center via the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/. They may also contact Beckman Coulter at (800) 854-3633 in the United States and Canada or through your local Beckman Coulter representative.Beckman Coulter will issue two additional recall notification (""UPDATE TO URGENT PRODUCT CORRECTIONSynchron LX20, LX20 PRO, LXi 725 Clinical Systems"") beginning on 05/20/2011, one to Laboratory Directors and one to Physicians. The notices will be mailed via US Postal Service on Friday, May 20th. Customers who have subscribed to email notifications will receive an email containing the letters on Monday, May 23th. Both letter informs the Laboratory Directors and Physicians that Beckman Coulter has received reports of erroneous/aberrant sodium, potassium, chloride and calcium results that have been released from the laboratory. Electrolyte shifts can be low or high and may occur above, below or within the normal range.Laboratory Directors were instructed to immediately disseminate the Attachment to this letter (via notification/alert procedure appropriate to your .",N/A,1284,1284 units total for all products,"Worldwide Distribution -- Australia, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Hong Kong, India, Ireland, Italy, Japan, Republic of Korea, Kuwait, Mexico, Netherlands, Oman, Panama, Philippines, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.",Terminated,"February 06, 2013",642,1284,Not_Computer,N/A,N/A,N/A
Z-2150-2011,58504,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CAThe S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.",ACUSON S2000 ABVS Ultrasound System,2,"May 06, 2011", 2011,"Siemens Medical Solutions USA, Inc.","The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Siemens Medical Solutions USA, Inc. initiated the recall via phone calls and e-mail on March 28, 2011, to all affected customers, informing them of the affected product and providing instructions on the recall. Three units S/N 250171, 250173, and 250177 were to be removed and shipped back to Siemens. Siemens Service personnel were to be dispatched to the customer sites to perform validated stress test on units S/N 250157, 250162, 250163, 250164, 250166, 250167, and 250169 at customer sites.For questions regarding this recall call 650-694-5993.",N/A,10,10,"Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.",Terminated,"May 06, 2011",0,10,Not_Computer,N/A,N/A,N/A
Z-2153-2011,58318,"clamp, circumcision",HFX,Obstetric-gynecologic specialized manual instrument.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.","Circumcision Clamp, models 1.1cm and 1.3cm",2,"May 06, 2011", 2011,Surgical Design Inc,Medical device used in surgical procedure is defective and may break during use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Surgical Design, Inc. sent a Customer letter dated February 23, 2011, informing them of the affected product and providing instructions for its specific consignees. The instructions to the User is to please check your inventory to determine whether any Circumcision Clamps bought directly match those on your shelves. Please fill out the form and mail it to Surgical Design at the address on the form. If any clamps from the affected lots remain in your inventory, please ship them back to Surgical Design, noting the number being returned on the Reply form. These are the affected Lots.100210 (1.3cm)100211 (1.1cm) and100060409 (1.3cm)If you have any further questions, please call (703) 541-0196.",N/A,6100,6100 clamps,Class 2 Recall -- Nationwide Distribution.,Terminated,"June 21, 2013",777,6100,Not_Computer,N/A,N/A,N/A
Z-2151-2011,58441,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential.Distributed by Siemens, Concord, CAMfg by Impac Medical Systems, Sunnyvale, CAElectronic patient records management system",LANTIS Commander,2,"May 06, 2011", 2011,"Siemens Medical Solutions USA, Inc",There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.,OTHER/UNDETERMINED: Pending,"Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact there Siemens Service Engineer or Application Specialist or contact Lantis4.healthcare@siemens.com.For questions regarding this recall 925-602-8157.",Contact the recalling firm for information,47,47,Nationwide Distribution.,Terminated,"April 19, 2012",349,47,Other,N/A,N/A,N/A
Z-2154-2011,58379,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 SystemThe ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.",Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges,2,"May 09, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.",Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.,DESIGN: Device Design,"Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to:Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method.To notify anyone to whom they may have distributed the product.Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467.For questions regarding this recall call (302) 631-6299.",N/A,1399,"1,399","Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.",Terminated,"December 19, 2013",955,1399,Not_Computer,N/A,N/A,N/A
Z-2157-2011,58308,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).",UniCel DxH 800 Coulter Cellular Analysis System,2,"May 09, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology.Impact: Specimens with NW7 labels cannot be read by the handheld scanner.,N/A,"Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Consignees were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions:If they use NW7 bar code symbiology, the labels can be read using one of the following methods:-At the single-tube presentation station (using the internal bar code scanner)-Enter the bar code information manually at the user interface of the single-tube station-Use cassette presentation.Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,566,566 units,"Worldwide Distribution - USA (nationwide) and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, and the United Kingdom",Open,N/A,N/A,566,Not_Computer,N/A,N/A,N/A
Z-2179-2011,55466,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System,Toshiba America Medical Systems Inc Aplio Artida;,2,"May 10, 2011", 2011,Toshiba American Medical Systems Inc,There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.,DESIGN: Device Design,"The recall was initiated on 4/20/10 with Toshiba America Medical Systems (TAMS) forwarding a Medical Device Correction with a Customer Reply Form (via US Postal Service for US Customers) to all customers who purchased the SSH-880CV Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid this problem until corrective action is taken, in case this problem occurs; please contact their Toshiba Representative. If emergency use is necessary, use the following procedure which allows the system to be used temporarily: 1. Turn OFF the breaker at the back of the system and confirm that the error code near the breaker disappears. 2. Turn ON the breaker again to supply power to the system. Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. This form can also be sent via email to raffairs@tams.com. If customers had any questions they can call Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.",N/A,14,14,"USA, including Puerto Rico.",Terminated,"May 25, 2011",15,14,Other,N/A,N/A,N/A
Z-2178-2011,55952,"calibrator, secondary",JIT,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.",Beckman Coulter Access Free T3 Calibrator,2,"May 10, 2011", 2011,Beckman Coulter Inc.,"Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date.The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions:- Discontinue use of the lots of reagent listed above.- Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications.NOTE: Out-of-range high quality control results may indicate invalid test results.Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification.Assistance or questions regarding this notification, were directed to TechnicalSupport at 1-800-854-3633 in the United States and Canada. Outside the United States andCanada, contact consignees were told to contact their local Beckman Coulter Representative.",N/A,2320,"2,320 kits",Distribution Nationwide and Canada.,Terminated,"March 29, 2012",324,2320,Not_Computer,N/A,N/A,N/A
Z-2169-2011,57446,"centrifuges (micro, ultra, refrigerated) for clinical use",JQC,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Statspin Express 4 Centrifuge Model Number: SSH4Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes,Statspin Express 4 Centrifuge,2,"May 10, 2011", 2011,"StatSpin, Inc., dba Iris Sample Processing",Rotors may fail due to wire spokes breaking,DESIGN: Device Design,"Iris notified customers by letter in August 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to install the new rotors and discard the older rotors with the wires. There was no need for customers to return the rotors, but the firm requested customers fax or e-mail the enclosed form to verify that they have installed the new rotors. For any questions customers should call 1-800-782-8774.",N/A,2090,2090 units,"Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia Belgium, Czech Republic, Finland, France, Greece, Kuwait, Norway, Turkey,UK, and Norway.",Open,N/A,N/A,2090,Not_Computer,N/A,N/A,N/A
Z-2162-2011,57472,"cannula, ophthalmic",HMX,Manual ophthalmic surgical instrument.,Ophthalmic,Ophthalmic,510(K) Exempt,BD VisitecHigh Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place.,BD Visitec High Viscosity Injector 6mm .90mm (20G) Hammer,2,"May 10, 2011", 2011,Becton Dickinson and Company,Restricted or no fluid flow for Visitec High Viscosity Injector.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. ,Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.",N/A,3990,3990 units,"Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.",Terminated,"July 03, 2013",785,19129,Not_Computer,N/A,N/A,N/A
Z-2167-2011,57594,N/A,N/A,N/A,N/A,N/A,N/A,"Philips NM3 Monitors, Model 7900PHILIPS NM3 Monitor, English - P/N 1051674PHILIPS NM3 Monitor, English Refurbished - P/N U1051674PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674PHILIPS NM3 Monitor, Spanish - P/N 1060462NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.",Philips,2,"May 10, 2011", 2011,"Respironics Novametrix, LLC.","Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.",DESIGN: Software Design,"Respironics issued Field Action Notification Letter via Fed'x on 1/4/11, notifying customers of the issue and to instruct them on conditions for continued use and return of the device. The device will be updated with revised software to correct the calculation errors. Any questions or need additional information about this recall action, Contact Respironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697-6488 for International customers.",N/A,182,182 units,"NationwideForeign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain",Terminated,"March 07, 2013",667,220,Software,Output/Calculation,Software update,Software Update
Z-1678-2011,58047,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),2.0 mL Cartridge/Syringe Piston component of Insulin PumpInsulin infusion,2.0 mL Cartridge/Syringe Piston component of Insulin Pump,2,"May 10, 2011", 2011,Animas Corporation,Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867.For any questions about returning the product call 1-877-280-2339.Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.",N/A,384180,"384,180",Worldwide Distribution - USA (nationwide) and France.,Open,N/A,N/A,384180,Not_Computer,N/A,N/A,N/A
Z-2165-2011,58060,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Instrumentation Laboratory GEM Premier 4000 PN 00025000000The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus",Instrumentation Laboratory GEM Premier 4000,2,"May 10, 2011", 2011,Instrumentation Laboratory Co.,"Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously highresults",DESIGN: Device Design,"Instrumentation Laboratory notified accounts by a Field Safety NotifIcation Letter dated Feb 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use whichever of the following mitigation options works best for their institution. Both options will have the same effect to eliminate the potential impact of a rare spike on the glucose and lactate sensors. Customers were instructed to complete the enclosed Response Tracking Form and return immediately fax to 781-861-4207 or e-mail to ra-usa@ilww.com.Customers were advised to contact their local representative with any questions.",N/A,4379,4379 units,Worldwide Distribution - USA (nationwide) and the countries of CANADA ISRAEL ITALY APAN KUWAIT MALAYSIA MEXICO NETHERLANDS NORWAY PANAMA POLAND PORTUGAL PUERTO RICO SAUDI ARABIA SLOVENIA SPAIN SWEDEN SWITZERLAND TAIWAN TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and URUGUAY.,Terminated,"May 23, 2012",379,4379,Other,N/A,N/A,Other
Z-2172-2011,58234,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"UniCel DxH 800 Coulter Cellular Analysis System,Part Number: 629029The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).",UniCel DxH 800 Coulter Cellular Analysis System,2,"May 10, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassetteThe impact:- Specimen tubes may fall out of cassettes and be misplaced inside the instrument- Specimen tubes may break upon impact, causing possible biohazard exposure- Patien",N/A,"Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form being sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Customers were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions:-Periodically inspect the mix station drip tray for misplaced tubes that may have fallen from the cassette.- Periodically examine the Type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Consignees were told to contact their Beckman Coulter representative for assistance with questionable grippers.- Clean any spills according to their laboratory standard operating procedures. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain the notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800-526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,566,566 units,"Worldwide Distribution - USA (Nationwide)and to the countries of Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, & United Kingdom",Terminated,"November 21, 2012",561,566,Not_Computer,N/A,N/A,N/A
Z-2176-2011,58252,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.","Optical Guidance Platform, version 2.6 and 2.6.1",2,"May 10, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.,DESIGN: Software Design,"The firm, Varian Medical Systems, sent an ""URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE"" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the Optical Guidance Platform (OGP) Instructions For Use on Loading a treatment plan; before positioning the patient, compare the plan details loaded into the OGP with the plan details printed from the treatment planning systems; verify that the patient information, isocenter, gantry and couch angles are identical as requested in the Instructions For Use, and advise the appropriate personnel working in their radiotherapy department of the content of this recall letter.Varian has made changes to the OGP Instructions For Use -Varian strongly recommends you download the most recent version at www.MyVarian.com or request a copy from your local Varian Customer Support District or Regional Manager. Varian also is preparing a software correction which will be applied to affected unites to correct this issue.If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager at the follow: USA and Canada - 1-888-827-4265; Europe +41 41 749 8844; E-mail-North America: support-americas@varian.com; Australia/New Zealand: support.anz@varian.com; Europe: support-emca@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com, and Latin America: soporte.al@varian.com; Internet: Oncology Systems customer site - www.myvarian.com and Varian Medical Systems public site-www.varian.com.",N/A,599,599 units,Worldwide distribution.,Terminated,"June 19, 2012",406,599,Software,Output/Calculation,Instructions for verification/Software update,Software Update
Z-2182-2011,58466,"bed, patient rotation, powered",IKZ,Powered patient rotation bed.,Physical Medicine,Physical Medicine,510(K) Exempt,"KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500.Indicated for treatment and prevention of pulmonary complications.",KCI RotoProne Critical Care Therapy ,2,"May 10, 2011", 2011,"KCI USA, Inc.",Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.,DESIGN: Device Design,"Firm sent a letter with the ""Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit"" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.",N/A,229,229 units,Worldwide Distribution - USA and Kuwait.,Terminated,"October 24, 2011",167,229,Not_Computer,N/A,N/A,N/A
Z-2175-2011,58182,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,Philips IntelliVue Clinical Information Portfolio software as follows:865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link,Philips IntelliVue Clinical Information Portfolio,2,"May 10, 2011", 2011,Philips Healthcare Inc.,Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.,DESIGN: Software Design,Philips Healthcare notified accounts on 3/16/11 via the Urgent Medical Device Correction Notification. Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel.All customers potentially affected by this issue will receive the software correction as part of the field action.,N/A,387,387 units,"Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.",Open,N/A,N/A,387,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2180-2011,58395,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240.DigiView is a digital image management and reporting system with an associated clinical database. It provides capture, review, and storage of images together with report creation and data basing.",DigiView software,2,"May 10, 2011", 2011,"Digisonics, Inc",Data from one patient's study had the potential for being put into another patient's report.,DESIGN: Device Design,"Digisonics notified end users via e-mail January 20, 2009 and January 21, 2009, that Data from one patient's study was being put into another patient's report. The problem occurred when a System bug was found in DigiView Release 3.6.4.4, and higher versions in which under certain circumstances (specific workflow) a failure to switch to a patient's images occurs. Two software patch versions will be made available to sites on or after February 5, 2009, to correct the reported problem.If you have any further questions, please contact Digisonics Customer Support at (800 ) 940-3240.",N/A,70,70 units,"Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.",Terminated,"May 31, 2011",21,70,Software,Output/Calculation,Software update,Software Update
Z-2170-2011,58168,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes.",Beckman Coulter HbA1c APT,2,"May 10, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177.When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032,elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may beinterpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medicalacti",N/A,"Beckman Coulter initiated the recall communication with a Product Corrective Action (PCA) letter with attached recall response form on March 1, 2011 to the affected customers. The letter explained the problem and identified the action to be taken. The PCA also instructed the consignees to:(1) Please discontinue the use of lots 9390 and 9472 and discard according to your local procedures.(2) Please contact your local Beckman Coulter support Organization for replacement reagent.(3) You may need to re-evaluate samples for HbA1c which were tested with either of the listed lots of reagent.In addition, customers were instructed to:(1) share the information with their laboratory staff and retain this notification as part of their Quality System documentation. If any of the affected product was forwarded to another laboratory, a copy of the letter should be provided to them.(2) complete and return the enclosed response form within 10 days so that the firm was assured the customer received the important communication. For any questions regarding this notice, customers were instructed to contact Customer Technical Support at 1-800-854-3633 in the U.S.A and at 00353656831111 in Europe.",N/A,373,373 kits,"Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam.",Terminated,"June 28, 2012",415,373,Not_Computer,N/A,N/A,N/A
Z-2181-2011,58590,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;,Varian Medical System TrueBeam ,2,"May 10, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Position sensor failure mode may result in an inaccurate position calculation. The error manifests itself in one of two possible ways.1. The video returned by one of the two cameras inside the Spectra is all white or all black. The consequence of this failure symptom is that the Spectra stops tracking immediately.2. The video returned by one of the two cameras inside the Spectra is returned b,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.",N/A,20,20,Nationwide distribution.,Terminated,"June 19, 2012",406,20,I/O,Output/Calculation,Notification,Safety Notice/Insructions
Z-2177-2011,58380,"enzymatic method, creatinine",JFY,Creatinine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.",Dimension(R) EZCR Flex(R) Reagent Cartridge,2,"May 10, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.",Patient results may be falsely depressed or falsely elevated across the assay range.,DESIGN: Device Design,Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit.,N/A,860,860,Nationwide distribution.,Terminated,"March 19, 2013",679,860,Not_Computer,N/A,N/A,N/A
Z-2166-2011,58400,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240.Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing.",DigiView software,2,"May 10, 2011", 2011,"Digisonics, Inc",Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.,DESIGN: Device Design,"Digisonics, Inc., notified consignees by telephone and e-mail on 10/17/2008, informing them that a problem had been found in the Save Linked Images functionality of DigiView Release 3.6 (and all releases which start with 3.6 such as 3.6.1.). The problem is the failure of the software to update some measurements when tracings or points are amended after measurement calculations have been performed. A utility program, called Linked Image Measurement Verify was being supplied to all sites as a patch to the DigiView program. Release 3.6.6 was to be provided to all customers having previous 3.6 version. Problem was fixed in version 3.6.6 and 3.7.1.If you have any questions, please contact Digisonics Customer Support at (800) 940-3240.",N/A,70,70 units total,"Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada.*** Due to the age of this recall, district is recommending no audit checks***",Terminated,"May 31, 2011",21,70,Software,Output/Calculation,Software update,Software Update
Z-2171-2011,58216,"drills, burrs, trephines & accessories (manual)",HBG,"Manual cranial drills, burrs, trephines, and their accessories",Neurology,Neurology,510(k),"Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119.Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.","Micro Ventricular Bolt Pressuring Monitoring, Cranial Access, and Drainage Kit ",2,"May 10, 2011", 2011,Integra LifeSciences Corp.,Outer box of Monitoring Kit was mislabeled with the incorrect part number.,PRODUCTION CONTROLS: Error in Labeling,"Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached ""Recall Acknowledgement and Return Form"" indicating whether or not they possess any of the product identified. For any questions regarding this recall call 609-936-2485.",N/A,45,45 kits,"Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.",Terminated,"May 10, 2011",0,45,Not_Computer,N/A,N/A,N/A
Z-2174-2011,58180,"prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer",MBH,Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN.Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.",NEXGEN COMPLETE KNEE SOLUTION REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTO,2,"May 10, 2011", 2011,Zimmer Inc.,"The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.",DESIGN: Device Design,"The firm, Zimmer, sent an ""URGENT MEDICAL DEVICE RECALL"" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via ""email return receipt"" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.",N/A,27,27 devices,"Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.",Terminated,"August 28, 2013",841,829,Not_Computer,N/A,N/A,N/A
Z-2184-2011,58583,"radioimmunoassay, human growth hormone",CFL,Human growth hormone test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"IGFBP-3 ELISA Reagent Kit; Part Number"" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830This assay is intended for in vitro diagnostic use.",IGFBP3 ELISA Reagent Kit,2,"May 11, 2011", 2011,Beckman Coulter Inc.,The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).,PRODUCTION CONTROLS: Process Control,"Beckman Coulter sent a Product Corrective Action (PCA) letter with attached customer response form on March 30, 2011 to all customers who have the affected product, IGFBP- 3 Enzyme-Linked immunosorbent Assay ( ELISA) kit .This kit provides materials for the quantitative measurement of IGFBP-3 in serum. The letter informed the customers of the reason for recall, the products affected and actions to be taken.Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they were asked to provide a copy of the letter to them.Beckman further asked consignees to complete and return the enclosed Response Form within 10 days so they are assured consignees have received this important communication.Questions were directed to the Beckman Coulter Customer Support Center.- Website: http://www.beckmancoulter.com/customersupport/support- Phone, call 1-800-854-3633 in the United States and Canada- Outside the United States and Canada contact local Beckman Coulter representative.",N/A,1212,"1,212 units","Worldwide -- USA, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Italy, Korea, Republic of, Lebanon, Luxembourg, Morocco, Netherlands, New Zealand, Puerto Rico, Syrian Arab Republic, Taiwan, Thailand, Turkey & United Kingdom",Terminated,"December 02, 2011",205,1212,Not_Computer,N/A,N/A,N/A
Z-2183-2011,58479,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT.Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.",TEMPUS IC PROFESSIONAL ,2,"May 11, 2011", 2011,Remote Diagnostic Technologies Ltd.,"It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Remote Diagnostic Technologies, Ltd notified its consignees of the problem and the work-around via letter with the subject line ""ECG Issue - Field Action Required"" on 03/25/2011. The letter stated that customers can avoid the issues by viewing the recorded ECG for at least 13 seconds. Two diagrams were attached with the letter depicting the conditions under which the issue can occur. Customers can continue to use the device normally in all other respects. The letter states that the firm is working on a software modification which will permanently fix the issue and prevent it from occurring. Customers are to contact the Regulatory Affairs and Operations Manager if they have any questions.",Contact the recalling firm for information,19,19 units,"Nationwide Distribution -- KY, MD, VA, and FL.",Terminated,"September 16, 2011",128,19,Software,Device Operation,Software update,Software Update
Z-2185-2011,57194,"monitor, blood-gas, on-line, cardiopulmonary bypass",DRY,Cardiopulmonary bypass on-line blood gas monitor.,Cardiovascular,Cardiovascular,510(k),"CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.",CDI 500 Blood Parameter Monitoring System,2,"May 12, 2011", 2011,Terumo Cardiovascular Systems Corporation,"The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracies. The CDI 101 and CDI 500 system are stand alone systems that are used during extracorporeal procedures to continuou",N/A,"The firm, TERUMO, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated October 27, 2010 to its customers. The letter described the product, problem and actionst to be taken. The customers were instructed to reveiw this notice; assure that customers are ware of this notice; confirm receipt of this notification by faxing the attached Customer Response Form, and place the attached stickers in a visible place in the Operators' Manuals, such as the inside of the front cover, if additional stickers are needed, the customers should contact Terumo CVS Customer Service at 1-800-521-2818. The letter states that when a displayed value is significantly different from expectations based on the clinical situatioin, the user should verify the accuracy by independent means before treating. The letter included ""Caution"" stickers that were to be applied to the CDI system operatros manual.The letter also states ""Please note that we are not recommending that you stop using your CDI monitor system.""If you have any questions or concerns, please contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are from Monday-Friday, 8AM - 6PM EST.",Contact the recalling firm for information,3260,3260 units all models.,"Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.",Open,N/A,N/A,3260,Other,Display/Image,Instructions,Safety Notice/Insructions
Z-2190-2011,58517,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE / RT Therapist v4.1 system.The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software.Siemens Healthcare, Concord, CA.The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.",ARTISTE / RT Therapist v4.1 system,2,"May 12, 2011", 2011,"Siemens Medical Solutions USA, Inc","When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.",N/A,"Distribution of the Urgent: Medical Device Correction Customer Advisory Notice began on March 24, 2011 via certified mail or by the Siemens Customer Service Group. The letter identified the issue and when it occurs. Users were asked to verify the isocenter position of the reference image in the Portal Review application before using a reference image imported from the treatment planning system. Siemens is currently working on a solution and will notify customers as soon as the update is available. The letter should be included with the Owner Manual of the system in the chapter for ""Safety Advisory Letters"" until an update is provided.",Contact the recalling firm for information,228,228 active devices,Worldwide Distribution,Terminated,"February 13, 2012",277,228,Software,Display/Image,Software update,Software Update
Z-2191-2011,58219,"lubricant, patient",KMJ,Patient lubricant.,General Hospital,General Hospital,510(k),"Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.",Forteo teriparatide (rDNA origin) injection starter kits ,2,"May 12, 2011", 2011,Eli Lilly and Company,"Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States.The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infecti",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm, Eli Lilly and Company, sent two letters entitled ""URGENT MEDICAL DEVICE RECALL TRIAD GROUP ALCOHOL PREP PADS INCLUDED IN FORTEO STARTER KITS ALL ALCOHOL PREP PAD LOTS"" to its customers. The first letter was dated March 18, 2011 and second follow-up letter was dated March 28, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to examine their inventory of Forteo starter kits; if they have any Forteo starter kits with a black bag, remove and appropriately discard the Triad Group alcohol prep pads; discontinue providing the product with the starter kits; inform any patients that may have received Forteo starter kits containing the Triad Group alcohol prep pads to discontinue use; note: after removing the Triad Group alcohol prep pads, all other components of the Forteo starter kits are acceptable for use: travel bag, pen case, gel packs, needles and instructional materials, and complete and return the enclosed business reply card. ""It is important to note that this recall does not affect or involve the Forteo delivery device.""For questions pertaining to the recall, contact Triad Group at 262-538-2900. (Please refer to the Triad Group press release issued on January 5, 2011 on the FDA website.) If you have product specific medical questions related to Forteo please call 1-800-LILLYRX.",N/A,47000,"approximately 47,000 kits","Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland.",Terminated,"August 30, 2011",110,47000,Not_Computer,N/A,N/A,N/A
Z-2192-2011,58451,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 SterileBD, Franklin Lakes, NJ MADE IN USAFor use in aspiration of medications, typically in the pharmacy setting.","BD 16 G x 1 in. Nokor"" noncoring vented needle",2,"May 13, 2011", 2011,Becton Dickinson & Company,"Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.",PRODUCTION CONTROLS: Packaging,BD sent an Urgent: Product Recall letter with return response forms to direct consignees on 03/01/11 and 03/02/11 via UPS. The letter identified the affected product and lot along with the reason for the recall. The letter asked customers to complete the enclosed Distributor Packing List and to follow the instructions provided on the Packing List for returning the affected product. The firm will issue a credit upon receipt of the affected product. Customers can contact BD Customer Service if they need assistance or have questions regarding the recall.,N/A,161000,"161,000 units","Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada.",Terminated,"November 30, 2012",567,161000,Not_Computer,N/A,N/A,N/A
Z-2193-2011,58421,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.","Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5",2,"May 13, 2011", 2011,"Digisonics, Inc",Left ventricle volume was inaccurate when the volumes were measured from images having different scales.,OTHER/UNDETERMINED: Pending,"The firm, Digisonics, notified consignees/customers via e-mail entitled ""Distribution of Notification of Biplane Error"" dated February 6, 2009. The email described the product, problem and actions to be taken. The customers were instructed to immediately contact Digisonics if their site calculates biplane volumes-a utility will be provided which will run on their database and identify all studies in which biplane volumes are calculated. The customers were also instructed to share the following important information with all users of DigiView at their site. The email stated -until the software patch has been installed, biplane volumes should be calculated only from pairs of images having the same depth scale. Replacement DigiView/ERS software that prevents further occurrence of this problem will be provided if it appears their site could be impacted.The Distribution of New Software Release was sent on March 6, 2009.If you have any questions, please call Digisonics Customer Support at 800-344-4266.",N/A,74,74 units,"Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.",Terminated,"May 31, 2011",18,74,Software,Output/Calculation,Software update,Software Update
Z-2198-2011,58198,"tape and bandage, adhesive",KGX,Medical adhesive tape and adhesive bandage.,General Hospital,General & Plastic Surgery,510(K) Exempt,"Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060",Curad Flexible Fabric Bandage,2,"May 13, 2011", 2011,"Jiangsu Wujin Hualian Health Dressing Co., Ltd.",The sterility of the product has the potential to be compromised due to weak sealing of the bandages.,PRODUCTION CONTROLS: Process Control,"Changzhou Hualian Health Dressing Co., Ltd notified sole consignee by e-mail and a Medical Device Recall letter, dated 3/18/2011. The letter identifies the affected product and the reason for the recall. The customer was to examine their inventory and quarantine the affected product. If the product had been further distributed, those customers were to be identified and notified of the recall. The enclosed response form was to be completed and returned to Medline Industries, Inc. Questions could be directed to Customer Service, Monday through Friday between 8:30 A.M. and 4:00 P.M.",Contact the recalling firm for information,1092,"1,092 cases",Nationwide Distribution -- IL.,Terminated,"April 23, 2012",346,1092,Not_Computer,N/A,N/A,N/A
Z-2197-2011,58167,"appliance, fixation, spinal intervertebral body",KWQ,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Manta Ray"" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7.","Manta Ray"" Anterior Cervical Plate (ACP) System",2,"May 13, 2011", 2011,Integra LifeSciences Corp.,"Based upon the results of the firm's literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adverse events.",N/A,"The firm, Integra Spine, sent an ""URGENT: FIELD CORRECTIVE ACTION"" letter dated January 10, 2011 with a Field Corrective Action Acknowledgement and Return Form sent via Fed Ex/ priority mail to all customers including physicians and distributors. The letter describes the product, problem and actions to be taken. The customers were instructed to review the current inventory to identify product from the affected part numbers; replace the existing IFU (22-PI-01 rev C) with the revised IFU (22-PI-01 rev D) and the existing Surgical Technique (ST-22-001 rev A) with the revised Surgical Technique (ST-22-001 rev B), and complete and return the Field Corrective Action Acknowledgement and Return Form via fax to: 877-558-6227 or email.If you have any additional questions, contact the Manager Quality Systems Integra Spine at 330-475-8646.",No consumer action necessary,244,244 IFU,"Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, GA, ID. IL, KS, LA, MD, MO, NH, NM, NV, NY, OH, OK, OR, PA, PR, SD, TN, TX, UT, VA, WI, and WV.",Terminated,"October 27, 2011",167,244,Not_Computer,N/A,N/A,N/A
Z-2195-2011,58438,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases.",VARIAN HIGH ENERGY LINEAR ACCELERATOR,2,"May 13, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.",PRODUCTION CONTROLS: Process Control,"The firm, Varian Medical, sent an ""Urgent Medical Device Correction"" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The customers were also instructed to advise the appropriate personnel working in their Radiotherapy Department of the content of this letter.Varian Service shall immediately begin an interim action to replace screw fasteners on all hard wedges for Clinacs installed prior to January 2004. Varian Service will contact the customers to arrange for the inspection visit.Varian also stated that they shall continue their Investigation of this issue to further clarify the exact conditions under which the wedge screw fasteners may fail, and to analyze possible final solutions. Varian will notify the customers when final determinations are made.If you require further clarification, please feel free to contact your local Varian Customer Support Services Manager and/or USA and Canada at 1-888-4265; Europe: +41 41 749 8844; or email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.Helpdesk@varian.com; Japan: Japan.apps helpdesk@varian.com; Latin America: soporte.al@varian.com, a d Internet: Oncology Systems-www.myvarian.com or Varian Medical Systems - www.varian.com.",N/A,5616,5616 units,Worldwide distribution:,Terminated,"June 07, 2013",756,5616,Not_Computer,N/A,N/A,N/A
Z-2194-2011,58490,"drills, burrs, trephines & accessories (manual)",HBG,"Manual cranial drills, burrs, trephines, and their accessories",Neurology,Neurology,510(k),"Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119.A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.",Integra NeuroSciences Combo Kit,3,"May 13, 2011", 2011,Integra LifeSciences Corp.,Outer packaging of Combo Kit was mislabeled with an incorrect lot number.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Integra LifeSciences Corp. sent a "" Urgent Product Recall Notification"" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients.An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.",N/A,7,7 Kits,Nationwide Distribution -- including the state of New York.,Terminated,"May 13, 2011",0,7,Not_Computer,N/A,N/A,N/A
Z-2196-2011,57951,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.The cannula perfuses blood to the ascending aorta during short-term (",Aortic Cannula,2,"May 13, 2011", 2011,Edwards Lifesciences Llc,Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.,N/A,"The firm, Edwards Lifesciences, sent an ""URGENT PRODUCT RECALL - ACTION REQUIRED"" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020. If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time.",N/A,20,20,Nationwide distribution: CA only.,Terminated,"May 13, 2011",0,20,Not_Computer,N/A,N/A,N/A
Z-2064-2011,58160,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDsSoftware version 2.004 or earlierThe product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.",Defibtech Lifeline AED and ReviveR AED,1,"May 16, 2011", 2011,"Defibtech, LLC",Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process,DESIGN: Software Design (Manufacturing Process),"The firm, Defibtech, sent an ""URGENT MEDICAL DEVICE SAFETY INFORMATION AND CORRECTION"" letter dated March 11, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:1) Remove the pads from the storage pouch on the back of their DDU-100 series AED and inspect the 9-digit serial number label.2)Carefully note the 9-digit serial number on the back of the AED, then visit the Defibtech website at www.defibtech.com/fa11 and enter their serial number to determine if their AED is affected; email their serial number and contact information to fa@defibtech.com or call Defibtech directly at 1-877-453-4507 or 1-203-453-4501 and Defibtech will inform them if their unit is affected.3) If their AED is affected, confirm receipt of this notification with Defibtech as soon as possible by website and/or confirmation card. Complete and return the confirmation form via fax to 1-203-738-1072. Note: ""it is very important for you to contact us either through the Defibtech website or return this card to confirm that you have received this notice. This information will expedite the process of upgrading your AEDs.""If your DDU-100 series AED serial number DOES NOT fall within the listed range, your AED is not affected by this recall.A letter was also sent to the distributors and direct accounts that have received the affected product by first class mail with a prepaid, return written acknowledgement card. The field action consists of a software change to the AED. All affected AEDs operating with software version 2.004 or earlier are to remain in the field and in service throughout the field action process.Upon receipt of contact information from affected customers, Defibtech will send an upgrade kit to customers consisting of a software data card, instructions on how to perform the upgrade, and a pre-paid upgrade confirmation postcard that must be returned to Defibtech upon completion.",N/A,563,"91, 472 units","Worldwide distribution: USA (nationwide) and countries including: AUSTRALIA, AUSTRIA , BAHRAIN, BRAZIL, CANADA, CHILE, CHINA , CYPRUS, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA, REPUBLIC OF LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND URUGUAY.",Open,N/A,N/A,91472,Software,Device Operation,Software update,Software Update
Z-2199-2011,58596,"separator, automated, blood cell and plasma, therapeutic",LKN,N/A,N/A,Gastroenterology/Urology,510(k),The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031.Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.,Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA),2,"May 16, 2011", 2011,"Fresenius Kabi, LLC","Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.",MISBRANDING: Labeling False and Misleading,"Fresenius Kabi sent a ""Urgent Notification"" letter dated May 6, 2011, to the affected consignees they are recalling the Operating Manual for the Fresinius AS104-Blood Cell Separator.The Red Blood Cell (RBC) sets have been recalled according to recall number Z-0616-2011, and will permanently not be used with the AS 104 Blood Cell Separator Device. The RBC set was never approved by the FDA according to Warning Letter (Reference # GEN1001508) dated 31 January 2011. The customers are being instructed to complete the self addressed postage pre-paid "" Product Response Card."" Place a check mark next to the disposition choice used.Fresenius plans to send the revised Operating Manual and a notification letters to consignees at the end of April 2011.Consignees who have questions about this recall can call the firm at 1-425-242-2074.",Contact the recalling firm for information,158,158 units,"Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.",Terminated,"December 06, 2011",204,158,Not_Computer,N/A,N/A,N/A
Z-2200-2011,58505,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA.For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.","Optical Guidance Platform, Version 2.6 and 2.6.1",2,"May 16, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.,DESIGN: Software Design,"On 3/30/2011, Varian distributed an Urgent Medical Device Correction Urgent Field Safety Notice to all affected users, with a description of the problem and identification of the affected product. The letter also informed customers of how they can determine if the problem affects them. The letter states that there is no work around for the issue unless they possess a FastPlan system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the content of the letter. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.",N/A,598,598 units,Worldwide Distribution,Terminated,"June 19, 2012",400,598,Software,Output/Calculation,Software update,Software Update
Z-2212-2011,55207,"equipment, laboratory, general purpose, labeled or promoted for a specific medical use",LXG,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - AutomateThe AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module.",AutoMate TM Sample Processing System,2,"May 19, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the AutoMate.",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent an Urgent Product Corrective Action letter dated May 7, 2009, with a Fax Back Response Form (sent by US mail) to all customers who received the AutoMate Sample Processing System. The letter identified the product, the problem and a workaround to correct the problem. Customers were instructed to take the following steps:If the stuck sample carrier is moved backwards during recovery from this error, the sample tube/input tray information will become mismatched.Figure 2 in the PCA letter shows the AutoMate viewed from the rear. Sequence 1 to 3 depicts the error recovery issue. The sample is loaded, but cannot move along the track. As the sample attempts to move along the track, it is captured by the track stopper (not seen) below the track. Error 81201001 will be displayed at the console with the following description: The stopper (SL01) did not stop the sample tube carrier. If the stopper or an operator forces the sample backward along the line, it will cause the information mismatch.If you encounter this scenario, do not move the carrier backward to the loading position. See Figure 3 in the PCA letter.Recovery from Error 81201001:1. The normal recovery for error 81201001 is to move the sample carrier forward. If there is no room to do so in the Input module, extra steps must be taken for the carrier to move forward.a. Resume the module by performing error recovery on the Hardware Error Recovery screen at the console. b. Continue the console error recovery process until a carrier is released from BR01, thereby creating space for the stuck carrier to be pushed forward.c. Move the stuck sample carrier forwardd. Once again, resume the module by performing error recovery on the Hardware Error Recovery screen. (The error should not return again)Recovery if Symptoms are Observed: 1. If the incorrect processing described above is observed, the system must be stopped immediately and shut down. All samples m.",N/A,5,5 units total,Nationwide Distribution including VA KY and CA,Terminated,"June 28, 2012",406,5,Not_Computer,N/A,N/A,N/A
Z-2204-2011,55542,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed",CHVH001A/1B Variable Helical Pitch (vHP) Software for TSX101A: Aquilion 64,2,"May 19, 2011", 2011,Toshiba American Medical Systems Inc,The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).,DESIGN: Software Design,"Toshiba America Medical Systems (TAMS) forwarded an Urgent: Medical Device Correction letter, dated 4/6/10, with attached Customer Reply Form, via US Postal Service to all customers who purchased the CHVH-001A/1B variable helical pitch (vHP) software for TSX-I0IA: Aquilion 64. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that a Toshiba service representative would contact them to schedule an appointment in order to install a corrective measure that will prevent the occurrence of the problem. Toshiba would like customers to set a scan range different from that for the previous scan for the second and subsequent vHP scans, if multiple vHP scans with the same scan conditions are performed in Auto Mode.Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. Customers with any questions can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Representative at (800) 521-1968.",N/A,35,35,"Nationwide Distribution -- MN, OH, MO, MI, NY, KS, MD, TX, NJ, IL, ID, TN, AZ, PA, HI, GA, MT, WA, FL, NC, WI, ME, & CA.",Terminated,"August 17, 2012",456,35,Software,Device Operation,Software update,Software Update
Z-2203-2011,55543,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound,SSH880CV Aplio Artida,2,"May 19, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.",DESIGN: Software Design,"The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect.Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com.If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.",Contact the recalling firm for information,28,28,"Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico.",Terminated,"April 20, 2012",337,28,Software,Output/Calculation,Software update,Software Update
Z-2201-2011,56389,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"Software CD is labeled in part:""BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***""The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.",EVOLIS Assay Protocol Files ( APF) Software,2,"May 19, 2011", 2011,Bio-Rad Laboratories,The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.,DESIGN: Software Design,"Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with "" Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.",Contact the recalling firm for information,272,272,Nationwide Distribution -- Including Puerto Rico.,Terminated,"August 25, 2011",98,272,Software,Output/Calculation,Software update,Software Update
Z-2215-2011,57469,"system,test,thyroglobulin",MSW,Tumor-associated antigen immunological test system.,Immunology,Immunology,510(k),"Access Immunoassay Systems Thyroglobulin,Part Number: 33860This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.",Access Immunoassay Systems Thyroglobulin,2,"May 19, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable range of the assay. When customers interchange between diluents there is an unacceptable shift in results. A mediandifference of 16% (ranging from 14% to 23%) b",OTHER/UNDETERMINED: Pending,"The firm, Beckman Coulter, sent an ""URGENT: PRODUCT CORRECTIVE ACTION (PCA)"" letter dated October 18, 2010, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems Thyroglobulin. The letter describes the product, problem and actions to be taken. The customers were instructed to:1. Do not dilute elevated thyroglobulin samples with Wash Buffer II.2. Do not run thyroglobulin patient samples using the onboard dilution feature on the UniCel DxI instrument.3. Dilute elevated thyroglobulin samples only with Access Thyroglobulin Sample Diluent (REF 33866).4. Review your patient result archives. Manually dilute and repeat the analysis of all elevated thyroglobulin samples that had previously been diluted with Wash Buffer II, using Access Thyroglobulin Sample Diluent instead.5. A forthcoming version of the UniCel DxI Assay Protocol File (APF) will remove the Access Thyroglobulin onboard dilution assay (dTg) from the list of available onboard dilution assays.6. The Access Tg product Instructions for Use will be updated to eliminate Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. Customers should update procedure manuals and other documents that your laboratory may have created which list Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples.In addition, customers were instructed to complete and return the enclosed PCA Response Form with in 10 days via fax to: 786-639-4000 or mail to: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. Customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman's Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact their local Be.",N/A,6414,"6,414 units",Worldwide distribution: USA (nationwide) and country of: Canada.,Terminated,"August 10, 2012",449,6414,Not_Computer,N/A,N/A,N/A
Z-2214-2011,57591,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4.The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.",GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM,2,"May 19, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.",DESIGN: Software Design,"The firm, GE Healthcare, sent an ""URGENT MEDICAL DEVICE CORRECTION GE Ref: 22932"" letter dated January 19, 2011 to its consignees/customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Contact Information, and Additional Dosimetric Information.A second letter dated March 11, 2011 was sent to the consignee/customer letter consisting of a cover letter and an attachment. ""This letter is to notify you of an error in the January 19, 2011, Urgent Medical Device Correction Letter, that you have already received (GE Ref: 22932). In the Safety Issue section of that letter it is written: ""If this issue were to occur, it would result in the remainder of the exposure being delivered at the patient position where the table stopped up to the prescribed scan time or 30 seconds, whichever is shorter."" The stated 30 seconds limitation is incorrect for your particular model. This information has been corrected on the attached Urgent Medical Device Correction letter, so please discard the original letter if it is still in your possession. ""GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction.The customers were also instructed as follows: prior to GE's installation of a software update, continue to monitor patient scanning closely. Should the table stop unexpectedly and X-ray remains on, manually stop the scan, and ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.If you have any questions, please contact GE immediately at the following: United States: 800-437-1171; Japan: 0120-055-919; Korea: 1544-6119; Australia/New Zealand: 800-659-465 and China: 800-810-8188. For other countries please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notifi.",Contact the recalling firm for information,479,479,"Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, PUERTO RICO, PORTUGAL, POLAND, PARAGUAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LEBANON, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, EGYPT, COLOMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BELARUS, BAHRAIN, AUSTRALIA, ANGOLA, ALGERIA. TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, PHILIPPINES, PARAGUAY, OMAN, NEW ZEALAND, MOROCCO, KUWAIT, KAZAKHSTAN, ISLAMIC REPUBLIC OF IRAN, ARGENTINA.",Terminated,"July 10, 2012",418,479,Software,Device Operation,Software update,Software Update
Z-2208-2011,58037,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORDProduct Code: 210811Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.",Depuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD,2,"May 19, 2011", 2011,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Metal debris in the shaft component of the device,PRODUCTION CONTROLS: Manufacturing Material Removal,"DePuy Mitek sent an Urgent Voluntary Product Recall Notification letter dated February 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check their inventory to determine if they have any affected product. Customers were asked to complete the enclosed business reply form and fax it to 508-828-3750 or email to mitekcomplaints@its.jnj.com whether or not they have any of the affected product remaining in their inventory. Customers were asked to utilize the return good authorization number provided by customer service and return all identified product to:DePuy MitekATTN: Recall Coordinator50 Scotland BoulevardBridgewater, MA 02324For any questions call 1-877-379-4871 or contact DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.",Contact the recalling firm for information,1126,1126 units,Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland,Terminated,"February 20, 2013",643,10139,Not_Computer,N/A,N/A,N/A
Z-2219-2011,58429,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911.Designed to be used only with the PercuNav"" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest.",PercuNav Field Generator Stand,2,"May 19, 2011", 2011,Philips Medical Systems North America Co. Phillips,"The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.",DESIGN: Device Design,"On 4/4/11, Philips Healthcare began sending out the URGENT-Medical Device Correction notification letter to their consignees.Philips informed their customers of a potential tipping hazard of the PercuNav Field Generator Stand. The notification letter also provides instructions to customers to ensure the articulating Mounting Arm is positioned so the Field Generator is not further than the specified distance from the back of the clamp on the stand's central pole during set up or during use. Customers are instructed to apply a provided label on stand to warn of a potential for tipping due to excessive force. For transport, customers are instructed to remove the Field Generator from the Mounting Arm and place the Field Generator in the storage compartment on the system cart. The Mounting Arm should then be collapsed and folded into a 90 degree angle.Customers are informed that a Philips field service representative will contact them to schedule installation of a service kit on the stand, free of charge, once service kits are available.Customers can call Philips Customer Service at 1-866-767-7822 and reference to FCO 79500197 for any questions about this recall.",Contact the recalling firm for information,65,65 units total (33 units distributed to US and 32 units to foreign consignees),"Worldwide Distribution -- USA, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.",Terminated,"March 15, 2012",301,65,Not_Computer,N/A,N/A,N/A
Z-2213-2011,58235,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"COULTER LYSE S III diff Lytic Part Number: 8546796.COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.",Coulter Lyse S III diff Lytic,2,"May 19, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing.",N/A,"Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action.For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results.Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation.Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.",Contact the recalling firm for information,1296,"1,296 units","Worldwide Distrubution-- USA ( nationwide) including states of : AL, AR, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI, & WV and country of Canada.",Terminated,"June 04, 2012",382,1296,Not_Computer,N/A,N/A,N/A
Z-2217-2011,58667,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information CenterThe intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.",Philips AudioVideo Engineering PAS210 Remote Active Speakers Kit ,2,"May 19, 2011", 2011,Philips Healthcare Inc.,PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation,DESIGN: Component Design/Selection,"Philips Healthcare issued an Urgent - Medical Device Correction letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the ""Action to be taken by Customer/User"" section of the instructions while they await the correction, which will likely come in the form of a replacement audio cable for all affected speaker assemblies.For further information or support concerning this issue, please contact Philips Healthcare Customer Care Service Center at 800-722-9377 # 3, # 1 and reference the letter or your local Philips representative in your area.",N/A,15062,15062 units,Worldwide Distribution - USA (nationwide) and the country of Canada,Open,N/A,N/A,15062,I/O,Alarm/Message,Replace cable,Remove or Replace
Z-2069-2011,57473,veterinary laser,RGB,N/A,N/A,N/A,N/A,"Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339.The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: ""***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***"".",Lockheed Martin Aculight Capella R1850 Laser,2,"May 19, 2011", 2011,Lockheed-Martin Aculight,"It has been determined that there are certain software driven operating sequences involving off-on cycling of the key-switch that do not result in a reset of the Stim Enable button, and emissions can resume after a standard 5 second countdown without pressing this button a second time.",RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"On 11/22/10, Lockheed Martin Aculight sent a Memo to their Customers and Users informing them of the ""Stim Enable"" button reset error. The defect involves the function of the ""Stim Enable"" button on the front panel of the Capella R-1850.In December 2010, the firm sent a second lletter with instructions on how to return the Capella R-1850 Laser back for repair.The firm's plan to correct the defect involved removal of existing software, installation of revised software, and documented verification testing, per written instructions, to confirm resolution of the Stim-Emit button failure to reset. Corrections were to be made at no cost to the customer. A Lockheed Martin Aculight customer service representative will contact you shortly and provide detailed information on how to return the Capella-R 1850 laser product in your possession for testing and repair on this defect.Should you have any questions, please call (425) 482-1100.",N/A,17,17 units,"Devices were distributed Universities, Institute, and government consignees in CT, IL, MA, MD, OH, TN, TX, and UT.One unit was distributed to Germany.",Terminated,"August 23, 2011",96,17,Software,Device Operation,Software update,Software Update
Z-2221-2011,58614,"implant, dermal, for aesthetic use",LMH,N/A,N/A,General & Plastic Surgery,N/A,"Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126.Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.",Radiesse Injectable Implant,3,"May 19, 2011", 2011,"Merz Aesthetics, Inc.","Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.",TRAINING: Employee Error,"The firm, Merz Aesthetics, Inc., contacted its consignee/customer via e-mail on April 6, 2011. The e-mail states the product, problem and action to be taken. The customer was instructed to follow up with the concerned and inform the status time to time to the Recall Coordinator. The product was confirmed to be quarantined and has been requested to be sent back.If you need any additional information regarding this issue or if you have any questions, contact the International Regulatory Affairs Specialist at 262-835-3300 ext. 3081.",Contact the recalling firm for information,695,695 units,International only: Taiwan.,Terminated,"November 17, 2011",182,695,Not_Computer,N/A,N/A,N/A
Z-2216-2011,58534,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2.The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. Distributed by Siemens Healthcare, Concord, CA 94520Intended use: Radiation therapy","ARTISTE , ONCOR and PRIMUS accelerators ",2,"May 19, 2011", 2011,"Siemens Medical Solutions USA, Inc","Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote ""Online 2D Image Review.",DESIGN: Software Design,"The firm, Siemens, sent an ""Urgent: Medical Device Correction Customer Safety Advisory Notice"" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the ""Online 2D Image Review"" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter ""Safety Advisory Letter"" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately.Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011.If you have any questions, contact Regulatory Affairs at 925-602-8157.",Contact the recalling firm for information,45,45 active devices,"Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.",Terminated,"March 30, 2012",316,45,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2220-2011,58581,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.",Eclipse Treatment Planning System,2,"May 19, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.",DESIGN: Software Design,"The firm, Varian Medical, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated April 4, 2011, to its customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:1) Set the Planning Approved status in Eclipse (Eclipse displays both the Actual and Planned SSD values during plan approval) and verify both SSD values prior to approving the plan.2)Verify the SSD values in the Eclipse Treatment Plan Report prior to approving the plan for treatment or proceeding with treatment delivery (this report lists both the Actual and Planned SSD values).3) Prior to approving the plan in RT Chart, verify both the Actual and Planned SSD values in the Parameters Workspace by selecting Field Parameters",N/A,5288,5288 units,Worldwide distribution.,Terminated,"June 27, 2012",405,5288,Software,Output/Calculation,Software update,Software Update
Z-2206-2011,58510,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.",Brilliance 64 CT XRay System,2,"May 19, 2011", 2011,Philips Medical Systems (Cleveland) Inc,A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.,OTHER/UNDETERMINED: Pending,"A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.",N/A,10,10 units,"Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.",Terminated,"February 22, 2013",645,23,Software,Output/Calculation,Software update,Software Update
Z-2223-2011,58514,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"V-CATH Insertion Kits, Sterile; Product Code Number: 301-00;Manufactured by Centurion Medical Products for Neo Medical;42514 Albrae Street, Fremont, CA 94538",VCATH Insertion Kits,2,"May 19, 2011", 2011,"Neo Medical, Inc.","Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or pjduvall@neomedicalinc.com. Replacement or credit would be issued for all product returned.",Contact the recalling firm for information,1990,1990,"Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.",Terminated,"November 22, 2011",187,1990,Not_Computer,N/A,N/A,N/A
Z-2222-2011,58586,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.","Colleague, Colleague CX and Colleague CXE Infusion Pumps",2,"May 19, 2011", 2011,Baxter Healthcare Corp.,"The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.",TRAINING: Employee Error,"The firm, Baxter Healthcare Corporation, telephoned the customers on April 14, 2011, informing them that that the Hi-Pot test,and sent a follow up ""URGENT DEVICE CORRECTION"" letter dated April 27, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the pumps and take them out of service as soon as possible (Baxter will then send a shipping container for retrieval, re-inspection and return of the device back to the customer at no cost.); and return their colleague pumps for full functional testing including the HiPot test to the Baxter Buffalo Grove Global Technical Services (GTS) Center at Baxter GTS, 900 Corporate Grove Drive, Buffalo Grove, IL 60089.Baxter will perform full functional testing, including the HiPot test, on affected Colleague pumps for which the customer has continuing medical necessity. Should Baxter identify any issues through repair or service prior to returning the Colleague pumps to the customer.If you have questions regarding this communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CT, Monday through Friday.",N/A,117,117 pumps,"Worldwide distribution: USA (nationwide) including states of :Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia, and country of: Canada.",Terminated,"May 09, 2012",356,117,Not_Computer,N/A,N/A,N/A
Z-2218-2011,58549,oximeter,DQA,Oximeter.,Cardiovascular,Anesthesiology,510(k),"AVOXimeter 1000, AVOXimeter 40001000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.","AVOXimeter 1000, AVOXimeter 4000",2,"May 19, 2011", 2011,International Technidyne Corp.,An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.,DESIGN: Device Design,"International Technidyne Corp. sent a letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to check their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to:ITC Technical Support20 Corporate Place SouthPiscataway, New Jersey 08854For any questions call the Distributor or ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International), ext 4707.",N/A,17,17,"Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand",Terminated,"October 25, 2012",525,17,Other,Output/Calculation,Remove,Remove or Replace
Z-2202-2011,58179,spinal vertebral body replacement device,MQP,Spinal intervertebral body fixation orthosis.,Orthopedic,Orthopedic,510(k),"Theken L""POD"" Titanium Vertebral Body Replacement System, Vu c""POD"" PEEK-Optima¶_ Vertebral Body Replacement System, c""POD"" Titanium Vertebral Body Replacement SystemThe Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.The Theken Vu C POD VBR System is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).",THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM,2,"May 19, 2011", 2011,Integra LifeSciences Corp.,"Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.",OTHER/UNDETERMINED: Pending,"The firm, Integra Spine, sent an ""URGENT: RECALL NOTIFICATION"" letter dated January 18, 2011, to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their current inventory and return all remaining kits; complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via fax to: 877-558-6227 or email: melissa.niosi@integralife.com, and contact Integra Spine Customer Service at 866-942-8698 regarding availability of suitable replacement products.Integra Spine will be taking immediate action to restore your inventory and ensure minimal impact on availability for surgical procedures.Should you have any additional questions, please feel free to contact me at 609-936-2495 or email at jon.caparotta@integralife.com.",No consumer action necessary,93,93 Kits,"Nationwide distribution: USA including states of: AL, AZ, CA, FL, ID, IL, MD, MI, NH, NM, NV, OH, OK, OR, PA, TX, UT and WI.",Terminated,"October 27, 2011",161,93,Not_Computer,N/A,N/A,N/A
Z-2228-2011,58675,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.",DeRoyal (R) AMNIOCENTESIS TRAY,2,"May 20, 2011", 2011,"Deroyal Industries, Inc. Lafollette","Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs.",N/A,"DeRoyal notified their consignees by letter with the subject line ""Re: DeRoyal Recall of Triad Medical Lubricating Jelly, Alcohol Prep Pads and Alcohol Swabs"" on 02/07/2011 that kits in their possession contained recalled Triad products that were possibly contaminated. Customers were to use the attached spreadsheet to identify and quarantine the affected product. The spreadsheet should have been completed even if there was no affected product. The form should have been faxed back to 865-362-3716 or emailed to recalls@deroyal.com. Customers' DeRoyal Sales Representative would re-label the affected product in order to prevent further use. The DeRoyal Sales Representatives are also providing in-service training on effectuating this recall, including the importance of identifying, retrieving and discarding the recalled products as well as the documentation necessary to account for these products. Distributors were directed to recall down to the retail level. If there are questions or if further assistance is needed, customers can contact their DeRoyal Sales Representative or customer support department at 1-800-251-9864.",N/A,340976,"340,976 units total",Nationwide Distribution,Open,N/A,N/A,340976,Not_Computer,N/A,N/A,N/A
Z-2227-2011,58584,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Unicel¶_ DxH 800 Coulter¶_ Cellular Analysis System.A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.",UniCel DxH 800 Coulter Cellular Analysis System,2,"May 20, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.,DESIGN: Software Design,"The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel¶_ DxH"" 800 Coulter¶_ Cellular Analysis System PN 629029. The letter provides customers with an explanation of the problem identified and an action to be taken. For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. Ensure an alternative method of analysis is available during database maintenance.For Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report. Instead, submit the missing file(s) by one of the following methods:- Submit your data at the electronic IQAP website (eIQAP) at(http://www.beckmancoulter.com/qap/index.jsp)- Fax printouts of the missing files to 786-639-3999- Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com.- Include the IQAP number on any communication. A corrected report will be returned to the customers' laboratories.For issue 4, customers were instructed to submit their control data to IQAP by one of the following methods:-Submit their data at the electronic IQAP website (eIQAP) at(http://www.beckmancoulter.com/qap/index.jsp)-Fax printouts of the missing files to 786-639-3999-Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com.-Include your IQAP number on any communication.Customers were instructed to complete and return the enclosed Response Form within ten days. Customers were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",Contact the recalling firm for information,673,673 units,"Worldwide Distribution -- US, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.",Terminated,"May 23, 2012",369,673,Software,N/A,N/A,N/A
Z-2231-2011,58569,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"COULTER¶_ Ac""T"" 5diff Fix Reagent. Part Number: 8547171COULTER¶_ AC""T"" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac""T 5diff hematology analyzers. Intended for use only with specific Ac""T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.","COULTER Ac""T"" 5diff Fix Reagent. ",2,"May 20, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.,OTHER/UNDETERMINED: Pending,"Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER¶_ Ac""T"" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use.Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter.The raw material issue has been corrected beginning with COULTER¶_ A T 5diff Fix lot 16902E.Customers were instructed to complete and return the enclosed Response Form within ten (10) days.Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",Contact the recalling firm for information,4662,4662 units total (2278 in US),"Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia",Terminated,"June 04, 2012",381,4662,Not_Computer,N/A,N/A,N/A
Z-2232-2011,58464,"camera, surgical and accessories",KQM,Surgical camera and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"MAKO PN 204588 Camera204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.***204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.***204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.***THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.",MAKO PN 204588 Camera,2,"May 20, 2011", 2011,Mako Surgical Corporation,"MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, MAKO, sent a ""RECALL NOTICE"" letter dated November 22, 2010, to its customer. The letter described the product, problem and action to be taken. The customer was instructed to complete and return the attached Acknowledgement Form to their MAKOplasty Specialist (MPS) via mail to: MAKO Surgical Corp., Attn: Jim Pomeroy, 2555 Davie Road, Fort Lauderdale, FL 33317. The letter stated that ""It is important that the camera be replaced immediately, and MAKO is currently addressing the situation with the camera manufacturer."" In addition, MAKO will replace the camera with a camera that is not affected by the recall and verify the customers system to meet the functional specifications.If you have any questions or concerns, please contact your MPS or Sr. Director of Quality Assurance at 954-927-2044 ext 604, and /or Sr. Director, Customer Support at 954-927-2044 ext. 442.",Contact the recalling firm for information,1,1,Nationwide distribution: NY only.,Terminated,"November 09, 2011",173,1,Hardware,Output/Calculation,Replace component,Remove or Replace
Z-2225-2011,58333,dermatome,GFD,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt.The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues.",Padgett Dermatome power supply units,2,"May 20, 2011", 2011,Integra LifeSciences Corp.,Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.,OTHER/UNDETERMINED: Pending,"Integra LifeSciences Corp. initiated their recall by contacting their Sales Representatives via telephone conference calls on 3/10/2011. Separate written recall communications, in the form of an 'URGENT PRODUCT RECALL NOTIFICATION' were provided via E-mail and FedEx to the firm's Sales Representatives on 3/11/2011; and to their hospital and distributor customers on 3/11/2011; 3/14/2011; and on 4/12/2011. The recall notification addressed to the non-Integra Sales Rep customers informs the customers of the problem with the power supply units (that they may not meet the required medical device electrical safety standards which may result in an increased potential for electrical shock). The notification goes on to ask that the customers examine their inventories and determine if they have any affected product on-hand; if so, the customers are instructed to discontinue use of the power supply unit and return the unit(s) to Integra LifeSciences Corporation immediately for reworking. The letter also provides photographs of the affected units which the customer can use to locate and verify the serial number(s) of the device (if applicable). In addition, the notification is accompanied by a 'RECALL ACKNOWLEDGMENT AND RETURN FORM' which the customer is asked to sign and complete in order to document receipt of the recall notification and whether or not the customer has any of the recalled power supply units available for return. The notification letter provided to the Integra Sales Representatives describes the device models affected; the reason for the recall; and asks that the Reps. examine their inventories for the presence of any of the affected power supply units. If found, the Reps are instructed not to use, or to further distribute any of the affected units in their possession, but to immediately make arrangements to return the unit(s) to Integra for rework. The notification supplied to the Sales Reps provides them with a synopsis of the firm's field action.",Contact the recalling firm for information,892,892 units were distributed in the U.S & 155 units were distributed in foreign countries,"Worldwide Distribution - USA including FL, CO, IL, AR, MD, IN, CA, MT, AZ, NY, LA, TX, MA, MO, CT, MI, NE, OH, NC, WV, VA, PA, NJ, TN, UT, MN, OK, WI, GA, AL, WA, KS, OR, AK, DC, SC, NE, MS, RI, NV, IA, and ND and the country of Canada",Terminated,"April 17, 2012",333,892,Not_Computer,N/A,N/A,N/A
Z-2237-2011,58563,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7"" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula.Single Patient Use. Do not SterilizeSalter Labs, 100 W. Sycamore Road, Arvin, CA 93293Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.",Nasal Cannula (Adult) Salter Style ,2,"May 20, 2011", 2011,"Salter Laboratories, Division of Regulatory Affairs",Complaint received that the product in the box was different from labeled product.,PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, Salter Labs, sent an ""URGENT PRODUCT RECALL"" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 661-854-6816 or Toll Free 1-800-628-4690.Should you have any questions, please contact Salter Labs at 1-800-235-4203.",N/A,22150,"22,150 pieces",Nationwide distribution.,Terminated,"August 23, 2011",95,22150,Not_Computer,N/A,N/A,N/A
Z-2226-2011,58555,"calibrator, secondary",JIT,Calibrator.,Clinical Chemistry,Clinical Chemistry,510(k),"SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.",SYNCHRON Systems Calibrator 1,2,"May 20, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558.During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been re",N/A,"Beckman Coulter initiated a Product Corrective Action (PCA) letter on the week of March 14, 2011, to the affected customers. Though Beckman is recalling the LX Cal 1, the recall letter was sent to the C4 reagent customers, as these are the only customers who will be impacted by the problem noted in the PCA letter. The letter provided the customers with an explanation of the problem identified and an action to be taken.The letter recommended consignees take the following actions:(1)Notify their clients to review and evaluate the impact on patients whose Complement C4 recovered near the clinical decision points.(2) Re-evaluate their laboratory's reference ranges for C4.The letter further requested that consignees share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation.Questions regarding this Product Announcement letter, or requests for the correlation graphs should be directed to Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Request or call (800) 854-3633 in the United States and Canada.",N/A,96173,"96,173 units","Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam",Terminated,"May 04, 2012",350,96173,Not_Computer,N/A,N/A,N/A
Z-2224-2011,58558,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CAIndicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.",Clinac,2,"May 20, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.,DESIGN: Process Design,"On 3/31/2011, all consignees were notified via an Urgent Medical Device Correction letter and on-site visit by the firm's sales representative, informing them of the affected products, the issue, and recommended actions. If non-Varian personnel service the device, then they should have been immediately notified of the content of the letter. Anyone who performs work on the device should exercise extreme care to identify any possible coolant leak and immediately locate and correct the source of the leak. Customers were to immediately notify Varian Service or their internal service personnel of any coolant leakage. Varian was to contact customers to arrange for inspection if one had not been performed. The appropriate personnel should have been advised of the content of the letter. If further clarification was needed, customers were to contact their local Varian Customer Support.",Contact the recalling firm for information,718,718 units,Worldwide Distribution,Terminated,"March 13, 2012",298,718,Not_Computer,N/A,N/A,N/A
Z-2242-2011,58564,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube.Single Patient use. Do not sterilize.Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.,Salter Laboratories Adult Nasal Cannula,2,"May 23, 2011", 2011,"Salter Laboratories, Division of Regulatory Affairs",One complaint received of product in box different from what was on label.,OTHER/UNDETERMINED: Pending,"Salter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication.It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner.No illness or injury would result from this product mix-ups.Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.",N/A,3500,3500 pieces,Worldwide Distribution - USA (nationwide) and the country of South America.,Terminated,"August 23, 2011",92,3500,Not_Computer,N/A,N/A,N/A
Z-2240-2011,58487,"mattress, flotation therapy, non-powered",IKY,Nonpowered flotation therapy mattress.,General Hospital,General Hospital,510(K) Exempt,"Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI.The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84"" x 35"" x 6"" mattress.",Styker Impression Mattress,2,"May 23, 2011", 2011,Stryker Medical Division of Stryker Corporation,Affected mattresses may not conform to federal flammability standards.,OTHER/UNDETERMINED: Pending,"Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689.",N/A,213,213,Worldwide Distribution - USA including California and the country of Canada.,Terminated,"October 07, 2011",137,213,Not_Computer,N/A,N/A,N/A
Z-2243-2011,58533,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software.Distributed by Siemens, Healthcare, Concord, CA 94520Radiation therapy","ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;",2,"May 23, 2011", 2011,"Siemens Medical Solutions USA, Inc",Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.,DESIGN: Software Design,"Siemens initiated an Urgent Medical Device Correction letter on March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:use only relataive table setup with all planned table values '0' if applicable.In cases where the treatment plan contains at least one table parameter other than '0' to consider the following:Use only one PVG plus resulting offset per fraction.Once an offset has been applied do not use 'apply offset' at RTT for any further offset.Select the PVG and treatment beams in the same auto-sequence. In casethis is not possible, the table position for each treatment beam, in the fraction, needs to be verified separately (especially for treatments with beams having different table posiitons. If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position.In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI.Scenario 2 - Manual change of table posiiton followed by a PVG calculated offset.Always deliver the PVG's at the planned table position. Avoid manual change of table posiiton prior to applicaiton of PVG.Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, need to be verified separately (especially for treatments with beams having different table positions).If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position.In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI.Customers were informed that a software update would be provided as soon as possible.Customers were asked to include the Customer Sa.",Contact the recalling firm for information,164,164 active devices,"Worldwide Distribution - USA including CA, DE, FL, KY, LA, MA, MI, MO, NC, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV and the countries of Australia, Belgium, Canada, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Turkey, and the United Kingdom.",Terminated,"March 30, 2012",312,164,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2238-2011,58789,"table, radiologic",KXJ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market)The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.",Maquet Magnus Carbonfibre table top ,2,"May 23, 2011", 2011,Maquet Inc.,Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.,DESIGN: Device Design,"Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected ""MAGNUS 1180.16F0 carbon-fibre table tops."" The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred.If you have additional questions, please contact yur local MAQUET Customer Service at 1-888-627-8383.",N/A,3,3,"LA, MO, VA",Terminated,"August 21, 2013",821,3,Not_Computer,N/A,N/A,N/A
Z-2241-2011,58582,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501.The device is labeled in part: ""***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***"".",NeuViz 16 MultiSlice CT Scanner System,2,"May 23, 2011", 2011,"Philips And Neusoft Medical Systems Co., Ltd.",Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.,OTHER/UNDETERMINED: Pending,"Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product.Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release.Consignees were instructed to contact Service Support Department by e-mail to nms-service@neusoft.com.",Contact the recalling firm for information,9,9 units distributed in US,"Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.",Terminated,"August 24, 2011",93,9,Other,Output/Calculation,Upgrade,Repair
Z-2239-2011,58685,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard¶_ Soft Mesh 4""x6"" (10cm x 15cm) Flat, Product Code: 0117010. The Bard¶_ Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is ""Mesh, Surgical, Polymeric"".",Bard Soft Mesh patch,2,"May 23, 2011", 2011,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeling: complaints of product labeled as Bard¶_ Soft Mesh 4"" x 6"" containing Bard¶_ Soft Mesh 6"" x 6""",PRODUCTION CONTROLS: Labeling Mix-Ups,"Davol issued an URGENT: MEDICAL DEVICE RECALL notification letter to customers dated April 25, 2011, informing them the recall involving a single lot of the BARD Soft Mesh - Lot# HUUF0530. This recall has been initiated because this lot number may contain a different size patch than is indicated. Customers were instructed to immediately examine inventory and quarantine product subject to recall. Customers are asked to identify and notify their customers to whom recalled product may have been further distributed. A Recall Effectiveness Check reply form should be completed and returned to Davol via fax (401-825-8753). For directions on returning product or for questions regarding the recall, contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027.",N/A,198,198 units,Nationwide Distribution,Terminated,"October 28, 2011",158,198,Not_Computer,N/A,N/A,N/A
Z-2246-2011,58565,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX 6.5 Client Software.IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.",IMPAX 6.5,2,"May 24, 2011", 2011,AGFA Corp.,Software issue that occurs after dictation of a study.,OTHER/UNDETERMINED: Pending,"Agfa Corp. sent an ""URGENT SAFETY NOTICE"" customer letter via Agfa email to customers on 4/14/2011, along with a ""URGENT SAFETY NOTICE FEEDBACK FORM,"" The letter identified the product , the problem, and the action to be taken by the customer.It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem.Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664.If you have any questions, please contact your local Agfa Healthcare organization.",Contact the recalling firm for information,95,95 units,"Nationwide Distribution -- including states of WI, and SC.",Terminated,"September 15, 2011",114,95,Software,N/A,Software update,Software Update
Z-2245-2011,58328,dental implant surgical tray (kit),OFY,Endosseous dental implant accessories.,Dental,Dental,Enforcement Discretion,"***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849.Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.",Osseotite NT Certain,2,"May 24, 2011", 2011,"Biomet 3i, LLC",Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411 . The internal thread was not manufactured correctly.,OTHER/UNDETERMINED: Pending,"Biomet 3i, LLC sent an Urgent Medical Device Recall letter dated March 14, 2011, via email or fax to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A small percentage of the implant lots may have a condition affecting the internal thread. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Customers were instructed to contact Customer Service at 1-800-342-5454 if this condition is recognized upon attempting to assemble any of the screws with the implant.Customers were instructed to return the implant to the firm for replacement to the following address:BIOMET 3iRegulatory Compliance Department4555 Riverside DrivePalm Beach Gardens, Florida 33410Incident No. CC117886Customers were also instructed to respond with the attached Response Fax or email to DomesticComplaints@Biomet.com.For any questions regarding this recall call 561-776-6906.",Contact the recalling firm for information,236,236,"Worldwide Distribution - USA (nationwide) and the countries of Europe, Japan, Asia, and South America.",Terminated,"January 25, 2012",246,236,Not_Computer,N/A,N/A,N/A
Z-2244-2011,58550,"system, blood culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),BacT/ALERT - FA Reagent BottleThe BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids.,BacT/ALERT FA Reagent Bottle,2,"May 24, 2011", 2011,"bioMerieux, Inc.",The charcoal suspension in a portion of the lot does not meet the intended density.,OTHER/UNDETERMINED: Pending,"BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An Acknowledgement and Product Replacement Form was included to be completed and returned to bioMerieux or credit or replacement of unused bottles.",N/A,327700,"327,700 bottles","Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium",Terminated,"April 03, 2012",315,327700,Not_Computer,N/A,N/A,N/A
Z-2293-2011,58545,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI.The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.",syngo Dynamics version 9.0,2,"May 25, 2011", 2011,"Siemens Medical Solutions, USA, Inc","If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a ""Preliminary"" watermark displayed.",DESIGN: Software Design,"The firm, SIEMENS, sent a ""Customer Safety Advisory Notice"" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks.If you have any questions, call +1 (734) 205-2400.",Contact the recalling firm for information,29,29 devices,"Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.",Terminated,"July 10, 2012",412,29,Software,Device Operation,Software update,Software Update
Z-2233-2011,58373,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.",MicroStream Filterline ICU,1,"May 25, 2011", 2011,Oridion Medical 1987 Ltd.,fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient,PRODUCTION CONTROLS: Equipment Maintenance,"The firm, Oridion, sent an ""Microstream Filterline Field Correction Notice"" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory. Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases. Oridion anticipates that new product will be available for shipment during the week of April 4th.Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.com.",Contact the recalling firm for information,350,350 units in US (14 boxes with 25 units ea),Worldwide distribution.,Terminated,"March 19, 2012",299,700,Not_Computer,N/A,N/A,N/A
Z-2291-2011,58420,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.",Logix Order Entry (OE) Software,2,"May 25, 2011", 2011,Baxter Healthcare Corp.,The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.,DESIGN: Software Design,"Baxter Healthcare Corp. sent an URGENT DEVICE CORRECTION letter dated March 29, 2011, via first class mail to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. It was discovered there is an issue with the LOGIX OE automated backup not retaining the three most recent backup files and instead will only retain the last three backups of the previous year. The accounts were requested to turn off the automated backup function on the LOGIX OE Software, and perform manual backups following the instructions included in the Urgent Device Correction letter, and retain a copy of the letter at each computer on which LOGIX OE Server is installed. The customer were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.",Contact the recalling firm for information,84,84 units,"Worldwide Distribution -- USA including Puerto Rico, and the country Canada.",Open,N/A,N/A,84,Software,Device Operation,Instructions on turning off auto backup,Safety Notice/Insructions
Z-2249-2011,58021,"tray, catheterization, sterile urethral, with or without catheter (kit)",FCM,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A.Tray Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free Contents: 1 - Graduated Tray, 1200 cc 1 - Green Bulb Syringe (Catheter Tip), 60 cc 1 - Graduated Solution Container, 500 cc 1- Underpad, 1 - Sterile Alcohol Prep Pad Reorder No. 37-103 Contents STERILE in unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A.Usage: The trays are irrigation trays for catheters",McKesson,2,"May 25, 2011", 2011,"Nurse Assist, Inc",The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.,OTHER/UNDETERMINED: Pending,"The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137.Only the product and lots identified on the attached list are affected.If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.",N/A,2840,2840 cases,"Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.",Terminated,"October 25, 2012",519,124789,Not_Computer,N/A,N/A,N/A
Z-2294-2011,58600,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Zoll E Series BLS Defibrillator/Pacemaker/MonitorSoftware versions 7.10 and 7.11The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG).",Zoll ,2,"May 25, 2011", 2011,ZOLL Medical Corporation,Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy,DESIGN: Software Design,"The firm, Zoll, sent an ""Urgent Medical Device Correction"" letter dated April 22, 2011 via UPS to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately alert all E Series BLS users to this problem; instruct users to not touch patient and keep the patient still during ECG analysis, Instruct users that if they experience this problem, to press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The letter also states that affected units can remain in service until the software has been updated. If you have any questions, please contact 24/7 technical support at 1 (800) 348-9011 or +1 (978) 421-9460.",N/A,874,874 units,"Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom.",Terminated,"January 23, 2014",974,874,Software,N/A,Software update,Software Update
Z-2292-2011,58601,"keratome, ac-powered",HNO,Keratome.,Ophthalmic,Ophthalmic,510(k),"WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2.The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.",WaveLight FS 200 Femtosecond Laser System,2,"May 25, 2011", 2011,Wavelight AG,The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.,OTHER/UNDETERMINED: Pending,"WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers todiscontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3.Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.",Contact the recalling firm for information,55,55 units,"Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.",Terminated,"September 23, 2011",121,55,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2295-2011,58612,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport HT50¶_ Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.",Newport HT50 Ventilator,2,"May 26, 2011", 2011,Newport Medical Instruments Inc,The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.,OTHER/UNDETERMINED: Pending,"Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344.",Contact your health professional,N/A,N/A,"Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.",Terminated,"June 01, 2011",6,N/A,Not_Computer,N/A,N/A,N/A
Z-2383-2011,58650,"accessories, catheter, g-u",KNY,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035"" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USAUreteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.",PTFE Coated 3 cm Flexible Tip Guidewire,2,"May 26, 2011", 2011,"Gyrus Acmi, Incorporated","Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected,",PRODUCTION CONTROLS: Process Control,"The firm, Olympus ACMI, sent an ""Urgent: Medical Device Recall"" letter dated April 15, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:1) Inspect their stock to confirm if any of the affected lot of products remains in their possession2)Immediately cease any further use of the affected product, remove, quarantine and return it. 3) Call their Gyrus ACMI customer service representative at 1-888-542-7266 to obtain a Returned Goods Authorization 4) Return the product to: Attn: PTFE Guidewire Recall RGA#_________Gyrus ACMI LP, 6845 Wedgwood Court, Maple Grove, MN 553115) Complete and return the RECALL REPLY FORM via fax, even if they are returning no product, to: Regulator Affairs (508) 804-2624. The letter states that the customer will receive repeat mailings until they have faxed in the form. Additionally, If they have further distributed the product they are requested to identify and notify their customers at once.If you have any questions, please do not hesitate to contact customer service at 1-888-524-7266.",Contact the recalling firm for information,145,145,"Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.",Terminated,"August 23, 2012",455,145,Not_Computer,N/A,N/A,N/A
Z-2248-2011,58471,"analyzer, gas, carbon-dioxide, gaseous-phase",CCK,Carbon dioxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),Philips Microstream¶_ Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPSThese products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.,MICROSTREAM FILTERLINE ICU,1,"May 26, 2011", 2011,Philips Healthcare Inc.,Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.,PRODUCTION CONTROLS: Equipment Maintenance,"The firm, Philips, sent a Field Safety Notice titled ""URGENT MEDICAL DEVICE RECALL"" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the ""Action to be taken by Customer/User"" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.",N/A,75,75 units (3 boxes),Worldwide distribution.,Terminated,"March 14, 2013",658,25475,Not_Computer,N/A,N/A,N/A
Z-2382-2011,58629,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B.The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)",Newport HT50 Ventilator,2,"May 26, 2011", 2011,Newport Medical Instruments Inc,The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.,OTHER/UNDETERMINED: Pending,"Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to "" Regulatory@NewportMedical.com "" Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.",Contact your health professional,1113,"1,113 EP cases","Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.",Terminated,"June 01, 2011",6,1113,Not_Computer,N/A,N/A,N/A
Z-2386-2011,58431,breast pump kit,OHH,Powered breast pump.,Obstetrics/Gynecology,Obstetrics/Gynecology,Enforcement Discretion,"AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010.Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.",AC Adaptor Article 9207010 ,2,"May 27, 2011", 2011,Medela Inc,The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.,DESIGN: Device Design,"Medela Inc., sent an "" IMPORTANT FIELD ACTION "" letter dated April 4, 2011, to all affected customers via The United States Postal Service ( USPS) United Parcel Service ( UPS) and E-mail .The letter identified the product, the problem, and the action to be taken by the customer. It was discovered the power adaptor/transformer used with the Pump in Style Advanced family of breast pumps can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the power cord. Use of the power adaptor with a damaged cord could result in a short in the cord resulting in sparks, smoke, burning and melting of the transformers. If the users have a damaged power adaptor or power adaptor cord, they were requested to discontinue use of the adaptor and visit Medela's website at www.poweradaptorhelp.com to request a replacement adaptor. Questions about the recall process were directed to Medela Customer Service at 1-855-367-0104 or e-mail at poweradaptor@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelapoweradaptorhelp.com on April 4, 2011.",Contact the recalling firm for information,478823,"17,681 units alone, 461,142 units with products","Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti.CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district.",Terminated,"October 16, 2012",508,478823,Battery,N/A,N/A,N/A
Z-2387-2011,58652,"enzyme immunoassay, opiates",DJG,Opiate test system.,Toxicology,Toxicology,510(k),"DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers :70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012, Export Only); 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, Lot 4A-500 110310, Exp MAY 2012, For forensic use only);30705 ( DIP DRUG TEST, AMP500/COC/MDMA/MET500/MTD/OP1300/TCH, Lot 705 112210, Exp MAY 2012);60702-6A AUS (AMP300-COC300-OP1300-OP12000-MET300-TCH50-BZ0200-ALC-pH,SG,OX-NI,CR-GL, Lot 6A-702 113010 & 6A-702 112910, Exp MAY 2012, Export Only); 60600-A (AMP-COC--OP1-TCH-MET-BZO-ALC, Lot A600 110310, Exp MAY 2012, For forensic use only);61205 (AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC, Lot 205 110410, Exp MAY 2012); 70701-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-pH,SG-NI,CR, Lot 4-701 102910, Exp APR 2012, Export Only); 31012-6 (DIP DRUG TEST, AMP/BAR/BZO/COC/MDMA/MTD/OPI/OXY/ PCP/THC/pH SG, OX/NI, CR, GL, Lot 6-012 110310, Exp MAY 2012);31003 (AMP/COC/OP10300/THC/MET/BZO/BAR/PCP/MTD/TCA/MET, Lot 003 102510, Exp APR 2012);Intended use: The DrugCheck Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.",DrugCheck,2,"May 27, 2011", 2011,"Express Diagnostics Int'l., Inc.","Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices,This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results.",EXPIRATION DATING: Incorrect or No Expiration Date,"The firm, Express Diagnostic Int'l, Inc., sent an ""Urgent Recall of DrugCheck Product"" letter dated April 19, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine the product; notify Express Diagnostic of the quantity even if no product is remaining; complete and return the DISTRIBUTOR/CUSTOMER RECALL CONFIRMATION FROM via fax to 1-507-526-2252 as soon as possible. In addition, if they have further distributed the product to identify their customers and notify them of the recall. Provided procedures to be followed for them to destroy the quarantined product. Express Diagnostics will replace the DrugCheck Drug Screen devices.If you have any questions, please contact the Quality Assurance Manager at 507-526-3951, ext. 117.",Contact the recalling firm for information,6925,6925 devices,"Worldwide distribution: USA (nationwide) including states of: FL, IA, MD, OK, and WA; and countries including: AUSTRALIA and ITALY.",Terminated,"July 06, 2012",406,6925,Not_Computer,N/A,N/A,N/A
Z-2385-2011,58199,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***""1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT***This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.",6 HOLE REGULAR DOUBLE Y PLATE,2,"May 27, 2011", 2011,"Biomet Microfixation, Inc.","Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, Biomet Microfixation, sent an ""URGENT MEDICAL SAFETY ALERT NOTICE"" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, if they have further distributed the product.If you have any questions, please contact the Customer Relations Specialist at 800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.",Contact the recalling firm for information,180,180,"Worldwide distribution: USA (nationwide) including states of: FL, IN, KY, MT, NC, NE, NY, OH, TX, VA, and WI; and countries including: Argentina, Canada, Colombia, Czech Republic, Japan, Korea, Mexico, Norway, South Africa, Spain and Turkey.",Terminated,"June 24, 2011",28,180,Not_Computer,N/A,N/A,N/A
Z-2384-2011,58632,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1BProduct Code: NOUThe device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.",Newport HT50 Ventilator,2,"May 27, 2011", 2011,Newport Medical Instruments Inc,The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has a slightly higher amperage draw than the single battery and as a result can cause the fuse in the external battery pack to blow making the battery inoperable.,OTHER/UNDETERMINED: Pending,"Newport Medical sent an IMPORTANT PRODUCT NOTICE on July 22, 2009, to all affected customers who purchased the Newport HT50 Dual Pac Ventilator with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. Newport Medical also sent an upgrade kit (FSK3301) which includes instructions for changing the fuse on the external battery. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to not use an external battery with the new Dual Pac Ventilator until they have completed the fuse replacement. Customers with any questions about this fuse replacement or require additional upgrade kits, were instructed to contact Newport Medical's Technical Support Department at (800) 451-3111 or (714) 427-5811 x500.",N/A,333,"11, 333 units total",Nationwide Distribution,Terminated,"June 01, 2011",5,11333,Battery,N/A,N/A,N/A
Z-2359-2011,58346,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Material ECVC1140, TRIPLE LUMEN INSERTION KIT, CENTURION TRIPLE LUMEN INSERTION KIT, REORDER ECVC1140, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.comFACILITATES LINE INSERTION",CENTURION TRIPLE LUMEN INSERTION KIT,2,"May 27, 2011", 2011,Centurion Medical Products Corporation,"This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates.",N/A,"Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.For any questions regarding this recall call 631-924-4000, ext 142.",Contact the recalling firm for information,10,10,Nationwide Distribution,Terminated,"September 13, 2011",109,71456,Not_Computer,N/A,N/A,N/A
Z-2392-2011,58665,"collector, urine, (and accessories) for indwelling catheter",KNX,Urine collector and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective WipeProduct ID: 8884732000Intended use: Collector urine from male patients (and accessories) for indwelling catheter,URIDRAIN Standard Male External Catheter ,2,"May 27, 2011", 2011,Covidien LP,A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P; Industries-Triad) a protective wipe due to bacterial contamination,OTHER/UNDETERMINED: Pending,"The firm, Covidien, sent an ""URGENT PRODUCT RECALL"" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks.For Customer Service questions regarding the recall please telephone: 1-800-962-9888 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393.",No consumer action necessary,5760,5760 units,Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.,Open,N/A,N/A,62352,Not_Computer,N/A,N/A,N/A
Z-2395-2011,58518,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ES0101, AEM Disposable Curved Scissors, 1/2"", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures",AEM Disposable Scissors,2,"May 31, 2011", 2011,"Encision, Inc.",Sterility may be compromised due to holes in packaging.,DESIGN: Packaging Design/Selection,"Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection.Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.",Contact the recalling firm for information,598,"574 Ten-Count Boxes, 24 Kits",Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand,Terminated,"August 09, 2011",70,2052,Not_Computer,N/A,N/A,N/A
Z-2401-2011,58568,"nucleic acid amplification assay system, group b streptococcus, direct specimen test",NJR,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,"Xpert Infinity Software, V 4.1a.Cepheid, Sunnyvale, CA 94089system software for GeneXpert Infinity 48",Xpert Infinity Software,2,"May 31, 2011", 2011,Cepheid,A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.,DESIGN: Software Design,"Cepheid sent an Corrective Action Notification letter dated April 13, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cepheid recommended customers using 4.1a software on the INFINITY 48 System that is interfaced to a LIS with Host Ordering to make these alterations in operationof the system.After scanning the Patient ID (optional). Sample ID and Cartridge barcode, the host test order information should apear highlighted in the Order Test workspace.Once the highlighted host order information appears select SUBMIT.Warning. If the host test order informaiton is not highlighted, cancel the order by selecting CLOSE. Re scan Patient ID (optional). Sample ID and cartridge barcode and verify highlighted host test order before SUBMIT. Contact Cepheid Technical Support at 888-838-3222 in the US or 33 5 63 82 53 19 outside of the US for any questions regarding this Corrective Action Notice.",No consumer action necessary,19,"16 US, 3 ROW","Worldwide Distribution - USA including CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia.",Terminated,"June 20, 2011",20,19,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-2403-2011,58636,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"Capsule Neuron UMPC is a component in the DataCaptor"" Connectivity System. Catalog Number: DC-NU-MPCCapsule Neuron"" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wiredEthernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity softwareThe DataCaptor"" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor"" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to",Capsule Neuron UMPC,2,"June 01, 2011", 2011,Capsule Tech Inc.,"Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored.If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes.Batteries can discharge completely in a Capsule Neuron"" UMPC even though it is connected to power source",DESIGN: Software Design,"Capsule Tech initiated three corrective action notifications for the Neuron"" UMPC units three failure modes as follows:a) Data cached on the Capsule Neuron"" UMPC due to server unavailability is not being delivered to the server after server availability is restored:i) A customer advisory was provided to a subset of consignees, along with DataCaptor software version 6.6.5 on December 1, 2010.ii) A customer advisory was provided to the remaining consignees, along with DataCaptor software version 6.6.7 on January 27, 2011.If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes:i) A customer advisory was provided to all consignees on March 23, 2011, via phone call, email and FedEx;.The correction will be provided as a software update. A formal recall notification letter will be provided to all consignees alerting them to the availability of the correction once it is released, via phone call, email and FedEx. c) Batteries can discharge completely in a Capsule Neuron"" UMPC even though it is connected to power. Note: the Capsule Neuron"" UMPC operates normally when connected to power.i) A customer advisory was provided to all consignees on April 23, 2010, via FedEx.For questions regarding this recall contact Capsule technical support team at (800) 260-9537 or e-mail support@capsuletech.com..",Discard product or return to place of purchase for a full refund or exchange,3144,"3,144 Capsule Neuron UMPC units",Worldwide Distribution - USA (nationwide) and the country of Canada,Terminated,"March 20, 2012",293,3144,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2402-2011,58557,"glucose oxidase, glucose",CGA,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Cholestech LDX Lipid Profile""GLU test cassettes, Catalog Number 10-991, Lot # 245104Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX.","Cholestech LDX Lipid Profile""GLU test cassettes",2,"June 01, 2011", 2011,Biosite Inc Dba Innovacon Inc.,The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as,N/A,"Alere San Diego, Inc ( formerly known as Biosite Incorporated sent an URGENT MEDICAL DEVICE RECALL letter on February 18, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were requested to:(1) Discontinue use and/or sale of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 245104.(2) Discard in accordance with your local regulations, all units of the above listed product.(3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation.(4) If you have forwarded the product listed above to another laboratory, please provide a copy of this letter to them.(5) Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of boxes of test cassettes discarded from your inventory and replacement product will be sent to you.For questions about the information contained in this notification, customers were instructed to contact Alere Technical Services at 1-877-308-8289 (24 hours a day, 7 days a week) or via e-mail at service.cholestech@alere.com.",N/A,5305,"5,305 Boxes","Worldwide Distribution - USA ( nationwide ) including the countries of South America ( EL Salvador) , Europe ( Denmark, France, Norway and Switzerland), Bahrain, Kuwait, South Africa, and United Arab Emirates.",Terminated,"April 02, 2012",306,5305,Not_Computer,N/A,N/A,N/A
Z-2407-2011,58267,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.50.00 and aboveUsed to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 02, 2011", 2011,Computerized Medical Systems Inc,"XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.",DESIGN: Software Design,"The firm, Elekta, issued an ""important Safety Notice"" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue.If you have any questions, please call 314-993-0003 or 800-878-4267.",N/A,415,415,"Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, and United Kingdom.",Open,N/A,N/A,415,Software,Display/Image,Notification,Safety Notice/Insructions
Z-2405-2011,58664,"bag, bile collecting",EXF,Biliary catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005.The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter.",Drainage Bag,3,"June 02, 2011", 2011,Remington Medical Inc.,There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.,OTHER/UNDETERMINED: Pending,"Remington Medical Inc.sent an Urgent Medical Device Recall letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine product subjec to recall. If they further distributed this product, they were to identify their customers and notify them at once of the product recall. Notification to their customers should include a copy of the recall notification letter. Customer were to receive a Return Authorization Form, reference RGA #600-D.For questions regarding this recall call 800-989-0057, ext. 213.",N/A,89294,89294 units,Nationwide Distribution,Terminated,"September 13, 2011",103,89294,Not_Computer,N/A,N/A,N/A
Z-2406-2011,58619,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.",Newport HT70 Ventilator,2,"June 02, 2011", 2011,Newport Medical Instruments Inc,"The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents thecord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di",OTHER/UNDETERMINED: Pending,"Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord.Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.",N/A,22,22 units total,"Worldwide Distribution--USA (nationwide) including the states of MA, PA, OH, IA and Puerto Rico and the countries of Colombia, UAE, Hong Kong, Hungary, India, Japan, Nepal, China, Philippines, Singapore and South Africa.",Terminated,"June 03, 2011",1,22,Battery,N/A,N/A,N/A
Z-2404-2011,58637,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are:ARTISTE MV System;ONCOR Avant GardeONCOR ImpressionONCOR Impression PlusONCOR Expression.Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany;Registered by Siemens Medical Solutions, Concord, CA.ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.",ARTISTE or ONCOR Linear Accelerators in combination with 160MLC,2,"June 02, 2011", 2011,"Siemens Medical Solutions USA, Inc","Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the ""Motion Stop"" button followed by ""Reset"" several times during the treatment of one beam or one segment.",OTHER/UNDETERMINED: Pending,"Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an ""in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption.Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.",Contact the recalling firm for information,221,221 active devices,"Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.",Terminated,"March 16, 2012",288,221,Not_Computer,N/A,N/A,N/A
Z-2409-2011,58681,"catheter, straight",EZD,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark.28022S 1400SureCath Set,acc CH8 Male,bulk28023S 1400Surecath Set,acc CH10 Male,bul28024S 1400Surecath Set,acc CH12 Male,bul280320 1400SureCath Set,acc CH14 Male 28032S 1400Surecath Set,acc CH14 Male,bul28036S 1400Surecath Set,acc CH14/1,2 Male28037S 1400Surecath Set,acc CH16 Male 280370 1400Surecath Set,acc CH16 Male 28033S 1400Surecath Set,acc CH16 Male280360 1400Surecath Set,acc CH14/1,2 Male 280340 1400SURECATH SET W.ACC FEM14`The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.",SureCath Set with Accessories,2,"June 03, 2011", 2011,"Coloplast Manufacturing US, LLC",Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i,EXPIRATION DATING: Incorrect or No Expiration Date,"Coloplast Manufacturing US, LLC sent a Coloplast ""Product Field Correction Notice"" dated April 21, 2011. The letter was addressed to ""Dear Valued Customer"". The letter described the problem and the product involved in the recall. Customers were advised to provide the current inventory levels of the lots affected and the firm will be providing them with new iodine prep pads with sufficient shelf life. This product will include customer instructions, informing the customer to discard the original prep pads and use the new prep pads instead. If they prefer, they could themselves send the affected product back to Coloplast and they in return will attach new prep pads to the product for them.If they have further distributed the product, they advised consignees to contact their customers and to include the letter provided to them to inform them of the recall.",Contact the recalling firm for information,438412,"438,412","Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.",Terminated,"April 24, 2012",326,564759,Not_Computer,N/A,N/A,N/A
Z-2411-2011,58785,"bed, hydraulic, adjustable hospital",FNK,Hydraulic adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,Eleganza 3 Hospital BedIntended use: AC Powered adjustable Hospital Bed,Eleganza 3 Hospital Bed,2,"June 03, 2011", 2011,Linet Americas Inc,Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up ""service advisory information"" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design.If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446.",Contact the recalling firm for information,1601,1601 units,"Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.",Terminated,"July 19, 2012",412,1601,Not_Computer,N/A,N/A,N/A
Z-2408-2011,58205,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above.Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 03, 2011", 2011,Computerized Medical Systems Inc,"When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.",DESIGN: Software Design,"Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.",N/A,1377,1377,"Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1377,Other,N/A,N/A,Other
Z-2412-2011,58735,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model #Duraspan Kit - 24cm 62152420Duraspan Kit - 28cm 62152820Duraspan Kit - 32cm 62153220Duraspan Exchange Kit - 32cm62153228Duraspan Kit - 36cm 62153620Duraspan Exchange Kit - 36cm62153628Duraspan Kit - 40cm 62154020Duraspan Exchange Kit - 40cm62154028Duraspan Kit - 55cm 62155520Duraspan Ultra Kit - 24cm621524E0Duraspan Ultra Kit - 28cm 621528E0Duraspan Ultra Kit - 36cm 621536E0Duraspan Ultra Kit - 40cm621540E0Duraspan Ultra Kit - 55cm621555E0The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (","DuraspanTM Dialysis Catheters, Ultra and Long Term",2,"June 06, 2011", 2011,R4 Vascular Inc,"r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lot",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"R4 Vascular Inc sent an Urgent Medical Device Recall letter dated May 3, 2011, to all affected customers. The letter described the problem and the product being recalled. Consignees were instructed to stop distributing the product and to quarantine the recalled lots and if they had already distributed the affected product to seek its return from their customers. A template letter to physicians and healthcare facilities was enclosed for Distributors/Retailers to send or hand deliver to their customers.For questions regarding this recall call 1-704-905-2105.",No consumer action necessary,2489,2489 kits,"Nationwide Distribution including CA, CO, CT, FL, GA, IL, LA, MD, MA, MN, MS, MO, NJ, NC, OH, PA, SC, TX, and WA.",Terminated,"July 27, 2012",417,2489,Not_Computer,N/A,N/A,N/A
Z-2415-2011,58677,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.","Pinnacle Destination Guiding Sheath, 6 French, 90 cm",2,"June 06, 2011", 2011,Terumo Medical Corporation,Molding defect in destination product that render the device unusable.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.",N/A,214,214 units,"Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama",Terminated,"July 07, 2011",31,258,Not_Computer,N/A,N/A,N/A
Z-2413-2011,58591,hepatitis a test (antibody and igm antibody),LOL,Hepatitis A virus (HAV) serological assays.,Microbiology,Microbiology,510(k),"ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25",ARCHITECT HAVABM Assay Reagent,2,"June 06, 2011", 2011,Abbott Laboratories,The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Abbott Laboratories issued a Product Recall letters dated April 20, 2011 to all affected customers that received ARCHITECT HAVAB-M reagent, lot 93794HN00. The letters informed the accounts of the increased grayzone and/or reactive results and were instructed to discontinue use of the lot and destroy any remaining inventory of the lot according to laboratory procedures. If the account did not have an alternate lot of reagent, they were told to continue using the recalled lot until their lab receives the replacement lot, and to perform supplemental testing with another HAVAB-M method to confirm the results for all specimens that are grayzone or reactive. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. For further questions regarding this please contact Abbott at 1-877-422-688.",Contact the recalling firm for information,788,788 kits,Nationwide Distribution including Puerto Rico,Terminated,"February 10, 2012",249,788,Not_Computer,N/A,N/A,N/A
Z-2420-2011,58658,"apparatus, autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(k),"Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion SystemUS Only: 1050-110-ENGOutside US:1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER,1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN.Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.",ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION ,2,"June 07, 2011", 2011,Haemonetics Corporation,2 Models Model 1:OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalledModel 2:OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum,DESIGN: Device Design,"The firm, Haemonetics, sent an ""Urgent Field Recall"" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped. Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling.The customers were instructed to follow the enclosed directions to confirm their possession of any units of this model and arrange for their return to Stericycle; immediately cease use of devices not equipped with a spill collection drainage system ( to determine whether their OrthoPAT device is equipped with the spill collection drainage system, please refer to the attached illustrations/instructions); complete and return the IMPORTANT-CUSTOMER CONFIRMATION sheet via fax to: Stericycle at 1-866-792-5450, and RETURN the OrthoPAT devices NOT equipped with spill collection drainage system (for instructions on how to arrange return of OrthoPAT Devices, call a Stericycle Representative at 1-866-918-8736). A Haemonetics representative will be in contact with the customers facility within 14 working days to assist with the recall actions.The firm, Haemonetics, will update the OrthoPAT labeling. The labeling will have specific instructions to permanently deploy the centrifuge spill collection bag at all times. Device cleaning instructions in the event of a blood spill are also clarified and include specific instructions to unplug the device from the AC outlet in the event of a fluid spill on the device. If a device does experience a fluid spill, new instructions direct the user to return the device to Haemonetics for evaluation and repair. Operator Manuals will be replaced with a new revisi.",Contact the recalling firm for information,2976,2976 units,"Worldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norway, Panama, Poland, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, Slovak Republic, EI Salvador, Turkey and Taiwan.,",Open,N/A,N/A,2976,Not_Computer,N/A,N/A,N/A
Z-2467-2011,58703,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10).The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.","HIVISION Preirus, Avius ultrasound systems",2,"June 08, 2011", 2011,Hitachi Medical Systems America Inc,"Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead",DESIGN: Software Design,"The firm, Hitachi, sent a ""DEVICE CORRECTION NOTICE"" letter dated April 15, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were inform of the nature of the software error in the Doppler Trace Measurement feature; the circumstances under which this error can occur; and the safety issue involved should incorrect values generated lead to a false diagnosis of stenosis in a patient. The letter provides the customer with a workaround solution in order to avoid this issue. The customer were also instructed to call the HMSA Applications Helpline at 877-871-2777 to reprogram their system to temporarily eliminate the noted safted issue and to immediately have all selections unchecked on the Doppler trace measurement result store setting set up screen. The notification letter also states that Hitachi Medical Systems America (HMSA) will be having their service personnel schedule a visit at each customer location and install a software upgrade on each affected system unit in order to directly address, and permanently resolve this issue. If you need any further information regarding this notice, please contact the Manager of Regulatory Affairs at 800-800-3106 x3720 or email to: thistlewaited@hitachimed.com.","For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.",24,24 system units,"Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.",Terminated,"February 19, 2013",622,24,Software,Output/Calculation,Software update,Software Update
Z-2468-2011,58620,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Newport e360 Ventilator, Model Number: e360The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.",Newport e360 Ventilator,2,"June 08, 2011", 2011,Newport Medical Instruments Inc,Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request.Should you have any questions or require additional information, please call (714) 427-5811 extension 344.",No consumer action necessary,18,18,"Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.",Terminated,"June 08, 2011",0,18,Software,N/A,Software update,Software Update
Z-2423-2011,58663,"prosthesis, hip, semi-constrained (metal uncemented acetabular component)",KWA,"Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.",Orthopedic,Orthopedic,510(k),"Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150, Biomet Orthopedics, Warsaw, IN.Intended Use: The Porous Plasma Spray (PPS) Ringloc¶_ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.",Porous Plasma Spray (PPS) Ringloc Acetabular System,2,"June 08, 2011", 2011,"Biomet, Inc.","The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.",TRAINING: Employee Error,"Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Immediately locate and remove the affected product.Follow the instructions on the enclosed ""FAX Back Response Form"" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.",Contact the recalling firm for information,762,762 all products,"Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.",Terminated,"September 16, 2011",100,2069,Not_Computer,N/A,N/A,N/A
Z-2541-2011,58571,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN.Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.", Shoulder humeral tray ,2,"June 09, 2011", 2011,"Biomet, Inc.",The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.,TRAINING: Employee Error,"The firm, Biomet Orthopedics, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580.Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.",N/A,1575,"1,575 units all products","Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.",Terminated,"February 21, 2013",623,1575,Not_Computer,N/A,N/A,N/A
Z-2552-2011,58263,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"IMPAX CV (Cardio Vascular)The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.",Cardio Review Station (CRS),2,"June 10, 2011", 2011,AGFA Corp.,Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.,OTHER/UNDETERMINED: Pending,"The firm, AGFA Healthcare, sent an ""URGENT SAFETY NOTICE"" letter dated March 21, 2011 via FED-EX to its customers.. The letter describes product, problem, and actions to be taken. The customers were instructed to distribute this information within their facility to all individuals who need to be aware and to complete and return the URGENT SAFETY NOTICE FEEDBACK FORM via fax to: 864-421-1664 or email. AGFA is supplying the customers with a CRS User Manual Addendum to emphasize the proper steps required to achieve an accurate measurement when using the calibration tool within CRS. Mitigation will provide the customer/end-user with awareness of the correct XA measurement calibration technique and the potential consequences if proper technique is not followed. Additionally, AGFA will offer customer training on the use of the calibration tool. This training will be provided remotely via the web at no cost. Customers were ask to register before May 1, 2011 by contacting AGFA Customer Support Center toll-free at 877-777-2432. Training sessions are from May-June 2011.If you have any questions about this matter, please contact your local AGFA HealthCare organization or the AGFA Customer Support Center at 877-777-2432.",N/A,536,536,Worldwide distribution: USA (nationwide) and country of Canada.,Terminated,"November 29, 2011",172,536,Not_Computer,N/A,N/A,N/A
Z-2419-2011,58405,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific, Atlantis ¶_ SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.",iCross Coronary Imaging Catheter,1,"June 10, 2011", 2011,Boston Scientific Corporation,Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.,DESIGN: Process Design,"Boston Scientific "" Important Customer Notification"" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications.The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation.Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific.",Contact the recalling firm for information,30669,"30,669","Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.",Terminated,"July 30, 2012",416,96702,Not_Computer,N/A,N/A,N/A
Z-2551-2011,58736,dialysate concentrate for hemodialysis (liquid or powder),KPO,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis LiquidPart number: 08-4000-LBFormulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates",NaturaLyte Sodium Bicarbonate Liquid Concentrate ,3,"June 10, 2011", 2011,"Fresenius Medical Care Holdings, Inc.",Mislabeled: incorrect lot number printed on case labels,TRAINING: Employee Error,"Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove thecorrectly labeled product from the incorrectly labeled case and discard the case.Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients.Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.",N/A,3190,"3,190 cases","Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA",Terminated,"September 12, 2012",460,3190,Not_Computer,N/A,N/A,N/A
Z-2553-2011,58730,"shield, nipple",HFS,Nipple shield.,General Hospital,General Hospital,510(K) Exempt,"Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.",Contact Nipple Shield (Sterile) 24mm (Standard),2,"June 10, 2011", 2011,Medela Inc,The product sterility may be compromised due to possible pinholes in the rigid tray of the package.,PRODUCTION CONTROLS: Packaging,"The firm, Medela, sent an ""Important Device Recall"" letter dated May 9, 2011 to all of their customers/direct accounts. Medala also began telephoning or visiting the direct accounts/customers on May 18, 2011. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:1) not to use the affected lots and place them in quarantine2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form inlcude with this letter4) complete and return the Product Inventory Form via fax to 800-995-7867 or email jim.hughes@medela.com, even if they have no affected product on hand5)If you have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. Each affected product will be replaced with (2) non-sterile nipple shields.5) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. Questions about the recall process were directed to Medela Customer Service at 1-888-835-5968 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.",N/A,4320,"4,320 units","Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV.",Terminated,"February 16, 2012",251,4320,Not_Computer,N/A,N/A,N/A
Z-2388-2011,58794,"pad, alcohol, device disinfectant",LKB,N/A,N/A,General Hospital,510(k),Churchill Medical SystemsAMS-7080CP (Dressing Change Kit).The device intended use is a dressing change kit.,Churchill Medical Systems,1,"June 11, 2011", 2011,Vygon Corporation,Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall.If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.",N/A,7900,"7,900 units","United States (FL, MA, MD, and VA).",Terminated,"June 18, 2012",373,38579,Not_Computer,N/A,N/A,N/A
Z-2414-2011,58661,"incubator, neonatal",FMZ,Neonatal incubator.,General Hospital,General Hospital,510(k),"Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.","System 98/98XT, CS100/CS100i, CS300 IntraAortic Balloon Pump",1,"June 13, 2011", 2011,Maquet Datascope Corp - Cardiac Assist Division,Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.,DESIGN: Device Design,"Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP failure. Customers were advised that their Service Representatiave would arrange to replace their supply which would contain a new fan assembly. Upon completion of the power supply replacement, customers were asked to sign a service repair order to verify satisfactory completion of the work. For technical questions contact Technical Support Department at 1-800-777-4222 and press 4.For scheduling a service visit by a Field Service Representatiave, contact the firm's US Call Center at 1-800-777-4222 and press 3.Maquet issued a press release on June 6, 2011 advising consumers of the issue and that their recall was considered a class one.",N/A,885,885 units,Worldwide Distribution,Terminated,"October 25, 2012",500,885,Not_Computer,N/A,N/A,N/A
Z-2557-2011,58455,"joint, hip, external limb component",ISL,External limb prosthetic component.,Physical Medicine,Physical Medicine,510(K) Exempt,"Accolade TMZF Plus Hip Stem:Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300Manufactured by "" Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, IrelandThe subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.",Accolade TMZF Plus Hip Stem,2,"June 13, 2011", 2011,Stryker Howmedica Osteonics Corp.,Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.,TRAINING: Employee Error,"Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069.Customers were also instructed to:Contact the hospitals in their territory that have the affected product to arrange return of the product.Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430. Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words ""Product Recall.""For any questions call (201) 972-2100.",N/A,44,total of all units is 44,Nationwide Distribution,Terminated,"October 10, 2012",485,44,Not_Computer,N/A,N/A,N/A
Z-2561-2011,57760,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.,Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. ,2,"June 14, 2011", 2011,Computerized Medical Systems Inc,"Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent a ""USER NOTICE"" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.",N/A,94,94,"Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.",Open,N/A,N/A,94,Software,Output/Calculation,Software update,Software Update
Z-2562-2011,57845,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above.Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods.,Focal Radiation Treatment Planning Workstation,2,"June 14, 2011", 2011,Computerized Medical Systems Inc,"Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V; System, the gantry angles all remain at zero which could lead to patient mistreatment.",DESIGN: Software Design,"Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO.Customers were instructed to contact their local customer support office with any questions.",N/A,155,155,"Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.",Open,N/A,N/A,155,Software,Output/Calculation,Software update,Software Update
Z-2559-2011,58226,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00.For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.",Focal Release 4.34.00 through 4.50.00 software,2,"June 14, 2011", 2011,Computerized Medical Systems Inc,"Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.",DESIGN: Software Design,"Computerized Medical System sent a CUSTOMER ADVISORY dated June 12, 2009, to all affected users. This advisory identified the product, the problem, and the action needed to be taken by the customer. There were no patients mistreated as a result of this issueThe firm will send out a User Notice to all sites still runningaffected software to remind them that the issue resolution is available.For further questions, please call (403 ) 830-8023.",N/A,462,462,"Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, Nicaragua, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, and Venezuela.",Open,N/A,N/A,462,Software,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-2560-2011,58229,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.",Monaco RTP System,2,"June 14, 2011", 2011,Computerized Medical Systems Inc,"Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent a ""MONACO CUSTOMER ADVISORY"" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter.This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above.Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.",No consumer action necessary,47,47,"Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Slovenia, South Korea, Spain, and United Kingdom.",Terminated,"April 04, 2013",660,47,Software,Output/Calculation,Instructions/Update,Safety Notice/Insructions
Z-2558-2011,58272,"electrode, ion-specific, chloride",CGZ,Chloride test system.,Clinical Chemistry,Clinical Chemistry,510(k),"OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.",OPTI LION EPlus,2,"June 14, 2011", 2011,"OPTI Medical Systems, Inc",The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"OPTIMedical Systems sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot.Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.",N/A,86,86 boxes (25 units (per box),"Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.",Terminated,"August 08, 2011",55,86,Not_Computer,N/A,N/A,N/A
Z-2556-2011,58762,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.",Terumo Coronary Ostia Cannulae ,1,"June 14, 2011", 2011,Terumo Cardiovascular Systems Corporation,"The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedu",PRODUCTION CONTROLS: Process Control,"Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.",Contact the recalling firm for information,960,960,"Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.",Terminated,"March 21, 2012",281,6400,Not_Computer,N/A,N/A,N/A
Z-2563-2011,58676,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results.",GE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Software,2,"June 14, 2011", 2011,Ge Healthcare It,The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted.,DESIGN: Software Design,"GE Healthcare sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated May 3, 2011 to all affected customers. The letter describes the product, problem, and action to be taken by the customer. The letter provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.",Contact the recalling firm for information,14,14 units,"Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar.",Terminated,"October 04, 2011",112,14,Software,Device Operation,Software update,Software Update
Z-2565-2011,58747,prothrombin-proconvertin and thrombotest,JPF,Prothrombin-proconvertin test and thrombotest.,Hematology,Hematology,Enforcement Discretion,"Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler¶_ 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler¶_ 2.0 Instrument using the Roche Confidential Page 3 of 9 LightCycler¶_ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001",Factor II (Prothrombin) G20210A Kit,2,"June 14, 2011", 2011,"Roche Molecular Systems, Inc.",Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market,OTHER/UNDETERMINED: Pending,"Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to discontinue use of the affected product by August 31, 2011.Complete the attached faxback form ( 4293-00-0311 ) and fax it to 1-888-345-5359.For questions or technical support, please contact Roche Molecular at 1-800-526-1247,.",Contact the recalling firm for information,13864,"13,864 units",Nationwide Distribution,Terminated,"August 13, 2012",426,30890,Not_Computer,N/A,N/A,N/A
Z-2564-2011,58258,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and aboveUsed to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.",Monaco Radiation Treatment Planning System,2,"June 14, 2011", 2011,Computerized Medical Systems Inc,"Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans.",DESIGN: Software Design,"Computerized Medical System sent a ""USER NOTICE"" letter dated June 24, 2010, to all affected users. This notice identified the product, the problem, and the actions to be taken. There is no current workaround. All customers will be mailed a postcard to be returned as proof of receipt and understanding of the notification. Consignees will be contact via telephone or e-mail after June 30, 2010 if the postcard is not returned This notice is to be distributed to any and all users of CMS software at your organization who are potentially affected. The notice states the issue will be resolved in Monaco Release 2.04, but no date for this release was given.For further questions, please call (403) 830-8023.",N/A,62,62,"Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom.",Open,N/A,N/A,62,Software,Output/Calculation,Software update,Software Update
Z-2569-2011,57843,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above.Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.,Monaco Radiation Treatment Planning Workstation,2,"June 15, 2011", 2011,Computerized Medical Systems Inc,"Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.",N/A,11,11,"Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.",Open,N/A,N/A,11,Software,Output/Calculation,Software update,Software Update
Z-2567-2011,58227,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00.Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO RTP System,2,"June 15, 2011", 2011,Computerized Medical Systems Inc,"XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent a ""XiO CUSTOMER ADVISORY"" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to ""Yes"" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023.",N/A,784,784,"Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Tajikistan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,784,Software,Output/Calculation,Software update,Software Update
Z-2572-2011,58233,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02.For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.","Focal Radiation Treatment Planning System, ",2,"June 15, 2011", 2011,Computerized Medical Systems Inc,"Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as",DESIGN: Software Design,"Computerized Medical Systems Inc sent a ""CUSTOMER ADVISORY"" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states ""Alternatively the plan can be imported directly into XIO"". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008.The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available.For further questions, please call (403) 830-8023.",N/A,307,307,"Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,307,Software,Display/Image,Software update,Software Update
Z-2574-2011,58214,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above.Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 15, 2011", 2011,Computerized Medical Systems Inc,"In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer.The issue was resolved in XiO Release 4.50.00 which has been available since June 2009.A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt.For further questions, please call ( 408) 380-8023.",N/A,936,936,"Worldwide Distribution -- USA (nationwide) including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,936,Software,Display/Image,Software update,Software Update
Z-2568-2011,58215,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00.Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 15, 2011", 2011,Computerized Medical Systems Inc,"In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.Computerized Medical Systems, Inc have created ""patches"" to resolve the problem. A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included.For further questions, please call (408) 380-8023.",N/A,1116,1116,"Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1116,Software,Display/Image,Software update,Software Update
Z-2571-2011,58657,"electrode, ion specific, calcium",JFP,Calcium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).",calcium membrane jackets,2,"June 16, 2011", 2011,Radiometer America Inc,"Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used",N/A,"The firm, Radiometer America, sent a ""MEDICAL DEVICE FIELD CORRECTION"" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. The letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed).The letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. Questions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.",N/A,30323,30323 boxes,"Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, and Venezuela.",Terminated,"February 19, 2012",248,30323,Not_Computer,N/A,N/A,N/A
Z-2579-2011,58197,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.3.0 and aboveUsed to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 16, 2011", 2011,Computerized Medical Systems Inc,"XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port",DESIGN: Software Design,"The firm, Elekta CMS Software, sent an ""IMPORTANT SAFETY NOTICE"" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice. The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available.If you have any questions, please call 314-993-0003 or toll free 800-878-4267.",Contact the recalling firm for information,1208,1208,"Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1208,Software,Device Operation,Software update,Software Update
Z-2578-2011,58200,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation treatment Planning System, XiO Release 4.2.0 and aboveUsage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation treatment Planning System,2,"June 16, 2011", 2011,Computerized Medical Systems Inc,"When a dialog box is displayed and the dose status is changed to ""Dose not current"", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t",DESIGN: Software Design,"The firm, Elekta CMS Software, sent an ""IMPORTANT SAFETY NOTICE"" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites when this solution is available. If you have any questions, please call 314-993-0003 or Toll Free: 800-878-4267.",Contact the recalling firm for information,1293,1293,"Worldwide distribution: USA (nationwide) including Puerto Rico, and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1293,Software,Device Operation,Software update,Software Update
Z-2577-2011,58210,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 16, 2011", 2011,Computerized Medical Systems Inc,"XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.",DESIGN: Software Design,"The firm, CMS, Inc., sent a ""XiO Customer Advisory"" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given.If you have any questions, please call 408-380-8023.",N/A,75,75,"Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.",Open,N/A,N/A,75,Software,Output/Calculation,Software update,Software Update
Z-2529-2011,58910,"stent, superficial femoral artery",NIP,N/A,N/A,Cardiovascular,PMA,"Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-07403. 7 mm x 40 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall.The Innova Self-Expanding Stent is available in a variety of diameters and lengths.The delivery system is also offered in two working lengths (75 cm and 130 cm).The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions",Innova SelfExpanding Stent System,1,"June 16, 2011", 2011,Boston Scientific Corporation,"Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d",DESIGN: Process Design,"Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number.Customers were instructed to contact their local Sales Representative for any questions.",N/A,N/A,N/A,"Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.",Terminated,"February 04, 2014",964,N/A,Not_Computer,N/A,N/A,N/A
Z-2582-2011,57807,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),XiO Radiation Treatment Planning System. XiO Release 4.50.00 and aboveUsed to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed.,XiO Radiation Treatment Planning System,2,"June 17, 2011", 2011,Computerized Medical Systems Inc,"XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati",OTHER/UNDETERMINED: Pending,"Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011.",N/A,556,556,"Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam",Open,N/A,N/A,556,Software,Treatment/Delivery/Therapy,Software Patch,Software Update
Z-2580-2011,58787,"equipment, traction, powered",ITH,Power traction equipment.,Physical Medicine,Physical Medicine,510(k),"MTD 4000 - Mettler Traction Decompression System, Model: ME 4000Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles","Mettler Traction Decompression System, Model: ME 4000",2,"June 17, 2011", 2011,Mettler Electronics Corp,The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.,N/A,"Mettler Electronics sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated April 14, 2011 to all affected consignees. The letter identified the product, the problem and the actions to be taken. Customers were instructed to immediately cease use of the recalled device, examine their inventory and quarantine product subject to recall. In addition, consignees were told if they have further distributed the affected product to please identify their customers and notify them at once of this product recall. The letter asks that that each includes a ""Recall Return Response Form"" that consignees are required to complete and return. If you have any questions please contact Mettler Electronics Corp 714-533-2221 x331, Monday through Friday, between the hours of 8:30 A.M. and 4:00 P.M. Pacific Time.",Contact the recalling firm for information,221,221,"Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti.",Terminated,"July 10, 2012",389,221,Hardware,N/A,Remove,Remove or Replace
Z-2590-2011,58717,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).",ENDOFUSE(R) Fusion Rods,2,"June 17, 2011", 2011,Wright Medical Technology Inc,"Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.",PRODUCTION CONTROLS: Process Control,"The firm, Wright Medical, sent an ""URGENT: Medical Device Voluntary Recall"" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401.If you have any questions regarding this matter, please contact 800-874-5630.",N/A,121,121,"Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.",Terminated,"December 27, 2012",559,186,Not_Computer,N/A,N/A,N/A
Z-2586-2011,58784,"assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus",MZP,N/A,N/A,Microbiology,N/A,"COBAS¶_ AmpliPrep / COBAS¶_ TaqMan¶_ HCV Test, US-IVDThe COBAS¶_ AmpliPrep/COBAS¶_ TaqMan¶_ HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS¶_ AmpliPrep Instrument for automated specimen processing and the COBAS¶_ TaqMan¶_ Analyzer or the COBAS¶_ TaqMan¶_ 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.","COBAS AmpliPrep / COBAS TaqMan HCV Test, USIVD",2,"June 17, 2011", 2011,"Roche Molecular Systems, Inc.",The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.,OTHER/UNDETERMINED: Pending,"The firm, Roche, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated April 14, 2011 and faxback form to their customers UPS ground. The letter described the product, problem and actions to be taken. The customers were instructed to review prior test results if there have been indications of discrepancies between test results generated with COBAS AmpliPrep/COBAS TaqMan HCV Test as compared to other relevant clinical and laboratory findings; complete and return the attached Product Advisory Notice: Affiliate Feedback Fax-Form via fax to: 1-866-792-5445, and file this letter for future reference, in particular for use with their 2010 CAP Survey Results to explain any under-quantitation of sample HVL 2-01.Please contact Roche Molecular Diagnostics Technical Support at 1-800-526-1247 if you have any questions about the information contained in this letter.",N/A,50993,"50,993 units","USA (nationwide) and countries of: Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudia Arabia, Sinagpore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.",Terminated,"August 27, 2012",437,339392,Not_Computer,N/A,N/A,N/A
Z-2584-2011,59037,electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(k),"Philips SureSigns VS3 Vital Signs Monitor Models:VS3863069, 863070, 453564041251, 453564041261, VS3863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.",Philips Healthcare,2,"June 17, 2011", 2011,Philips Healthcare Inc.,"Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound",DESIGN: Software Design (Manufacturing Process),"Philips Healthcare sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken.The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the ""Speaker Malfunct."" INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative.The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge.Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.",Contact the recalling firm for information,5225,5225 units,"Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Terminated,"August 15, 2013",790,5740,I/O,N/A,Replace,Remove or Replace
Z-2591-2011,58853,instrument for treatment of hyperhidrosis,OUB,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece(MD3001-HP), the miraDry biotip and the miraDry Treatment Template system.Miramar Labs, Inc.445 Indio WaySunnyvale, CA 94085Intended use: Treatment of primary axillary hyperhidrosis.",MiraDry System ,2,"June 17, 2011", 2011,"Miramar Labs, Inc.",Reports of skin burns on axilla after treatment with the miraDry System.,DESIGN: Device Design,"The firm,Miramar, has a service provider in Japan that assists in dealing with customers. The service providers were provided a copy of the investigation report and communicated directly with the customers to set up appointments for the field correction. The customers were personally visited by a representative from Miramars service provider in Japan. All devices had field correction performed on April 26-28, 2011.",N/A,8,8 units,International only: Japan,Terminated,"June 17, 2011",0,8,Not_Computer,N/A,N/A,N/A
Z-2588-2011,58808,"appliance, fixation, nail/blade/plate combination, multiple component",KTT,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used.SubsequentProduct Codes: HWC, JDQ.","SuperCable ScrewDriver, 3.5mm Hex",2,"June 17, 2011", 2011,Kinamed Inc,"The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tipfeature, causing it to strip during final tightening.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Kinamed Inc., sent a recall letter dated August 18, 2010 to consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The customers were instructed to Immediately examine their stock and return any Kinamed SuperCable Screwdriver, 3.5mm Hex bearing these lot numbers, along with the completed attached Effectiveness Check Form and shipment under RMA #74567 to the attention of: ""Director of Quality Assurance""Kinamed, Inc.820 Flynn RoadCarnarillo, CA 93012-8701Note: The Kinamed sales agent shipped and had the product replaced for the customers.If you have any questions, please contact (303)-681-2208, (805) 384-2748 or(800) 827-5775.",N/A,8,8 units,Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.,Terminated,"October 25, 2011",130,8,Not_Computer,N/A,N/A,N/A
Z-2585-2011,58837,"instrument, ultrasonic surgical",LFL,N/A,N/A,General & Plastic Surgery,510(k),"Integra CUSA NXT Ultrasonic Tissue Ablation System Service ModuleThe CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery.",Integra CUSA Selector NXT Ultrasonic Surgical Aspirator,2,"June 17, 2011", 2011,Integra Limited,"The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.",DESIGN: Device Design,"Integra sent a ""FIELD ACTION NOTIFICATION"" dated May 2, 2011 to all affected customers. The letter identified the product, the problem and the actions to be taken. Customers were informed of a Field Corrective Action that is being initiated. All devices (customer owned, Integra Loaner Pool, and Sales demos) will undergo rework of the vacuum pump assembly. The rework will be scheduled, at customer sites by Integra Field Service Technicians or returned to a designated Integra Service Center for rework. A loaner will be presented to customer accounts upon request. The letter asks that each customer complete and return the enclosed Recall Acknowledgement and Return Form to Integra, maintaining a copy of the letter and form for your records. For any additional information please call 609-936-2485.",N/A,105,105 units,"Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan",Open,N/A,N/A,105,Hardware,Treatment/Delivery/Therapy,Rework,Repair
Z-2603-2011,58763,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous",MBL,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.","Encompass Hip Stem, Plasma Spray",2,"June 20, 2011", 2011,Ortho Development Corporation,Tests on PVC packaging material resulted in alert levels for cytotoxicity.,DESIGN: Packaging Design/Selection,"Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31.",N/A,113,113 units,"Nationwide Distribution - USA including CA, FL, and TX.",Terminated,"November 09, 2011",142,113,Not_Computer,N/A,N/A,N/A
Z-2599-2011,58250,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00.Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.",FOCAL Workstation,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to",DESIGN: Software Design,"Elekta CMS Software sent an ""ADVISORY NOTICE"" dated February 6, 2009 to its affected customers. The notice identified the product, the problem, and the actions to be taken. Customers were informed that the workaround method available is to (edit the MLC pattern using the aperture first and the individual MLC leaf edits second). The firm states that this issue will be resolved in Focal version 4.50.00 and above. A ""User Notice"" will be sent to all users still using the affected software notifying them of the updated software available to correct the problem. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.",No consumer action necessary,760,760,"Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Uruguay and Venezuela.",Open,N/A,N/A,760,Software,Output/Calculation,Software update,Software Update
Z-2598-2011,57801,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and aboveTo create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.",Monaco Radiation Treatment Planning Workstation,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.",DESIGN: Software Design,"Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.",No consumer action necessary,137,137,"Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.",Open,N/A,N/A,137,Software,Display/Image,Software update,Software Update
Z-2597-2011,58502,"processor, tissue, automated",IEO,Automated tissue processor.,Pathology,Pathology,510(K) Exempt,"Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0005.This tissue processor prepares tissue samples for sectioning by transforming fixed samples into wax embedded samples. This is achieved by exposing the tissue samples to a sequence of reagents in the processing retorts.",Peloris II Rapid Tissue Processor,2,"June 20, 2011", 2011,"Leica Microsystems, Inc.","The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another,",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Leica Microsystems sent a MEDICAL DEVICE CORRECTION letter dated April 11, 2011, to the affected customers via first class mail. The letter identified the product, the problem, and the action needed to be taken by the customer.The Customers were instructed to discontinue use of the device until their local Leica Microsystems representative contact them to arrange the replacement of the faulty impellor. The accounts were asked to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.",No consumer action necessary,22,22 units,"Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.",Terminated,"June 20, 2011",0,22,Not_Computer,N/A,N/A,N/A
Z-2595-2011,58260,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.0.2 and aboveUsed to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM",DESIGN: Software Design,"Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available.No date was given for the mailing or the solution.",No consumer action necessary,1292,1292,"Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1292,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-2592-2011,58269,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.50.00 and abovefor use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.",Focal Radiation Treatment Planning System,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.",DESIGN: Software Design,"Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround.",N/A,308,308,"Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan.",Open,N/A,N/A,308,Software,Display/Image,Instructions,Safety Notice/Insructions
Z-2604-2011,58270,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above",XiO Radiation Treatment Planning System,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.",DESIGN: Software Design,"A Safety Notice, dated 5/20/10, was sent to Elekta / Computerized Medical Systems Inc clients in May 2010. The notice indicates the problem, the clinical impact. The notice states a future XiO Release will resolve the issue. A return postcard is included with the mailing to verify consignee received the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via phone or email to confirm receipt of the notice. The notice also informed the consignees they would be contacted when a solution was available.",No consumer action necessary,57,57,"Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.",Open,N/A,N/A,57,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2573-2011,58811,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status.Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (",Ultraview SL Capnography Module,2,"June 20, 2011", 2011,"Spacelabs Healthcare, Llc","Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.",DESIGN: Software Design,"Spacelabs Medical sent a ""URGENT-MEDICAL DEVICE CORRECTION"" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to ""ON"". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption.A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost to the customer. For questions about this corrective action program, call Spacelabs Medical at 1-800-522-7025, Select 2 for Technical Support. For outside the US, customers can call 1-425-657-7200, x5089.",N/A,5883,5883 units,"Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE,GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, ITALY,JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEPAL,NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PALESTINE, PANAMA,PERU, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND,SYRIAN ARAB REPUBLIC, TAIWAN, REPUBLIC OF CHINA, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.",Terminated,"December 02, 2011",165,5883,Software,Device Operation,Upgrade,Repair
Z-2596-2011,58256,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.",Focal Radiation Treatment Planning System,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col",DESIGN: Software Design,"Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.",No consumer action necessary,233,233,"Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Turkey, United Kingdom, Uruguay, and Venezuela.",Open,N/A,N/A,233,Software,Output/Calculation,Software update,Software Update
Z-2594-2011,58253,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above.Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.",FOCAL Workstation,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.",DESIGN: Software Design,"Elekta CMS Software sent an ""ADVISORY NOTICE"" dated January 19, 2009 to its affected customers. The notice identified the product, the problem, and the acton to be taken. Customers were informed that the workaround method available is to (use the image fusion feature already in Focal to relign the scans). The firm states that this issue is resolved in Focal version 4.62.00, which was released in March 2011. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.",No consumer action necessary,31,31,"Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.",Open,N/A,N/A,31,Software,Display/Image,Software update,Software Update
Z-2593-2011,58262,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO Release 2.1.0 and aboveUsed to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"June 20, 2011", 2011,Computerized Medical Systems Inc,"XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated.",DESIGN: Software Design,"Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available.",No consumer action necessary,1400,1400,"Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.",Open,N/A,N/A,1400,Software,N/A,Instructions,Safety Notice/Insructions
Z-2608-2011,58906,"culture media, antimicrobial susceptibility test, mueller hinton agar/broth",JTZ,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"BBL"" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates.Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.","BBL"" OXACILLIN SCREEN AGAR",2,"June 21, 2011", 2011,Becton Dickinson & Co.,Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BD Diagnostic Systems sent an ""URGENT PRODUCT RECALL"" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers.The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced.Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908.",N/A,5440,5440 plates,"Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.",Terminated,"August 15, 2011",55,5440,Not_Computer,N/A,N/A,N/A
Z-2601-2011,59000,"controller, infusion, intravascular, electronic",LDR,N/A,N/A,General Hospital,510(k),"""***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18-24 08635 Sant Esteve Sesrovires BARCELONA-SPAIN***Distributed by: Victus www.victus.com 4918 S.W. 74th Court Miami, FL 33155***"" To control intravascular infusion of medication.",DOSIFLOW 1 I.V. EXTENSION SET ,2,"June 21, 2011", 2011,Leventon S. A. U.,"Leventon, S.A.U. Barcelona, Spain is recalling DOSI-FLOW REGULATOR, Part Number 259-0250, Lot Numbers 101444L and 101494L. Product has potential to leak.",DESIGN: Device Design,"The firm, Leventon, S.A.U. sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated March 11, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer.The letter instructs the customer to examine their inventory and quarantine any product subject to the recall. They were also instructed to identify their customers who have received the product, notify them of the recall, send a copy of the recall notification letter and request that the customers return any unused product. The customers were also instructed to complete and return the attached RECALL RESPONSE FORM within 5 working days via fax to 00 34 93 6532556 or e-mail to dsalvatierra@leventon.es.Questions concerning this recall should be directed to the QA Manager at 00 34 93 8176316 or e- mail to dsalvatierra@leventon.es.",Contact the recalling firm for information,1000,"1000 cases (50,000 units)",Nationwide Distribution: FL only.,Terminated,"June 28, 2011",7,1000,Not_Computer,N/A,N/A,N/A
Z-2606-2011,58833,single (specified) analyte controls (assayed and unassayed),JJX,Quality control material (assayed and unassayed).,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay SystemsQuality Control Kits, Part Number: 37309The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.",Access Ostase QC,2,"June 21, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers.Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio",DESIGN: Packaging Design/Selection,"Beckman Coulter sent an PRODUCT CORRECTIVE ACTION (PCA) letter on May 10, 2011 to all affected customers who purchased Access Ostase Calibrators and Access Ostase QC. The letter identified the customers with an explanation of the problem and the potential impact should the problem occur and the action needed to be taken. Customer were instructed to:(1) Inspect all Access Ostase Calibrator and QC vials and packaging for signs of failure prior to use, including:-Cracking, particularly along the bottom of the vial,-Absence of reagent and/or leaking of contents into the box(2) Human source material used in the preparation of Access Ostase Calibrator and QC material has been tested and found non-reactive for Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV-1 and HIV-2). No known test method can offer complete assurance that infectious agents are absent. Access Ostase Calibrator and QC vials should be handled in accordance with Good Laboratory Practices, and should be handled as if capable of transmitting infectious disease.(3) Skin contact with Access Ostase Calibrator and QC material may cause sensitization. Wear suitable gloves when handling vials. If contact with skin occurs, wash immediately with plenty of soap and water.Customers were told to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide a copy of the letter to them.In addition, customers were requested to complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.For replacement of defective vials:(1) In the United States, please contact Client Services at 1-800-526-3821, option 1.(2) In Canada, please contact Customer Service at 1-800-463-7828.(3) Outside of the United States and Canada, contac.",Contact the recalling firm for information,702,702 kits,"Nationwide in US and worldwide to: Algeria,Argentina,Australia,Austria,Belgium,Canada,China,Colombia,Czech Republic,France,Georgia,Germany,Greece,Hong Kong,Hungary,India,Italy,Japan,Jordan,Lebanon,Liechtenstein,Mexico,Morocco,New Zealand,Panama,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Singapore,Slovakia,South Africa,Spain,Sweden,Switzerland,Taiwan,Turkey,United Kingdom",Terminated,"July 11, 2012",386,891,Not_Computer,N/A,N/A,N/A
Z-2570-2011,58896,"system, test, blood glucose, over the counter",NBW,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.",ACCUCHECK PERFORMA STRIP,1,"June 21, 2011", 2011,"Roche Diagnostics Operations, Inc.",Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.,DESIGN: Component Design/Selection,"Direct accounts were notified by a Roche Diagnostics press release on 5/18/2011 that included the product's name, lot number, and information to withdraw the remaining inventory of lot 470049 from storage.",N/A,27019,"27,019 units","No US distribution, in France Only.",Terminated,"October 25, 2011",126,27019,Not_Computer,N/A,N/A,N/A
Z-2607-2011,56787,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Eon Mini Neurostimulation (IPG) System Model 3788System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.",Eon Mini Neurostimulation Sysem,2,"June 22, 2011", 2011,Advanced Neuromodulation Systems Inc.,Defective battery was identified as cause for reports of inability to communicate or recharge the product.,PRODUCTION CONTROLS: Process Control,"St. Jude Medical sent an ""IMPORTANT MEDICAL DEVICE RECALL"" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers.St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.",N/A,17141,"17,141","Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA,SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.",Open,N/A,N/A,17141,Battery,Device Operation,Replace,Remove or Replace
Z-2575-2011,58995,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.",Integra PICC INSERTION TRAY,1,"June 22, 2011", 2011,Integra LifeSciences Corp.,Kits contain protective wipes that may be contaminated with Bacillus cereus.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210.",Contact the recalling firm for information,520,520 kits,UT,Terminated,"August 01, 2011",40,560,Not_Computer,N/A,N/A,N/A
Z-2610-2011,58779,"monitor, blood-gas, on-line, cardiopulmonary bypass",DRY,Cardiopulmonary bypass on-line blood gas monitor.,Cardiovascular,Cardiovascular,510(k),"CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.",CDITM 101 Monitor,2,"June 22, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the valuesdisplayed by the CDI""101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.",DESIGN: Device Design,"Terumo Cardiovascular Systems, Corp issued an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer. After a solution has been verified, Terumo CVS will implement a correction for all affected units. Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form.For further question please contact Terumo CVS Customer Service at 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST.",Contact the recalling firm for information,622,622,"Worldwide Distribution -- USA ( nationwide) and the countries of Colombia, Vietnam, India, Indonesia, Pakistan, Canada, Chile, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Singapore, Taiwan, Belgium, Thailand, Vietnam and India",Terminated,"November 06, 2012",503,622,Other,Output/Calculation,N/A,Other
Z-2625-2011,58822,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"12-lead ECG Cable Assembly contains the following cable and attachments:Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs.Precordial Lead Attachment: The precordial lead attachment includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps). This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is notconnected.This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the Emergency Department.",12Lead ECG Cable,3,"June 22, 2011", 2011,"Physio Control, Inc.","The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or ""lead off"" indications.",PRODUCTION CONTROLS: Storage,"Physio-Control, Inc. sent an ""URGENT-MEDICAL DEVICE ACCESSORY INFORMATION"" letter dated May 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The customers were advised to follow the instructions:-Use standard hard paddles or therapy electrodes for ECG monitoring if monitoring cannot be performed using the ECG cable. Refer to Troubleshooting Tips for ECG Monitoring in the LIFEPAK 12or LIFEPAK 15 Operating Instructions-Monitoring chapter.-Disconnect the ECG cable from the monitor after use and coil it loosely for storage. Please refer to the Storage Instructions for 12-lead ECG Cable.-Inspect cables daily for bulges which may indicate damaged internal wires. If bulges are visible, replace the ECG cable.-Perform periodic 6 month function testing: Refer to Maintenance and Testing Schedule in the LIFEPAK 12 or LIFEPAK 15 Operating Instructions- Maintaining the Equipment chapters for instructions on how to perform a patient ECG cable function check to confirm proper operation ofthe cable.Customers can visit Physio-Control's website at www.physio-control-notices.com/12LeadECG for additional information or todownload copies of current LIFEPAK 12 defibrillator/monitor or LIFEPAK 15 monitor/defibrillator Operating Instructions and Operator's checklists.Customers can also call Physio-Control's Technical Support Team at 1-800-442-1142, option 5, from 6:00 A.M. to 4:00 P.M. (Pacific), Monday-Friday.",Contact the recalling firm for information,21825,"21,825 units distributed worldwide","Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia.",Terminated,"August 12, 2011",51,21825,I/O,N/A,N/A,N/A
Z-2612-2011,59072,"sterilization wrap containers, trays, cassettes & other accessories",KCT,Sterilization wrap.,General Hospital,General Hospital,510(k),"45cm Laparoscopic Instruments Sterilization tray.Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.",45cm Laparoscopic Instruments Sterilization tray,2,"June 22, 2011", 2011,Stryker Endoscopy,"During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Stryker Endoscopy sent a ""URGENT: DEVICE CORRECTION"" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers.Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link:http://stryker.com/45cm tray. Additionally, customers were instructed to complete and return an attached ""acknowledgement of receipt"" form and fax to 408-754-8378 or scan and e-mail to trays@stryker.com.Questions can be answered by calling 1-800-624-4422 or by e-mail at trays@stryker.com.",N/A,603,603,"Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.",Terminated,"October 25, 2011",125,603,Not_Computer,N/A,N/A,N/A
Z-2609-2011,58767,"defibrillator, implantable, dual-chamber",MRM,N/A,N/A,Cardiovascular,N/A,"Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) ItalyPARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).",Paradym DR Model 8550 and Paradym VR Model 8250,2,"June 22, 2011", 2011,ela Medical Llc,"On February 28, 2011, the company discovered that since the beginning of the US commercial distribution of Paradym DR 8550 and Paradym VR 8250 ICDs in October 2010, the devices included an incorrect version of the Patient Booklet.The company determined that there is no risk of adverse event associated with this labeling error.",PRODUCTION CONTROLS: Error in Labeling,"Sorin CRM USA instructed its field representatives on April 27, 2011 via a conference call to attach the correct Patient Booklet (ref. N582,) as an addendum to the device's external packaging, along with a cover letter ""Quality Note"" dated May 2, 2011 explaining the discrepancy. The field representatives were fedexed the information on May 2, 2011.The letter instructed the Field Representative to attach the correct patient booklet and an addendum, to the outside of the device box.Field Representatives were asked to complete the acknowledgement form by identifying S/N's in which they attached the pouch and their signature of completion and fax the form to 866-500-6096 or e-mail a scanned copy to sorin.ptusa.sorin.com.For questions regarding this recall call 877-663-7674."" For affected units that were already implanted as of April 27, 2011, the patient booklet given to the patient may include information written by the physician or hospital staff that is related to the implanted system (ICD and leads), physician references and patient medications. For this reason and given the fact that the company determined that there is no risk for the patient associated with this labeling error, the company decided to not replace the patient booklet for this population.",Contact the recalling firm for information,275,275,"Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.",Terminated,"April 26, 2012",309,275,Not_Computer,N/A,N/A,N/A
Z-2624-2011,58877,"implant, eye sphere",HPZ,Eye sphere implant.,Ophthalmic,Ophthalmic,510(k),"Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer.Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital.Model Number: I0016C, I0018C, I0020C, I0022C, I0024C.Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids inimplant insertion and provides a means of securing muscles to the implant.The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.",Coated BioEye Orbital Implant w/Conformer.,2,"June 22, 2011", 2011,Integrated Orbital Implants Inc,The recall was initiated because Integrated Orbital Implants has confirmed certain lots of the Coated Bio-Eye were manufactured without expiration dating visible on the packaging. All unlabeled product is currently beyond its expiration date.,OTHER/UNDETERMINED: Pending,"Integrated Orbital Implants Inc initiated a recall communication on 5/20/2011 with Integrated Orbital Implants (IOI) forwarding a Urgent Safety Notification letter to all their customers who had purchased the Coated Bio-Eye implants. The letter asked the customers to look for evidence of a printed expiration date on Coated Bio-eye package. If any Coated BioEye packages were not labeled with an expiration date the letter instructed customers to immediately sequester the products and not to use the products in surgery and contact IOI by telephone at (858) 6779990 or 1 (800) 4246537 to request an RMA number and shipping instructions.Also stated in the letter, IOI will replace Coated BioEye implants without expiration dates free of charge upon receipt of the implants labeled withoutexpiration dates.",Contact the recalling firm for information,4237,4237,"Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore.",Terminated,"January 11, 2012",203,4237,Not_Computer,N/A,N/A,N/A
Z-2623-2011,58834,"stopcock, i.v. set",FMG,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.",Baxter Interlink System Large Bore 4Way Stopcock,2,"June 22, 2011", 2011,Baxter Healthcare Corp.,"There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.",DESIGN: Packaging Design/Selection,"Baxter Urgent Product Recall letters dated May 17, 2011 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that potential pinholes and tears in the individual packaging could compromise the sterility of the stopcock. The accounts were requested to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/17/11, and instructed to notify their customers and ministries of health of the recall.",N/A,4800,"4,800 units",California and internationally to Japan and Australia,Terminated,"June 18, 2012",362,4800,Not_Computer,N/A,N/A,N/A
Z-2611-2011,59004,"computer, diagnostic, programmable",DQK,Programmable diagnostic computer.,Cardiovascular,Cardiovascular,510(k),"Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: ""***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***"".The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis).",Pathfinder Holter Analyzer,2,"June 22, 2011", 2011,"Spacelabs Healthcare, Llc",A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed.,DESIGN: Software Design,"Spacelabs Healthcare sent a ""URGENT-MEDICAL DEVICE CORRECTION"" letter dated June 3, 2011 to all customers. The letter describes the product, problem, and the actions to be taken by the customers. Spacelabs Healthcare recommended that until software upgrades can be done, the customers should weigh the benefits versus the risks when deciding whether or not to continue using the product. Spacelabs Healthcare also recommended that customers advise their staff that the second 24 hours of a 48 hour EVO recording would not be analyzed.Field service engineers will be contacting customers to set up a time and date to install the revised version of the Pathfinder software. Spacelabs will upgrade Pathfinder software regardless of whether the consignees are using EVO recorders to ensure this hazard does not happen in the future.Consignees can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the US, 44 1992 507740 for any questions about this recall.",N/A,58,58 units total (5 units in US and 53 units internationally),"Worldwide Distribution--USA (nationwide) including states of CA and NC and countries of Czech Republic, Denmark, Hong Kong, Israel, The Netherlands, and United Kingdom.",Terminated,"October 26, 2011",126,58,Software,Output/Calculation,Software update,Software Update
Z-2616-2011,58838,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.",Pressure Monitoring Kit ,2,"June 22, 2011", 2011,Terumo Cardiovascular Systems Corporation,The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing.The firm determined that the defect was caused by a change in the pressure dome's manufacturing process.,DESIGN: Component Design/Selection,"Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 3, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were sent 10 replacement pressure monitoring kits with the removal notice as immediate replacements. The firm will send additional replacements to customers that have more than 10 units of affected product as noted on the Customers' returned reponse form. Customers that received the custom packs were provided stickers to identify the recalled packs. The customers were instructed not to open the packs to remove the affected pressure monitoring kit prior to clinical use, but to replace the pressure domes at the time of use.For more information please contact Terumo Cardiovascular Customer Service at 800- 521-2818.",N/A,1515,1515 all custom packs,"Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatamala, Honduras, Hong Kong, Indonesia, Kuwait, Malaysia, Mexico, Pakistan, Panama, Philippines, Singapore, South Korea, Thailand, United Arab Emirates, Uruguay and Vietnam",Terminated,"July 18, 2012",392,21010,Not_Computer,N/A,N/A,N/A
Z-2581-2011,58854,blood pressure cuff,DXQ,Blood pressure cuff.,Cardiovascular,Cardiovascular,510(k),"Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico.The cuff is used to determine a subject's blood pressure.",Cuffable Blood Pressure Cuffs,2,"June 22, 2011", 2011,"GE Healthcare, LLC",BP cuffs may not properly inflate due to a leak,DESIGN: Device Design,"GE Healthcare sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated April 26, 2011 to all affected customers. The letter identified the product, the problem and the action to be taken. Customers were instructed to discontinue use of the product, isolate all affected products, return only unused products and distribute this letter to any other healthcare institutions that are potentially affected by this issue. The letter asks that each customer complete and return the enclosed confirmation form via fax to 800-535-7923, in order to confirm receipt of the notification letter. For any questions, contact your local Vital Signs Account Manager or the International Customer Service at 1-800-932-0760.",N/A,2684996,"2,684,996 units","Worldwide Distribution -- USA (nationwide) including Puerto Rico and countries of: Argentina, Australia, Belgium, Canada, Chile, Ecuador, Finland, Germany, Hong Kong, Israel, Italy, Latvia, Lebanon, Nicaragua, Panama, Peru, Saudi Arabia, Slovenia, UK, Uruguay and Venezuela",Terminated,"May 28, 2013",706,2684996,Not_Computer,N/A,N/A,N/A
Z-2633-2011,55276,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Tubing Assembly #142, V2, V12 Mixer/Wash a component ofthe DxC instruments.Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)",Beckman Unicel DxC 600 and DxC 800 Clinical Systems,2,"June 23, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals.The impact of this issue would include:(1) Quality Control and patient results can potentially be affected.(2) If system has been calibrating properly and Quality Control is recovering within es,N/A,"Beckman Coulter sent out an ""Urgent Product Corrective Action"" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions:"" If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada."" This issue will be corrected with an upcoming software version and tubing modification."" Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records.Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.",No consumer action necessary,2392,2392 units,Worldwide Distribution - USA (Nationwide) and Canada,Terminated,"July 02, 2012",375,2392,Computer,N/A,N/A,N/A
Z-2622-2011,58228,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Interplant Radiation Treatment Planning System, Interplant Release 3.4.0Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation.",Interplant,2,"June 23, 2011", 2011,Computerized Medical Systems Inc,"Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied t",DESIGN: Software Design,"Computerized Medical Systems, Inc. sent a ""CUSTOMER ADVISORY"" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.",N/A,41,41,"Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.",Terminated,"April 04, 2013",651,41,Software,Display/Image,Software update,Software Update
Z-2627-2011,58873,"system, blood culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),"BACTEC"" FX Instrument-Top, catalog #441385. The BD BACTEC"" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.","BACTEC"" FX InstrumentTop",2,"June 23, 2011", 2011,Becton Dickinson & Co.,In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.,DESIGN: Software Design,"BD Diagnostics Systems sent an ""URGENT PRODUCT RECALL"" letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken.The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit.Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.",N/A,907,907units,"Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.",Terminated,"July 05, 2011",12,907,Software,N/A,N/A,N/A
Z-2629-2011,58793,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Servo-s Ventilator Systems; Article number 66 40 440.Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.",Servos Ventilator Systems,2,"June 23, 2011", 2011,Maquet Inc.,"Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.",OTHER/UNDETERMINED: Pending,"Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer.The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators:'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.'Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual.For further questions, please call (973) 709-7660.",Contact the recalling firm for information,17881,17039 units worldwide; 842 units US,Worldwide Distribution - USA (nationwide),Terminated,"September 17, 2013",817,61091,Not_Computer,N/A,N/A,N/A
Z-2636-2011,58813,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Mevatron K2, camera imaging system, Part Number: 1940753;Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.", camera imaging system,2,"June 23, 2011", 2011,"Siemens Medical Solutions USA, Inc - Radiation Oncology",The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.,OTHER/UNDETERMINED: Pending,"The firm, SIEMENS, sent a ""Customer Information"" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter ""Safety Advisory Letters"" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter.If you have any questions, contact the Service Manager- Regulatory Affairs at 925-246-8407.",N/A,N/A,N/A,Worldwide distribution:,Terminated,"November 14, 2011",144,N/A,Not_Computer,N/A,N/A,N/A
Z-2645-2011,58206,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.",ERGO ,2,"June 23, 2011", 2011,Computerized Medical Systems Inc,ERGO Release 1.6.3 is overestimating the MU values.,DESIGN: Software Design,"Computerized Medical Systems, Inc. sent an ""USER NOTIFICATION"" dated December 11, 2009, to all affected customers. The notice identified the product, problem and suggested a workaround to minimize the risk. The notice stated that this workaround does NOT substitute the need for regular Quality Assurance. Customers are instructed to review page 39 of user manual for further explanation of warnings. Customers were asked to complete the Notice for Customer section and return to 3D Line Medical System. This issue has been resolved in Release 1.7.0 and above. No follow-up notice will be distributed to customers. For further information please contact: CMS Software (314) 812-4460 (St Louis Office).",Contact the recalling firm for information,45,45,"Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malaysia, Poland, Portugal, Serbia, and Spain.",Open,N/A,N/A,45,Software,Output/Calculation,Software update,Software Update
Z-2630-2011,58859,N/A,N/A,N/A,N/A,N/A,N/A,"1500T12 Cool Path Ablation System - GeneratorThe generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode (dispersive pad or ""DIP""), which is in compliance with ANSUAAMI Standard HF-18-60601-2-2. The Generator operates in Temperature Control mode only. The generator is a temperature controlled system, where temperature measured by the temperature sensor in the Therapy 1300 Series Steerable Ablation Catheter or other compatible catheters is monitored and the power delivered by the generator adjusts within the selected limits until the desired temperature is achieved. The generator's thermocouple temperature control circuitry is based on a Type T thermocouple. The front panel displays the actual real-time power output, impedance, duration, and measured tip electrode temperature. The amount and duration of RF power delivery is user selectable, The desired catheter tip electrode temperature is also user selectable. A low pass filter is enabled during ablation to permit recording of intracardiac electrograms and alternately disables the filter during stimulation (pacing). The output power of the Generator will shut off if the measured temperature exceeds 80¶_C or if the measured temperature exceeds the user selected temperature set point by more than 5¶_C for more than 3 seconds. The Generator has built-in safety features, which include a self test at power up and automatic RF power shut off if the measured tissue impedance falls below 50 Ohms or exceeds 300 Ohms or the preset impedance value for more than 2 seconds. The 1500Tl2 Cardiac Ablation Generator is only compatible with the Cool Point Irrigation Pump.",1500T12 Cool Path Ablation System Generator,2,"June 23, 2011", 2011,St Jude Medical,"The recall was initiated because St. Jude Medical has confirmed its T14 and T12 RF Generatormay malfunction upon encountering an unexpected electric current (e.g. static electricity).The resulting malfunction results in a failure of the generator to respond to key pressesproperly, and may cause unexpected energy delivery or inability to discontinue energydelivery with the start / stop butt",OTHER/UNDETERMINED: Pending,"The firm, St. Jude Medical (SJM), sent a ""Product Correction"" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit.If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.",N/A,154,154,International distribution only: Canada and Japan.,Terminated,"April 03, 2012",285,168,Not_Computer,N/A,N/A,N/A
Z-2634-2011,58887,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID: 321933 Reorder: 002405 Lot #(Donor ID): 101050353 Expiration: 02/21/2013***STERILE***""Bone Void Filler used in spinal surgery.","OSTEOFIL DBM Paste, 5cc ",2,"June 23, 2011", 2011,"RTI Biologics, Inc.","RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.",PRODUCTION CONTROLS: Labeling Mix-Ups,"RTI Biologics sent a ""VOLUNTARY RECALL"" letter dated April 9, 2008 to the one distributor, Spinal Graft Technologies. LLC. The letter describes the product, problem, and action to be taken by the distributor.The letter states that some of the product was issued a return authorization and requests that the distributor recover the remaining product from distribution. The recovered product will be issued a return authorization. RTI states the grafts can be returned in a non frozen state.Recall effectiveness will be determined by return of the product.",N/A,26,26 units,Domestic Distribution--TN only.,Terminated,"July 24, 2012",397,26,Not_Computer,N/A,N/A,N/A
Z-2647-2011,57906,"mask, oxygen",BYG,Oxygen mask.,Anesthesiology,Anesthesiology,510(K) Exempt,"First Breath ¶_ Adult Oxygen Mask with Tubing, 213cm (7ft)Reorder Number: 001421Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (",Portex First Breath Adult Oxygen Mask with Tubing,2,"June 24, 2011", 2011,Smiths Medical,A sticky substance on the inside and/ or outside of the Mask,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273.",N/A,8652,"8,652 units","Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.",Open,N/A,N/A,88653,Not_Computer,N/A,N/A,N/A
Z-2657-2011,58828,"tube, tracheostomy (w/wo connector)",BTO,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway managementArcadia Medical Corporation1450 East American Lane, Schaumburg, IL 60173 USAArcadia Medical Corporation Tortola, British Virgin Islandswww.arcadiamedical.com, Made in USA",Silicone CTS Tracheostomy Tube ,2,"June 24, 2011", 2011,Arcadia Medical Corporation,"The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.",PRODUCTION CONTROLS: Process Control,"Arcadia Medical Corporation sent a ""MEDICAL DEVICE RECALL"" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.",N/A,118,118,"Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania",Terminated,"August 30, 2011",67,118,Not_Computer,N/A,N/A,N/A
Z-2658-2011,58875,"dna probe, nucleic acid amplification, chlamydia",MKZ,Chlamydia serological reagents.,Microbiology,Microbiology,510(k),"BD ProbeTec"" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***The BD ProbeTec"" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper"" instrument.","BD ProbeTec"" CT/GC/AC Reagent Pack",2,"June 24, 2011", 2011,Becton Dickinson & Co.,In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.,PRODUCTION CONTROLS: Process Control,"BD Diagnostic Systems sent an ""URGENT PRODUCT RECALL"" letter dated September 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers were instructed to discontinue use of the product and discard any remaining product. BD will replace any discarded products. Additionally, customers were requested to complete and return an attached form whether or not they have any inventory remaining, to confirm receipt of the notification. The letter instructed the customers to fax the completed form to: Attention: Regulatory Compliance at 410-316-4258.For assistance regarding replacements, contact BD Customer Service Department at 1-800-675-0908. All other inquiries should contact BD Technical Services Department at 1-800-638-8663.",N/A,130,130 kits,"Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.",Terminated,"June 24, 2011",0,130,Not_Computer,N/A,N/A,N/A
Z-2663-2011,58442,"infusor, pressure, for i.v. bags",KZD,Pressure infusor for an I.V. bag.,General Hospital,General Hospital,510(K) Exempt,"Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc.A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.",Infusable and Infusa Scan Single Patient Use Pressure Infusors,2,"June 24, 2011", 2011,"GE Healthcare, LLC",Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.,DESIGN: Device Design,"The firm, GE Healthcare, sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated February 25, 2011 with an attached return response form to its customers via Fed Ex. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:1) DO NOT use infusable or InfusaScan pressure infusors (listed lot numbers).2) Isolate all affected product and contact Vital Signs Customer Service at +1-973-956-5300 to arrange for the return and replacement of the infusor.3) If they have forwarded any of the affected product to any other healthcare institution, forward a copy of this letter to those institutions.4)Return only unused product.In addition, the customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions, and to complete and return the attached confirmation form via fax to +1-973-956-5440.Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.",N/A,954888,"954,888 units","Worldwide distribution: USA (nationwide) states including: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY; and countries of: Argentina, Australia, Chile, Colombia, Canada, Denmark, Dominican Republic, Finland, Germany, Greece, Hong Kong/Macao, India, Israel, Italy, Korea, Lebanon, Lativia, Mexico, Malaysia, Nicaragua, Netherlands, New Zealand, Paraguay, Philippines, Portugal Panama, Puerto Rico, Peru, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.",Terminated,"October 31, 2012",495,954888,Not_Computer,N/A,N/A,N/A
Z-2661-2011,59064,"test, time, prothrombin",GJS,Prothrombin time test.,Hematology,Hematology,510(k),"0200086, Triad Alcohol Prep Pads, 100 box0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; orHemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System;0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self-Test System;0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit",Triad Alcohol Prep Pads,2,"June 24, 2011", 2011,Alere San Diego,"The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.",OTHER/UNDETERMINED: Pending,"Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers.The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads.The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.",Contact the recalling firm for information,4829,Estimated 4829 total units,"Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico",Terminated,"February 29, 2012",250,4829,Not_Computer,N/A,N/A,N/A
Z-2660-2011,58864,"prosthesis, elbow, constrained, cemented",JDC,Elbow joint metal/polymer constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.",Discovery Elbow System with Humeral Condyle,2,"June 24, 2011", 2011,"Biomet, Inc.",The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.,PRODUCTION CONTROLS: Packaging Process Control,"Biomet sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers.The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form.Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.",N/A,10,10 KITS,Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.,Terminated,"August 29, 2011",66,10,Not_Computer,N/A,N/A,N/A
Z-2659-2011,58770,"pack, hot or cold, water circulating",ILO,Water circulating hot or cold pack.,Physical Medicine,Physical Medicine,510(K) Exempt,"Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK).The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing.The owner's manual is labeled in part: ""PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903"".The sticker which is placed on the back of the control board is labeled in part: ""MOD#4BB02BK***SER#100***"".The shipping box is labeled in part: ""Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***"".The knee wrap is labeled in part: ""***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***"".",Precision Ice,2,"June 24, 2011", 2011,Pro Trainers' Choice Company,"The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue. The control panel printed circuit boards were missing a jumper connection across resistors R28 A, B, C, and D.",OTHER/UNDETERMINED: Pending,"Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers.The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346.The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed.Customers can call Pro Trainers' Choice Company at 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.",Contact the recalling firm for information,336,336 units,"Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.",Terminated,"March 01, 2012",251,336,Hardware,Physical Safety Hazards,Return,Remove or Replace
Z-2662-2011,58186,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Impac Software Sequencer Verify & Record System, for MOSAIQThe intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.",Elekta Impac Software Sequencer,2,"June 24, 2011", 2011,Impac Medical Systems Inc,"There's a problem in the database conversion program that is used when upgrading from the Multi-ACC¶_S to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.",DESIGN: Software Design (Manufacturing Process),"The firm, Elekta, sent a ""USER NOTICE"" to its customers with an attached confirmation of receipt form. The notice describes the product, problem and actions to be taken. The customers were instructed to follow the Interim mitigation instructions noted in the notice -verify the Arc start angle of the Simple ARC with MLC treatment field definition prior to delivery and if the customer identifes a field with an errant gantry start angle, to cease using that plan immediately and consult with the original plan for that field and make the correction to the gantry start angle. In addition, the customers were instructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at their organization who are potentially affected by this issue.For questions or requests for upgrade, email support@impac.com (North America/Asia) or europe.support@impac.com (Europe) or call USA 1-800-488-4672.",Contact the recalling firm for information,840,840,Worldwide distribution: USA (nationwide) and country of Canada.,Terminated,"September 16, 2011",84,840,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-2646-2011,58894,"sterilization wrap containers, trays, cassettes & other accessories",KCT,Sterilization wrap.,General Hospital,General Hospital,510(k),"Smith & Nephew Hip Arthroscopy Repair Instrument TrayPart Number: 72202732Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.",Smith & Nephew Hip Arthroscopy Repair Instrument Tray,2,"June 24, 2011", 2011,"Smith & Nephew, Inc. Endoscopy Division",Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU),PRODUCTION CONTROLS: Labeling Mix-Ups,"Smith & Nephew sent an ""URGENT FIELD CORRECTION NOTIFICATION"" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810.Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.",N/A,11,11 units,"Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.",Terminated,"May 09, 2012",320,11,Not_Computer,N/A,N/A,N/A
Z-2670-2011,58716,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.",SCREENERS Dip Drug Test,2,"June 27, 2011", 2011,Ameditech Inc,The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.,PRODUCTION CONTROLS: Process Control,"Ameditech, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated April 18, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer.The letter requested the customer to:(1) Cease distribution of the affected lot and provide remaining inventory count to Ameditech.(2) Destroy any remaining inventory of these lots and document destruction per your site requirements.(3) Ensure that all users of the device receive a copy of the Urgent Medical Device Recall letter.A recall verification form was attached to the letter to be completed and returned by the customer via fax at 1-858-677-0243.Any questions about the information contained in the recall notice should be directed to Ameditech at amd.complaint@alere.com or call 858-535-1968.",N/A,6000,6000 test cards (120 kits),Nationwide Distribution,Terminated,"August 11, 2011",45,6000,Not_Computer,N/A,N/A,N/A
Z-2671-2011,58718,"port & catheter, implanted, subcutaneous, intravascular",LJT,"Subcutaneous, implanted, intravascular infusion port and catheter.",General Hospital,General Hospital,510(k),"B. Braun Celsite¶_ Venous Access Ports , Distributed by Aesculpa Inc.Model ST301, ST305V, ST301G, ST501G and ST315Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315",B.Braun Celsite ,2,"June 27, 2011", 2011,B. Braun Interventional Systems,The affected products contain the incorrect winged Surecan¶_ needle accessory component in certain Celsite¶_ Access Port package configurations. The winged Surecan¶_ needle is used to deliver medications and fluids into implanted Celsite¶_ Access Ports.Two winged Surecan¶_ needle sizes are provided in Celsite¶_ U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle,DESIGN: Process Design,"B.Braun Interventional Systems Inc, (BIS) sent a ""Urgent Medical Device Recall"" letter on April 16, 2011 to all affected customers.The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite¶_ Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite¶_ Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist.For additional information contact 800 523-9676 x4459.",Contact the recalling firm for information,83,83,"NY, ND, OK ,PA",Terminated,"July 06, 2012",375,83,Not_Computer,N/A,N/A,N/A
Z-2664-2011,58884,"catheter, electrode recording, or probe, electrode recording",DRF,Electrode recording catheter or electrode recording probe.,Cardiovascular,Cardiovascular,510(k),"ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #D7R20P14CTThe affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.","ISMUS CATH Mapping Catheter with Auto ID Technology,",2,"June 27, 2011", 2011,"Biosense Webster, Inc.","The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.",DESIGN: Software Design,"Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter.Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.",N/A,429,429 units (333 in US),"Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore",Terminated,"October 12, 2012",473,1531,Not_Computer,N/A,N/A,N/A
Z-2672-2011,58966,"bag, urine collection, leg, for external use, sterile",FAQ,Urine collector and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"RUSCH Urinary Drainage Bag, 2000 mlProduct Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.",RUSCH,2,"June 27, 2011", 2011,Teleflex Medical,Sterile integrity cannot be guaranteed.,OTHER/UNDETERMINED: Pending,"Teleflex Medical sent an "" URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions.*****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers.The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details.",N/A,14488,"14,488 eaches","Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.",Terminated,"April 05, 2013",648,14489,Not_Computer,N/A,N/A,N/A
Z-2673-2011,58878,"electrode measurement, blood-gases (pco2, po2) and blood ph",CHL,"Blood gases (PCO2, PO2) and blood pH test system.",Clinical Chemistry,Clinical Chemistry,510(k),"Instrumentation Laboratory GEM Premier 3500 Blood Gas AnalyzerPN 00026000000The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.",Instrumentation Laboratory GEM Premier 3500 analyzer,2,"June 27, 2011", 2011,Instrumentation Laboratory Co.,Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.,DESIGN: Software Design,"Instrumentation Laboratories sent a ""FIELD SAFETY NOTIFICATION"" letter dated April 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers.Included with the letter was an upgrade package containing Software V7.2.2 disk along with installation instructions. Also included with the upgrade kit was a Upgrade Tracking Form to be completed and returned via fax at 781-861-4207 or via e-mail at ra-usa@ilww.com.Customers with questions were directed to contact their local representative.",N/A,840,840 units,"Worldwide Distribution-- USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE , INDONESIA, ISRAEL, ITALY, JAPAN , KOREA, REPUBLIC OF CHINA, MALAYSIA, NETHERLANDS , PHILIPPINES, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, THAILAND ,TURKEY, and UNITED KINGDOM.",Terminated,"March 15, 2013",627,840,Software,Output/Calculation,Software update,Software Update
Z-2669-2011,58832,"device, incontinence, mechanical/hydraulic",EZY,Implanted mechanical/hydraulic urinary continence device.,Gastroenterology/Urology,Gastroenterology/Urology,N/A,"AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.",AMS 800 Urinary Control System Control Pump,2,"June 27, 2011", 2011,"American Medical Systems, Inc.","American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps.Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"American Medical System sent an ""URGENT MEDICAL DEVICE RECALL letter dated May 9, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customerCustomers were instructed to return any existing stock . Please contact American Medical System at 1 (800) 328-3881 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product.For further questions please contact American Medical Systems at 1- (800)328-3881.",Contact the recalling firm for information,15466,"15,466","Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BELGIUM NETHERLANDS, PERU, VENEZUELA, SRI LANKA, PORTUGAL, TUKEY, BRAZIL AUSTRALIA, CZECH REPUBLIC, TUNISIA. LUXWMBOURG, QATAR, SOLOMON ISLANDS, BOSNIA & HERZEGOVIA, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, ECUADOR, ESTONIA, FINLAND, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, POLND, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SLOVENIA, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM and URUGUAY.",Terminated,"July 06, 2012",375,15691,Not_Computer,N/A,N/A,N/A
Z-2685-2011,56408,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3,Beckman Coulter UniCel DxI 800 ,2,"June 28, 2011", 2011,Beckman Coulter Inc.,"Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type i",DESIGN: Software Design,"Beckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to:A revised version of UniCel DxI System Software that corrects this issue is currently in development. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default sample type setting. See the appendix included with this letter for additional information.Refer to the attached Questions and Answers document for additional details and instructions, and to determine if their laboratory is running UniCel DxI Sytem Software version 4.3. Customers may wish to confirm that proper ranges and units of measure are being reported for any Access assays with sample type settings that were changed while running software version 4.3.Customers were asked to share this information with their laboratory staff, and retain the notification as part of their laboratory Quality Ststem documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that consignees received the notification.If they need assistance or have any questions regarding this notification, customers were told to contact Technical Support at 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.",Contact the recalling firm for information,626,626 units,Nationwide in the US and to Canada,Terminated,"May 07, 2012",314,794,Software,Output/Calculation,Software update,Software Update
Z-2676-2011,58807,"tube, tracheostomy (w/wo connector)",BTO,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),"Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z a.N. GermanyAllows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.",Jet Ventilation Catheter (transtracheal),2,"June 28, 2011", 2011,VBM Medical Inc.,Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.,PRODUCTION CONTROLS: Error in Labeling,"VBM Medical Inc sent an ""URGENT FIELD SAFETY NOTICE"" dated May 9, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.The reference and lot numbers, details of the error, along with the incorrect and correct box label, and instructions to the customers to discard the box with the incorrect label or send the complete product back to VBM Medical Inc. for re-packaging. For any further or detailed questions, please contact VBM Medical Inc. at (317) 776-1800.On 7/12/11 upon receiving the recall classification letter, the firm sent out an additional letter to its direct accounts informing them of the recall's classification and reiterating the instructions listed above.",Contact the recalling firm for information,29,29,Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC,Terminated,"March 14, 2012",260,417,Not_Computer,N/A,N/A,N/A
Z-2692-2011,58560,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Software versionsEos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2.sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850.EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images.",EOS System,2,"June 28, 2011", 2011,Eos Imaging,"Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factorduring printing. T",DESIGN: Software Design,"EOS imaging sent a ""FIELD SAFETY NOTICE"" letter dated April 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to wait for the printing queue to empty before sending a second ""print true queue"" request with different print settings. Customers should then click the button shown on the instruction sheet to view the print queue.EOS imaging will provide a software update to correct all affected systems at no cost to the customers. An EOS representative will contact customers to schedule a time to upgrade the software.Questions can be answered by calling 33 1 55 25 63 90.",N/A,15,"5 EOS Systems, 10 sterEOS workstations","Worldwide Distribution--USA (nationwide) including the states of CA, IA, MO, VA, and WI, and countries of Canada and Europe.",Terminated,"January 18, 2012",204,15,Software,Output/Calculation,Software update,Software Update
Z-2677-2011,59005,"culture media, antimicrobial susceptibility test, excluding mueller hinton agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS.The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain.",Remel Spectra MRSA,2,"June 28, 2011", 2011,Remel Inc,The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA),PRODUCTION CONTROLS: Process Control,"Remel, Inc. sent an ""IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE"" letter, dated May 10, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to review their inventory and discard all remaining product lots. Additionally, customers are to complete the Product Inventory Checklist and indicate whether or not they desire replacement of the product or credit. A self-addressed , stamped envelope was enclosed in the letter to use to return the checklist. Questions can be answered by contacting the Technical Services Department at 800-255-6730 or 913-888-0939.",N/A,558,187/10-packs and 261/100-packs,Nationwide Distribution--including Puerto Rico.,Terminated,"June 18, 2013",721,448,Not_Computer,N/A,N/A,N/A
Z-2693-2011,58975,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),THD155428- 15.5F X 28cm Titan HD(TM) Catheter KitProduct Usage: Hemodialysis catheter insertion kit,Titan Hemodialysis Catheter,2,"June 28, 2011", 2011,"Medical Components, Inc dba MedComp",Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Medcomp sent a ""PRODUCT ALERT"" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.",Contact the recalling firm for information,90,90,"Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands",Open,N/A,N/A,90,Not_Computer,N/A,N/A,N/A
Z-2687-2011,59019,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"The product is the ""FASTx Sternal Intraosseous Device"".The expiration date for the recalled products is end of June, 2012.The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.",FASTx Sternal Intraosseous Device,2,"June 28, 2011", 2011,Pyng Medical Corporation,Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects.,OTHER/UNDETERMINED: Pending,"Pyng Medical Corp. sent a ""FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H"" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx. Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.",N/A,402,402 devices,"Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.",Terminated,"August 10, 2011",43,402,Not_Computer,N/A,N/A,N/A
Z-2680-2011,58532,"monitor, blood-gas, on-line, cardiopulmonary bypass",DRY,Cardiopulmonary bypass on-line blood gas monitor.,Cardiovascular,Cardiovascular,510(k),"Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV.",CDI 500 ,2,"June 28, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K",DESIGN: Device Design,"Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.",N/A,4267,3767 all CDI 500 models,"Worldwide distribution, including USA, Australia, Barbados, BELGIUM, BRAZIL, CANADA, Chile, Colombia, Costa Rica, Dominican Republic, ECUADOR, El Salvador, France, Germany, Guatemala, Holland, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Korea, Libya, MALAYSIA, MEXICO, PAKISTAN, PANAMA, Paraguay, Saudi Arabia, SINGAPORE, South Africa, Spain, TAIWAN, THAILAND, The Phillipines, TRINIDAD, UNITED ARAB EMIRATES, Uruguay, Venezuela and Vietnam.",Terminated,"August 06, 2012",405,6082,Not_Computer,N/A,N/A,N/A
Z-2690-2011,58444,"coagulator-cutter, endoscopic, unipolar (and accessories)",KNF,Unipolar endoscopic coagulator-cutter and accessories.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.",LiNA Loop,2,"June 28, 2011", 2011,LINA Medical ApS,Potential for the LiNA Loop to break during operating procedure.,DESIGN: Labeling Design,Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.,N/A,1950,"1,950 pieces","GA, MN, PA, WA, TN, MA, IN, Ontario Canada",Terminated,"February 23, 2012",240,2720,Not_Computer,N/A,N/A,N/A
Z-2674-2011,58909,"separator, automated, blood cell and plasma, therapeutic",LKN,N/A,N/A,Gastroenterology/Urology,510(k),"Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215.The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.", Spectra Optia Apheresis System,2,"June 28, 2011", 2011,"Caridian BCT, Incorporated",An additional air detection system is being added to all existing systems to detect air in the system's return line.,DESIGN: Software Design,"CaridianBCT sent a ""MEDICAL DEVICE RECALL"" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers.Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months.Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.",N/A,594,594 units,"Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.",Terminated,"September 12, 2011",76,594,Software,N/A,N/A,N/A
Z-2691-2011,59039,"ligator, esophageal",MND,Hemorrhoidal ligator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook MedicalProduct Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.",WilsonCook Endoscopic Clipping Device,2,"June 28, 2011", 2011,Cook Endoscopy,The disposable clip may not deploy after being positioned inside the patient.,DESIGN: Device Design,"Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an ""URGENT: PRODUCT RECALL"" notice dated June 7, 2011 and a ""PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at CustomerRelationsNA@cookmedical.com .",N/A,307,307 units,"(USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.",Terminated,"May 15, 2012",322,307,Not_Computer,N/A,N/A,N/A
Z-2703-2011,58936,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"""***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***""The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.",CrossFT Suture Anchor with Two 2 HiFi Sutures,2,"June 29, 2011", 2011,Linvatec Corp. dba ConMed Linvatec,"ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black).",DESIGN: Device Design,"ConMed Linvatec sent an ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product.Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.",Contact the recalling firm for information,45,45 each,Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.,Terminated,"July 18, 2011",19,45,Not_Computer,N/A,N/A,N/A
Z-2708-2011,58913,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Solution Set for Epidural Use, 110"" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554sThe tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours.",Baxter Solution Set for Epidural Use,2,"June 29, 2011", 2011,Baxter Healthcare Corp.,"The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.",TRAINING: Employee Error,"Baxter Healthcare sent Urgent Product Recall letters dated May 31, 2011, via UPS overnight delivery to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/31/11, and instructed to notify their customers and ministries of health of the recall. *** The recall was expanded to include two additional lots of product code 2C7554s on July 11, 2011 via letter of the same date. The recall strategy remains the same as that of May 31, 2011. ***.",N/A,13920,"13,920 units","Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa.",Terminated,"June 18, 2012",355,13920,Not_Computer,N/A,N/A,N/A
Z-2698-2011,58702,"prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer",HRY,Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,N/A,"Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138)This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.",Oxford Femoral Knee System,2,"June 29, 2011", 2011,"Biomet U.K., Ltd.","This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.",PRODUCTION CONTROLS: Packaging,"Biomet sent a ""FIELD SAFETY NOTICE"" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor. Customers were also instructed to complete and return the attached ""Fax Back Response Form"" to their local Biomet distributor.For questions customers should contact their local Biomet Contact.",Contact the recalling firm for information,12,12 devices,"Outside the US to Austria, Belgium, and Germany",Terminated,"August 03, 2011",35,12,Not_Computer,N/A,N/A,N/A
Z-2701-2011,58145,intracranial neurovascular stent,NJE,N/A,N/A,Neurology,HDE - Humanitarian Device Exemption,CODMAN ENTERPRISE¶_ Vascular Reconstruction Device and Delivery System 4.5mm x 28mmProduct code: ENF452812,Codman,2,"June 29, 2011", 2011,"Codman & Shurtleff, Inc.","Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.",DESIGN: Labeling Design,"Codman & Shurtleff, Inc.sent an ""Urgent Medical Device Correction Notice"" on March 21, 2011.The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman.Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative.",No consumer action necessary,380,380 units,"Worldwide - Nationwide (USA), Canada, Korea.",Open,N/A,N/A,380,Not_Computer,N/A,N/A,N/A
Z-2705-2011,58376,"instrument, surgical, non-powered",HAO,Nonpowered neurosurgical instrument.,Neurology,Neurology,510(K) Exempt,"Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to apply final torque to closure tops of the implant.The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal.",Sequoia final driver closure top retention,2,"June 29, 2011", 2011,Zimmer Inc.,"A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.",DESIGN: Device Design,"The firm, ZIMMER, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated April 4, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that each instrument tray had both final drivers (with and without retention feature); contact their customer service representative if they do not have both versions; ensure proper seating of the drive by moving the driver side to side, and complete and return the Distributor Certification Form via fax to: Zimmer Spine at 512-258-0995. The letter states the firm will be distributing the version of the screwdriver with no retention feature beginning in March 2011 and distributing the new surgical technique in April 2011. The firm is including an additional final driver in the instrument tray for final tightening of the closure tops. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.",Contact the recalling firm for information,505,505 devices,"Worldwide distribution: USA (nationwide) including the states of: AL, AZ, CA, CT, CO, FL, GA, LA, MI, MN, MO, NC, NY, OH, OK, PA, TN, TX, WA and WI; and countries of: Czech Republic, Denmark, France, Singapore, Spain, Switzerland, and United Kingdom.",Terminated,"August 28, 2013",791,505,Not_Computer,N/A,N/A,N/A
Z-2707-2011,58576,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-CProduct Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.",Intravascular Administration Set and Extension Set,2,"June 29, 2011", 2011,"Carefusion 303, Inc.",Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.,DESIGN: Device Design,"CareFusion initiated on May 3, 2011, two distinctive ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned.2.) All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods number through their distributor or CareFusion. 3.) Also, enclosed is a Frequently Asked Question (FAQ) Letter to address any questions or concerns related to the use of the MaxPlus"" bifuse extension sets.The second notification was specifically addressed to distributors. The distributors were provided specific instructions for product returned. For customers who may have questions, please contact your distributor directly, or call the CareFusion Support Center at 1-800- 562-6018. The Support Center will be in operation from 7 a.m. - 4 p.m. PST. For distributors who may have any questions or require additional materials, please contact the CareFusion Support Center at 1800- 562-6018. Additionally, instructions were given to report adverse reactions experienced via the FDA's Med Watch Program.",N/A,26150,"26,150 units","Nationwide Distribution -- USA including states of: CA, IA, IN, and TX",Terminated,"November 28, 2011",152,26150,Not_Computer,N/A,N/A,N/A
Z-2706-2011,59028,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,N/A,Brand NameSTAAR Surgical Collamer¶_ Ultraviolet-Absorbing Posterior Chamber SinglePiece Foldable Intraocular LensCommon NamesCollamer single piece IOLCollamer plate haptic IOLThe Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).,STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single,2,"June 29, 2011", 2011,Staar Surgical Co.,"The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), alsoknown as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could beimplanted in the ciliary sulcus.",OTHER/UNDETERMINED: Pending,"Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.",N/A,16750,"16,750 devices distributed to the field","Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka",Open,N/A,N/A,16750,Not_Computer,N/A,N/A,N/A
Z-2697-2011,58592,tube tracheostomy and tube cuff,JOH,Tracheostomy tube and tube cuff.,Anesthesiology,Anesthesiology,510(k),RUSCH Percutwist Set with Crystal Clear SterileCrystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway.,RUSCH Percutwist Set with Crystal Clear Sterile,2,"June 29, 2011", 2011,Teleflex Medical,"Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.",OTHER/UNDETERMINED: Pending,"Teleflex Medical sent an URGENT FIELD SAFETY NOTICE dated January 4, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for product, cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately. Customers were instructed to complete the field safety corrective action acknowledgement and stock status form and fax to their local Teleflex Medical Customer Service Sales Rep.If the customers did have stock from the affected lot number, they were to contact their local Teleflex Medical Customer Service/Sales Rep or distributor as indicated on the attached field safety corrective action acknowledgement and stock status form for a Return Autorization Number.Distributors were to communicate the field safety corrective action notice to their customers and forward the completed Acknoweldgement Form to orders.intl@teleflexmedical.com or fax to +353 1 437 0773.For questions regarding this recall call +353 906 460 838.",N/A,1.0,see line 1.,"Worldwide Distribution - Arabia, Asia, Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Ireland, Italy, Spain, Saudi Kuwait, Portugal, Russia Federation, Sweden, Slovenia and South America.",Terminated,"March 02, 2012",247,1.0,Not_Computer,N/A,N/A,N/A
Z-2704-2011,58857,"mask, oxygen",BYG,Oxygen mask.,Anesthesiology,Anesthesiology,510(K) Exempt,"Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USAThe kit contains oxygen masks and blood pressure cuffs use on pediatric patients",Broselow/Hinkle Pediatric Emergency System,2,"June 29, 2011", 2011,"Vital Signs Devices, a GE Healthcare Company",Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.,OTHER/UNDETERMINED: Pending,"GE issued an URGENT MEDICAL DEVICE CORRECTION letter dated April 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the affected product, isolate all affected product, complete the attached confirmation form and fax back per the instructions and return any unused product.For any product forwarded to any other healthcare institution, customers were instructed to forward a copy of the URGENT MEDICAL DEVICE CORRECTION letter to those institutions. For any questions contact Vital Signs Customer Service at 1-800-932-0760.",N/A,33002,"33,002 units",IL,Terminated,"January 14, 2013",565,33002,Not_Computer,N/A,N/A,N/A
Z-2700-2011,58810,"catheter,intravascular,therapeutic,long-term greater than 30 days",LJS,"Percutaneous, implanted, long-term intravascular catheter.",General Hospital,General Hospital,510(k),"LIFECATH S PICC with Microflash IntroducerCatheter, Percutaneous, IntravascularProduct Code 2296.214Product Usage: Intravascular catheter",VYGON LIFECATH S PICC,2,"June 29, 2011", 2011,Vygon Corporation,"Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.",OTHER/UNDETERMINED: Pending,"Vygon Corporation sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed.If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at customerservice@yygonus.com.",N/A,600,600 individual units,"Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.",Terminated,"June 01, 2012",338,1170,Not_Computer,N/A,N/A,N/A
Z-2702-2011,58836,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Radiation Treatment Planning System, model H48;Varian Medical Systems Inc..",Eclipse Radiation Treatment Planning System,2,"June 29, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.",DESIGN: Software Design,"Varian Medical Systems, Inc. Oncology Systems sent a ""Urgent Medical Device Correction"" letters on May 3, 2011***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc. at 888- 827-4265.",N/A,5201,5201 units ***12-12-12 AMENDED TO: 5448 units***,"Worldwide distribution; Nationwide (USA) and the countries of Vietnam, Venezuela, United Kingdom, United Arab Emirates, Ukraine, Turkey, Tunisia, Trinidad and Tobago, Thailand, Taiwan, Syria, Switzerland, Sweden, Sri Lanka, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russia, Romania, Qatar, Portugal. Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Malaysia, Macau, Lithuania, Libya, Latvia, Kuwait, Kazakjstan, Japan, Italy, Israel, Ireland, Iraq, Indonesia, India, Hungary, Hong Kong,, Guam, Greece, Germany, France, Finland, Egypt, Ecuador, Denmark, Czech Republic, Colombia, China, Canada, Brazil, Belgium, Belarus, Bangladesh, Bahrain, Austria, Australia, Argentenia, Algeria and Canada.",Open,N/A,N/A,5201,Software,Treatment/Delivery/Therapy,Instructions/Software Update,Software Update
Z-2694-2011,58912,"system, communication, powered",ILQ,Powered communication system.,Physical Medicine,Physical Medicine,510(K) Exempt,"Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices.Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.",Tobii CSeries Lithium Batteries ,2,"June 29, 2011", 2011,"Tobii Assistive Technology, Inc.",Lithium Batteries may overheat and become combustible,PRODUCTION CONTROLS: Environmental Control,"Tobii Technology AB sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.Customers were advised to stop using the batteries and to remove them from their devices. They were instructed to dispose of the batteries in an environmentally responsible manner as hazardous materials. Tobii will replace the affected batteries. Customers were asked to complete and return an acknowledgement form via fax at 781-461-8213 or e-mail at recall@tobiiati.com.Contact the firm by E-mail: recall@tobiiati.com or telephone: 1-800-793-9227.",Contact the recalling firm for information,2430,2430 units,USA (nationwide),Terminated,"October 01, 2012",460,2430,Battery,Physical Safety Hazards,Replace,Remove or Replace
Z-2711-2011,58809,"replacement, ossicular prosthesis, total",ETA,Total ossicular replacement prosthesis.,Ear Nose & Throat,Ear Nose & Throat,510(k),"Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06.Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.","Total Ossicular Replacement Prosthesis, CliP Piston MVP",2,"June 30, 2011", 2011,Heinz Kurz GmbH Medizintechnik,Outer package labels product .75 mm longer than actual size.,MISBRANDING: Labeling False and Misleading,"Kurz Medical, Inc. sent an ""URGENT VOLUNTARY MEDICAL DEVICE RECALL"" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.",Contact the recalling firm for information,40,"32, only 8 consigned with U. S. hospitals","Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.",Terminated,"November 23, 2011",146,40,Not_Computer,N/A,N/A,N/A
Z-2709-2011,59043,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: "" Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. "" Avascular necrosis of the femoral head. "" Acute traumatic fracture of the femoral head or neck. "" Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. "" Dislocation risks.",Versafitcup Double Mobility Liner Inserter,2,"June 30, 2011", 2011,Medacta Usa Inc,"Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washingprocedures. This is due to an incorrect raw material used by one of our suppliers during theproduction phase of this lot. For this reason, Medacta International has made the decision toremove all the pieces",MISBRANDING: Labeling False and Misleading,"Medacta USA sent an ""URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER"" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days.Questions regarding this recall are directed to the Director of Regulatory and Quality at 805-437-7085 ext. 26.",Contact the recalling firm for information,18,Worldwide: 18 pieces. In the USA: 9 pieces,"Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.",Terminated,"July 12, 2011",12,18,Not_Computer,N/A,N/A,N/A
Z-2713-2011,58544,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal.The instrument is used to insert the shoulder implant into the shoulder.",Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control,2,"June 30, 2011", 2011,"Biomet, Inc.","When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Biomet Orthopedics, sent two ""URGENT MEDICAL DEVICE RECALL NOTICE"" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed ""FAX Back Response Form""; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756.Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.",N/A,469,469 both products,"Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.",Terminated,"April 08, 2013",648,469,Not_Computer,N/A,N/A,N/A
Z-2715-2011,59174,"filter, infusion line",FPB,Intravascular administration set.,General Hospital,General Hospital,510(k),"Pall Total Nutrient Admixture Filter, 1.2 micron filterThis filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.","Pall ""TNA1"" Total Nutrient Admixture Filter",2,"June 30, 2011", 2011,Pall Life Sciences Puerto Rico Llc,Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Pall Life Sciences LLC, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated June 15, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers.The letter instructed customers to maintain the product in quarantine. If distributed, the letter request that customers notify the user to discontinue use. Additionally, customers were asked to complete and return an attached Recall Response Form. The letter also included instructions on how to return the product.Please contact the Customer Service Department at 516-801-9923, if you have questions.",N/A,15575,"15,575 units","Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.",Terminated,"January 10, 2013",560,15575,Not_Computer,N/A,N/A,N/A
Z-2714-2011,56848,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008.SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).",SoftReports versions 1.1.6.x and 1.1.7.x ,2,"June 30, 2011", 2011,SCC Soft Computer,"SCC Soft Computer is issuing a correction for SoftReports Versions 1.1.6.x released 02/2008 and 1.1.7.x released 06/2008. Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.",DESIGN: Software Design,"SCC Soft Computers sent a ""RISK TO HEALTH NOTIFICATION TASK"" letter dated June 9, 2010 to affected customers. The letter identified the product, problem, and actions to be taken by the customers.Customers were offered an upgrade or hot fix. The letter requested acknowledgement of receipt of the task notification and permission to install the hot fix.",N/A,49,49,Worldwide Distribution--USA (nationwide) and the country of Canada.,Terminated,"July 26, 2012",392,49,Software,Display/Image,Software update,Software Update
Z-2710-2011,58695,"system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy",MEQ,N/A,N/A,Gastroenterology/Urology,N/A,"The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447.UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447.CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447.CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447.Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447.The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.","Urologix Targis System, Coolant Bag",2,"June 30, 2011", 2011,"Urologix, Inc.","Urologix is recalling certain lots of Targis¶_ System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus¶_ balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sensor Module. This leak is detectabl",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Urologix, Inc. sent an ""IMPORTANT RECALL INFORMATION"" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443.Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.",Contact the recalling firm for information,119,119,"Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.",Terminated,"April 26, 2012",301,119,Not_Computer,N/A,N/A,N/A
Z-2721-2011,58971,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.",Cardiopulmonary bypass temperature controllers,2,"July 01, 2011", 2011,Cincinnati Sub-Zero Products Inc,"The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.",DESIGN: Component Design/Selection,"Cincinnati Sub-Zero Products Inc issued an ""Urgeant Medical Device Field Action"" letter on May 2, 2011 to all affected customers.The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form.For additional contact the firm at 1-800-989-7373 or (513) 772-8810.",N/A,256,212 units - U. S. distribution & 44 units foreign distribution,"Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.",Terminated,"March 07, 2013",615,372,Not_Computer,N/A,N/A,N/A
Z-2719-2011,58465,"passer, wire, orthopedic",HXI,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.",PERPOS PLS SYSTEM,2,"July 01, 2011", 2011,Interventional Spine Inc,This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position.Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance.For further questions, please call (949) 472-0006.",N/A,864,864 units total for all products,"Nationwide Distribution including the states of to NC, NY, TN & VA",Terminated,"February 14, 2013",594,864,Not_Computer,N/A,N/A,N/A
Z-2717-2011,58855,"immunohistochemistry antibody assay, estrogen receptor",MYA,Immunohistochemistry reagents and kits.,Hematology,Pathology,N/A,"iView DAB Detection Kit, Part number: 760-091(05266157001)This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.",iView DAB Detection Kit,2,"July 01, 2011", 2011,Ventana Medical Systems Inc,"The recall was initiated because Ventana Medical Systems, Inc. (Ventana), hasidentified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraViewUniversal DAB Detection Kit (part number 760-500, lot A05885 and lot B00988) and one lot of iViewDAB Detection Kit (part number 760-091, lot B01057A.)",N/A,"The firm, Ventana, sent two letters dated May 16, 2011, an ""URGENT Medical Device Recall"" notice to customers who received the affected lots and an ""URGENT Medical Device Correction"" to customers of unaffected lots. The letters described the product, problem and actions to be taken. The customers were instructed to discontinue use of any kits from the lots identified above; follow their internal standard operating procedures for assessing potential impact to reported patient results, If their laboratory had already used kits from these lots; conduct visual inspections of any DAB chromogen dispensers in use as part of their daily maintenance routine; inspect their current inventory and contact their local customer support team (800-227-2155) to replace any unused or partially used kits from the affected lots.Ventana highly recommends use of same-slide controls, especially when testing for targets of therapy, to mitigate any impact on patient results.If you find a dispenser containing precipitate in lots not identified in this letter or have any questions and concerns, please notify/contact your local customer support team (800-227-2155) .",Contact the recalling firm for information,25,25 units,"Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.",Terminated,"February 10, 2012",224,4015,Not_Computer,N/A,N/A,N/A
Z-2732-2011,58733,"saw, powered, and accessories",HAB,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"DYONICS POWER Shaver Blades,4.5mm Long Full Radius, package of 3Catalog Number: 7205341Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.",Smith & Nephew,2,"July 01, 2011", 2011,"Smith & Nephew, Inc. Endoscopy Division","Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Smith & Nephew notified customers by an ""URGENT - PRODUCT RECALL 1st NOTIFICATION"" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.",N/A,555,555 units,"Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.",Terminated,"May 09, 2012",313,1299,Not_Computer,N/A,N/A,N/A
Z-2734-2011,58678,broach,HTQ,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Foundation Knee System Instrumentation, Tibial Broach Assembly.Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.","Foundation Knee System Instrumentation,Tibial Broach",2,"July 05, 2011", 2011,"Encore Medical, Lp",Strike plate may dislodge from the broach stem handle during impaction of the device.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Encore Medical, Lp (d.b.a. DJO Global) sent out a ""Urgent Field Safety Notice"" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well. The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a ""Field Safety Response Form"" to fill out and return. The firm also e-mailed the consignees as well. For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.",Contact the recalling firm for information,15,15 units,"Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.",Terminated,"April 06, 2012",276,15,Not_Computer,N/A,N/A,N/A
Z-2733-2011,58686,"recorder,event,implantable cardiac,(without arrhythmia detection)",MXC,Medical magnetic tape recorder.,Cardiovascular,Cardiovascular,510(k),"SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE).This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia","SJM Confirm, Implantable Cardiac Monitor (ICM) ",2,"July 05, 2011", 2011,St Jude Medical CRMD,The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"St. Jude Cardiac Rhythm Management Division sent an ""Important Product Correction"" letter on March 25, 2011 to all affected customers.The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a ""Physician Acknowledgement Form"".For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774.",N/A,83,83 units,"Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany",Terminated,"July 19, 2011",14,83,Software,Output/Calculation,Software update,Software Update
Z-2744-2011,58919,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cmCatalog Number:LA1101-12Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.",Cambridge Endoscopic Autonomy LaparoAngle 5mm Metzenbaum Scissors with Monopolar Cautery,2,"July 06, 2011", 2011,"Cambridge Endoscopic Devices, Incorporated",PET shrink sleeve insulation material dislodgingfrom the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors,PRODUCTION CONTROLS: Process Control,"Cambridge Endoscopic Devices, Inc. sent an ""IMPORTANT MEDICAL DEVICE RECALL"" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced.Questions regarding this recall, call 508-405-0790 for assistance.",N/A,255,255 units,"Worldwide Distribution--USA (nationwide) and the countries of Armenia , Australia, Austria, Chile, China, Denmark, Hong Kong, India, Ireland , Italy, Japan, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.",Terminated,"July 24, 2012",384,902,Not_Computer,N/A,N/A,N/A
Z-2751-2011,58525,"solvent, adhesive tape",KOX,Surgical skin degreaser or adhesive tape solvent.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label: ***smith&nephew;***#403100*** REMOVE Universal Adhesive Remover Wipes Gently removes tapes and adhesives Reduces risk of irritation and skin stripping Contains Aloe***1 wipe and 50 wipes*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: Dipropylene Glycol Methyl Ether, C10-11 Isoparaffin, Aloe Extract, Benzyl Alcohol, Fragrance. ------------------- Brand: Universal Adhesive Remover Wipes - Carton Label: ***smith& nephew Universal Adhesive Remover Wipes ***Quantity 20 Cartons of 50 Code #403100***. Product Usage: Adhesive removers gently clean all types of adhesive residue from the skin, including hydrocolloid-based, acrylic-based and ruber-based adhesives.",Adhesive Remover Wipe ,2,"July 06, 2011", 2011,Smith & Nephew Inc.,"Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO-STING SKIN-PREP Protective Wipes. These products were manufactured by H&P; Industries dba The Triad Group who has initiated a recall of products manufactured i",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Smith & Nephew Inc. sent an ""URGENT DEVICE CORRECTION"" letter dated April 8, 2011 to all customers who received the recalled products. The letter described the product, problem and the appropriate actions to be taken. Customers are instructed to immediately discontinue using the recalled products, examine their inventory, and follow the return or disposition instructions provided. The letter instructed customers to seek an alternative product for use. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271.",Contact the recalling firm for information,50,"118,896 boxes of 50 count","Worldwide Distribution -- USA (nationwide) including the states of: NC, PA, NM, OR, VA, TN, NY, OR, AL, IL, MN, TX, and Puerto Rico and the countries of: Australia, Canada, England, France, Germany, Hong Kong, Japan, Mexico, New Zealand, Singapore, South Africa, Taiwan, and United Kingdom",Terminated,"July 18, 2011",12,408316,Not_Computer,N/A,N/A,N/A
Z-2747-2011,58845,"system, peritoneal, automatic delivery",FKX,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560",Quinton BETACAP Adapter,2,"July 06, 2011", 2011,Baxter Healthcare Renal Div,A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"Baxter sent an URGENT PRODUCT RECALL letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter described the problem of loose connections when using the Quinton BETA-CAP with Baxter transfer sets. Baxter requested the dialysis centers to contact their patients currently using a Quinton BETA-CAP adapter to schedule an office visit with their attending physician as soon as practical tohave the connection inspected or replaced. If they choose to continue use of the Quinton BETA-CAP adapter, Baxter recommends the clinician exercise extra caution and vigilance to ensure the connection between the Quinton BETA-CAP adapter and the Baxter Transfer Set is secured and tight. The clinicians were instructed to also check their inventory for the Quinton Beta Cap adapter 8814-661001 purchased directly from Baxter, and contact Baxter at 888-229-0001 to arrange for the return and credit of the unused product. Baxter recommends that the Covidien BETA CAP adapter no longer be used and to instead exclusively use the Baxter Titanium Adapter (5C4129) which has sufficient thread geometry for maintaining a secure connection with the Baxter Transfer Set. The customers were also instructed to complete and fax the enclosed customer reply form to (847) 270-5457, indicating the quantity of Quinton Beta Cap adapters being returned and acknowledging the understanding and dissemination of the information in the letter.",Contact the recalling firm for information,13942,"13,942 units",Class II Recall -- Nationwide Distribution,Terminated,"May 21, 2012",320,13942,Not_Computer,N/A,N/A,N/A
Z-2741-2011,58655,"lift, patient, ac-powered",FNG,AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight capacity.The recalled product is an electrically-powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another.",JASMINE Full Body (Patient) Lift,2,"July 06, 2011", 2011,Invacare Corporation,"Component Defect. The rear mast connector on certain patient lifts distributed by the firm, may break. Failure of the rear mast connector, while in use would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider.",OTHER/UNDETERMINED: Pending,"INVACARE contacted their customers via telephone on 4/8/2011 and 4/11/2011, and informed them of this recall. During these telephone conversations, the customers were asked to immediately cease use of the JASMINE patient lifts and to quarantine all product on-site until further notice from Invacare. The firm followed up on the telephone recall notification with a recall letter dated: April 18, 2011. The recall letter was sent via registered mail or Federal Express so as to verify customer's receipt of the recall notification. The recall letter refers the customer/care provider back to the telephone conversations. and notifies the customer of the possibility of failure of the rear mast connector which could result in a patient's possibly being dropped from the patient lift. The letter asks that the customer remove the suspect patient lift(s) from service and quarantine the device in order to prevent further use until such time as an Invacare Rep. contacts the customer by telephone and makes arrangements to pick-up the affect product. The letter is accompanied by a Response Form and a Product Tracking Sheet which lists all of the JASMINE devices shipped to the customer's facility. The customer is asked to complete the attached Response Form and to fax the form back to Invacare at the telephone number provided on the bottom of the form. The signed Response Form provides information to Invacare documenting the customers receipt of the form and understanding of the instructions contained therein, and also; the number of affected devices remaining on-hand at the customer's location, and the number of devices further distributed by the customer. In those instances in which the products have been further distributed, the customer is asked to 'carry out the instructions of the recalling firm and extend the recall to their sub-account customers.",N/A,274,274 units,"Worldwide Distribution - USA including DC, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, RI, SC, TN, VA, WA, and WI and the countries of Canada, Ireland, United Kingdom, Norway, Austria, Germany, and Australia.",Terminated,"February 28, 2013",603,274,Not_Computer,N/A,N/A,N/A
Z-2723-2011,58536,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, INProduct Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.",Pathfinder NXT Closure Top Driver Short,2,"July 06, 2011", 2011,Zimmer Inc.,"Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and final locking of Closure Tops during the screw and rod construct assembly of the Pathfinder NXT Pedicle Screw System.When the hex tip of the Closure Top Driver is",DESIGN: Device Design,"Zimmer, Inc. issued an ""URGENT MEDICAL DEVICE RECALL"" letters dated April 2011, to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed that (THE GOLD CLOSURE TOP DRIVERS 3566-1 and 3566-2 ARE NOT TO BE USED FOR FINAL TIGHTENING); an alternate instrument for final construct tightening will be included in the instrument set 3570-1 short and 3570-2 long (These instruments are silver instead of gold for easy identification and do not include a retention feature for holding the Closure Top); to ensure final drivers are added to each PathFinder NXT set and inspect Closure Top Drivers for rounded hex wear; contact their customer service representative if they do not have both versions; and complete and return all attached forms via fax to: Zimmer Spine at 512-258-0995. The letter states that the firm will revise the surgical technique to show the updated uses of the screwdrivers. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.",N/A,135,135 devices,"Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.",Terminated,"October 07, 2011",93,269,Not_Computer,N/A,N/A,N/A
Z-2739-2011,58562,"prosthesis, shoulder, semi-constrained, metal/polymer cemented",KWS,Shoulder joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008.The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.",Reverse Shoulder Prosthesis System,2,"July 06, 2011", 2011,"Encore Medical, Lp",The device has the potential to not appropriately mate with the humeral stem.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"DJO Surgical sent an ""URGENT FIELD SAFETY NOTICE"" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers.The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA.Questions are directed to the Director of Commercial Logistics at 512-834-6330.",N/A,81,81 units,"Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.",Terminated,"January 25, 2012",203,81,Not_Computer,N/A,N/A,N/A
Z-2738-2011,58547,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Large Roller Pump 6"" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.",Terumo Advanced Perfusion System 1 ,2,"July 06, 2011", 2011,Terumo Cardiovascular Systems Corporation,"The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.",N/A,"Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated March 21, 2011. The letter identified the product, the problem and the action needed to be taken by the customer. An additional URGENT MEDICAL DEVICE RECALL correction notification and cover letter was sent to all consignees on XX/XX/XX to explain the reason for the expansion of the recall and will provide an update to the timing of implementation of the field correction.Expansion now includes devices manufactured between 2006 and March 2012.The correction strategy is to issue the customers a letter and addendum to the Operator's Manual that specifies what the user should do in the event of a tube clamp failure for any reason. The letter states that the firm is still investigating the issue and the correction. The letter states that in the coming months when a resolution is identified, consignees may be contacted to make arrangements for a upgrade to the system. There is no specific timeline for the correction to be made.If you have any further questions, please call a Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours Monday - Friday, 8 Am - 6 Pm EST.",N/A,111,111 devices.,"Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Jordan, Korea, Kuwait, Malaysia, Mexico, Pakistan, Republic of Georgia, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, The Phillipines, Turkey, United Arab Emirates and Vietnam.",Terminated,"August 28, 2013",784,3679,Not_Computer,N/A,N/A,N/A
Z-2745-2011,58908,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"HALO Ultra Ablation Catheter:Rx only; for use only with the Halo Flex Energy generator and accessories;Manufactured in the USA at B¶_RRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085.Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.",HALO90 ULTRA Ablation Catheter Model 909200,2,"July 06, 2011", 2011,"Barrx Medical, Inc.",Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.,DESIGN: Component Design/Selection,"BARRX Medical, Inc. sent a ""PRODUCT RECALL NOTIFICATION"" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. B¶_RRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The ""Steps for Voluntary Recall"" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to B¶_RRX Medical Customer Service at 888-662-2779.",N/A,936,936 devices,Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China,Terminated,"September 07, 2011",63,936,Not_Computer,N/A,N/A,N/A
Z-2746-2011,58907,"instrument, manual, surgical, general use",MDM,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210.This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.",Stryker Wire Caddy,2,"July 06, 2011", 2011,Stryker Instruments Division of Stryker Corporation,The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Stryker Instruments sent an ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter to all affected customers. The letter described the product, problem, and actions to be taken by the customers.The letter instructs customers to quarantine affected product and return the recalled product using the shipper supplied to them by Stryker. Replacements will be issued to customers upon receipt of the product.For questions regarding this recall please call 1-800-800-4236 ext. 3808.",No consumer action necessary,522,"87 boxes, 435 untis","Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.",Terminated,"August 03, 2011",28,435,Not_Computer,N/A,N/A,N/A
Z-2740-2011,58792,real time nucleic acid amplification system,OOI,Instrumentation for clinical multiplex test systems.,Clinical Chemistry,Clinical Chemistry,510(k),NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300In Vitro Diagnostic Test,NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1,2,"July 06, 2011", 2011,"bioMerieux, Inc.","The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.",DESIGN: Device Design,"BioMerieux Vitek, Inc. sent an ""Urgent Product Correction Notice"" letter on/about May 10, 2011.The letter included; a description of the product, problem, possible impact to the patient and recommendations. Recommendations included instructing customers to discontinue the use of the kit for the detection of Enterovirus 68 and Rhinovirus 87 serotypes and noted the corrected IFU will be available the first week of April 2011. An Acknowledgement form was attached to be returned via fax.For additional questions please contact your local BioMerieux Clinical Customer representative at (800) 682-2666, option 3, option 2.",Contact the recalling firm for information,42,42 kits,"(USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA",Terminated,"October 06, 2011",92,42,Not_Computer,N/A,N/A,N/A
Z-2742-2011,58847,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),TEG Hemostasis System Level II Control:Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 SeriesUsed as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System,TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit ,2,"July 06, 2011", 2011,Haemoscope Division of Haemonetics Corp,"Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).",OTHER/UNDETERMINED: Pending,"Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge.For additional information please contact Haemoscope at 847-588-0453, ext-217 .",Contact the recalling firm for information,568,568 kits,"Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines",Terminated,"September 25, 2012",447,568,Not_Computer,N/A,N/A,N/A
Z-2753-2011,59024,"marker, radiographic, implantable",NEU,Implantable clip.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile.It is intended to be used to radiographically (with X-Ray) mark the site of the ""gastropexy"" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.",Bariatric Target Ring (Nitinol) ,2,"July 07, 2011", 2011,Kapp Surgical Instrument Inc,During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Kapp Surgical Instrument, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical.Questions about this recall are directed to the QA Manager at 800-282-5277.","For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.",222,222 units (rings),"Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.",Terminated,"February 19, 2013",593,222,Not_Computer,N/A,N/A,N/A
Z-2758-2011,58335,endoscope and/or accessories,KOG,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.",JVAC Bulb Suction Reservoir,2,"July 07, 2011", 2011,"Ethicon, Inc.","There is a potential for the sterile barrier to be compromised in multiple lots of Blake silicone drains, Blake silicone drain kits, Blake cardio connectors, J-VAC reservoirs, J-VAC drain adaptors.",PRODUCTION CONTROLS: Packaging Process Control,"Ethicon, Inc. sent an ""URGENT VOLUNTARY PRODUCT RECALL"" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.Customers with questions regarding this recall are directed to call 1-866-664-1401.",N/A,846990,"846,990","Worldwide Distribution-- USA (nationwide) and Puerto Rico and the countries of Armenia, Australia, Austria, Azerbaijan, Columbia, Cyprus, Czech Republic, Denmark, French Guinea, French Polynesian, Germany,Israel, Italy, Japan, Kuwait , Netherlands, New Caledonia, New Zealand, Norway, Singapore, Slovenia, South Africa, Spain, Belarus, Belgium, Brazil, Canada, Chile, Dominica Republic, Egypt, Estonia, Finland, France, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Latvia, Lithuania, Malaysia, Martinique, Mozambique, Portugal, Reunion, Russia, Saudia Arabia, Sweden, Switzerland, Ukraine, and United Kingdom.",Terminated,"January 10, 2014",918,3389796,Not_Computer,N/A,N/A,N/A
Z-2730-2011,59110,"wire, orthodontic",DZC,Orthodontic appliance and accessories.,Dental,Dental,510(K) Exempt,"Stainless Steel, Natural, Lower, .018"": Arch Wires.Highland Metals, San Jose, CA 95125","Stainless Steel, Natural, Lower, .018"": Arch Wires",3,"July 07, 2011", 2011,Highland Metals,Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.,TRAINING: Employee Error,"Highland Metals sent out ""Highland Metals Advisory Notice Mislabeld Products Alert"" and ""Advisory Notice"" letters from January 11, 2008 to April 18, 2008 to all affected costumers.The letter included: product name and affected lots. It advised them of the mislabeling and instructed them to return the product for replacement.For additional information contact Highland Metals at (408) 271-2955.",N/A,40,40 packs of 100,"Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.",Terminated,"July 07, 2011",0,146,Not_Computer,N/A,N/A,N/A
Z-2755-2011,58850,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Elevate¶_ System with IntePro¶_ Lite"", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USAProduct Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair",Elevate Anterior and Apical Prolapse Repair Systems,2,"July 07, 2011", 2011,"American Medical Systems, Inc.","This is an important notification regarding the Elevate¶_ Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue.The complaint rate to-date for the affected product is 0.045%, however th",N/A,"American Medical Systems (AMS) sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated May 9, 2011 to all customers who received the recalled product. The letter identified the product, problem, and emphasize that the recalled product should not be implanted. The customers were instructed to examine their inventory for the recalled product and call AMS Customer Service at 1-800-328-3881 (select option 1) for an exchange of the product. For assistance in evaluating inventory the customers are instructed to contact their local AMS sales representative.",Contact the recalling firm for information,8563,8563,"Worldwide Distribution -- USA (nationwide) including DC and Puerto Rico and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, FRANCE, GERMANY, PORTUGAL SPAIN, UNITED KINGDOM, ARGENTINA, COLOMBIA, ESTONIA, FINLAND, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TAIWAN REPUBLIC OF CHINA, VENEZUELA",Terminated,"June 28, 2012",357,8563,Not_Computer,N/A,N/A,N/A
Z-2761-2011,55227,"radioimmunoassay, cortisol",CGR,Cortisol (hydrocortisone and hydroxycorticosterone) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Active Cortisol EIA, 96 Wells, DSL-10-2000The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.",Active Cortisol EIA,2,"July 08, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values.Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica",OTHER/UNDETERMINED: Pending,"Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970.Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below.Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification.Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.",N/A,1369,1369 Kits,Worldwide Distribution - USA (nationwide) and Canada.,Terminated,"April 27, 2012",294,1369,Not_Computer,N/A,N/A,N/A
Z-2764-2011,58976,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Clinac Linear Accelerator;Model numbers H14, H27 and H29.Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.",Varian High Energy Linear Accelerator,2,"July 08, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.",OTHER/UNDETERMINED: Pending,"Varian Medical Systems, Inc. Oncology Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letters on May 18, 2011, via certified mail, return receipt requested. The letter identified the product, problem and recommended actions to be taken. The letter states that customers will be contacted by Varian Service to arrange for replacement of the recalled product. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.",Contact the recalling firm for information,93,93,"Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.",Terminated,"March 13, 2012",249,93,Not_Computer,N/A,N/A,N/A
Z-2763-2011,58974,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARIA, versions 8.0 and 8.1;Varian Medical Systems, Palo Alto, CA.Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.",Image Database,2,"July 08, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the ""Convert to Setup Field"" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.",DESIGN: Software Design,"Varian Medical Systems, Inc. sent an ""URGENT MEDICAL DEVICE CORRECTION"" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***.",N/A,357,357,"Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan Jordan, Kuwait, Malaysia, Morocco, Netherlands, Oman, Pakistan, Panama, Portugal, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunsia, Turkey, Ukraine, United Arab Emirates, and United Kingdom,",Terminated,"March 15, 2012",251,357,Software,N/A,N/A,N/A
Z-2762-2011,58830,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"syngo Dynamics Picture Archiving Communication SystemThe software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.",syngo Dynamics 9.0,2,"July 08, 2011", 2011,"Siemens Medical Solutions, USA, Inc","For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.",DESIGN: Software Design,"Siemens Medical Solutions, USA, Inc sent a letter entitled ""Customer Safety Advisory Notice"" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.",N/A,38,38,Nationwide Distribution,Terminated,"July 09, 2012",367,38,Software,Output/Calculation,Software update,Software Update
Z-2765-2011,58566,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures","Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal XRay System ",2,"July 08, 2011", 2011,Philips Healthcare Inc.,"Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken",DESIGN: Device Design,"Philips Healthcare notified accounts by letter on April 18, 2011. The letter advised users of the problem and provided updated instructions for proper placement of the patient during the examination. An Updated Instruction For Use was provided.For further information and support customers were instructed to contact the Philips representative.",N/A,52,52 units,Nationwide Distribution,Terminated,"February 15, 2013",588,52,Not_Computer,N/A,N/A,N/A
Z-2766-2011,58994,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TrueBeam Linear Accelerators (aka Trilogy Mx)Varian Medical Systems, Palo Alto, CAProduct Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.",Trilogy Mx Radiotherapy Delivery System,2,"July 08, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.,DESIGN: Device Design,"Varian Medical Systems, Inc. Oncology Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.",Contact the recalling firm for information,77,77,"Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.",Terminated,"March 13, 2012",249,77,Not_Computer,N/A,N/A,N/A
Z-2768-2011,58981,"susceptibility test cards, antimicrobial",LTW,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228).VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.",VITEK 2 XL,2,"July 09, 2011", 2011,Biomerieux Inc,Cards may not load into the incubator correctly causing them to be loaded in the wrong order which could result in the results being linked to the wrong accession number and reporting results erroneously.,DESIGN: Device Design,"Biomerieux, Inc. sent an ""URGENT PRODUCT CORRECTION NOTICE"" dated June 2, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers.The letter explains how to recognize the issue and instructs customers to take certain steps to resolve the problem. Additionally, an Acknowledgement Form is attached to the letter for customers to complete and return via fax to 919-314-4539. A firmware update will be applied by Biomerieux, Inc. technical support representatives.Questions regarding this recall are directed to the Customer Service Department at 1-800-682-2666, option 3.",Contact the recalling firm for information,1107,"1,107 instruments","Worldwide Distribution-- USA (nationwide) and the countries of Austria, Australia, Belgium, Brazil, Canada, China, Colombia, Germany, France, India, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirate, and United Kingdom.",Terminated,"June 06, 2013",698,1734,Not_Computer,N/A,N/A,N/A
Z-2769-2011,58993,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument.The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit.It has a System Part Number: 989605392501, 989605396032, 989605395201.Tool Connection Unit Part Number: 453561426002, 453561443201The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2.PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.","PercuNav, Tool Connection Unit",2,"July 09, 2011", 2011,Philips Medical Systems North America Co. Phillips,"PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips Healthcare sent an ""MEDICAL DEVICE CORRECTION"" letter dated May 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The notification letter instructs customers to follow all directions in the Instructions for Use. A Philips Healthcare representative will schedule an appointment to replace the Tool Connection Unit at no charge to the customers.If further information is needed concerning this recall please call Philips Customer Service at 866-767-7822.",N/A,10,10 units (6 in US and 4 internationally). This was later changed to 7 US and 3 International) all serial codes remain the same,"Worldwide Distribution--USA (nationwide) including the states of CA, GA, OH, WA, and Washington DC, and the countries of Australia, India, Netherlands, and South Korea.",Terminated,"February 15, 2012",221,10,Not_Computer,N/A,N/A,N/A
Z-2781-2011,54621,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems.Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture Archiving and Communication System (PACS) for patient DICOM scans. The user can then transfer the identified scan to a Medtronic StealthStation system.","DICOM Query/Retrieve, version 1.1.4",2,"July 11, 2011", 2011,"Medtronic Navigation, Inc.",Software allows incorrect patient or patient history to be displayed.,DESIGN: Software Design,"Medtronic Navigation sent a ""FIELD SAFETY NOTICE"" letter dated June 2, 2011 to all affected customers. The letter identified the product, problem and description of the corrective action. The letter states that Medtronic field representatives will visit each consumer/user and upgrade the version of DICOM Q/R to 1.1.5. Further information is available by contacting Medtronic Navigation Technical Services at 1-800-595-9709.",N/A,90,90,"Worldwide distribution - USA (nationwide) -- including states of: TX, NC, ID, FL, OH, UT, CA, TN, IL, AZ, NE, LA, PA, OR, AR, MI, NJ, MD and countries of: Canada, Denmark, Finland, Great Britain, Hungary, Ireland, Japan, Korea, Netherlands, Poland, South Africa, Spain, and Taiwan.",Terminated,"July 12, 2011",1,90,Software,Display/Image,Software update,Software Update
Z-2782-2011,57012,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc.Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.","Site Rite Vision Ultrasound System,",2,"July 11, 2011", 2011,Bard Access Systems,Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.,PRODUCTION CONTROLS: Process Control,"Bard Access Systems, Inc sent out an ""Urgent"" Medical Device Recall (User Level)"" dated June 2011 to all affected customersThe letter included: product name, description of problem and requested the return of units bearing ""B50"" on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000.",Contact the recalling firm for information,86,86 units,"Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA.",Terminated,"July 11, 2012",366,86,Not_Computer,N/A,N/A,N/A
Z-2788-2011,59006,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System;Varian Medical Systems, Palo Alto, CARadiotherapy treatment for patients with malignant and benign diseases.",Eclipse Treatment Planning System,2,"July 11, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.,DESIGN: Software Design,"Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail dated May 20, 2011, to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product from use and advise users to manually initiate the configuration process for resampling to be applied when a previous calculation model is copied. Customers were asked to sign and return the notice to confirm receipt. For questions call USA and Canada 1-888-827-4265For Europe call +41 41 749 8844.",N/A,10356,"10,356",Worldwide Distribution - USA (nationwide),Terminated,"July 13, 2012",368,10356,Software,Output/Calculation,Remove,Remove or Replace
Z-2771-2011,55164,"radioassay, intrinsic factor blocking antibody",LIG,Vitamin B12test system.,Clinical Chemistry,Clinical Chemistry,510(k),"UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical SystemsThe Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements","UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems",2,"July 11, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited to numerical Intrinsic Factor Ab results produced on integrated systems running UniCel Dxl system software version 4.0, 4.1, or 4.2. The DxC portion of your inte",DESIGN: Software Design,"Beckman Coulter, Inc. sent out an ""Urgent: Product Corrective Action"" letter dated May 19, 2009 to all affected customers.The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response formFor additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.",N/A,5,5 units,Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.,Terminated,"May 07, 2012",301,5,Software,Output/Calculation,Software update,Software Update
Z-2783-2011,59115,"catheter,intravascular,therapeutic,long-term greater than 30 days",LJS,"Percutaneous, implanted, long-term intravascular catheter.",General Hospital,General Hospital,510(k),"Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.",Cuffed central venous catheter,2,"July 11, 2011", 2011,Bard Access Systems,Kit label indicates the wrong dimension for an enclosed introducer.,DESIGN: Labeling Design,"Bard Access Systems, Inc. notified customers by letter dated June 16, 2011. The letter notified customers of the mislabeling issue and offered a replacement product if desired. For additional information contact Bard Access Systems at 1-800-443-3393.",Contact the recalling firm for information,6485,"6,485 units","Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.",Terminated,"March 01, 2012",234,6485,Not_Computer,N/A,N/A,N/A
Z-2780-2011,58969,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34)Varian Medical Systems, Inc.Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.",Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34),2,"July 11, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.",DESIGN: Software Design,"Varian Medical Systems, Inc sent a ""Urgent Medical Device Correction Urgent Field Safety Notice"" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265).",N/A,10664,"10,097***12-12-12 AMENDED TO: 10664 units***",Worldwide distribution: Nationwide (USA) and the country of Canada.,Open,N/A,N/A,10664,Software,N/A,N/A,N/A
Z-2787-2011,58897,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Siemens YSIO - solid state x-ray imagerSolid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system",Siemens YSIO solid state xray imager,2,"July 11, 2011", 2011,"Siemens Medical Solutions USA, Inc","There is a potential hazard to staff or patients when lowering the table height on the Ysio system. If staff or patients lower extremities are placed underneath the table and the user lowers the table top, it is possible that parts of the table may collide with extremities and cause injuries.",OTHER/UNDETERMINED: Pending,"Siemens sent a Safety Advisory Notice to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to place the Safety Notice in the System's instruction for use. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner. Customers were instructed to complete the Acknowledgement of Receipt Form and return to the firm.",N/A,141,141,"Nationwide Distribution including Washington, DC and the following States: AR, CA, CO, FL, ID, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.",Open,N/A,N/A,141,Not_Computer,N/A,N/A,N/A
Z-2778-2011,58970,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.","Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear ",2,"July 11, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Some drive stand bolts may fail to meet mechanical specifications.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Varian Medical Systems, Inc sent a ""Urgent Medical Device Correction Urgent Field Safety Notice"" letter dated May 13, 2011 to all affected customers.The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary.For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265).",Contact the recalling firm for information,36,36,"Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom.",Terminated,"July 13, 2012",368,36,Not_Computer,N/A,N/A,N/A
Z-2789-2011,59055,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS.The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.,ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist,2,"July 11, 2011", 2011,"Siemens Medical Solutions USA, Inc",Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system,DESIGN: Software Design,"Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.",Contact the recalling firm for information,45,"45 customers with affected configuration in US, 37 customers ROW.","Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.",Terminated,"March 01, 2012",234,45,Software,Device Operation,Software update,Software Update
Z-2779-2011,59100,"screw, oral",KBW,"Ear, nose, and throat manual surgical instrument.",Ear Nose & Throat,Ear Nose & Throat,510(K) Exempt,"Labeled in part:""***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***"".Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.",2.0x7mm Fossa Xdrive screws,3,"July 11, 2011", 2011,"Biomet Microfixation, Inc.","Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm Fossa x-drive screws, 5 pack.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Biomet Microfixation, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated June 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to complete and return an Inventory Reconciliation form via fax to 904-741-9425. The form requests that customers indicate whether they want to keep the product or return for credit.Customers can contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400 ext. 468 for questions regarding this recall.",Contact the recalling firm for information,25,25 units,Product was distributed to one distributor in Argentina.,Terminated,"November 09, 2011",121,25,Not_Computer,N/A,N/A,N/A
Z-2776-2011,59135,"catheter, cannula and tubing, vascular, cardiopulmonary bypass",DWF,"Cardiopulmonary bypass vascular catheter, cannula, or tubing.",Cardiovascular,Cardiovascular,510(k),"Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9"", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.",Endopledge Sinus Catheter Kit,2,"July 11, 2011", 2011,"Edwards Lifesciences, LLC",Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.,PRODUCTION CONTROLS: Process Control,"Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at:Edwards Lifesciences12060 Lone Peak PkwyDraper, UT 84020Attention: Suzanne Carpenter, RGA #Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.",Contact the recalling firm for information,2798,2798 units,Nationwide Distribution.,Terminated,"June 01, 2012",326,2895,Not_Computer,N/A,N/A,N/A
Z-2786-2011,58885,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM SystemNuclear magnetic resonance imaging system","Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System",2,"July 11, 2011", 2011,"Siemens Medical Solutions USA, Inc",Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens initated their recall of the device on March 31, 2001, by sending a Customer Safety Advisory Notice/Letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer.Customers were notified that detectors will be installed in appropriate locations on the system, which will switch off the system's power electronics in the event of a malfunction in the power supply of the gradient coils, preventing damage to the system and its environment.",N/A,440,440,"Nationwide Distribution including AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Puerto Rico.",Terminated,"January 08, 2014",912,440,Not_Computer,N/A,N/A,N/A
Z-2775-2011,58720,"enzyme immunoassay, inhibin-a",NDR,Estradiol test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.,Manual Inhibin A ELISA Reagent Kit; Part Number DSL10281001,2,"July 11, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration.Erroneously elevated results may lead to unnecessary ultrasound testing to confirmgestational age, patient psychological stress until diagnostic testing is completed, and/ormedical decis",DESIGN: Process Design,"Beckman Coulter sent an ""Urgent Product Correction"" letter dated March 31, 2011 to all affected customers.The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return.For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulterrepresentative.",Contact the recalling firm for information,5521,5521 units total for all products,"Worldwide distribution: (USA) Nationwide and the countries of Armenia, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Peru, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.",Terminated,"July 11, 2012",366,5521,Not_Computer,N/A,N/A,N/A
Z-2770-2011,59003,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.",Langston Dual Lumen Catheters,2,"July 11, 2011", 2011,"Vascular Solutions, Inc.","Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264.Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal,posing a risk of product contamination. It is possible that a compromised sterile barrier",PRODUCTION CONTROLS: Packaging Process Control,"Vascular Solutions, Inc. sent an ""URGENT MEDICAL DEVICE FIELD ACTION- LOT SPECIFIC"" letter dated June 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructed customers to check their inventory for the affected product and provided information on how to examine the product. Customers are to complete and return a Field Action Customer Inventory Form via fax at 763-656-4250 or e-mail at www.vascularsolutions.com. VSI Customer Service will contact customers to set up return shipment of affected product. All affected product will be replaced upon receipt of the shipped product.Customers should contact their local Sales Representative for questions concerning this recall.",Contact the recalling firm for information,23,23 (5 pack) boxes,"Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, MA, MI, MO, NM, NC, OK, and WA and the countries of Austria and Canada.",Terminated,"April 05, 2012",269,23,Not_Computer,N/A,N/A,N/A
Z-2794-2011,59057,"blade, saw, general & plastic surgery, surgical",GFA,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLYFor Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.",STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE,2,"July 12, 2011", 2011,Stryker Instruments Division of Stryker Corporation,Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION"" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.",Contact the recalling firm for information,95,95 Units,"Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.",Terminated,"August 03, 2011",22,95,Not_Computer,N/A,N/A,N/A
Z-2790-2011,59035,"humidifier, respiratory gas, (direct patient interface)",BTT,Respiratory gas humidifier.,Anesthesiology,Anesthesiology,510(k),"HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709.Use to add water vapor to a dry medical gas for administration to a patient.","HUDSON RCI, Humidifier Adaptor",2,"July 12, 2011", 2011,Teleflex Medical,"The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.",PRODUCTION CONTROLS: Packaging,"Teleflex Medical sent an ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken.The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify receipt of the notification.Contact Customer Service at 1-866-246-6990 if you have questions regarding this recall. and a record of returns. A third letter was addressed to the Risk Manager with the above instructions.",Contact the recalling firm for information,960,"228, 960 eaches","Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MI, MN, MO, MS, NM, NE, NY, OH, OK, PA, TX, VA, WI and WM and the countries of Japan, Philippines, and Thailand.",Open,N/A,N/A,228960,Not_Computer,N/A,N/A,N/A
Z-2793-2011,58979,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.",Guidant RAPIDO CutAway Guiding Catheter,2,"July 12, 2011", 2011,Abbott Vascular,"Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.",PRODUCTION CONTROLS: Process Control,"Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager:-Help customer identify aflected product.- CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below.- Fax this completed form to (951) 914-3826.- Return a copy of this completed form with the returned product.",N/A,389,389 units total,"Nationwide distribution, and Ireland.",Terminated,"June 26, 2012",350,389,Not_Computer,N/A,N/A,N/A
Z-2795-2011,58824,"system and accessories, isolated heart, transport and preservation",MSB,Isolated kidney perfusion and transport system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.",Perfadex with THAM,2,"July 12, 2011", 2011,"Vitrolife, Inc.",Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.,PRODUCTION CONTROLS: Process Control,"XVIVO Perfusion, part of the Vitrolife Group, sent out a ""Partial recall of Perfadex with THAM"" letter on May 13, 2011 to all affected customers.Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO.For additional Information please call (303) 762-1933.",N/A,1457,1457 bottles,Worldwide distribution including USA and Europe.,Terminated,"July 15, 2011",3,1457,Not_Computer,N/A,N/A,N/A
Z-2799-2011,58768,"restoration, base metal",NSQ,N/A,N/A,Dental,Enforcement Discretion,"""***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***""Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.",EP HEALING ABUTMENT ,3,"July 13, 2011", 2011,"Biomet 3i, LLC","Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.",PRODUCTION CONTROLS: Error in Labeling,"The firm, BIOMET 3i, initially contacted each US customer by telephone using a prepared phone script. Following telephone contact, the firm followed up each call with a faxed ""Urgent: Medical Device Recall"" letter dated March 1, 2010. International customers were notified first by email then by fax. The letter and email described the product, problem and actions to be taken. The customers were instructed to return the healing abutment(s) for replacement if they have not already opened and used the product; respond with the attached response fax and return the product(s) to the: Regulatory Affairs Department, BIOMET 3i, 4555 Riverside Drive, Palm Beach Gardens, FL 33410, Incident No. IC95863. BIOMET will send a replacement healing abutment(s) once the returned product is received.If you have any questions or concerns, please contact the Recall Coordinator at 561-776-6906.",Contact the recalling firm for information,49,49,"Worldwide distribution: USA (nationwide) and countries of: Australia, Europe and Japan.",Terminated,"November 09, 2011",119,49,Not_Computer,N/A,N/A,N/A
Z-2798-2011,58863,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Terumo(tm) Hypodermic Needle, sterile, individually packaged into a ""blister-pack"" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case.Product Usage: Aspiration and injection of fluids for medical purposes.",DISP. HYPODERMIC NEEDLE,2,"July 13, 2011", 2011,Terumo Medical Corporation,"Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025",PRODUCTION CONTROLS: Packaging,"The firm, Terumo Medical Corporation sent an ""URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT"" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a ""Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification"" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.",Contact the recalling firm for information,453000,"453,000 needles","Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA",Terminated,"July 14, 2011",1,453000,Not_Computer,N/A,N/A,N/A
Z-2796-2011,58806,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.",Colleague 3 and 3 CX Infusion Pumps,2,"July 13, 2011", 2011,Baxter Healthcare Corp.,The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.,TRAINING: Employee Error,"Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost.Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.",Contact the recalling firm for information,12,12 pumps,"Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and Puerto Rico.",Open,N/A,N/A,12,Not_Computer,N/A,N/A,N/A
Z-2797-2011,58916,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A.The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.",Sysmex StromatolyserIM (SIM220A),2,"July 13, 2011", 2011,"Sysmex America, Inc.","The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false ""Platelet Clump"" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.",PRODUCTION CONTROLS: Environmental Control,"Sysmex America, Inc. sent a ""MEDICAL DEVICE RECALL"" letter dated June 2009 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax at 800-218-2711. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.",Contact the recalling firm for information,4005,"4,005 cubetainers","Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.",Terminated,"July 13, 2011",0,4005,Not_Computer,N/A,N/A,N/A
Z-2724-2011,56016,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.",IQecg,2,"July 14, 2011", 2011,Brentwood Medical Technology Corp,"The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient's age. The software does this without notifying the user of the change from use of the Bazett equation, which is utiliz",DESIGN: Software Design,"The firm, Midmark, sent an ""URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION"" letter on May 19, 2010 with an attached Corrective Return Material Authorization (RMA) form via US Postal Service Certified Mail to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their IQecg, IQmanager, or lQiC Centricity software to determine the software version currently in use. If it is a listed product, it is subject to this field corrective action. A sample software label was attached to aid the consignees/customers in locating and identifying the software CD. For customers who have already installed the software, the version number can be identified in the ""About"" page.Consignees/customers were instructed to complete the enclosed Field RMA form and return it with the affected software to:Quality Assurance DepartmentMidmark Diagnostics Group1125 West 190 S t.Gardena, CA 90248In addition, if they further distributed this product, identify customers and notify them at once of this product field corrective action.Replacement software was to be shipped to the consignees/customers upon receipt of the returned software CD. If they require a UPS return shipping label or an on-line download of replacement software, contact Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or 5108. If you have any questions, call Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or QA/RA Manager, Midmark Diagnostics Group 310-516-5116.",N/A,90,90 units,"Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia.",Terminated,"August 22, 2011",39,1621,Computer,N/A,N/A,N/A
Z-2802-2011,59207,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,PMA,iSert Intraocular Lens (Model PC-60AD),iSert Intraocular Lens (Model PC60AD),2,"July 14, 2011", 2011,"Hoya Surgical Optics, Inc.",The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.,PREMARKET APPROVAL: No Marketing Application,"Hoya Surgical Optics Inc. sent an ""URGENT MEDICAL DEVICE REMOVAL"" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken.The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986.Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com.",N/A,33743,"33,743 units total",Nationwide Distribution,Terminated,"November 29, 2012",504,33743,Not_Computer,N/A,N/A,N/A
Z-2800-2011,59018,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. The device draws in room air through a filter by means of an electric blower. It heats the air to the desired temperature by controlling the air temperature entering a flexible connecting hose, and conveys it to the disposable blanket (i.e. FilteredFlow Blankets, Warming Tube) in contact with the patient, in order to warm the patient. This device provides a continuous flow of heated air as a means of warming patients suffering the common, but significant problems of hypothermia. The system can be used in Post Anesthesia Care Units (PACUs), Intensive Care Units (ICUs), Surgical Intensive Care Units (SICUs), Emergency Rooms (ERs), Operating Rooms (ORs), or any other departments or hospital facilities requiring patient temperature management.","Model 134, WarmAir Convective Warming Device",2,"July 14, 2011", 2011,Cincinnati Sub-Zero Products Inc,"A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir 134 device's Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CSZ Cincinnati Sub-Zero sent an ""URGENT MEDICAL DEVICE RECALL FIELD ACTION"" notice to all affected customers. The letter identifies the product, problem, and actions to be taken.CSZ instructs customers to complete and return an enclosed recall response form and to state whether or not their facility is in possession of the device. The completed form should be returned via fax at 513-772-9119 or via e-mail to WA134Recall2011@cszinc.com. Additionally, customers are instructed to discontinue use of the device and return to their Biomedical Engineering and/or Service Department for device exchange and return.Questions regarding this notice are directed to the WarmAir 134 field action (recall) administrator at 1-800-989-7373.",No consumer action necessary,463,463 units were distributed,"Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the country of Canada.",Terminated,"February 26, 2013",593,463,Hardware,Physical Safety Hazards,Return,Remove or Replace
Z-2835-2011,59078,"lancet, blood",FMK,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"OneTouch Delica Lancing Device;LifeScan Inc., Milpitas, CATesting of Blood Glucose Levels",OneTouch Delica Lancing Device,2,"July 15, 2011", 2011,Lifescan Inc,Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.,OTHER/UNDETERMINED: Pending,"Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.",Contact the recalling firm for information,1032515,"1,032,515 in US",Worldwide Distribution - USA (nationwide) and Canada.,Terminated,"January 05, 2012",174,1032515,Not_Computer,N/A,N/A,N/A
Z-2833-2011,59096,"prosthesis, tracheal, expandable",JCT,Tracheal prosthesis.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Boston Scientific, WALLGRAFT¶_¶_ OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.The WALLGRAFT Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Material Catalog #DescriptionM00170502070-502WALLGRAFT PKG T/B/10X20 10FR COMMLM00170503070-503WALLGRAFT PKG T/B/10X30 10FR COMMLM00170505070-505WALLGRAFT PKG T/B/10X50 10FR COMMLM00170507070-507WALLGRAFT PKG T/B/10X70 10FR COMMLM00170523070-523WALLGRAFT PKG T/B/12X30 11FR COMMLM00170525070-525WALLGRAFT PKG T/B/12X50 11FR COMMLM00170527070-527WALLGRAFT PKG T/B/12X70 11FR COMMLM00170545070-545WALLGRAFT PKG T/B 14X50 12 FRM00170547070-547WALLGRAFT PKG T/B 14X70 12FRM00170562070-562WALLGRAFT PKG T/B/6X20 9FR COMMLM00170563070-563WALLGRAFT PKG T/B/6X30 9FR COMMLM00170565070-565WALLGRAFT PKG T/B/6X50 9FR COMMLM00170567070-567WALLGRAFT PKG T/B/6X70 9FR COMMLM00170572070-572WALLGRAFT PKG T/B/7X20 9FR COMMLM00170573070-573WALLGRAFT PKG T/B/7X30 9FR COMMLM00170575070-575WALLGRAFT PKG T/B/7X50 9FR COMMLM00170577070-577WALLGRAFT PKG T/B/7X70 9FR COMMLM00170582070-582WALLGRAFT PKG T/B/8X20 9FR COMMLM00170583070-583WALLGRAFT PKG T/B/8X30 9FR COMMLM00170585070-585WALLGRAFT PKG T/B/8X50 9FR COMMLM00170587070-587WALLGRAFT PKG T/B/8X70 9FR COMMLM00170592070-592WALLGRAFT PKG T/B/9X20 10FR COMMLM00170593070-593WALLGRAFT PKG T/B/9X30 10FR COMMLM00170595070-595WALLGRAFT PKG T/B/9X50 10FR COMMLM00170597070-597WALLGRAFT PKG T/B/9X70 10FR COMML",WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM,2,"July 15, 2011", 2011,Boston Scientific Corporation,"Boston Scientific is initiating an important field correction related to WALLSTENT"", WALLSTENT"" RP, and WALLGRAFT¶_ Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT"", WALLSTENT"" RP, and WALLGRAFT¶_ Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.",N/A,"The firm, Boston Scientific, sent an ""Urgent Medical Device Field Correction"" letter dated May 25, 2011 to its customers. The letter described the product, the problem and actions to be taken. The letter states that no product is being recalled and asks consignees not to return the product. The customers were instructed to read the enclosed information and post it in a way to ensure it is easily accessible to all users of this device; complete and return the Reply Verification Tracking Form via fax to: CV Field Action Center, 1-866-213-1806, and if they are a distributors to forward this notification to their customers. If you have any questions or would like assistance with this field correction, please contact your local Sales Representative and/or call 763-494-1133.",Contact the recalling firm for information,23218,"23,218 FOR ALL PRODUCTS",Worldwide distribution.,Terminated,"August 10, 2012",392,23218,Not_Computer,N/A,N/A,N/A
Z-2812-2011,59104,"suture, nonabsorbable, silk",GAP,Natural nonabsorbable silk surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Syneture Sofsilk 5/0 BLACK 5 X 18"" CV-22 D*TACHnon-absorbable silk sutures GS43MSofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery",Syneture Sofsilk,2,"July 15, 2011", 2011,Covidien LP,Potential for the sterile barrier to be breached compromising the sterility of the product,PRODUCTION CONTROLS: Equipment Maintenance,"Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.",N/A,528,528 units,"Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore",Terminated,"February 10, 2014",941,93600,Not_Computer,N/A,N/A,N/A
Z-2834-2011,59099,"light, operating, dental",EAZ,Dental operating light.,Dental,Dental,510(K) Exempt,"LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000.The product is labeled in part: "" Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***"".Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.",LuxStar Dental Light,2,"July 15, 2011", 2011,Dental Equipment LLC,Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.,DESIGN: Device Design,"Dental Equipment, LLC sent an ""URGENT MEDICAL DEVICE RECALL"" notification letter via USPS 1st class to US consignees and via Federal Express or Fax to foreign consignees on June 24, 2011. The letter informed customers about the product, problem and tether upgrade corrective action. A Field Correction Acknowledgement Form and the Field Correction Completion Form was attached for customers to complete and return via the fax number 503-537-3617. The letter states that customers are to review their records in order to identify where the affected devices are located and which are still in service. Customers can call the Customer Service at 800-304-5332 and order the self-install Upgrade Kits with the Part Number 30792 at no charge. Customers are instructed to complete the Rework Correction Form once all of the lights have been updated and fax or mail to Marcus, attention Bonnie Dundas, at (503) 537-3617.",N/A,13226,"13,226 units distributed worldwide","Worldwide Distribution -- USA (nationwide) including states of: CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico and the countries of: Australia, Belgium, Canada, France, Germany, Ireland, Italy, Mexico, Norway, Poland, Russia, United Kingdom, Vietnam, and Trinidad.",Terminated,"October 24, 2012",467,13226,Not_Computer,N/A,N/A,N/A
Z-2831-2011,59184,"sheath, corrugated rubber, for non-indwelling catheter, non-sterile",NNY,Urine collector and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical.Used for urine collection.","Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device",2,"July 15, 2011", 2011,Teleflex Medical,"The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.",OTHER/UNDETERMINED: Pending,"Teleflex Medical sent an ""Urgent Medical Device Recall Notification"" dated June 27, 2011 to all affected customers.The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall.For additional information please contact Customer Service at 866-246-6990 or your local sales representative.",No consumer action necessary,6880,6880 units (total for both products),"Nationwide Distribution (USA) including the states of FL, GA, OH and SC.",Terminated,"March 20, 2012",249,6880,Not_Computer,N/A,N/A,N/A
Z-2837-2011,59263,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6 (17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.",Baxter Interlink System NonDEHP I.V. Catheter Extension Set,2,"July 15, 2011", 2011,Baxter Healthcare Corp.,"Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.",PRODUCTION CONTROLS: Packaging,"The firm, Baxter, sent an ""Urgent Product Recall"" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to fca@baxter.com and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",Contact the recalling firm for information,9800,"9,800 sets","Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.",Terminated,"April 18, 2012",278,9800,Not_Computer,N/A,N/A,N/A
Z-2838-2011,58769,"restoration, porcelain",NSP,N/A,N/A,Dental,Enforcement Discretion,"""***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***""Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.",Incise Zirconia Coping (CBZR0102),3,"July 16, 2011", 2011,"Biomet 3i, LLC","On December 1, 2010 Biomet 3i recalled their product Incise Zirconia Coping (CBZR0102). The Coping contains a manufacturing defect. Coping is oversized. All affected direct accounts were notified by letter on December 14, 2010.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Biomet 3i sent an ""MEDICAL DEVICE RECALL"" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken.The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product.Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906.",No consumer action necessary,16,16,Worldwide Distribution--USA (nationwide) and the country of Canada.,Terminated,"July 18, 2011",2,16,Not_Computer,N/A,N/A,N/A
Z-2840-2011,59155,N/A,N/A,N/A,N/A,N/A,N/A,"ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves",ENCORE(R) UNDERGLOVE,2,"July 18, 2011", 2011,Ansell Healthcare Products LLC,Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.,N/A,"Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.",N/A,9580,9580 pairs,Nationwide Distribution,Terminated,"January 10, 2013",542,1176176,Not_Computer,N/A,N/A,N/A
Z-2839-2011,57518,"system, photopheresis, extracorporeal",LNR,N/A,N/A,Gastroenterology/Urology,N/A,"Therakos Cellex Procedural Kits.Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.",Therakos Cellex Procedural Kits,2,"July 19, 2011", 2011,Therakos Inc,Cellex Procedural kits may have minor tears in their Tyvek covers.,PRODUCTION CONTROLS: Process Control,"Therakos, Inc. sent an ""Important Product Notification"" dated December 2, 2010 to all affected customers.The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form.For additional information contact Therakos Customer Technical Services at 877-865-6850.",N/A,110,110 units,"Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.",Open,N/A,N/A,110,Not_Computer,N/A,N/A,N/A
Z-2852-2011,58980,"kit, surgical instrument, disposable",KDD,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"""***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***"" Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.",Arthrosimplicity Kit,2,"July 19, 2011", 2011,"Biomet Microfixation, Inc.","Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.",N/A,"Biomet Microfixation (formerly W. Lorenz) sent an ""URGENT MEDICAL DEVICE SAFETY ALERT"" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices). If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.",Contact the recalling firm for information,103,103,"Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.",Terminated,"April 19, 2012",275,828,Not_Computer,N/A,N/A,N/A
Z-2853-2011,59270,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.",Colleague CX Infusion Pump,2,"July 19, 2011", 2011,Baxter Healthcare Corp.,"While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.",PRODUCTION CONTROLS: Process Control,"Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up ""URGENT PRODUCT RECALL"" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.",N/A,2,2 units,Nationwide (USA) Distribution -- including the state of Pennsylvania.,Terminated,"January 20, 2012",185,2,Not_Computer,N/A,N/A,N/A
Z-2858-2011,59051,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FHProduct Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)",Runthrough NS Guidewire,2,"July 20, 2011", 2011,Terumo Medical Corporation,Baloon catheter guidewires may become uncoiled during angioplasty procedures.,DESIGN: Component Design/Selection,"Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an ""URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT"" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.",N/A,70,70 units,"Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.",Terminated,"July 27, 2011",7,70,Not_Computer,N/A,N/A,N/A
Z-2804-2011,58996,"electrode, ion specific, potassium",CEM,Potassium test system.,Clinical Chemistry,Clinical Chemistry,510(k),"GEM PREMIER 4000 CARTRIDGE K+ REPORTING:GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510150 test iQM Part Number:00027415010300 test iQM Part Number: 00027430010450 test iQM Part Number: 00027445010600 test iQM Part number: 00027360010The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters",Instrumentation Laboratory,1,"July 21, 2011", 2011,Instrumentation Laboratory Co.,"K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, withbiases exceeding allowable error claim of a¶_ 0.5 moUL",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Instrumentation Labs, issued a Revised ""Urgent Field Safety Notification"" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com. The letter also noted an Important Change to Customer Actions from June Urgent Field Safety Notification.Prior strategy :Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements.If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.",N/A,24787,24787,"Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.",Terminated,"November 27, 2012",495,28616,Not_Computer,N/A,N/A,N/A
Z-2859-2011,59103,"injector, contrast medium, automatic",IZQ,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray.The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.","Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)",2,"July 21, 2011", 2011,Mallinckrodt Inc,"Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.",PRODUCTION CONTROLS: Labeling Mix-Ups,"COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to productmonitoringhazelwood@covidien.com. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot.For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.","For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.",11000,"11,000 units (200 cases/50 units per case)","Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.",Terminated,"February 19, 2013",579,11000,Not_Computer,N/A,N/A,N/A
Z-2836-2011,59161,"drape, surgical",KKX,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.","KimberlyClark, Three Quarter Drape",2,"July 21, 2011", 2011,Kimberly-Clark Corporation,Metal shavings were found within the folded portion of the surgical drape.,N/A,"Kimberly-Clark Corporation sent an ""Urgent: Voluntary Product Recall"" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011.The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.",N/A,223,223 cases (300 units per case),"Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.",Terminated,"October 14, 2011",85,223,Not_Computer,N/A,N/A,N/A
Z-2855-2011,59291,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"MatriStem¶_ Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair","MatriStem Plastic Surgery Matrix XS,",2,"July 21, 2011", 2011,"ACell, Inc",Surgical mesh for implantation may have elevated endotoxin levels.,N/A,"ACELL, Inc. sent an ""Urgent: Medical Device Safety Alert"" letter dated July 07, 2011 to all affected customers.The letter notified customers (physicians) of the possibility of elevated endotoxin levels in the product and affected lots. They were instructed to monitor their patients receiving the affected implants.For additional information please contact the Director of Regulatory Affairs & Quality Assurance at (410) 953-8508.",N/A,30,30 units,"Nationwide (USA) Distribution including the states of CA, CT, FL, ID, IL, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, TX and VA",Terminated,"October 21, 2011",92,30,Not_Computer,N/A,N/A,N/A
Z-2856-2011,59259,gonococcal antibody tests,LGB,Gonococcal antibody test (GAT).,Microbiology,Microbiology,PMA,"PALL Medical LeukoGuard¶_ LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.",Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop,2,"July 21, 2011", 2011,Pall Corporation,Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.,TRAINING: Employee Error,"Pall Medical sent an ""Important Customer Notification"" letter dated May 26, 2011 to all affected customers.The letter included a description of the problem, affected lots and provided recommendations including the return of the product.For additional information, please contact the firm at (516) 484-0263.",Contact the recalling firm for information,232,232 units,"Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.",Terminated,"October 03, 2012",440,232,Not_Computer,N/A,N/A,N/A
Z-2854-2011,59189,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular SystemIndicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.",VirtoSaph Plus Endoscopic Vessel Harvesting System ,2,"July 21, 2011", 2011,Terumo Cardiovascular Systems Corporation,Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situation. Teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.,DESIGN: Device Design,"Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone.There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product.For information on this recall call (734) 741-6173.",No consumer action necessary,35,35 units,Nationwide (USA) Distribution including the state of New York.,Terminated,"July 27, 2011",6,35,Not_Computer,N/A,N/A,N/A
Z-2158-2011,58419,"monitor, patient position, light-beam",IWE,Light beam patient position indicator.,Radiology,Radiology,510(K) Exempt,GE Healthcare DISCOVERY MODEL NM/CT 670NM/CT system,GE Healthcare DISCOVERY MODEL NM/CT 670,2,"July 21, 2011", 2011,"GE Healthcare, LLC",GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - DoNot Stare Into Beam) affecting certain Discovery Systems.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011.For questions call 262-513-4122.,Contact the recalling firm for information,4,4,Nationwide Distribution,Terminated,"August 31, 2012",407,4,Not_Computer,N/A,N/A,N/A
Z-2864-2011,59201,"stretcher, wheeled",FPO,Wheeled stretcher.,General Hospital,General Hospital,510(K) Exempt,Eye Surgery Stryker Medical Stretchers Model 1089Intended to transport patients in a horizontal position.,Eye Surgery Stryker Medical Stretchers Model 1089,2,"July 22, 2011", 2011,Stryker Medical Division of Stryker Corporation,"The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Stryker Medical sent an ""Urgent Medical Device Correction"" dated July 19 ,2011 to all affected customers.The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included.For additional information call (269) 389-6604.",Contact the recalling firm for information,5,5,"Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.",Terminated,"August 29, 2013",769,112,Not_Computer,N/A,N/A,N/A
Z-2873-2011,59002,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"""***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159"") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA*** www.biometmicrofixation.com***QTY 00001***"".Internal fixation screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system."," THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159"") (WXL)TITANIUM",2,"July 22, 2011", 2011,"Biomet Microfixation, Inc.","On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Biomet Microfixation notified distributors and customers by letter, email and telephone calls. Distributors and customers were instructed to fill out and return the Inventory Reconciliation sheet, via Fax to 904-741-9425. Distributors were also instructed to notify their customers if the product was distributed further.For questions regarding this recall customers were instructed to call 1-800-874-7711 or 904-741-4400, ext. 468.",Contact the recalling firm for information,927,927,"Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.",Terminated,"October 12, 2011",82,927,Not_Computer,N/A,N/A,N/A
Z-2866-2011,59167,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDLProduct Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.",MEDRAD Avanta Fluid Management Injection System,2,"July 22, 2011", 2011,Medrad Inc,"Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing ""Important Product Use Reminder"" to remind users of proper procedures for using the system and the need for diligence in reducing air embo",DESIGN: Software Design,"Medrad Inc., sent two types of ""MEDICAL DEVICE FIELD CORRECTION"" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.",No consumer action necessary,842,842,"Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA.",Terminated,"June 05, 2012",319,842,Software,N/A,N/A,N/A
Z-2871-2011,59077,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Philips brand BrightView Gamma Camera System,SYST, BRIGHTVIEW-TILT, 3/8"", Model Number: 2170-3002A;Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc.,Cleveland, OHThe BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.","Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWTILT, 3/8""",2,"July 22, 2011", 2011,Philips Medical Systems,The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.,DESIGN: Device Design,"Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instruction for use for their system, which states ""Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels. Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue. For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5. In all other countries the local Philips Healthcare office should be contacted.",Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.",Terminated,"November 06, 2012",473,N/A,Not_Computer,N/A,N/A,N/A
Z-2879-2011,59146,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"Arthrex Reciprocating Saw AttachmentType: V-600SRDistributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E; Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries",Arthrex Reciprocating Saw Attachment,2,"July 25, 2011", 2011,W & H DentalWerk Buermoos GMBH,"Reciprocating saw attachment V 600 Sr (REF: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.",PRODUCTION CONTROLS: Equipment Maintenance,"Madrimed GmbH (Distributor partner) of W&H; Dentalmechanik GmbH sent a letter dated May 24, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were ask to advise their users to check the adapters thoroughly before and after each application, until the conversion of all attachments have been completed and to send all products that need to be converted to the nearest service centers.W&H; decided to convert all products that might be affected in their service centres and equip them with an additional security device.If you have any questions, call +43627462360 or email: regulatory@wh.com.",Contact the recalling firm for information,194,194 units,"Worldwide distribution: USA (nationwide) and countries of: Austia, Australia, Canada, Czech Republic, Denmark, France, Germany, Italy, Kuwait, Malaysia, Netherlands, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey and United Kingdom.",Open,N/A,N/A,194,Not_Computer,N/A,N/A,N/A
Z-2875-2011,59021,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.",CD HORIZON (R) LEGACY (TM) MAS,2,"July 25, 2011", 2011,Medtronic Sofamor Danek USA Inc,Screws are longer then size etched on the screw.,PRODUCTION CONTROLS: Error in Labeling,"Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011.For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.",N/A,199,199 units,"Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico.",Terminated,"December 24, 2012",518,460,Not_Computer,N/A,N/A,N/A
Z-2880-2011,59178,"stimulator, muscle, powered",IPF,Powered muscle stimulator.,Physical Medicine,Physical Medicine,510(k),eSwallow Multi-Program Dysphagia Therapy Test unitIntended Use: Powered Muscle Stimulator for treatment of dysphagia.,eSwallow MultiProgram Dysphagia Therapy Test unit,2,"July 25, 2011", 2011,eSwallow USA LLC,It was discovered that the firm was distributing medical devices without FDA approval.,OTHER/UNDETERMINED: Pending,"eSwallow USA LLC sent an URGENT MEDICAL DEVICE RECALL letter dated June 22 2011, via US mail and email notification to each distributors. The letter identified the product, the problem, and the action to be taken. Distributors were instructed to immediately examine inventory, quarantine all product subject to recall, and identify customers that received these products and notify them at once of the recall. The letter advised distributors to forward a copy of the recall notification letter to their customers. The letter states that the distributors are to return all inventories to the eSwallow Corporate Office eSWALLOWusa, 106 Hidden Drive, Scottsboro, Al 35769. The recall should be carried out to the customer/user level. Customers are instructed to complete and return the attached Response Form as soon as possible. If you have any questions, call (256) 571-0443.",Contact the recalling firm for information,123,123 units,"Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA.",Terminated,"July 03, 2012",344,123,Not_Computer,N/A,N/A,N/A
Z-2882-2011,57968,"radioimmunoassay, dehydroepiandrosterone (free and sulfate)",JKC,Dehydroepiandrosterone (free and sulfate) test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,DHEA RIA ReagentThe DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.,DHEA RIA Reagent,2,"July 26, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples.,PRODUCTION CONTROLS: Process Control,"Beckman Coulter sent an ""URGENT: PRODUCT CORRECTION ACTION"" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return.Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.",N/A,3542,"3,542 units (1181 in US)","Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.",Terminated,"May 04, 2012",283,3542,Not_Computer,N/A,N/A,N/A
Z-2885-2011,59109,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; ""Environmental Conditions and Test Procedures for Airborne Equipment"" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: -CPR training -AED training equivalent to that recommended by the American Heart Association -Training in the use of the LIFEPAK 500 AED.",LIFEPAK 500 AED,2,"July 26, 2011", 2011,"Physio Control, Inc.",The potential reliability issue is the result of a design characteristic of a SRAM (Static Random AccessMemory) electronic component on the main printed circuit board assembly.,DESIGN: Component Design/Selection,"Physio-Control, Inc. sent an ""URGENT- ACTION REQUIRED"" letter dated June 2011 to all affected customers. The letter describes the product, problem, and the action to be taken by the customer.The letter recommends that users who store their device(s) in hard-shelled carrying cases remove them from the case(s)immediately and discontinue the use of the case(s). Additionally, the letter recommends that customers perform regular maintenance in accordance with the Operating Instructions. A Confirmation Sheet was enclosed with the letter for customers to complete and return via fax at 1-866-448-9567. Customers can call the Technical Support Team at 1-800-442-1142, Option 5.",N/A,12197,12197 units distributed worldwide (5169 units outside US; 7028 units in the US),"Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay.",Terminated,"February 23, 2012",212,12197,Hardware,N/A,Instructions,Safety Notice/Insructions
Z-2884-2011,58921,"abutment, implant, dental, endosseous",NHA,Endosseous dental implant abutment.,Dental,Dental,510(k),LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3iCastable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast, LPCCC2: Low Profile Abutment NonHexed Castable Cylinder ,3,"July 26, 2011", 2011,"Biomet 3i, LLC","Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was distributed in Europe only.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Biomet 3i sent a ""Medical Device Advisory Notice"" letter dated February 17, 2011 to all affected customers.The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification.For additional information, please contact Customer Service at 800-342-5454.",No consumer action necessary,232,232 unit,Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType;=RCL,Terminated,"July 27, 2011",1,232,Not_Computer,N/A,N/A,N/A
Z-2881-2011,59101,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.",Calloway LabsMultiDrug 9 Panel Assay ,2,"July 27, 2011", 2011,Alere San Diego,"Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectlylabeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"Alere San Diego sent an ""Urgent Medical Device Recall"" letter dated June 9, 2011 to all affected customers.The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere.For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.",N/A,2400,"2400 kits (60,000 devices)",(USA) Nationwide Distribution including the states of MO and MA.,Terminated,"April 04, 2012",252,2400,Not_Computer,N/A,N/A,N/A
Z-2887-2011,59016,"system, test, rheumatoid factor",DHR,Rheumatoid factor immunological test system.,Immunology,Immunology,510(k),"IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529.Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.",IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent,2,"July 27, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.,N/A,"Beckman Coulter sent an ""URGENT FIELD SAFETY NOTICE/PRODUCT CORRECTION"" letter dated May 31, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to discontinue use of the affected products. Customers were asked to complete and return an attached FAX BACK Response Form to 714-961-4234. Replacement products may be obtained by calling Order Assistance at 800-526-3821 in the United States, (800) 463-7828 in Canada or contacting your local Beckman Coulter representative.For any questions regarding this notice, contact the Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the United States and Canada; or contact your local sales representative.",N/A,6302,6302 units (850 in the US),"Worldwide Distribution--USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Macao, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.",Terminated,"June 03, 2013",677,6302,Not_Computer,N/A,N/A,N/A
Z-2857-2011,59288,"centrifuges (micro, ultra, refrigerated) for clinical use",JQC,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Global Focus Marketing and Distribution, Silencer S2200 Centrifuge",Silencer S2200 Centrifuge,1,"July 27, 2011", 2011,Global Focus Marketing & Develop,Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Global Focus Marketing and Distribution, Ltd issued a press release on 07/19/11 and a URGENT: DEVICE RECALL letter was mailed to the firm's customers on 07/15/11 and 07/21/11. Discontinue use. For questions, contact: (800) 323-4306 or silencer@gfmd.com.",N/A,859,859 units,"Worldwide to USA, United Kingdom, Ireland, Canada, and China.",Terminated,"November 06, 2013",833,859,Not_Computer,N/A,N/A,N/A
Z-2889-2011,59346,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"D-10 Dual Program Reorder Pack;contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2.Bio-Rad Laboratories Inc. Hercules, CA.Product Usage: Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use.",D10 Dual Program Reorder Pack,3,"July 27, 2011", 2011,Bio-Rad Laboratories Inc,Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.,OTHER/UNDETERMINED: Pending,"Bio-Rad Laboratories Inc sent ""URGENT: MEDICAL DEVICE CORRECTION"" letters to all affected D-10 Dual customers and Bio-Rad subsidiaries on July 11, 2011 via FedEx or fax. The letters identified the product, the problem, and the action needed to be taken. The letters ask that inventory be examined and affected reorder pack lots be quarantined and destroyed according to local, state and federal regulations. All D-10 Dual customers were instructed to review their chromatograms generated from these lots. If the calibration has passed with good chromatography, the controls are within specification, and the F, A1c, and A2 peaks elute in their specified retention time windows for the patient samples, the customer may continue to use and report results with the affected buffer lots. The letters include a chart showing Good Patient Chromatogram with Correct Retention times and Failed Calibrator Chromatogram with late retention times. If calibration fails and/or late retention times cause one or more peaks to be misidentified, affected reorder packs should be destroyed. The correction letters and response form should be translated, if necessary, and distributed to all affected customers. Tracking documentation should be compiled for all customers who receive the Medical Device Correction letter. The Medical Device Correction Response Forms should be completed and returned by fax to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or a PDF copy to Jackie_Buckley@bio-rad.com.",N/A,418,418,"Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. Korea.",Terminated,"March 12, 2012",229,418,Not_Computer,N/A,N/A,N/A
Z-2888-2011,59023,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc.Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket",WarmAir Model 135 Convective Warming Device,2,"July 27, 2011", 2011,Cincinnati Sub-Zero Products Inc,Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.,DESIGN: Component Design/Selection,"Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice"" dated July 12, 2011 to all affected customers.The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a ""Recall Response Form"".For additional information e-mail WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810.",Contact the recalling firm for information,5474,5474 units,"Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.",Terminated,"August 02, 2013",737,5474,Hardware,N/A,Return,Remove or Replace
Z-2893-2011,59088,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Clinac Linear Accelerators;Varian Medical Systems, Palo Alto, CA.Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.",Clinac Linear Accelerators,2,"July 28, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.,DESIGN: Device Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter provides directions on how to re-install the gantry center throat cover.Customers can contact their Varian Customer Support Manager at 1-888-827-4265 for further clarification.",Contact the recalling firm for information,278,278,Worldwide Distribution-including USA (nationwide),Terminated,"March 14, 2012",230,278,Not_Computer,N/A,N/A,N/A
Z-2890-2011,59036,"system, blood culturing",MDB,Microbial growth monitor.,Microbiology,Microbiology,510(k),"BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A.Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and a tube for each drug, as well as a barcoded tube carrier that holds the set. The carrier barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. Large or small AST carrier sets can be placed in the rack. The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.",BD BACTEC(tm) MGIT (tm) 960 System,2,"July 28, 2011", 2011,Becton Dickinson & Co.,Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.,DESIGN: Software Design (Manufacturing Process),"BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An ""URGENT PRODUCT RECALL"" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter. If further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.",Contact the recalling firm for information,421,421 disks,"Nationwide Distribution (USA) including states of: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.",Terminated,"July 29, 2011",1,421,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-2891-2011,59272,"tray, surgical",LRP,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican RepublicLot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican RepublicLot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 20835339, 21511803, 23485821DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321Custom Surgical kits.",DeRoyal Incision and Drainage Tray,2,"July 28, 2011", 2011,"Deroyal Industries, Inc. Lafollette",Custom surgical kits contain recalled Triad PVP prep pads,PRODUCTION CONTROLS: Process Control,"DeRoyal sent a Customer letter dated July 6, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.The customer was instructed to reference the attached spreadsheet to identify your accounts kits/trays and the corresponding lot numbers affected by this recall.Please complete and return the Acknowledgement Form by fax ( 865-362-3716) confirming you have been notified of this action.For further questions, please call ( 865) 362-2334.",N/A,11856,"11,856 kits/trays","Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.",Open,N/A,N/A,11856,Not_Computer,N/A,N/A,N/A
Z-2892-2011,59377,N/A,N/A,N/A,N/A,N/A,N/A,"Aquamantys 2.3 Bipolar SealerModel #23-113-1.Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization",Salient Surgical,2,"July 28, 2011", 2011,"Salient Surgical Technologies, Inc",Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Salient Surgical Technologies, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" notification letter dated July 18, 2011 to all affected customers and distributors. The letter describes the product, problem and the actions to be taken. The letter requested that customers and distributors immediately identify and discontinue use of all Aquamantys 2.3 Bipolar Sealer devices in inventory and quarantine them until they can be returned to Salient. The letter states that a Salient sales representative will arrange return of the recalled product to Salient. The letter provides information for customers about the replacement of the recalled product. If you have any questions, please contact Customer Service, at 866-777-9400, or your sales representative.",N/A,1011,"48, 963 units","Worldwide Distribution - USA (nationwide) and countries ofChina, Denmark, France, Germany, Greece, Italy, Japan, , South Africa, Spain, and Turkey.",Terminated,"March 09, 2012",225,48963,Not_Computer,N/A,N/A,N/A
Z-2860-2011,59148,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.",IFlow ONQ with SelectAFlow Pumps,2,"July 28, 2011", 2011,I-Flow Corporation,"The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.",PRODUCTION CONTROLS: Process Control,"I-Flow Corporation sent an ""Important Voluntary Market Withdrawal Notice"" dated May 12, 2011 to all affected customers.The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.",N/A,96892,"96,892 units total (95,637 units in US)","Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.",Terminated,"August 09, 2012",378,96892,Not_Computer,N/A,N/A,N/A
Z-2897-2011,57856,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),"Aplio Artida Ultrasound Diagnostic System SSH-880CV.Toshiba American Medical Systems, Inc.A diagnostic ultrasound system.",Aplio Artida Ultrasound Diagnostic System SSH880CV,2,"July 29, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).",DESIGN: Software Design,"Toshiba America Medical Systems, Inc. sent out an ""Urgent Medical Device Correction"" dated December 21, 2010 to all affected customers.The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included. For questions on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.",Contact the recalling firm for information,46,46 units,"Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico.",Terminated,"April 20, 2012",266,46,Software,Device Operation,Software update,Software Update
Z-2894-2011,59113,anesthesia conduction kit,CAZ,Anesthesia conduction kit.,Anesthesiology,Anesthesiology,Enforcement Discretion,"Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc.Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.",Arrow ASK20608CMC StimuCath Continuous Nerve Block Kit,2,"July 29, 2011", 2011,Arrow International Inc,"Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.",PRODUCTION CONTROLS: Packaging,"Arrow International, Inc. sent an ""Urgent Medical Device Recall"" letter dated June 17, 2011 to all affected customers.The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer.For additional information call 800 233-3187.",Contact the recalling firm for information,95,95 kits,Nationwide Distribution including the state of North Carolina.,Terminated,"October 01, 2012",430,95,Not_Computer,N/A,N/A,N/A
Z-2896-2011,58031,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography.Toshiba American Medical Systems, Inc.A multislice CT system that supports whole-body scanning.",Aquilion One: Aquilion TSX301B,2,"July 29, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.",DESIGN: Software Design,"Toshiba America Medical Systems, Inc. sent an ""Urgent Medical Device Correction"" letter dated January 4, 2011 to all affected customers.The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.",N/A,5,5,"(USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.",Terminated,"August 17, 2012",385,11,Software,N/A,N/A,N/A
Z-2883-2011,59212,"catheter, hemodialysis, implanted",MSD,Blood access device and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Arrow NextStep Antegrade Chronic Hemodialysis Catheter.Product is used for attaining long-term vascular access for hemodialysis and apheresis.,Arrow NextStep Antegrade Chronic Hemodialysis Catheter,1,"July 30, 2011", 2011,Arrow International Inc,Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.,DESIGN: Device Design,"An ""Urgent Medical Device Recall"" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the ""Recall Acknowledgement & Stock Status Form"", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.",No consumer action necessary,41,41,"United States (states of CA, DE, FL, MI, NC, and TN).",Terminated,"April 16, 2012",261,41,Not_Computer,N/A,N/A,N/A
Z-2848-2011,59047,"condenser, heat and moisture (artificial nose)",BYD,Heat and moisture condenser (artificial nose).,Anesthesiology,Anesthesiology,510(K) Exempt,"Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300.The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.",Vital Signs A GE Healthcare Company,1,"July 30, 2011", 2011,"Vital Signs Devices, a GE Healthcare Company","The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.",DESIGN: Device Design,"An ""Urgent Medical Device Correction"" letter with the return confirmation form was sent to affected customers. Phone calls were also placed to customers. Consignees were informed of the affected device, issue, and actions to take. Customers were instructed to isolate all affected product, arrange return by contacting Customer Service at 1-800-932-0760, and return only unused product. Customers were asked to complete the attached confirmation form and fax back as per the instructions. For questions, contact your local Vital Signs Account Manager or call Customer service at 1-800-932-0760.",N/A,222009,"222,009",Worldwide Distribution including the United States.,Open,N/A,N/A,222009,Not_Computer,N/A,N/A,N/A
Z-2913-2011,58920,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"""***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***""Blade used to implant screws.",Center Drive Stainless Steel 2.0MM System Screwdriver Blade,2,"August 01, 2011", 2011,"Biomet Microfixation, Inc.","Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Biomet Microfixation, sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed. If you have any questions, contact the Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.",Contact the recalling firm for information,35,35,"Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa.",Terminated,"November 09, 2011",100,35,Not_Computer,N/A,N/A,N/A
Z-2915-2011,59210,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023.The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.",GEMINI TF Big Bore ,2,"August 01, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects.",DESIGN: Software Design (Manufacturing Process),"Philips Medical Systems (Cleveland) Inc. sent an ""GEMINI TF BIG BORE CPE CUSTOMER LETTER"" dated October 20, 2011 to all affected customers. The letter describes the product, problem, and updates that are available to the customers. The letter provides additional information about acquisition workflows for SUV Calibrations and Validations.For support concerning this upgrade, contact the Customer Care Solutions Center at 1-800-722-9377.",N/A,23,23 units,"Worldwide Distribution-USA (nationwide) including the states of CO, LA, MD, MI, MO, MN, PA, TX, VA, VT and WI and the countries of Belgium, Germany, Italy, Saudi Arabia and Switzerland.",Terminated,"September 21, 2012",417,23,Software,Output/Calculation,Software update,Software Update
Z-2902-2011,59136,"analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)",CBR,Nitrous oxide gas analyzer.,Anesthesiology,Anesthesiology,510(k),"Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14.Spacelabs Healthcare Llc.Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.","Ultraview Spacelabs Medical Multigas Analyzer, Model 91518",3,"August 01, 2011", 2011,"Spacelabs Healthcare, Llc",Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.,DESIGN: Software Design,"Spacelabs Healthcare, Llc. sent a ""Customer Bulletin"" dated June 20, 2011 to all affected customers. The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual.For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.",Contact the recalling firm for information,481,481 units worldwide (333 units internationally and 148 units in the US),"Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGUA, PARAGUAY, PERU, POLAND, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, CHINA, THAILAND, UNITED ARAB EMIRATES, U.K., URUGUAY, VENEZUELA, and VIETNAM.",Terminated,"September 21, 2011",51,481,Software,N/A,N/A,N/A
Z-2901-2011,59046,"electrode, cutaneous",GXY,Cutaneous electrode.,Neurology,Neurology,510(k),"AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2""x2"", 2""x2.5"", 2""x3"", 2""x3.5"", 2""x4"", 2""x5"", 2""x6"", 2""x8"", 1.5""x3"", 1.5""x5"", 1.5""x6"", and 1""x1.5"".Cutaneous electrode garments for neuromuscular electrical stimulation.",AxioBionics Wearable Therapy BioVest/Unitard,2,"August 01, 2011", 2011,"Axiobionics, LLC",Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information.If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office . All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011.All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using. 1. Are you using your garment?2. Is your garment delivering the stimulation required for your therapy?3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel?4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair.Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated.Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.",Contact the recalling firm for information,7,7,"Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.",Terminated,"August 29, 2013",759,53,Not_Computer,N/A,N/A,N/A
Z-2910-2011,58698,"drills, burrs, trephines & accessories (simple, powered)",HBE,"Powered simple cranial drills, burrs, trephines, and their accessories.",Neurology,Neurology,510(k),"***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-06SD, QTY: 1***0.6 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium","Anspach Single Use, Sterile Bone Cutting Burrs",2,"August 01, 2011", 2011,"The Anspach Effort, Inc.","On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The Anspach Effort, Inc. sent an ""URGENT: MEDICAL DEVICE PRODUCT REMOVAL"" letter dated October 20, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers.The letter instructs customer to screen their inventory for the affected product and not to include any product received after October 18, 2010. Customers are instructed to contact Anspach Customer Support at 800-327-6887 to arrange for return and replacement of product. Customers are to complete and return a Customer Reply Form via fax at 800-327-6661.Questions regarding this notice should be directed to Anspach Customer Support at 800-327-6887.Customer notification began on 10/20/2010 in writing (Fed Ex) with instructions to return the required devices. Anspach utilized their sales representatives to facilitate the product replacement and return activities.",Contact the recalling firm for information,68,68,"Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.",Terminated,"November 07, 2011",98,908,Not_Computer,N/A,N/A,N/A
Z-2914-2011,59166,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817.Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",MX8000 Dual v. Exp CT XRay System,2,"August 01, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical,DESIGN: Device Design,"Philips Medical Systems (Cleveland) Inc. issued an ""URGENT - Medical Device Correction - Field Safety Notice"" letter dated June 1, 2011 to all affected customers, via Certified Mail for tracking purposes. The notification identified the product, the problem involved, and the action(s) to be taken by the customers with regard to this device issue. The notification instructs the customers to monitor their units and if the recalled product malfunctions, to immediately notify their Phillips service representative. The letter also states that a Philips Field Service Engineer will visit each customer location and perform a brake repair or replacement on their system to resolve the issue. For further information or support, the customers are instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada the customers are instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompt(s).",N/A,412,412 system units were distributed.,"Worldwide Distribution -- USA (nationwide) including the states of: AR, AZ, CA, CO, FL, FA, HI, IL, IN, KY, MA, MI, MO, MS, NC, NV, NY, OH, OK, SC, SD, TN, TX, VA, VT, WA and Puerto Rico and the country of Canada.",Terminated,"August 07, 2013",737,412,Not_Computer,N/A,N/A,N/A
Z-2916-2011,59441,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Vital Sign elance Monitor, Model 93300Spacelabs Healthcare, Llc.A vital signs patient monitor with arrhythmia detection.","Vital Sign elance Monitor, Model 93300",2,"August 02, 2011", 2011,"Spacelabs Healthcare, Llc","Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.",DESIGN: Process Design,"Spacelabs Healthcare, Llc sent an ""Urgent-Medical Device Correction"" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments.Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.",N/A,1970,1970 units,"Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Malaysia, Napel, Netherlands, Nicaragua, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Republic of Macedonia, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, Venezuela, and Vietnam.",Terminated,"January 25, 2012",176,1970,Other,Device Operation,Notification,Safety Notice/Insructions
Z-2919-2011,59102,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.",XiO Radiation Treatment Planning System,2,"August 03, 2011", 2011,Computerized Medical Systems Inc,The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm).,DESIGN: Software Design,"The firm, Eletka, Inc., issued an ""Important Safety Notice"" dated May 18, 2011 via mail to all affected sites. The notice explains the issue and identifies a work around to the problem until the new release is available. The customers were instructed to complete and return the enclosed ""Confirmation of Receipt"" form via FAX to 314-993-1175, attn: QA; e-mail or mail: CMS Software, Attn: QA, 13723 Riverport Drive, Suite 100, Maryland Heights, MO 63043.The notice states that ""this problem has existed since XiO Release 2.4.0 and has been resolved in XiO Release 4.63.0 by adding warning messages and explanations to the XiO On-Line Help. Your site will be notified when this release is available.""If you have any question, call 314-993-0003, 800-878-4267 or 408-830-8023.",No consumer action necessary,7,7,"Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany.",Terminated,"April 04, 2013",610,7,Other,Display/Image,Software update,Software Update
Z-2929-2011,58684,"culture media, antimicrobial susceptibility test, excluding mueller hinton agar",JSO,Culture medium for antimicrobial susceptibility tests.,Microbiology,Microbiology,510(k),"remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS.For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.",remel Haemophilus Test Medium (Agar),2,"August 03, 2011", 2011,Remel Inc,Organism strains may fail to consistently produce confluent growth,OTHER/UNDETERMINED: Pending,"The firm, Remel, Inc., sent two ""IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE"" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.",N/A,548,538/10-pack boxes,Nationwide distribution.,Terminated,"June 21, 2013",688,781,Not_Computer,N/A,N/A,N/A
Z-2918-2011,58978,"detector and alarm, arrhythmia",DSI,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System.Welch Allyn Protocol, Inc.Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.","Aruba Wireless Access Points, Model 65 ",2,"August 03, 2011", 2011,"Welch Allyn Protocol, Inc","Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.",DESIGN: Software Design,"Welch Allyn Protocol, Inc. sent a letter dated May 16, 2011 to affected customer.The letter stated there were concerns over drop-outs in the system recommended the system at this hospital to revert back tothe Symbol wireless infrastructure. For questions call Welch Allyn at 315-685-4100.",Contact the recalling firm for information,12,12 units were affected,"Worldwide distribution: (USA) Nationwide distribution including the state of California; and the countries of Singapore; Philippines, France, Italy, Malaysia, Poland, UK, England, UAE, Germany, Spain, Ireland, Portugal, New Zealand, Hong Kong, Thailand, Australia, Canada, and the Netherlands.",Terminated,"August 12, 2011",9,12,Other,N/A,N/A,N/A
Z-2931-2011,58852,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE.Boston Scientific, Corp.Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.","Pinnacle Pelvic Floor Repair KitAnterior/Apical, and Pinnacle Pelvic Floor Repair KitPosterior",2,"August 03, 2011", 2011,Boston Scientific Corporation,The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.,DESIGN: Device Design,"Boston Scientific Corporation sent on May 10, 2011 an ""URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED"" letter to all affected customers.The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm.For information call (508) 683-4678.",Contact the recalling firm for information,540,540,"Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.",Terminated,"November 15, 2011",104,540,Not_Computer,N/A,N/A,N/A
Z-2932-2011,59356,"catheter, urological",KOD,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.",RUSCH,2,"August 03, 2011", 2011,Teleflex Medical,Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.,OTHER/UNDETERMINED: Pending,"Teleflex Medical sent an ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990.",Contact the recalling firm for information,14378890,"14,378,890 units",Worldwide Distribution and (USA) Nationwide Distribution.,Open,N/A,N/A,14378902,Not_Computer,N/A,N/A,N/A
Z-2927-2011,59214,"stretcher, wheeled, powered",INK,Powered wheeled stretcher.,Physical Medicine,Physical Medicine,510(k),Stryker Medical Stretcher Model 1105 Prime 5th WheelA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.,Stryker Medical 1105 Prime 5th Wheel,2,"August 03, 2011", 2011,Stryker Medical Division of Stryker Corporation,"Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Stryker Medical sent an ""URGENT- MEDICAL DEVICE CORRECTION"" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers.The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.",Contact the recalling firm for information,23,23,"Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.",Terminated,"August 28, 2013",756,164,Not_Computer,N/A,N/A,N/A
Z-2920-2011,59419,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Baxter Solution Set with Duo-Vent Spike; 109"" (2.8 m), Male Luer Lock Adapter 10 drops/mL.Baxter Healthcare Corporation.A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.",Baxter Solution Set with DuoVent Spike,2,"August 03, 2011", 2011,Baxter Healthcare Corp.,"The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.",TRAINING: Employee Error,"Baxter Healthcare Corporation sent a ""Urgent Product Recall"" letter dated July 21, 2011 to all affected customers.The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers.For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.",N/A,4752,"4,752 units","(USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.",Terminated,"June 18, 2012",320,4752,Not_Computer,N/A,N/A,N/A
Z-2930-2011,59300,"system,surgical,computer controlled instrument",NAY,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Intuitive Surgical da Vinci Si Surgical System (IS3000);Mfg by: Intuitive Surgical, Sunnyvale, CA 94086Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.",Intuitive Surgical da Vinci Si Surgical System (IS3000),2,"August 03, 2011", 2011,"Intuitive Surgical, Inc.",Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.,DESIGN: Device Design,"Intuitive Surgical sent an ""URGENT- MEDICAL DEVICE CORRECTION"" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent medical device correction and actions to be taken. If you have any questions, please contact Customer Service at 1-800-876-1310 or for Outside United States call +41 21 821 2020.",N/A,183,183,"Worldwide Distribution -- USA (nationwide) and the countries of: Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Netherlands, Norway, Philippines, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Turkey and United Kingdom.",Terminated,"September 02, 2011",30,183,Not_Computer,N/A,N/A,N/A
Z-2917-2011,59301,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530.The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years.The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.","Powerheart AED, G2",2,"August 03, 2011", 2011,Cardiac Science Corporation,"Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying any ""Service Required"" self test messages.",PRODUCTION CONTROLS: Manufacturing Material Removal,"Cardiac Science Corporation (CSC) sent two ""9200 SERIES CARDIAC SCIENCE AED NOTICE"" letters dated August 2010 and March 2011 to all affected customers. The letters identifies the product, problem, and actions to be taken by the customers.Customers are encouraged to upgrade their devices through special offers by calling CSC at 800-426-0337, Option 2.For questions about the end of factory support for the affected devices, call the Technical Support team at 800-426-0337, Option 1.*****In August 2011, Cardiac Science sent out another updated recall notification letter to their consignees. This letter stated that once a device has entered the ""Service Required"" state, please contact the firm at 800.426.0337 Option 2. Per prior notifications, the 9200 series AEDs have reached the end of service life and can no longer be repaired. Information about these notifications may be found as an announcement in the Services and Support section of Cardiac Science website.Cardiac Science advised the customers to upgrade to a Powerheart AED G3 (this device supports the 2010 AHA/ERC Guidelines). It is stronglyrecommended that customer to choose a replacement AED prior to the current AED displaying any ""Service Required"" self test messages. For information about special offers to help you upgrade please call 800.426.0337. Option 2.",Contact the recalling firm for information,7304,"48,700 units (41396 units in US; 7304 units Internationally)","Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.",Terminated,"December 20, 2011",139,48700,Not_Computer,N/A,N/A,N/A
Z-2945-2011,59058,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Vanguard PS Open Box Femoral 70 MM Left Interlock, "" FOR CEMENTED USE ONLY"" CO-CR-MO ALLOY.Biomet, Inc.A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.",Vanguard PS Open Box Femoral 70MM Left Interlok,2,"August 04, 2011", 2011,"Biomet, Inc.",The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.,TRAINING: Employee Error,"Biomet Orthopedics sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" letter to all affected customers.The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form.For information or questions on this recall call Biomet at (574) 371-3756.",N/A,8,8,"Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.",Terminated,"September 26, 2012",419,8,Not_Computer,N/A,N/A,N/A
Z-2948-2011,59252,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"BrightView XCT Gamma Camera, 3/8"".Philips Medical Systems, Inc.Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.","BrightView XCT Gamma Camera, 3/8"".",2,"August 04, 2011", 2011,Philips Medical Systems,"Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.",DESIGN: Software Design,"Philips Medical Systems, Inc. set a ""Customer Information"" letter dated July 8, 2011 to all affected customers.The letter informed them of an upcoming software updated (version 2.5).For questions please contact 800-722-9377 (option 5).",N/A,213,"213 units, all systems","Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.",Terminated,"February 15, 2013",561,213,Software,N/A,N/A,N/A
Z-2950-2011,59454,"reservoir, blood, cardiopulmonary bypass",DTN,Cardiopulmonary bypass blood reservoir.,Cardiovascular,Cardiovascular,510(k),"CAPIOX¶_ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921***Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.",CAPIOX Flexible Venous Reservoir,2,"August 04, 2011", 2011,Terumo Cardiovascular Corporation,Reservoir blood bag used in cardiovascular procedures may leak.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo Cardiovascular Systems Corporation sent an ""URGENT MEDICAL DEVICE REMOVAL"" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.",N/A,253,253 reservoirs,"(USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.",Terminated,"February 10, 2012",190,253,Not_Computer,N/A,N/A,N/A
Z-2946-2011,59368,"catheter, embolectomy",DXE,Embolectomy catheter.,Cardiovascular,Cardiovascular,510(k),"Vascular Solutions, Pronto¶_ V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall.The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.","Vascular Solutions, Pronto V4, Extraction Catheter",2,"August 04, 2011", 2011,"Vascular Solutions, Inc.","Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This maycause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patientwhich may require medical intervention.",PRODUCTION CONTROLS: Process Control,"Vascular Solutions, Inc. sent an ""URGENT: MEDICAL DEVICE FIELD ACTION"" letter dated July 8, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers.The letter instructs customers to identify the affected product and remove from current inventory. Included with the letter was a Field Action Customer Inventory Form for customers to complete and return. VSI will contact customers for replacement product upon receipt of the form and returned product.Contact your local representative for questions concerning this notice.",Contact the recalling firm for information,1086,1086,"Nationwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, FL, ID, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK ,OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.",Terminated,"April 03, 2012",243,1086,Not_Computer,N/A,N/A,N/A
Z-2952-2011,59382,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.",Laser Guide Catheter,2,"August 04, 2011", 2011,Spectranetics Corporation,"Packaging integrity may be compromised, thus sterility can not be assured.",DESIGN: Packaging Design/Selection,"Spectranetics sent an ""PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS"" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers.The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product.Further information is available at +011.49.719.447.2539.",Contact the recalling firm for information,123,123 units,"Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.",Terminated,"August 12, 2011",8,180,Not_Computer,N/A,N/A,N/A
Z-2953-2011,58043,"system, multipurpose for in vitro coagulation studies",JPA,Multipurpose system for in vitro coagulation studies.,Hematology,Hematology,510(k),Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx.A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.,Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). ,2,"August 05, 2011", 2011,International Technidyne Corp.,Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments.,DESIGN: Device Design,"International Technidyne Corp. (ITC) sent ""Urgent Medical Device Recall"" letters dated May 10, May 25 and June 09, 2011 to all affected customers.The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement.For questions, please contact ITC Technical Support at (800) 631-5945.",N/A,4713,"6,218 boxes in US ; 4713 boxes outside US","Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.",Terminated,"November 02, 2012",455,10931,Not_Computer,N/A,N/A,N/A
Z-2956-2011,59379,"apparatus, autotransfusion",CAC,Autotransfusion apparatus.,Anesthesiology,Anesthesiology,510(k),"Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion SystemModel 2050 USModels Out-Side the US:02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JAThe Haemonetics¶_ Cardiovascular Perioperative Autotransfusion Systemfor Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgicalprocedures, where the expected rate of processing of salvaged blood and fluidaspirated from the surgical site is less than or equal to two liters per hour.",Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System,2,"August 05, 2011", 2011,Haemonetics Corporation,Updated Operations Manual for the deployment of the spill collection system and cleaning,DESIGN: Component Design/Selection,"Haemonetics sent a ""FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING"" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and Quick Reference Guide Addendum are enclosed with the letter.Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..",Contact the recalling firm for information,316,316 units,"Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.",Open,N/A,N/A,316,Not_Computer,N/A,N/A,N/A
Z-2955-2011,59392,"cable, electrode",IKD,Electrode cable.,Physical Medicine,Physical Medicine,510(K) Exempt,"Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345.Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.",Supreme Electrophysiology Extension Cable,2,"August 05, 2011", 2011,St. Jude Medical,St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexap,PRODUCTION CONTROLS: Labeling Mix-Ups,"St. Jude Medical sent an ""IMPORTANT MEDICAL DEVICE FIELD ADVISORY NOTICE"" letter dated June 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to locate the affected product and to complete and return an attached SJM AFD Reconciliation Form. The form will be used to replace product and as documentation that the customers received the notice. Fax the completed form to 877-497-031.Contact the Director of Product Marketing at 512-329-1054 for questions regarding this notice.",Contact the recalling firm for information,32,32,"Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.",Terminated,"August 16, 2012",377,32,Not_Computer,N/A,N/A,N/A
Z-2959-2011,59119,"catheter, peritoneal, long-term indwelling",FJS,Peritoneal dialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.",Aspira Peritoneal Drainage system ,3,"August 08, 2011", 2011,Bard Access Systems,Labeling for drainage kit contained incomplete information.,PRODUCTION CONTROLS: Error in Labeling,"The firm, BARD, sent a letter entitled ""Labeling Discrepancy on Aspira Drainage Accessory Kits"" dated June 12, 2011 to its customers. The letter provides the customers with the information missing from the labeling and/or IFU stating that the product can be safely used for peritoneal and pleural applications.If you have any questions please do not hesitate to contact BARD at 1-800-290-1689. If there are any clinical questions please contact Medical Services and Support at 1-866-893-2691.",N/A,39290,"39,290 units",Nationwide distribution.,Terminated,"November 02, 2011",86,68530,Not_Computer,N/A,N/A,N/A
Z-2957-2011,59352,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.",HOLDEX SingleUse Holder PP,2,"August 08, 2011", 2011,"Greiner Bio-One North America, Inc.","At removal of the tube from the holder, the needle may dislodge and blood spill can occur.",OTHER/UNDETERMINED: Pending,"Greiner Bio-One North America, Inc. sent a ""Recall HOLDEX Single Use Holder PP"" letter dated June 29, 2011 to all affected customers.The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item.For additional information call Greiner Bio-One at (888) 266-3883.",Contact the recalling firm for information,142400,"142,400 pieces","Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.",Terminated,"November 03, 2011",87,142400,Not_Computer,N/A,N/A,N/A
Z-2958-2011,59449,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.",Colleague CX Infusion Pump,2,"August 08, 2011", 2011,Baxter Healthcare Corp.,Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications,OTHER/UNDETERMINED: Pending,"Baxter Healthcare Corp. notified the consignee by telephoned on July 22, 2011, with the call documented per the approved call script. A follow-up ""URGENT PRODUCT RECALL"" notification was sent dated July 25, 2011, reiterating the telephone communication informing them that the COLLEAGUE pump may not have met certain PSIG (Pounds-force per Square Inch) specifications after testing by the Baxter Global Technical Service Center. Both forms of notification identified the affected product, problem description, hazard involved, and actions needed to be taken. The consignee was instructed to locate the device, remove it from service and return it to Baxter by contacting Baxter Global Technical Services at 1-800-843-7867 option 1, to obtain a prepaid UPS label and shipping box. Upon receipt of the returned unit, Baxter will perform the required testing and address any issues through repair or service. The notication instructs the consignee to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter as per the instructions provided. If the recalled product have been distributed to another facility, or if you are a dealers, wholesalers and distributors, the letter request that this communication be forward to the pump owner as appropriate. For any questions regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central time.",N/A,1,1 unit,(USA) Nationwide Distribution including the state of Minnesota.,Terminated,"February 14, 2012",190,1,Not_Computer,N/A,N/A,N/A
Z-2965-2011,59330,excimer laser system,LZS,N/A,N/A,Ophthalmic,N/A,"STAR S4 IR Excimer Laser System; Software Version 5.00Mfg by : AMO Manufacturing USA, LLC510 Cottonwood DriveMilpitas, CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.",STAR S4 IR Excimer Laser System; Software Version 5.00,2,"August 09, 2011", 2011,"AMO Manufacturing USA, LLC",Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version.,DESIGN: Software Design,"Abbott Medical Optics (AMO) sent an ""ADVISORY NOTICE"" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.Contact an AMO representative for questions regarding this notice.",N/A,673,673 total v 5.00 - 5.22,"Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.",Terminated,"September 10, 2013",763,673,Software,N/A,Instructions,Safety Notice/Insructions
Z-2964-2011,59426,"instrument, measuring, corneal radius",HJB,Corneal radius measuring device.,Ophthalmic,Ophthalmic,510(K) Exempt,"Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System.Haag-Streit USA, Inc.A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.","Lenstar LS 900 EyeSuite Biometry version i2.000,",2,"August 09, 2011", 2011,Haag-Streit USA Inc,A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.,N/A,"Haag-Streit USA, Inc. sent an ""Urgent Field Safety Notices"" dated June 20, 2011 to all affected customers.The letter included a description of the affected product and problem. The firm instructed their customers to make sure all new and current templates are saved and upgrade to EyeSuite version i4.000. Customers are asked to complete and return the Software Update Verification Form.For additional information contact the Haag-Streit at (513) 398-3937.",N/A,216,216,Nationwide (USA) Distribution.,Terminated,"March 08, 2013",577,216,Software,Output/Calculation,Software update,Software Update
Z-2963-2011,59349,"wire, orthodontic",DZC,Orthodontic appliance and accessories.,Dental,Dental,510(K) Exempt,"Heat Activated Niti Arches, Natural, Upper, .019x 25"", Arch Wires.Packaged in 19 packages of 100 and 6 packages of 10.Highland Metals, Inc.Wire used for orthodontic treatment to place in the brackets to shape teeth.","Heat Activated Niti Arches, Natural, Upper, .019x 25"", Arch Wires.",3,"August 09, 2011", 2011,Highland Metals,"Heat Activated Niti, Natural, Upper, .019 x 25"" Arch wires mixed with size 021x0.25"" Arch Wires.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Highland Metals, Inc. notified their affected customers by e-mail and followed with an ""Important Alert"" letter dated July 12, 2011.The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued.For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.",N/A,10,10 packages of 100,"Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.",Terminated,"September 14, 2011",36,10,Not_Computer,N/A,N/A,N/A
Z-2981-2011,55941,"system, imaging, pulsed echo, ultrasonic",IYO,Ultrasonic pulsed echo imaging system.,Radiology,Radiology,510(k),"Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.",Aplio XG model SSA790A ,2,"August 10, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.",DESIGN: Device Design,"Toshiba America Medical Systems (TAMS) sent an ""URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054.Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.",Contact the recalling firm for information,78,78,Nationwide Distribution,Terminated,"April 20, 2012",254,78,Not_Computer,N/A,N/A,N/A
Z-2980-2011,58918,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc.An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet.",Symbia Radiation Therapy Pallet,2,"August 10, 2011", 2011,"Siemens Medical Solutions USA, Inc.","There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.",DESIGN: Device Design,"Siemens Medical Solutions USA, Inc. sent an ""Urgent Field Correction Recall"" letter dated June 06, 2011 to all affected customers.The letter informs customers of the potential safety issue if the patient is not iso-centered before starting a scan and a non-circular orbit is selected and provided recommendations including ensure the patient is iso-centered before starting a scan. If the patient cannot be positioned at the iso-center of the RTP, instructions were provided. The customers are asked to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.For questions or assistance contact Siemens Medical Solutions USA, Inc. at (800) 888-7436 (USA).",N/A,18,18 pallets,"Worldwide Distribution: Nationwide (USA) including the states of Florida and Texas; and the countries of Canada, China, Italy, Mexico, Poland, Portugal and Russia.",Terminated,"November 27, 2012",475,18,Not_Computer,N/A,N/A,N/A
Z-2977-2011,59107,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems.Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany.Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.",ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems,2,"August 10, 2011", 2011,"Siemens Medical Solutions USA, Inc",A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.,DESIGN: Software Design,"Siemens sent an ""URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE"" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter provides preventive measure instructions for customers to use until an update for the system is available.",Contact the recalling firm for information,121,121 devices,"Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.",Terminated,"March 30, 2012",233,121,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-2994-2011,58744,"system, photopheresis, extracorporeal",LNR,N/A,N/A,Gastroenterology/Urology,N/A,"XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENTSingle-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient.",THERAKOS UVAR XTS Procedural Kits,2,"August 10, 2011", 2011,"Therakos, Inc.",Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.,DESIGN: Device Design,"The firm, Therakos Photopheresis, sent a ""URGENT PRODUCT CORRECTION NOTIFICATION"" letter dated March 31, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue using the affected products; deface and discard their remaining inventory of affected procedural kits, following their internal procedures for destroying and discarding of medical waste, and complete and return the attached Confirmation of Receipt Form no later than 08-April-2011 via fax to: Safety, Risk Management and Surveillance at 1-888-557-3759 or 1-585-453-4110. If you have any additional technical questions, please contact Therakos Customer Service Center at 1-800-828-6316. If you have technical questions regarding this communication, please call Therakos Technical Support at 1-877-865-6850.",N/A,13239,13239 kits,"Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD,TN, TX, UT, VA, VT, WA, and WI; and countries of: Argentina, Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Kingdom of Saudi Arabia, Jordan, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.",Open,N/A,N/A,13239,Not_Computer,N/A,N/A,N/A
Z-2990-2011,59042,"ventilator, non-continuous (respirator)",BZD,Noncontinuous ventilator (IPPB).,Anesthesiology,Anesthesiology,510(k),DeVilbiss Model DV5x Series CPAP with Heated HumidifierDevice is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.,DeVilbiss Model DV5x Series CPAP with Heated Humidifier,2,"August 10, 2011", 2011,Sunrise Medical HHG Inc. dba DeVilbiss Healthcare,"Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, DeVilbiss Healthcare, issued a ""URGENT: MEDICAL DEVICE CORRECTION"" letter dated March 11, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to verify their inventory of CPAPs with Heated Humidifiers and isolate any units that are included in the list; replace the humidifier chamber o-rings with the new ones provided; discard the original o-ring removed from the humidifier chamber; complete and return the URGENT: MEDICAL DEVICE CORRECTION Confirmation letter via mail to Quality Manager, DeVilbiss Healthcare LLC, 100 DeVilbiss Drive, Somerset, PA, 15501; affirm that all units have been corrected and that all end users have been sent replacement parts, when all of the CPAPs on the serial number list have been corrected, and return a copy of the sign serial number sheet as confirmation.If you have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800-388-1988 from 8:00AM-5:00PM EST.",N/A,210,210,"Worldwide distribution; USA (nationwide) including states of AL, AR, CA, FL, IL, IN, IA, KS, KY, MD, MA, MI, MS, NE, NJ, NY, OH, PA, WA, WV, and WI; and countries of Europe.",Open,N/A,N/A,210,Not_Computer,N/A,N/A,N/A
Z-2978-2011,59087,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators.Varian Medical Systems, Inc. Oncology SystemsIntended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.","Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators",2,"August 10, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.",DESIGN: Device Design,"Varian Medical Systems sent an ""Urgent Medical Device Correction-Urgent Field Safety Notice"" letter dated May 26, 2011 to all affected customers.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifies the product, describes the problem and provides recommendations. Varian recommends maintenance only be performed by qualified personnel with appropriate training, always verify collimator calibration and anytime a collimator posthion readout calibration is performed, and always verify that the collimator angle is not calibrated in reverse by performing the appropriate checks. For questions contact Varian at (888) 827-4265.",N/A,5685,5685,"Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and Herzegoniva, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Rep., Denmark, D.R. Ecuador, Egypt, Estonia, Finland, France, French Poly., Georgia, Germany, Greece, Guam, Guatemala, H.K., Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Martinique, Mexico, Moldova, Monte Negro, Morocco, Nepal, Netherlands, N.Z., Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, P.R., Qatar, Reunion, Romania, Russia, S.A.,Serbia, Singapore, Slovakia, South Africa, S.K., Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Ukrain, U.A.E., U.K., Uruguay, Venezuela, Vietnam, V.I., and Zimbabwe.",Terminated,"July 13, 2012",338,5685,Not_Computer,N/A,N/A,N/A
Z-2979-2011,59170,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging,MAGNETOM Aera/Skyra,2,"August 10, 2011", 2011,"Siemens Medical Solutions USA, Inc","Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens sent a ""CUSTOMER SAFETY ADVISORY NOTICE"" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken.The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.",N/A,26,26,"Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.",Terminated,"January 14, 2014",888,26,Not_Computer,N/A,N/A,N/A
Z-2992-2011,59401,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm.Remote controlled radionuclide applicator system.Varian Medical Systems, Inc.Mfg by Varian Medical Systems Haan GmbH, Haan, GermanyProduct Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin",GammaMed Plastic Needle with Mandrin,2,"August 10, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.,DESIGN: Device Design,"Varian sent an ""Urgent Medical Device Correction/Urgent Field Safety Notice"" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous ""Customer Technical Bulletins"" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.",N/A,601,601 - all sizes.,"Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.",Terminated,"June 20, 2012",315,601,Not_Computer,N/A,N/A,N/A
Z-2989-2011,59362,"system, therapeutic, x-ray",JAD,X-ray radiation therapy system.,Radiology,Radiology,510(k),"INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO0.05 mm Pb Equivalent (50keV)Carl Zeiss Meditec AGIndicated for radiation therapy treatments.",INTRABEAM Shielding Material ,2,"August 10, 2011", 2011,"Carl Zeiss Meditec, Inc.","Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,",PRODUCTION CONTROLS: Process Control,"Carl Zeiss Meditec, Inc. sent an ""Important Field Correction Action"" letter dated July 13, 2011 to all affected customers.The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844.",N/A,8,8 boxes of 10 sterile packages.,"Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.",Terminated,"October 13, 2011",64,8,Not_Computer,N/A,N/A,N/A
Z-2983-2011,59347,"device, digital image storage, radiological",LMB,Medical image storage device.,Radiology,Radiology,510(K) Exempt,"LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens.An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface.System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander.Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS,LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.",IMPAC / Elekta Medicals Sequencer,2,"August 10, 2011", 2011,"Siemens Medical Solutions USA, Inc",A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R; system via a third party interface is used.,DESIGN: Software Design,"Siemens sent an ""Update Instructions/Customer Safety Advisory Notice"" to all affected users, beginning June 30, 2011.The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system.If you have questions contact Siemens at (925) 602-8157.",N/A,59,59 devices,"Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.",Terminated,"March 09, 2012",212,59,Software,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-2986-2011,59367,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BXIntended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.",Direct Drive Grasper,2,"August 10, 2011", 2011,Applied Medical Resources Corp,"The recall was initiated because Applied Medical has confirmed specific lot numbers of the DirectDrive¶_ Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing and the jaw locking in the closed position.",DESIGN: Device Design,"Applied Medical sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated June 22, to all affected consignees. The letter described the product, problem and actions to be taken. Consignees were instructed to check their inventory for the recalled products and returned immediately as per the instructions. The letter instructs consignees to complete the attached Voluntary Recall Notification Confirmation Form and fax it to Regulatory Affairs at 949-713-8832 or email it to recall60342148@appliedmedical.com. For questions pertaining to product return contact Chris Jacobson, Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. For regulatory questions contact Susan Fehrenbacher at (949) 713-8041 or by email at sfehrenbacker@appliedmedical.com.",Contact the recalling firm for information,38864,"38,864 units total (24,868 units in US)","Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.",Terminated,"March 26, 2012",229,38864,Not_Computer,N/A,N/A,N/A
Z-2982-2011,59386,N/A,N/A,N/A,N/A,N/A,N/A,"Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case.Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies",North Coast MediTek Inc Biopsy Trays,2,"August 10, 2011", 2011,North Coast Medi-Tek Inc,"During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as",OTHER/UNDETERMINED: Pending,"North Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product.For further questions please call (440) 974-0750.",N/A,2190,"2,190 trays","Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX",Terminated,"February 16, 2012",190,2190,Not_Computer,N/A,N/A,N/A
Z-2985-2011,59221,N/A,N/A,N/A,N/A,N/A,N/A,"ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516).Medtronic Sofamor Danek USA, Inc.This instrument is a precision device which incorporates a measuring function.",ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy ,2,"August 10, 2011", 2011,Medtronic Sofamor Danek USA Inc,Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.,PRODUCTION CONTROLS: Process Control,"Medtronic Sofamor Danek USA, Inc. sent ""Voluntary Recall - Medtronic"" letters on July, 2011 to all affected customers.The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement.For question on this recall call Medtronics Global Quality Department at (800) 876-3133.",Contact the recalling firm for information,191,191 units,"Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.",Terminated,"April 26, 2013",625,1064,Not_Computer,N/A,N/A,N/A
Z-2976-2011,59296,"system, x-ray, angiographic",IZI,Angiographic x-ray system.,Radiology,Radiology,510(k),"Allura Xper Systems Models:Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table)Allura Xper FD20- High resolution fixed-x rayAllura Xper FD20/10Allura Xper FD20/20Allura CV20The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)",Philips Medical Allura Xper Systems,2,"August 10, 2011", 2011,Philips Healthcare Inc.,System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.,DESIGN: Software Design,"Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly.Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.",Contact the recalling firm for information,1423,1423 units,Nationwide Distribution,Open,N/A,N/A,1423,Software,Device Operation,Firmware update,Software Update
Z-3001-2011,58322,N/A,N/A,N/A,N/A,N/A,N/A,"Micro-Fuel Cell Oxygen Sensor, Class RI5Sensor Part Number: C41131-R15Teledyne Instruments - Analytical InstrumentsDisposable oxygen sensors with limited useful life. These sensors are accessories to other oxygen diagnostic devices, and are not in themselves suitable for therapeutic use.","MicroFuel Cell Oxygen Sensor, Class RI5",2,"August 11, 2011", 2011,Teledyne Instruments - Analytical Instruments,"The recall was initiated because during a test on a batch of sensors on the company shipping dock, Teledyne Instruments discovered electrolyte loss from the sealing cylinder on a few sensors. This test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. The riskof a leak form the oxygen sensor while in use is the disruption of therape",DESIGN: Process Design,"Teledyne Instruments sent emails and ""Urgent--Device Field Corrections/Removal"" letters in December 2010 to all affected customers.Th letter includes description of device and problem. Customers are advised to check them before use for any signs of electrolyte loss and if discoloration is noted to discontinue its use. and provides recommendation. Teledyne-desplaines to generate a product field corrections/removal log that lists names/addresses of the consignees, quantity of sensors shipped, sensor serial numbers and the date of shipment.For additional information or questions contact Teledyne Instruments at (626) 934-1504.",N/A,2813,2813,"Worldwide Distribution: Nationwide (US) distribution including the states of CA, TN and WI; and the countries of , Canada, Brazil, Chile, Saudi Arabia, and the U.K.",Terminated,"August 22, 2011",11,2813,Not_Computer,N/A,N/A,N/A
Z-3010-2011,59112,"stretcher, hand-carried",FPP,Hand-carried stretcher.,General Hospital,General Hospital,510(K) Exempt,Stryker Evacuation Chair Model 6254It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.,Stryker Evacuation Chair ,2,"August 11, 2011", 2011,Stryker Medical Division of Stryker Corporation,"Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanently engage the track locking mechanism",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Stryker Medical, sent an ""Urgent-Medical Device Recall"" letter dated June 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate the listed product; inspect each unit prior to use; return the enclosed post card to confirm receipt of this notification; if they have loaned or sold any of the chairs listed, forward a copy this letter to the new users and advise Stryker of new users names and locations, and if they have disposed of any of the affected chairs and they are no longer in use, advise Stryker of their obsolescence by providing them with the serial numbers. Stryker stated in the letter that, their goal is the timely upgrade of all affected units within the next 90 days.If you have any questions or concerns, please contact us at 800-STRYKER, option 2. Please reference RA-2011-027. Normal business hours are Monday-Friday 8am-5pm EST.",N/A,220,220,"Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.",Terminated,"August 29, 2013",749,434,Not_Computer,N/A,N/A,N/A
Z-3003-2011,59122,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"ARTISTE Linear Accelerator with RT Therapist v4.1 system.Siemens Medical Solutions, Kemnath, Germany.Distributed by Siemens Medical Solutions, Concord, CA 94520.Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.", Linear Accelerator,2,"August 11, 2011", 2011,"Siemens Medical Solutions USA, Inc",A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.,DESIGN: Software Design,"Siemens sent an ""Urgent: Medical Device Correction/ Customer Safety Advisory Notice"" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter ""Safety Advisory Letters"" where it should remain.",N/A,223,223 active devices,"Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.",Terminated,"February 17, 2012",190,223,Software,Device Operation,Software update,Software Update
Z-2997-2011,59404,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 80 mm, 30 degree angle.Varian Medical Systems, Palo Alto, CA;Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany.To treat cancer of the uterus, cervix, endometrium and vagina.",Titanium Fletcherstyle Applicator Set Defined Geometry CT Compatible,2,"August 11, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.,DESIGN: Device Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE"" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to return all affected product to Varian Brachy Therapy by using the contact information provided in the letter. Replacement product will be provided free of charge to the customers.Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.",N/A,437,437 - all sizes,Worldwide Distribution.,Terminated,"June 20, 2012",314,437,Not_Computer,N/A,N/A,N/A
Z-3008-2011,59445,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161",Colleague CX Infusion Pump,2,"August 11, 2011", 2011,Baxter Healthcare Corp.,A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.,OTHER/UNDETERMINED: Pending,"The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up ""Urgent Product Recall"" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com.If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.",Contact the recalling firm for information,1,1 pump,Nationwide distribution: Missouri only.,Terminated,"October 19, 2011",69,1,Hardware,Treatment/Delivery/Therapy,Return,Remove or Replace
Z-3002-2011,59378,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System;Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (Brachytherapy) treatments.",ECLIPSE TREATMENT PLANNING SYSTEM,2,"August 11, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution.",DESIGN: Software Design,"Varian sent an ""Urgent Medical Device Correction/Urgent Field Safety Notice"" letter dated June 30, 2011 to all affected consignees. The letter identifies the affected product, problem, and actions to be taken. The letter states that Varian will contact all affected customers to apply a database configuration script to the database and is preparing a correction for Eclipse Version 10 to address the issue. A Varian representative will contact each site to schedule correction when it is available. The letter also provides RECOMMENDED USER ACTIONS to follow. The Letters go on to reiterate caution and warnings from Eclipse instructions for use. All appropriate personnel should be notified of the correction notice. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. For further clarification, contact your local Varian Customer Support District or Regional Manager.",N/A,2436,2436,Worldwide Distribution.,Open,N/A,N/A,2436,Software,Treatment/Delivery/Therapy,Upgrade,Repair
Z-3007-2011,59448,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.",Colleague CX Infusion Pump,2,"August 11, 2011", 2011,Baxter Healthcare Corp.,The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.,DESIGN: Process Design,"The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up ""Urgent Product Recall"" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump; promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com, and forward this communication to the pump owner as appropriate, if they distributed the pump to another facility or if they are dealers, wholesalers, or distributors/resellers.The letter states ""Upon receipt of the returned device, Baxter will perform required testing on the affected COLLEAGUE pump for which you have indicated there is continuing medical necessity. Should Baxter find any issues during testing, Baxter will address those issues through repair or service prior to returning the pump to you at no charge"".If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.",Contact the recalling firm for information,1,1 Pump,Nationwide distribution: MN only.,Terminated,"November 09, 2011",90,1,Not_Computer,N/A,N/A,N/A
Z-3005-2011,59416,"clamp, vascular",DXC,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/BxSurgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.",Surgical Clamp Inserts,2,"August 11, 2011", 2011,Applied Medical Resources Corp,"The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier.",PRODUCTION CONTROLS: Packaging Process Control,"The firm, Applied Medical, sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated March 11, 2011 to its customers. The letter provides customers with an explanation of the problem identified and actions to be taken. The customers were instructed to check their inventory; complete and return the attached Voluntary Recall Notification Confirmation Form via fax to Regulatory Affairs at 949-713-8832, and return the recalled Standard 86mm Inserts immediately to Applied Medical, Attn: RGA# 60308783, 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688.Customers with product return questions, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.",Contact the recalling firm for information,20247,"20,247 units total","Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.",Terminated,"March 26, 2012",228,20247,Not_Computer,N/A,N/A,N/A
Z-3009-2011,59275,"system, x-ray, mobile",IZL,Mobile x-ray system.,Radiology,Radiology,510(k),Siemens Axiom Artis U mobile x-ray systemProduct Usage: Mobile x-ray system,Axiom Artis U,2,"August 11, 2011", 2011,"Siemens Medical Solutions USA, Inc","When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message ""Door is Open"" or ""Err 421/240:",MISBRANDING: Labeling False and Misleading,"Siemens sent a ""Customer Safety Advisory Notice"" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.",N/A,18,18,"Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.",Terminated,"January 24, 2014",897,18,Not_Computer,N/A,N/A,N/A
Z-3014-2011,59463,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems.Aesculap AG.Intended to replace a hip joint,Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Sho,2,"August 12, 2011", 2011,Aesculap Inc,"Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.",N/A,"AESCULAP Implant Systems sent an ""Important Recall Notification"" letter dated to all affected customers.The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP.For additional information on this recall call (610) 984-9239 or (610) 984-9300.",N/A,149,149,"Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.",Terminated,"March 19, 2013",585,149,Not_Computer,N/A,N/A,N/A
Z-3018-2011,57583,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"i-CAT Classic (X-Ray Tube head and Power Supply)X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.",iCAT Classic (XRay Tube head and Power Supply),2,"August 12, 2011", 2011,"Imaging Sciences International, LLC",Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply,OTHER/UNDETERMINED: Pending,"The firm, Imaging Sciences, sent an ""Urgent Medical Device Field Correction"" letter dated December 15, 2011 via first class USPS to its customer. The letter noted the product and described the problem and action to be taken. The customer was instructed to complete and return the ACKNOWLEDGEMENT FORM via fax to 215-997-5665 or email: darin.oppenheimer@imagingsciences.com. Imaging Sciences stated in the letter that an X-ray tube head and power supply will be provided and installed by one of their technicians. Should you have any questions regarding this information, call 215-622-1545.",Contact the recalling firm for information,1,1,"X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169",Terminated,"March 01, 2013",567,1,Not_Computer,N/A,N/A,N/A
Z-3012-2011,59059,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.","GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations ",2,"August 12, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety.When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1.Two different",DESIGN: Software Design,"GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer.GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you to arrange for this correction.If you have any questions or concerns regarding this notification, please call one of the following phone numbers:United States: 800 437 1171Japan: 0120 - 055 - 919For other countries, please contact your local GE Healthcare Service Representative.",Contact the recalling firm for information,391,391,"Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.",Terminated,"June 29, 2012",322,391,Software,N/A,N/A,Other
Z-3017-2011,59517,"pump, infusion, insulin",LZG,Infusion pump.,General Hospital,General Hospital,510(k),Animas 2020 Insulin Infusion Pump.Animas Corp.An insulin infusion.,Animas 2020 Insulin Infusion Pump,2,"August 12, 2011", 2011,Animas Corporation,"Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a ""Replace Battery"" alarm not related to the condition of the battery.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Animas Corporation sent an ""Urgent: Insulin Pump Recall"" letter dated July, 29 20011 to all affected customers.The letter included affected product and problem. They requested anyone who received the pump to send it back to Animas and a replacement pump will be sent at no charge.For additional information contact the Customer Support Department at (877) 937-7867.",Contact the recalling firm for information,380,380,"Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.",Terminated,"December 07, 2011",117,380,Hardware,Alarm/Message,Replace device,Remove or Replace
Z-3015-2011,59398,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and OfficemateThe Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: "" Officemate has one small monitor "" FSIII has two larger monitors "" FSIIIc is an international version of the FSIII (power kit)",Fluoroscan Mini Carm,2,"August 12, 2011", 2011,"Hologic, Inc.",The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Hologic, Inc., sent an ""Urgent: Medical Device Recall"" letter dated July 25, 2011 via FedEx to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to visually check the the Flex arm/C-arm on their unit for any sign of damage or cracking, if any damage or cracks are observed, remove the unit from service until they receive the retrofit kit; and to complete and return the Confirmation of Notification form via fax to Hologic at 781-280-0662 or mail using the enclosed pre-addressed, pre-paid return envelope. After the customer confirms that they have the unit in their possession, Hologic will expedite the user installable repair kit. The kits will be available starting the first week of August. The kits will also be dispatched via FedEx. Confirmation of installation will be requested for all dispatched kits.Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.",N/A,540,540 units,"Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.",Terminated,"June 19, 2012",312,540,Not_Computer,N/A,N/A,N/A
Z-3016-2011,59376,nebulizer (direct patient interface),CAF,Nebulizer.,Anesthesiology,Anesthesiology,510(k),"AirLife Nebulizer Heater, Catalog Code 2M8021The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing.",AirLife Nebulizer Heater,2,"August 12, 2011", 2011,Carefusion 211 Inc,"The recall was initiated because CareFusion's Investigation has confirmed the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks being emitted from the device. In the presence of oxygen enriched environments and a fuel source, this failure represents a potentialrisk of flame. CareFusion is voluntarily rec",OTHER/UNDETERMINED: Pending,"Carefusion sent a URGENT PRODUCT RECALL letter dated July 15, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to examine their inventory for the affected product as indicated on the sample shown in the enclosed Attachment A-1 and remove any affected heaters present in their facility. Confirm the total number of affected units in their possession and enter the quantity and respective serial number on the enclosed Customer Response Card (Attachment A-2). Customers were instructed to contact CareFusion's Technical Support Department at 800-554-8933, (6:30 am to 5:00 pm PDST), to obtain an RMA (returned materials authorization) number for the return of the affected product. Upon receipt of their response, CareFusion will ship to their customers new replacement Nebulizer Heaters in exchange for the affected units.Customers were instructed to acknowledge receipt of this communication by completing the enclosed Customer Response Card and faxing or sending a copy by return mail to the address indicated on the Customer Response Card, (Attachment A-2).",Contact the recalling firm for information,22670,"22,670 units total",Nationwide Distribution,Terminated,"April 30, 2012",262,22670,Hardware,Physical Safety Hazards,Remove,Remove or Replace
Z-3013-2011,59388,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF.Varian Medical Systems, Palo Alto, CA.Mfg by Varian Medical Systems, Haan GmbH.Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.",GammaMed Flexible Applicator ,2,"August 12, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.,PRODUCTION CONTROLS: Process Control,"Varian Medical Systems, Inc. sent out Customer Technical bulletins in August 2008 and Urgent Medical Device Correction/Urgent Field Safety Notices on July 13, 2011 to all affected customers.The letter included description of device and problem. The current notice supplements and modifies previous instructions and ask that they stop using any flexible applicator probes in inventory. They are to be returned to Varian Brachy Therapy for replacement. Letter go on to list possible scenarios if the length deviation is not detected and advised all personnel working in the radiotherapy department should be notified of the recall. For additional information contact (800) 360-7909.",N/A,1343,1343,"Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.",Terminated,"June 20, 2012",313,1343,Not_Computer,N/A,N/A,N/A
Z-3024-2011,56839,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Spacelabs Medical elance Vital Signs Monitor, Model 93300.The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.","Vital Signs Monitor, Model 93300",2,"August 15, 2011", 2011,"Spacelabs Healthcare, Llc",The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.,PRODUCTION CONTROLS: Error in Labeling,"Spacelabs Healthcare sent an ""URGENT-MEDICAL DEVICE CORRECTION"" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken.The letter includes the revised Operator's Manual as a replacement for customers current manual.For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2.",Contact the recalling firm for information,2517,2517,"Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.",Terminated,"August 17, 2011",2,2517,Not_Computer,N/A,N/A,N/A
Z-3019-2011,57543,"table, radiographic, stationary top",IXQ,Radiologic table.,Radiology,Radiology,510(K) Exempt,"CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.","CIVCO ProLok Platform, REF MTSBRT002",2,"August 15, 2011", 2011,Civco Medical Instruments Inc,"Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CIVCO issued a ""FIELD SAFETY NOTIFICATION"" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.",N/A,20,20 platforms,"Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.",Terminated,"June 28, 2013",683,134,Not_Computer,N/A,N/A,N/A
Z-3023-2011,59235,"radioimmunoassay, estriol",CGI,Estriol test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Access¶_ Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.",Access Immunoassay Systems Unconjugated Estriol,2,"August 15, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.,OTHER/UNDETERMINED: Pending,"Beckman Coulter sent a PRODUCT CORRECTIVE ACTION (PCA) letter dated December 8, 2009, to all affected customers. The letter was sent via US Postal Service for all US customers with attached PCA response form. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of Access Unconjugated Estriol reagent lot number 913348. "" No further orders of Access Unconjugated Estriol reagent lot number 913348 will be shipped."" Abnormally low Access Unconjugated Estriol results from samples tested previously with the affected lot should be reviewed in the context of other diagnostic tests."" Access Unconjugated Estriol results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Rerun any tests that produce a questionable result.In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at (800) 854-3633 in the US and Canada. Outside of Canada and the US, customers were instructed to contact their local Beckman Coulter Representative.",Contact the recalling firm for information,2786,2786 units total (2776 in the US),"Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.",Terminated,"April 16, 2012",245,2786,Not_Computer,N/A,N/A,N/A
Z-3022-2011,59394,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.",Eclipse Treatment Planning System,2,"August 15, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution.,DESIGN: Software Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION/FIELD SAFETY NOTICE"" letter dated July 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to cease using the 4D Structure Merge tool option in the Eclipse until further notice. Additionally, it is recommended that customers ensure that a qualified physician reviews the accuracy and placement of all patient structures used for plan development and evaluation and to conduct standard quality assurance procedures prior to patient treatment. Customers will be contacted by a Customer Service representative when the technical correction for this issue is available.Contact your local Varian Customer Support District or Regional Manager if you have questions regarding this notice.",N/A,N/A,N/A,Worldwide Distribution,Open,N/A,N/A,N/A,Computer,N/A,N/A,N/A
Z-3025-2011,59661,"tenaculum, uterine",HDC,Obstetric-gynecologic specialized manual instrument.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207Intended for intrauterine device (IUD) insertion.",IUD INSERTION KIT 935K,2,"August 15, 2011", 2011,GYN Disposables Inc,Lack of sterility assurance.,DESIGN: Process Design,"GYN Disposables Inc. sent out an ""Urgent: Medical Device Recall"" letter dated July 29, 2011 to all affected customersThe letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included.For questions on this recall call (888) 372-2203, extension 101.",N/A,3987,3987 units,Nationwide Distribution.,Terminated,"October 29, 2012",441,3987,Not_Computer,N/A,N/A,N/A
Z-3028-2011,59218,"system, blood collection, vacuum-assisted, manual",KST,Vacuum-assisted blood collection system.,Hematology,Hematology,510(K) Exempt,"BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4"" x 12 "" (0.6 x 19 mm x 305 mm);BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12"" 0.8 x 19 mm x 305 mmBlood collection system.",BD Vacutainer Push Button Blood Collection Set,2,"August 16, 2011", 2011,Becton Dickinson & Company,BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.,DESIGN: Device Design,"BD Diagnostics sent a ""Lot Specific Product Recall"" letter dated April 22, 2011 to all affected customers.The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment.For question on this recall contact BD Diagnostics at (201) 847-5117.",Contact the recalling firm for information,1744000,"1,744,000",Nationwide (USA) Distribution.,Terminated,"June 06, 2012",295,1778960,Not_Computer,N/A,N/A,N/A
Z-3026-2011,59408,"exerciser, powered",BXB,Powered exercise equipment.,Physical Medicine,Physical Medicine,510(K) Exempt,"AlterG Anti-Gravity Treadmill;Alter G, 48349 Milmont Drive, Fremont, Ca 94538Product Usage: Rehabilitation of lower body injury & Neurological conditions.",GTrainer,2,"August 16, 2011", 2011,"Alter-G, Incorporated",Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.,PRODUCTION CONTROLS: Equipment Maintenance,"Alter-G, Inc. notified all affected customers by telephone, e-mail and followed by a ""Medical Device Customer Advisory Notification"" letter dated July 15, 2011. Customers were provided information on the installation error, the potential harm to patients, and the actions to be taken. The letter instructs customers to discontinue use of the Alter G until the recalling firm can evaluate the machine and correct any installation error. The letter states that the recalling firm is planning to visit affected customer's facility as quickly as possible and will contact customers to schedule this visit. Questions or concerns should be directed to David Tjon at 510-270-5369.",Contact the recalling firm for information,16,16 potentially affected units,Nationwide Distribution (USA ) - including the states of: OK and TX.,Terminated,"August 16, 2011",0,16,Not_Computer,N/A,N/A,N/A
Z-3027-2011,59239,"enzyme immunoassay, non-radiolabeled, total thyroxine",KLI,Total thyroxine test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access¶_ Immunoassay Systems Total T4 Calibrators, Part Number: 33805,Subsequent Product Code: JISThe Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.",Access Immunoassay Systems Total T4 Calibrators,2,"August 16, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Beckman Coulter sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests.Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.",Contact the recalling firm for information,2495,2495 units total (2492 in US),Worldwide Distribution-USA (nationwide) and the country of Canada.,Terminated,"July 11, 2012",330,2495,Not_Computer,N/A,N/A,N/A
Z-3032-2011,59456,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (option D), which includes Start case/End case functionality.Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.Product Usage: When a clinician enters END CASE mode, there is the expectation the operation is over and the patient is being disconnected from the monitor. Removing the patient cables will trigger multiple alarms so clinicians will enter this END CASE mode to prevent having to listen to false alarms. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (ie. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.",Spacelabs Medical Patient Monitor ,2,"August 17, 2011", 2011,"Spacelabs Healthcare, Llc",The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.,DESIGN: Device Design,"Spacelabs sent an ""URGENT - MEDICAL DEVICE CORRECTION"" letter dated July 25, 2011 along with the Perioperative section of the Operations Manual to all consignees in the US. This letter includes recalled model 91369, 91370, 91387, & 91393 (option D). On July 27, 2011, Spacelabs sent out an updated recall notification letter to include one additional model 91367 to all consignees in the US. The letter identifies the products, problem, and actions to be taken. On August 2, 2011, a recall notification letter (translated as necessary) and the Perioperative section of the Operations Manual was emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The letter states that the firm is in the process of upgrading the software and will be contacting customers to update monitors at no cost. If customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.",Contact the recalling firm for information,2812,total 2812 units distributed worldwide,"Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, Bahrain, Bolivia, Brazil, Canada, Caymen Island, Chile, China, Colombia, Cyprus, Ecuador, Finland, France, Germany, Guam, India, Indonesia, Israel, Italy, Jordan, Mexico, Morocco, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Uruguay, and Venezuela.",Terminated,"May 23, 2012",280,2812,Software,Alarm/Message,Software update,Software Update
Z-3030-2011,59488,hemoglobin a2 quantitation,JPD,Hemoglobin A2assay.,Hematology,Hematology,510(k),"Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan.Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.",Hemoglobin F & A2 Calibrator.,3,"August 17, 2011", 2011,Tosoh Bioscience Inc,"The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.",PRODUCTION CONTROLS: Process Control,"TOSOH Bioscience sent an ""Urgent Recall Notification"" letter dated July, 25, 2011 to all affected customers.The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement.For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.",Contact the recalling firm for information,6,6 boxes/4/2 mL btls,Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.,Terminated,"February 24, 2012",191,6,Not_Computer,N/A,N/A,N/A
Z-3036-2011,56806,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option.Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.",Portable patient monitor with arrhythmia detection or alarms.,2,"August 18, 2011", 2011,"Spacelabs Healthcare, Llc",Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem.,DESIGN: Software Design,"Spacelabs Medical sent an ""URGENT - MEDICAL DEVICE CORRECTION"" notification letter to U.S. consignees by mail on September 17, 2010 and to international consignees by e-mail on September 24, 2010. The letter identified the recalled product, warns customers of the potential hazard and identifies some ways to mitigate the risk if they decide to continue use. The letter states to correct this situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to install a free software update. If customers have any questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.",N/A,579,579 total (517 to US acc'ts; 62 to international acct's.,"Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.",Terminated,"August 22, 2011",4,579,Software,Device Operation,Software update,Software Update
Z-3033-2011,58381,"system, facet screw spinal device",MRW,N/A,N/A,Orthopedic,510(k),"PERPOS PLS, CATALOG #'s 9045-01 & 9045-02A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.","PERPOS PLS, CATALOG 's 904501 & 904502",2,"August 18, 2011", 2011,Interventional Spine Inc,"This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool.Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.",OTHER/UNDETERMINED: Pending,"Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once.Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product.They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors.For questions regarding this recall call 949-472-0006.",N/A,553,553 units,"Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI",Terminated,"February 11, 2013",543,960,Not_Computer,N/A,N/A,N/A
Z-3035-2011,59365,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8.Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.",Horizon Medical ,2,"August 18, 2011", 2011,Mckesson Information Solutions LLC,Images for one patient may appear in the study of another patient.,OTHER/UNDETERMINED: Pending,"Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.",N/A,438,438 devices,"Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.",Terminated,"October 04, 2012",413,438,Software,Output/Calculation,Software update,Software Update
Z-3037-2011,59465,"catheter, electrode recording, or probe, electrode recording",DRF,Electrode recording catheter or electrode recording probe.,Cardiovascular,Cardiovascular,510(k),"ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CTThe ISMUS Catheter with Auto ID Technology has been designed for electrophysiological mapping of cardiac structures.",ISMUS Catheter Mapping Catheter with Auto ID Technology,3,"August 18, 2011", 2011,"Biosense Webster, Inc.","The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the ""10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue"", Catalog Number D128709,through the J&J; Gateway (i.e., e-IFU websi",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Biosense Webster sent an ""URGENT FIELD SAFETY NOTICE"" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm.The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense. Customers with questions or require additionial information were instructed to contact their Biosense Webster representative.",N/A,325,325 units,Nationwide Distribution,Terminated,"October 12, 2012",421,1855,Not_Computer,N/A,N/A,N/A
Z-3044-2011,59375,"appliance, fixation, spinal interlaminal",KWP,Spinal interlaminal fixation orthosis.,Orthopedic,Orthopedic,510(k),"TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumber, and/or sacral spine.",TSRH(R) Spinal System SCREW,2,"August 19, 2011", 2011,Medtronic Sofamor Danek USA Inc,Screws are 5 mm longer than the size etched on the screw.,PRODUCTION CONTROLS: Error in Labeling,"On 07/12/2011, the recalling firm, Medtronic notified the Sales Managers and Sales Force by conference call and email regarding the imminent notification and follow-up activities. A ""VOLUNTARY RECALL"" notification letter was sent to Risk Managers and Sales Representatives on 07/13/2011 with a delivery date of 07/14/2011. The letter states to immediately remove the recalled product from use and return to Medtronic. The letter includes a questionnaires form to be completed and returned as per the instructions. If appropriate, personal follow up with Sales Representatives will be made to assure that Risk Managers understand the recall communication and to facilitate return of product and the associated questionnaire documentation. For questions, contact your Medtronic Sales Representative or the Global Quality Department at 800-876-3133, extension 3173.",N/A,17,17 units,"Nationwide Distribution (USA) including the states of: OH, NY, and WI",Terminated,"July 20, 2012",336,17,Not_Computer,N/A,N/A,N/A
Z-3039-2011,59391,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma and urine.Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum, plasma and urine.",Dimension Calcium Flex Reagent ,2,"August 19, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.","Siemens Healthcare Diagnostic has confirmed a high frequency of ""Abnormal assay"" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.",OTHER/UNDETERMINED: Pending,"An Urgent Field Safety Notice datey July 2011 was issued to all affected customers. Customers are being advised to immediately discontinue use and discard any remaining inventory of Dimension(R) CA Flex(R0 reagent cartridge - lot EA2153. Replacement order for the affected lot is in process, and will be sent to impacted customers free of charge.Customers were instructed to forward the Field Safety Notice to anyone whom they may have distributed the affected product.For questions regarding this recall call 302-631-6299.",N/A,2500,2500 cartons,"Worldwide Distribution to Guam, Puerto Rico, Chile, Costa Rica, Venezuela, South Korea, Vietnam and domestically to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MN, MI, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WV, WI, and WY.",Terminated,"December 27, 2013",861,2500,Not_Computer,N/A,N/A,N/A
Z-3041-2011,59520,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"Amsco¶_ V-PRO 1 and Amsco¶_ V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco¶_ V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture.",Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems ,2,"August 19, 2011", 2011,Steris Corporation,STERIS learned that Amsco¶_ V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test.,OTHER/UNDETERMINED: Pending,"Steris Corporation sent an URGENT VOLUNTARY FIELD CORRECTION NOTICE dated August 5, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer.A STERIS Service Representative will contact your facility to arrange for STERIS to upgrade your V-PRO System(s). You can continue to use your system prior to the installation of the system upgrades. In the interim period should you experience any alarms or aborted cycles, the load mustbe handled in accordance with the Amsco¶_ V-PROTM 1 and V-PROTM 1Plus Low Temperature Sterilization Systems Operators Manual and your internal hospital procedures.For further information or if you have questions regarding this matter, please contact Field Service Dispatch at 1-800-333-8828.",N/A,663,663 units,"Worldwide Distribution -- USA (nationwide) including the states of: AK, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV & WY, and countries of: Australia, Bangladesh, Belgium, Belarus, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, India, Iraq, Ireland, Italy, Japan, Kuwait, Lebanon, Mexico, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, Vietnam, United Arab Emirates, and United Kingdom.",Terminated,"March 27, 2013",586,663,Not_Computer,N/A,N/A,N/A
Z-3042-2011,59525,"accessories, solution, ultrasonic cleaners for lenses",LYL,Soft (hydrophilic) contact lens care products.,Ophthalmic,Ophthalmic,510(k),"Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.","Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile",3,"August 19, 2011", 2011,Bausch & Lomb Inc,"Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.",PRODUCTION CONTROLS: Packaging,"Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer.The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference.Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.",Contact the recalling firm for information,1200,1200 bottles,Distribution-in the state of AK only,Terminated,"November 16, 2011",89,1200,Not_Computer,N/A,N/A,N/A
Z-3040-2011,59688,"warmer, thermal, infusion fluid",LGZ,N/A,N/A,General Hospital,510(k),"enFlow IV Fluid Warmer Part number 980105VS;(510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120)Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.",enFlow IV Fluid Warmer,2,"August 19, 2011", 2011,"Vital Signs Devices, a GE Healthcare Company",enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.,DESIGN: Device Design,"GE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy.",Contact the recalling firm for information,1307,1307 units,Worldwide Distribution - USA (nationwide) and the country of Vietnam,Terminated,"June 14, 2013",665,1307,Not_Computer,N/A,N/A,N/A
Z-3051-2011,56251,"antinuclear antibody, indirect immunofluorescent, antigen, control",DHN,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"""BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN""The test kit contains slides and substrate.For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.",Kallestad Mouse Stomach/Kidney (MSK) Test Kit,3,"August 22, 2011", 2011,Bio-Rad Laboratories,KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.,TRAINING: Employee Error,Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010.The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709.,N/A,224,224 kits were distributed; 35 of those kits were determined to contain the wrong slides.,"Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.",Terminated,"August 22, 2011",0,224,Not_Computer,N/A,N/A,N/A
Z-3050-2011,59329,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x12 working length. Non-SterileCatalog Number: 013554Orthopedic Manual Surgical Instrument",Smith & Nephew,2,"August 22, 2011", 2011,"Smith & Nephew, Inc. Endoscopy Division","Shaft tip (casting) does not meet the SNE 416specification, which could result in rusting of the Tendon Strippers",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to Hoangthi.le@smith-nephew.com or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, endo.andreturns@smith-nephew.com. For questions, contact Hoangthi by phone at 508-337-3731.",Contact the recalling firm for information,570,570 units,"Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Dubai, Finland, France, Germany, Greece, Hong Kong, India, Italy, Israel, Japan, Korea, Malaysia, Mexico, Netherland, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, and Venezuela",Open,N/A,N/A,570,Not_Computer,N/A,N/A,N/A
Z-3045-2011,59713,"indicator, physical/chemical sterilization process",JOJ,Sterilization process indicator.,General Hospital,General Hospital,510(k),"Verify¶_ SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom.Verify¶_ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¶_F 30 minute Gravity Cycle).",Verify SixCess Indicator Strips,2,"August 22, 2011", 2011,Steris Corporation,During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.,MISBRANDING: Labeling False and Misleading,"STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3).For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.",N/A,2500,"2,500 (one per customer)",Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.,Terminated,"March 19, 2013",575,2500,Not_Computer,N/A,N/A,N/A
Z-3049-2011,59466,"kit, i.v. start",LRS,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Churchill Medical Latex-Free IV Start KitProduct Code: AMS-623ATLFThe kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M"" Transpore tape roll, 2 gauze sponges, a 3M"" Tegaderm"" dressing, and a dressing change labelAMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy",Churchill Medical,2,"August 22, 2011", 2011,"Churchill Medical Systems, Inc.",Outer Kit labeled expiration date longer than the expiration of the shortest expired product,TRAINING: Employee Error,"Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com.",N/A,130750,"130,750 units",Nationwide Distribution,Terminated,"March 27, 2013",583,130750,Not_Computer,N/A,N/A,N/A
Z-3057-2011,59576,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),Maquet HL Console for Heart Lung Machine HL20:HL 20 4-pumps console base: P/N 917741HL 20 5-pumps console base: P/N 917751The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.,Maquet HL Console for Heart Lung Machine HL20,2,"August 22, 2011", 2011,Maquet Inc.,HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.,DESIGN: Component Design/Selection,"Maquet sent an URGENT PRODUCT RECALL NOTIFICATION letter dated June 17, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge receipt of the notification by completing and sending back the attached response form whether or not they have any affected product, fax to 973-807-9210 no later than June 30, 2011. For any questions customers were instructed to contact thier local MAQUET representative.",N/A,229,229 units,Nationwide Distribution,Terminated,"October 16, 2012",421,229,Not_Computer,N/A,N/A,N/A
Z-3048-2011,59568,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc.Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.",Gamma X XL Portable Patient Monitor,2,"August 22, 2011", 2011,"Draeger Medical Systems, Inc.","Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.",DESIGN: Device Design,"Draeger Medical sent an ""Urgent Medical Device Recall Notification"" letters dated July 2011 to all affected customers.The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative.For questions or for information on this recall please call Draeger Service at (800) 543-5047 (press 1 at the prompt, then 2, then 32349).",No consumer action necessary,29,29,"Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Georgia, Greece, Hungary, Italy, Ireland, India, Kazakhstan, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Norway, Russian Fed., Romania, Saudi Arabia, Slovakia, Spain, South Africa, Switzerland, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.",Terminated,"August 16, 2012",360,61,Not_Computer,N/A,N/A,N/A
Z-3055-2011,59402,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"Flexible Probe with Blocking Washer (part of Segmented Cylinder Set)The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.",Flexible Probe with Blocking Washer ,2,"August 22, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.,DESIGN: Device Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy.Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.",N/A,1019,1019 total,Worldwide Distribution,Terminated,"June 20, 2012",303,1019,Not_Computer,N/A,N/A,N/A
Z-3056-2011,59476,"ligator, hemorrhoidal",FHN,Hemorrhoidal ligator.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system.Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation",Resolution II Clip,2,"August 22, 2011", 2011,Boston Scientific Corporation,"Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.",N/A,"Boston Scientific sent an URGENT MEDICAL DEVICE RECALL letter dated August 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Medical Device Recall to their customers. Customers were instructed to:Immediately discontinue use of any affected product.Complete and return the Reply Verification Tracking Form by fax to 508-683-5578.Package and return any affected product to:Boston Scientific CorporationDistribution CenterAttn: QA Returns500 Commander Shea BlvdQuincy, MA 02171For questions regarding this recall call 508-683-5578.",N/A,93,"14, 093 boxes of both 155 cm and 235 cm size clips",Worldwide Distribution - including USA (nationwide),Terminated,"June 22, 2012",305,14093,Not_Computer,N/A,N/A,N/A
Z-3052-2011,59226,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),High-Definition 120 Multileaf CollimatorHD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.,HighDefinition 120 Multileaf Collimator (HD120 MLC),2,"August 22, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.",DESIGN: Device Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated June 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letter describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.",N/A,106,173***12-20-12 AMENDED TO: 106 units***,Worldwide Distribution.,Terminated,"December 23, 2011",123,106,Not_Computer,N/A,N/A,N/A
Z-3059-2011,59524,"cpb check valve, retrograde flow, in-line",MJJ,Cardiopulmonary bypass blood reservoir.,Cardiovascular,Cardiovascular,510(k),"Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: 100 DESCRIPTION: ADJUSTABLE VENT VALVE, NON-STERILE; and 3T Medical Systems Catalog# 030NS Adjustable One Way Vent Valve, Quantity: 100, NON-STERILEThe TruChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.",TruChoice and 3T Medical Systems Adjustable Vent Valve,2,"August 23, 2011", 2011,Alliant Enterprises LLC,The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together.,N/A,"Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770.Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.",Contact the recalling firm for information,149,149 Boxes of 100,"Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea",Terminated,"April 23, 2012",244,678,Not_Computer,N/A,N/A,N/A
Z-3053-2011,59693,"wire, guide, catheter",DQX,Catheter guide wire.,Cardiovascular,Cardiovascular,510(k),"Katzen"" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Boston Scientific. NW 41 Street, Miami, FL 33166.Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a ""pulse -spray"" or "" slow weep"" technique.","Katzen"" Infusion Wire",2,"August 23, 2011", 2011,Boston Scientific Corporation,"Boston Scientific is voluntarily recalling one lot/batch of Katzen"" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm.",PRODUCTION CONTROLS: Labeling Mix-Ups,"Boston Scientific sent an ""Urgent Medical Device Recall Removal"" letter dated August 1, 2011 to all affected customers.The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form.For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133.",Contact the recalling firm for information,33,33,"(USA) Nationwide distribution including the states of AZ, AR, CA, CO, FL, GA, IL, IN, NV, NY, NC, OH, PA, RI, and TX.",Terminated,"August 10, 2012",353,33,Not_Computer,N/A,N/A,N/A
Z-3063-2011,59523,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.",Sysmex StromatolyserIM (SIM220A),2,"August 23, 2011", 2011,"Sysmex America, Inc.","The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false ""Platelet Clump"" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Sysmex America, Inc. sent a ""PRODUCT NOTIFICATION"" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.",No consumer action necessary,1887,"1,887 cubetainers","Worldwide Distribution--USA (nationwide and Puerto Rico) and the countries of Canada, Colombia, Ecuador, Mexico, Netherland Antilles and Peru.",Terminated,"March 14, 2012",204,1887,Not_Computer,N/A,N/A,N/A
Z-3054-2011,59276,"antigens, all groups, streptococcus spp.",GTY,Streptococcusspp. serological reagents.,Microbiology,Microbiology,510(K) Exempt,@ Home Strep TestRapid Strep TestProduct Usage: For in-vitro diagnostic use - detection of Strep., Home Strep Test,2,"August 23, 2011", 2011,Jay Bird Investments Inc,Home Strep Test does not qualify as a Class I device and needs pre-market approval.,PREMARKET APPROVAL: No Marketing Application,"Jay Bird Investments, Inc. sent a notification letter dated July 6, 2011 to customers. The letter describes the product, problem and the actions to be taken. The customers were instructed to notify retailers and remove the product from the shelves. For questions regarding disposition of the product please contact Myron Bouwhuis at 801-721-3528.",Contact the recalling firm for information,7541,"7,541",Nationwide Distribution (USA) including the states of OR and UTAH.,Terminated,"June 20, 2012",302,7541,Not_Computer,N/A,N/A,N/A
Z-3070-2011,59588,"lift, patient, non-ac-powered",FSA,Non-AC-powered patient lift.,General Hospital,General Hospital,510(K) Exempt,"Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100xEntroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.",Entroy Pool Lift,2,"August 24, 2011", 2011,"Arjo, Inc. dba ArjoHuntleigh","The Entroy Pool Lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver.",DESIGN: Device Design,"ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 54485.",N/A,1,"1 unit in the U.S., 311 units in the rest of the world",Worldwide Distribution - USA including CT,Terminated,"November 28, 2011",96,1,Not_Computer,N/A,N/A,N/A
Z-3073-2011,59680,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc.,One Horizon Way, Manchester, GA 30816.Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.","Habib, 4x Kit 4401",2,"August 24, 2011", 2011,"Angiodynamics, INC",The labeling contains errors which result in the products being misbranded,MISBRANDING: Labeling False and Misleading,"AngioDynamics, Inc. sent out a ""Medical Device Recall"" letter dated August 30, 2010 to all affected customers.The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.",N/A,527,527 units,"Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom",Terminated,"March 12, 2012",201,769,Not_Computer,N/A,N/A,N/A
Z-3069-2011,59560,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.",Applied Medical Kii Optical Access System,2,"August 24, 2011", 2011,Applied Medical Resources Corp,"The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in a tip breakage.",DESIGN: Component Design/Selection,"Applied Medical Resources Corp. notified customers via an overnight ""URGENT: MEDICAL DEVICE RECALL"" letter dated December 22, 2009. The letter informed customers of the recalled products, problem, and actions to be taken. The letter asked that the listed recalled products be returned immediately. The customers were asked to check their inventory, complete the attached Voluntary Recall Notification Confirmation Form and fax as per the instructions. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).",Contact the recalling firm for information,13791,"13,791 units total","Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.",Terminated,"September 06, 2011",13,13791,Not_Computer,N/A,N/A,N/A
Z-3075-2011,58489,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"GE Healthcare, DASH 3000, 4000, 5000 Patient MonitorsThe Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.","GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors",2,"August 25, 2011", 2011,"GE Healthcare, LLC",GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option that may impact patient safety. The Dash monitor may exhibit reboots on some networks when the 802.11b wireless LAN option is used to connect to the hospital wireless LAN infrastructure. This reboot results in a loss of patient monitoring for approxima,DESIGN: Software Design,"GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. GE recommended actions that should be taken by a qualified service representative. For any questions regarding the medical device correction or identification of affected items contact Technical Support at 1-800-558-7044 or customers should contact their local Service Representative.UPDATE: A second letter dated 12/13/11 was sent on 1/20/12 to consignees. The revised letter provides an update to the safety instructions and product correction.",Contact the recalling firm for information,8029,8029 devices,"Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI and the countries of UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVENIA, SINGAPORE, SAUDI A ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, KUWAIT, JAPAN, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, ECUADOR, DENMARK, CANDA, BELGIUM AUSTRIA, AUSTRALIA, and ALGERIA.",Terminated,"September 11, 2012",383,8029,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-3043-2011,59317,"pump, infusion, implanted, programmable",LKK,N/A,N/A,General Hospital,N/A,"Medtronic SynchroMed II, Model 8637, (The SynchroMed¶_ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.",Medtronic SynchroMed II ,1,"August 29, 2011", 2011,"Medtronic, Inc. - Neuromodulation",Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize,DESIGN: Component Design/Selection,"Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations. UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.",Contact the recalling firm for information,139653,"139,653 (105,002 US, 34,61 OUS)","Worldwide including USA, Puerto Rico, Algeria, Aruba, Australia, Austria, Belarus, Belgium, Brazil, Chile. Colombia. Costa Rica. Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran Iraq, Ireland, Israel Italy, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Uruguay.",Terminated,"August 24, 2012",361,139653,Battery,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-3086-2011,59469,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps TipRef: 3642The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula",Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip,2,"August 29, 2011", 2011,"Microline Surgical, Inc.",Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled asproduct number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged andlabeled as 3262 (Long Fenestrated Grasper,PRODUCTION CONTROLS: Packaging Process Control,"Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.",No consumer action necessary,300,300 units,"Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.",Terminated,"September 09, 2011",11,470,Not_Computer,N/A,N/A,N/A
Z-3079-2011,58874,N/A,N/A,N/A,N/A,N/A,N/A,"Elekta SynergyThe Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",The Elekta Synergy System,2,"August 29, 2011", 2011,"Elekta, Inc.","A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.",OTHER/UNDETERMINED: Pending,"ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.",Discard product or return to place of purchase for a full refund or exchange,368,368,Nationwide and Puerto Rico,Terminated,"October 02, 2012",400,368,Not_Computer,N/A,N/A,N/A
Z-2600-2011,58804,analytical measuring and detection laser product,REO,N/A,N/A,N/A,N/A,Prism Laser 7642Laser System,Prism Laser 7642,2,"August 29, 2011", 2011,"American Stress Technologies, Inc.",It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The product lacks User In formation,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message.(2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011.(3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report.(4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message.If you have any further questions please call (724) 410-1030.",Contact the recalling firm for information,1,1,Nationwide Distribution,Open,N/A,N/A,1,Not_Computer,N/A,N/A,N/A
Z-3083-2011,59483,hemodialysis system for home use,ONW,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Fresenius 2008K@homeThe Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.,Fresenius ,2,"August 29, 2011", 2011,"Fresenius Medical Care Holdings, Inc.","Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)",DESIGN: Device Design,"Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit.Please return the receipt for confirmation that you have received this notice.Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.",No consumer action necessary,705,705 units,"Nationwide Distribution.Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines",Open,N/A,N/A,705,Software,N/A,Software update,Software Update
Z-3081-2011,59462,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.",Mini MaxLock Extreme Plating System Case and Tray,2,"August 29, 2011", 2011,Orthohelix Surgical Designs Inc,The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Orthohelix Surgical Designs Inc sent a RECALL NOTIFICATION letter dated July 6, 2011 and an UPDATED URGENT RECALL 2ND NOTIFICATION letter dated July 13, 2011 to all affected customers. The letter identified the recalled product, the problem, and the Field Correction actions to be taken. Customers were instructed to remove the blue rubber mat in the utility bay of the tray base immediately, tag the mat with the tray number, and return it to recalling firm immediately. The letter states once customers have removed the blue rubber mat from the tray base, they may continue to use the tray and system normally. No further actions or precautions are needed. Distributors were also asked to notify their customers of the recall. If you have any questions, please call 330-247-1444 or 330-247-1445.",Contact the recalling firm for information,61,61 trays,"USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY.",Terminated,"September 10, 2012",378,61,Not_Computer,N/A,N/A,N/A
Z-3080-2011,59400,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006.Accessory for 700 Series 754/754m Ventilators during MRI examinations",Model 754/754M Disposable MRI Ventilator Circuit ,2,"August 29, 2011", 2011,"Impact Instrumentation, Inc.",Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).,MISBRANDING: Labeling False and Misleading,"Impact Instrumentation Inc. sent an ""Urgent Product Recall"" dated May 27, 2011 to all affected customers.The letter informed customers the product is not a cleared product and to return the product back to Impact Inst. for credit. A notification form is included in the letter to be return to the firm.For information on this recall contact the firms Customer Service Department at (800) 969-0750, 8:30 am to 5:00 pm EST.",N/A,492,492 units,"Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA.",Terminated,"May 23, 2013",633,492,Not_Computer,N/A,N/A,Other
Z-3084-2011,59577,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),Maquet HL Console for Heart Lung Machine HL20HL 20 4-pumps console base: P/N 917741HL 20 5-pumps console base: P/N 917751Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.,Maquet HL Console for Heart Lung Machine HL20,2,"August 29, 2011", 2011,Maquet Inc.,Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.,DESIGN: Software Design,"Maquet sent a PRODUCT RECALL NOTIFICATION LETTER/return response forms, dated June 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until a software update was performed by their trained technicians. Customers were also asked to forward the information contained in the notification letter to all users and to all appropriate Biomedical Staff. Customers were instructed to acknowledge receipt of the notification letter by completing and faxing back the attached response form to 973-807-9210 whether or not they have any of the affected product. For questions customers were instructed to contact their local MAQUET representative. For questions regarding this recall call 973-709-7994.",N/A,299,299 units,Nationwide Distribution,Terminated,"October 16, 2012",414,299,Software,Device Operation,Software update,Software Update
Z-3078-2011,59370,"equipment, laboratory, general purpose, labeled or promoted for a specific medical use",LXG,General purpose laboratory equipment labeled or promoted for a specific medical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)Roche Diagnostics Operations, Inc.An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.",MagNA Pure LightCycler ,2,"August 29, 2011", 2011,"Roche Diagnostics Operations, Inc.","Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.",OTHER/UNDETERMINED: Pending,"Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled ""URGENT MEDICAL DEVICE CORRECTION"" to all affected customers.The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue.For questions on this recall please call Roche at (800) 428-5074.",Contact the recalling firm for information,148,148,Nationwide Distribution; including the islands of Puerto Rico and Hawaii.,Terminated,"July 02, 2012",308,570,Computer,N/A,N/A,N/A
Z-3082-2011,59399,"prosthesis, elbow, semi-constrained, cemented",JDB,Elbow joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"Latitude"", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA.The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.",Tornier Latitude Elbow Prosthesis,2,"August 29, 2011", 2011,"Tornier, Inc",Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Tornier, Inc. sent an ""Urgent Product Correction"" letter dated June 23, 2011. The letter was addressed to the doctors. The letter described the product and the problem. Doctors were insructed to monitor patients that have received the units for evidence of humeral screw loosening.For questions customers were instructed to contact the Customer Service Department at 1-888-494-7950.",No consumer action necessary,3,3,Nationwide Distribution including FL and MO,Terminated,"July 17, 2012",323,3,Not_Computer,N/A,N/A,N/A
Z-3091-2011,57806,"stimulator, spinal-cord, totally implanted for pain relief",LGW,N/A,N/A,Neurology,N/A,"Software version 3.3 for Rapid Programmer devices, Model 3832.Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.",Rapid Programmer,2,"August 30, 2011", 2011,Advanced Neuromodulation Systems,Product programmed with unapproved software was distributed.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken.All affected devices were returned to the firm as instructed.",N/A,14,14 units,Distributed in New Hampshire and Puerto Rico.,Terminated,"September 27, 2012",394,14,Software,N/A,Software update,Software Update
Z-3092-2011,59754,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301.Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.",Evident MWA Generator,2,"August 30, 2011", 2011,"Covidien, PLC",Generator may deliver full power when a lower power is selected.,DESIGN: Component Design/Selection,"Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to:CovidienEnergy Based Devices5920 Longbow RoadBoulder, Colorado 80301Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them.For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.",N/A,357,357 units,"Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK.",Terminated,"August 30, 2011",0,357,Not_Computer,N/A,N/A,N/A
Z-3100-2011,59351,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CAProduct Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.",4D Integrated Treatment Console (4DITC) ,2,"August 30, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","The firm has identified that in certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different than",DESIGN: Software Design,"Varian sent an ""Urgent Medical Device Correction/Urgent Field Safety Notice"" letter dated June 27, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that Varian Service will contact customers to arrange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification, contact your local Varian Customer Support District or Regional Manager. The letter also provides Varian Oncology Help desk contact information 1-888-827-4265 for USA and Canada and +41417498844 for Europe.",N/A,645,645,Worldwide Distribution - USA (nationwide),Terminated,"December 05, 2013",828,645,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-3089-2011,59662,"unit, phacofragmentation",HQC,Phacofragmentation system.,Ophthalmic,Ophthalmic,510(k),"Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NYFor use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery","Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112",2,"August 30, 2011", 2011,Bausch & Lomb Inc,The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product.For question on this recall contact Bausch & Lomb at (949) 521-7895.",Contact the recalling firm for information,8,2/6-unit cases,Nationwide Distribution.,Terminated,"June 21, 2013",661,270,Not_Computer,N/A,N/A,N/A
Z-3097-2011,59781,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.","Encision AEM Suction Irrigation Electrode, Needle Tip,",2,"August 30, 2011", 2011,"Encision, Inc.",Electrode tips have been reported breaking off during use or cleaning.,DESIGN: Device Design,"Encision Inc. sent out an ""Urgent Product Recall"" letter dated August 24, 2011 to all affected customers.The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory.For information on this recall call Encision at (303) 339-6917.",N/A,10,10 units,"Worldwide Distribution: Nationwide distribution, and the country of New Zealand.",Terminated,"September 04, 2012",371,1078,Not_Computer,N/A,N/A,N/A
Z-3099-2011,59238,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),PFC Sigma Round Dome Patella 38 MM 3 PegDevice is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement.,PFC Sigma Round Dome Patella ,2,"August 30, 2011", 2011,"DePuy Orthopaedics, Inc.","DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella.",TRAINING: Employee Error,"The firm, Depuy , sent an email that included a letter entitled ""URGENT INFORMATION - RECALL NOTICE"" dated June 28, 2011 to DePuy Area customers ( Directors, Distributors, Office Managers, Hospital Representatives, and Doctors). The letter described the product, problem and actions to be taken. The letter also included implications of implanting the recalled device and patient communication information. The customers were instructed to immediately cease further implantation/use or distribution of the product, immediately return any recalled devices in their inventory, notify their customer of the recall and complete, sign and return the Reconciliation Form(s) via fax to DePuy at 574-372-7567 within seven business days.The letter also states that DePuy is not recommending prophylactic revision or additional follow up in the absence of symptoms. Additionally, DePuy recommends that surgeons continue to follow patients as per their standard care.Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's Scientific Information Office at 1-888-554-2482.",Contact the recalling firm for information,29,29,"Nationwide distribution: CA, MI, NJ and WI.",Terminated,"August 28, 2013",729,29,Not_Computer,N/A,N/A,N/A
Z-3102-2011,57590,urethrotome,EZO,Urethrotome.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),OLYMPUS Pediatric Knives and Resection ElectrodesThe pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.,OLYMPUS Pediatric Knives and Resection Electrodes,2,"August 31, 2011", 2011,Olympus America Inc.,The device sterile package seal shows evidence of being breached or was breached,PRODUCTION CONTROLS: Packaging Process Control,"Olympus America Inc. sent an ""URGENT PRODUCT RECALL"" letter dated December 22, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to check their inventory for the affected product and to destroy or discard, if found. A questionnaire was attached to the letter for customers to complete and return via fax to Olympus at 484-896-7128.Contact the firm at 484-896-5688 for questions regarding this recall.",N/A,1305,1305 devices,"USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.",Terminated,"September 28, 2012",394,1305,Not_Computer,N/A,N/A,N/A
Z-3106-2011,59229,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).,Depuy Mitek,2,"August 31, 2011", 2011,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.",N/A,75,75 units,Nationwide distribution.,Terminated,"January 19, 2012",141,75,Not_Computer,N/A,N/A,N/A
Z-3103-2011,59217,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems.3100 Hansen Way, Palo Alto, California 94304-1038.Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.","BrachyVision Software, part of Eclipse TPS",2,"August 31, 2011", 2011,"Varian Medical Systems, Inc.",Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.,DESIGN: Software Design,"Varian Medical Systems, Inc. sent a ""Medical Device Recall"" letter dated August 05, 2010 to all affected customers.The letter included description of product affected and problem. Customers were advised to review template files to ensure that there are no characters immediately after the string in the customized dose quality parameters. Device users were requested to return a response form.For information on this recall contact Varian Technical Support at (800) 360-7909.",N/A,1252,1252 units,Worldwide and Nationwide Distribution.,Terminated,"November 25, 2011",86,1252,Software,N/A,Instructions,Safety Notice/Insructions
Z-3101-2011,59262,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0;Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CAThe On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.",OnBoard Imager (OBI); Trilogy Mx,2,"August 31, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated June 21, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***The letter recommends several user actions. The firm is developing a correction for the issue and will contact customers when the correction is available.Questions regarding this notice may be addressed by contacting the Varian Oncology Help Desk at 1-888-827-4265.",N/A,2268,2268,Worldwide Distribution,Terminated,"March 15, 2012",197,2268,Software,Display/Image,Correction,Repair
Z-3113-2011,59632,"enzyme immunoassay, propoxyphene",JXN,Propoxyphene test system.,Toxicology,Toxicology,510(k),"DrugCheck¶_, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A.In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.",DrugCheck,2,"August 31, 2011", 2011,"Express Diagnostics Int'l., Inc.","Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck¶_ Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as ""forensic use only"", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States.",MISBRANDING: Labeling False and Misleading,"The firm, Express Diagnostics Int'l, Inc., sent a ""RECALL NOTICE"" letter dated October 4, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to notify their customers of the labeling change, and complete and return the DISTRIBUTOR/CUSTOMER CONFIRMATION FORM via fax to Express Diagnostics Int'l, Inc., at 1-507-526-2252. The letter also noted that ""Further shipment of product containing BUP and/or PPX cannot continue until Express Diagnostics Int'l, Inc. receives the signed form.""If you have any questions, call 507-526-3951.",No consumer action necessary,196750,"196,750","Nationwide distribution:AZ, CA, CT, GA, MD, MA, MN, MO, NH, NJ, OR, SC, and WA.",Terminated,"July 06, 2012",310,196750,Not_Computer,N/A,N/A,N/A
Z-3104-2011,59567,"alcohol dehydrogenase, specific reagent for ethanol enzyme method",DIC,Alcohol test system.,Toxicology,Toxicology,510(k),"Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013.Following Cup and Dip product models involved in the recall: 409004090130500-A30575 -A30603-A30671-A30800-A30802-3A30900-A30950-A31102-A40901C60410-3A60500-A60505-A60524-A60526-A60535-A60600-A60602-4A60630-A60635-4A60640-4A60705-4A60709-A60800-6A60800-A60801-A60820-A60903-A60910-A60921-A60925-A60930-A61020-A61023-A61026-4A61028-3A61030-3A61044-6A61052-4A61100-A61204-A61206-4A61206-6A61303-A61401-A61404-A65500-4A70410-4A70500-3A70500-A70550-A70602-3A70604-6A70630-3A70640-4A70808-6A70910-AIn Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.",DrugCheck,2,"August 31, 2011", 2011,"Express Diagnostics Int'l., Inc.","Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could not be labeled as such in the US.",PRODUCTION CONTROLS: Error in Labeling,"Express Diagnostics Intl., Inc. sent an Updated Recall Notice dated November 1, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have open orders of the affected product to contact customer service about their order. Customers were asked to complete and fax the form on page 3 of the document to 507-526-2252. Further shipment of products could not continue until Express Diagnostics received the signed form.For questions regarding this recall call 507-526-3951.",No consumer action necessary,56650,"56,650","Nationwide Distribution including AZ, CA,K CT, FL, GA, IL, IA, LA, MD, MA, MN, MS, MO,K MT, NE, NJ, NY, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY.",Terminated,"July 06, 2012",310,56650,Not_Computer,N/A,N/A,N/A
Z-3108-2011,59439,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Hi¶_Art versions 4.0.x, and HD versions 1.0.x, H-0000-0003.The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.",TomoTherapy HiArt System,2,"August 31, 2011", 2011,Accuray Incorporated,"As a result of an internal review, TomoTherapy has identified an issue with Hi¶_¶_Art versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention.During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu",DESIGN: Software Design,"TomoTherapy sent a ""Urgent Medical Device Correction"" letter dated July 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.This issue will be remedied with Hi¶_¶_Art software version 4.1 and HD software version 1.1 and later.If you have any questions, please contact the TomoTherapy Technical Solutions Center by e-mail ""support@tomotherapy.com"" . Please refer to the letter for what phone number you should call depending on where you are.",Contact the recalling firm for information,346,346,"Worldwide Distribution-- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and the countries United Arab Emirates United Kingdom Turkey Switzerland Sweden Spain Saudi Arabia Poland Netherlands Italy Germany France Belgium Taiwan Singapore Malaysia Korea Japan India Hong Kong China Australia Mexico El Salvador and Canada",Open,N/A,N/A,346,Software,Display/Image,Software update,Software Update
Z-3111-2011,59297,"display, cathode-ray tube, medical",DXJ,Medical cathode-ray tube display.,Cardiovascular,Cardiovascular,510(k),"Philips Medical:865047 IntelliVue Clinical Information Portfolio Release D.03865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01865300 IntelliVue Clinical Information Portfolio NICU LinkIntended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.", IntelliVue Clinical Information Portfolio ,2,"August 31, 2011", 2011,Philips Healthcare Inc.,"Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.",DESIGN: Software Design,"Philips Healthcare sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.Customers are asked to follow the guidelines in the ""Action to be taken by Customer/User"" section of the Urgent Medical Device Correction Notice. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devices, customers are instructed to follow the instructions for use for the device, which includes the directions to:1. Always use the medication administration record (MAR) in determining patient care.2. Always review orders and pending administrations in the administration record after any changes to an order are stored.For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011.If you need any further information or support concerning this issue, please contact your local Philips representative.",Contact the recalling firm for information,454,454 units,"Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.",Open,N/A,N/A,454,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-3098-2011,59350,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CAProduct Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.",4D INTEGRATED TREATMENT CONSOLE ,2,"August 31, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information.,DESIGN: Software Design,"Varian Medical Systems, Inc. sent an ""Urgent Medical Device Correction/Urgent Field Safety Notice"" letter dated June 23, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that the recalling firm will issue a Customer Technical bulletin to inform users of the mandatory upgrade and related information. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. Any questions regarding this Product Notification letter, contact Varian Medical Systems Help desk at 1-888-827-4265 for USA and Canada and +41417498844 for Europe.",Contact the recalling firm for information,N/A,N/A,Worldwide Distribution - USA (nationwide),Terminated,"March 15, 2012",197,N/A,Software,Device Operation,Software update,Software Update
Z-3105-2011,59572,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Treatment version 6.6.5052.Varian Medical Systems,Palo Alto, Ca Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.",Varian Treatment ,2,"August 31, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.,OTHER/UNDETERMINED: Pending,"Varian Medical Systems sent out ""Urgent Medical Device Correction/Urgent Field Safety Notice"" letters dated July 20, 2011 to all affected customers.The letter identified product, problem and provided recommended user actions when setting up and running the system. It also asked customers to notify appropriate personal provided instructions.For information or questions on this recall please call Varian at (888) VARIAN5 (888- 827-4265).",N/A,118,118,"Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.",Terminated,"December 05, 2013",827,118,Other,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-3116-2011,59777,"patient examination glove, specialty",LZC,Patient examination glove.,General Hospital,General Hospital,510(k),"MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia","MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves",2,"August 31, 2011", 2011,Ansell Healthcare Products LLC,Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results,"Ansell account managers were notified on August 4, 2011 to contact (by phone, fax, e-mail) their respective accounts and notify them of the recall situation. The Ansell account managers were provided with a copy of the recall notification to provide to their accounts. The recall notification includes a request that if these gloves have been further distributed to other customers, please advise them of the recall situation and have them return any outstanding stocks.",N/A,250,250 cases of 10,"Nationwide distribution: NC, GA, IL, MO, LA, and PA",Terminated,"November 27, 2012",454,1442,Not_Computer,N/A,N/A,N/A
Z-3107-2011,59470,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only.The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.",Hospira GemStar Docking Station ,2,"August 31, 2011", 2011,Hospira Inc.,"Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.",DESIGN: Device Design,"Hospira Inc. sent an ""URGENT DEVICE FIELD CORRECTION"" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921.Contact Hospira at 1-800-441-4100 for questions concerning this notice.*** Hospira sent an update letter dated September 26, 2012 to the accounts, informing them of the availability of the improved design replacement docking stations, and requesting them to complete and return the enclosed reply via fax or e-mail to Hospira, indicating the number of docking stations to be returned for replacement at no charge if the old docking stations are returned within 45 days of receipt of the replacement stations. ***.",N/A,18000,"18,000 units","Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Jordan, the Netherlands, Portugal, Saudi Arabia, Singapore, Spain, Sweden and Switzerland.",Open,N/A,N/A,18000,Not_Computer,N/A,N/A,N/A
Z-3109-2011,59366,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.",Juggerknot Soft Anchors,2,"August 31, 2011", 2011,"Biomet, Inc.","The device packaging was punctured by the device, resulting in loss of implant sterility.",DESIGN: Packaging Design/Selection,"Biomet Sports Medicine notified distributor accounts by telephone on July 08, 2011 with instructions to quarantine all lots of the recalled product. Urgent Medical Device Recall Notice letters dated July 21, 2011 were sent to all affected customers. The letter identified the recalled product, problem, and actions to be taken. The customers were instructed to immediately locate and discontinue use of the recalled product. The distributors are advised to communicate this notice to their customers if the recalled products were further distributed. The letter also states that distributors are responsible for the return of the recalled product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Customers were instructed to provide phone confirmation at 800-348-9500, extension 3755 or 3756, when the recall notice is received. Further questions should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8 AM to 5 PM.",Contact the recalling firm for information,4925,4925,"Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.",Terminated,"April 26, 2013",604,4925,Not_Computer,N/A,N/A,N/A
Z-3112-2011,59345,drug metabolizing enzyme genotyping systems,NTI,Drug metabolizing enzyme genotyping system.,Toxicology,Toxicology,510(k),"xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.",Luminex xTAG,2,"August 31, 2011", 2011,Luminex Corporation,"Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.",OTHER/UNDETERMINED: Pending,"Luminex sent a ""Customer Advisory"" letter dated May 24, 2011, by email and courier to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to destroy any remaining product and to submit a return postcard to confirm that the consignee had been notified of the recall and had destroyed the product.For further questions please call Luminex Technical Support at 1-877-785-2323 ( US ) and 1-512-381-4397 ( Outside US ) Monday through Friday.",Contact the recalling firm for information,45,45 kits,"Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.",Terminated,"March 23, 2012",205,45,Not_Computer,N/A,N/A,N/A
Z-3110-2011,59436,immunohistochemistry reagents and kits,NJT,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(K) Exempt,"Cell Marque antibody CD99 (H036-1.1)Mouse Monoclonal Antibody.Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.",CD99 (H0361.1) Mouse Monoclonal Antibody.,3,"August 31, 2011", 2011,Cell Marque Corporation,"Incorrect label on product bottle, although labeling on outer box is correct.",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product.If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.",Contact the recalling firm for information,2,2 units,Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.,Terminated,"August 31, 2011",0,2,Not_Computer,N/A,N/A,N/A
Z-3118-2011,59570,"disinfector, medical devices",MEC,Medical washer-disinfector.,General Hospital,General Hospital,510(K) Exempt,"Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983,The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.",Reliance Vision Single Chamber Washer/Disinfector,2,"September 01, 2011", 2011,Steris Corporation,STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit.,N/A,"The firm, STERIS sent an ""URGENT FIELD CORRECTION NOTICE"" letter dated May 9, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed that they can continue using their Vision SC Washer(s) prior to installation of the system upgrades. The letter states that STERIS is correcting the issues by implementing a series of quality improvements to the customers Vision SC Washer(s) to ensure satisfaction. Additionally, a STERIS Service Representative will contact the customers facility to arrange for STERIS to upgrade their Vision SC Washer(s).For further information or if you have questions regarding the servicing of your unit, please contact STERIS Field Service Dispatch at 1-800-333-8828.",N/A,404,404 Units,"Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea.",Terminated,"March 01, 2013",547,404,Not_Computer,N/A,N/A,N/A
Z-3125-2011,58705,"counter, differential cell",GKZ,Automated differential cell counter.,Hematology,Hematology,510(k),"Unicel DxH 800 Coulter Cellular Analysis SystemProduct Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: 1. Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. 2. Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).",Unicel DxH 800 Coulter Cellular Analysis System,2,"September 01, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal",N/A,"Beckman Coulter sent an ""URGENT PRODUCT CORRECTION"" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to another laboratory, customers were instructed to provide a copy of the letter to that party. Customers were also asked to complete and return the enclosed Response Form within ten (10) days, so Beckman can be assured they have received this important communication. Questions concerning this notice, were directed to the Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.",N/A,680,680 units,"Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.",Terminated,"June 18, 2012",291,680,Not_Computer,N/A,N/A,N/A
Z-3124-2011,59752,"sterilizer, chemical",MLR,Ethylene oxide gas sterilizer.,General Hospital,General Hospital,510(k),"SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060.Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.",SYSTEM 1E Liquid Chemical Sterilant Processing System,2,"September 01, 2011", 2011,Steris Corporation,STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.,OTHER/UNDETERMINED: Pending,"STERIS sent an ""Urgent Field Correction Notice"" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.",N/A,2235,"2,235 units",Worldwide Distribution - USA (nationwide) and the country of Bahrain.,Terminated,"March 19, 2013",565,2235,Not_Computer,N/A,N/A,N/A
Z-3122-2011,59232,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750)Product Usage: The GE Sigma MR750 System is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic images, parametric maps, and/or dynamic images of the structures and organs of the entire body, including, but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Sigma MR750 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.",SIGNA 3.0T MR750 SYSTEM,2,"September 01, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety.1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with",DESIGN: Software Design,"GE Healthcare sent an ""Urgent Medical Device Correction"" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.",N/A,171,171,"Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WT, WY.and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROAT IA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUKEYand UNITED KINGDOM.",Terminated,"August 07, 2013",706,385,Software,Display/Image,Software update,Software Update
Z-3119-2011,59691,"system, thermal regulating",DWJ,Thermal regulating system.,Cardiovascular,Cardiovascular,510(k),"Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.",WarmAir Model 135 Hyperthermia System and Blankets,2,"September 01, 2011", 2011,Cincinnati Sub-Zero Products Inc,Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.,MISBRANDING: Labeling False and Misleading,"Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice"" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached ""Recall Response Form"" via fax to (513) 772-9119 or scan and email to WA135manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241.For additional information the customers are provided with an e-mail address: WA135-2011@cszinc.com as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..",N/A,6561,6561 units were distributed.,"Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.",Terminated,"July 05, 2013",673,6561,Not_Computer,N/A,N/A,N/A
Z-3128-2011,59685,"enzyme immunoassay, inhibin-a",NDR,Estradiol test system.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Inhibin A ELISA, Part Number: DSL-10-28100-4Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.",Inhibin A ELISA,3,"September 02, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761.",OTHER/UNDETERMINED: Pending,"Beckman Coulter initiated an ""URGENT PRODUCT CORRECTION"" on June 15, 2011, via a telephone script to the only one customer impacted by the recalled product. The telephone script provided an explanation of the problem identified and the actions to be taken. Beckman Coulter recommended that the customer discontinue use of the recalled product as a preventative measure. Beckman will send a representative to the customer's facility to replace the recalled product in all remaining kits of the affected lot. The customer was instructed to share this information with laboratory staff. For any questions concerning this information, contact Beckman Coulter at 952-368-7874.",Contact the recalling firm for information,342,342 units,(USA) Nationwide Distribution in the state of CA,Terminated,"July 11, 2012",313,342,Not_Computer,N/A,N/A,N/A
Z-3129-2011,59601,"enzyme linked immunoabsorbent assay, (chlamydiae group)",LJC,Chlamydia serological reagents.,Microbiology,Microbiology,510(k),"VIDAS Chlamydia test kitsVIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.",VIDAS Chlamydia kits,2,"September 02, 2011", 2011,"bioMerieux, Inc.","Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.",OTHER/UNDETERMINED: Pending,"bioMerieux sent an ""URGENT PRODUCT REMOVAL NOTICE"" letter dated July 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to discontinue using and to destroy any of the affected product. The firm advises customers to confirm all positive results obtained with the affected lot number with another method prior to reporting results. An Acknowledgement and Product Replacement form was attached for customers to complete and return to the firm.Customers should contact their local bioMerieux Customer Service representative for questions regarding this notice.",Contact the recalling firm for information,283,283 units,"Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.",Terminated,"October 23, 2012",417,283,Not_Computer,N/A,N/A,N/A
Z-3130-2011,58613,"system, endovascular graft, aortic aneurysm treatment",MIH,N/A,N/A,Cardiovascular,N/A,"Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile",Zenith Flex AAA,3,"September 06, 2011", 2011,"Cook, Inc.",The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.,TRAINING: Employee Error,The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.,Contact the recalling firm for information,4,4 units,"US, Canada, Japan",Terminated,"September 13, 2011",7,71,Not_Computer,N/A,N/A,N/A
Z-3159-2011,59659,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack.Calibrator/Diluent Set.IVD.Kit components:Elution Buffer A, 2 x 2500 mLElution Buffer B, 1 x 2100 mLWash/Diluent Solution, 1 x 2500 mLCartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges;CD-ROM -Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized waterWhole Blood Primer, 6 x 1 mLSample Vials, 2 x 100Instruction Manual.Bio-Rad Laboratories Inc. Hercules, CA 94547Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).",VARIANT II TURBO Link Hemoglobin A1c Program ,3,"September 06, 2011", 2011,"Bio-Rad Laboratories, Inc.","The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.",TRAINING: Employee Error,"The firm, BIO-RAD, sent a ""Medical Device Correction"" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replacement Elution Buffer B. In addition, the customers were to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, Attention: BIO-Rad CSD Regulatory Affairs Department.If you have any questions, please contact your regional Bio-Rad office or 510-724-7000.",N/A,40,40,"Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.",Terminated,"November 01, 2011",56,40,Not_Computer,N/A,N/A,N/A
Z-3120-2011,59692,"tray, start/stop (including contents), dialysis",FKG,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123Product Usage: custom dialysis prep kits",Custom dialysis prep kits,1,"September 07, 2011", 2011,Lee Medical International Inc,Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due to possible bacterial contamination.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm, Lee Medical International Inc., notified their consignees by email and telephone on 03/22/2011. Consignees were instructed to pull product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers.For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.",N/A,19625,"19,625 units","Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.",Terminated,"January 30, 2012",145,19625,Not_Computer,N/A,N/A,N/A
Z-3160-2011,59737,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,"Picis ED PulseCheck-Software, transmission & storage, patient dataService Pack v5.0 L and MThis product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.",Picis ED PulseCheckSoftware,2,"September 07, 2011", 2011,Picis Inc.,Software does not display appropriate allergy interaction warning,DESIGN: Software Design,"Picis issued notification on 08/01/11 to affected clients, explaining the potential for the error, with instructions to monitor documented patient allergies closely when prescribing medication orders in ED PulseCheck, using Muitum drug database content. Picis will track the progress on acknowledgement of notification letter receipt through the implementation of software upgrade, for all potentially affected Customers.For questions regarding this recall call 781-557-3000.",Contact the recalling firm for information,62,62,Nationwide Distribution,Terminated,"June 27, 2013",659,62,Software,Alarm/Message,Software update,Software Update
Z-3162-2011,58473,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case.Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.",Ratcheting Torque Limiting Handle,2,"September 07, 2011", 2011,"Orthofix, Inc.","Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.",DESIGN: Device Design,"Orthofix, Inc. sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322.Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.",Contact the recalling firm for information,287,287 units,Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.,Terminated,"March 23, 2012",198,287,Not_Computer,N/A,N/A,N/A
Z-3161-2011,59305,"wheelchair, mechanical",IOR,Mechanical wheelchair.,Physical Medicine,Physical Medicine,510(k),TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite.The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.,TiLite ZR Series 2 and ZRA Series 2 Wheelchairs,2,"September 07, 2011", 2011,"TiSport, Llc",The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.,DESIGN: Component Design/Selection,"An Urgent Medical Device Correction letter, Product Correction Kit , and the Installation Instructions were sent to domestic suppliers, international suppliers, Veterans Administration hospitals and international distributors by US Priority Mail and by FedEx three days service.The letter identified the affected product and the reason for the recall. Customers were instructed not to send the product to their end user until the correction was made or to identify their end user and notify the end user of the product correction. Replacement parts and instructions to correct the issue were enclosed with the letter. Customers were to destroy the removed parts once they had completed the correction. Customers were to also return the Medical Device Correct Report that was provided, by fax to 509-586-2413, or email to ProdCorrection@tilite.com.Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.",N/A,1037,"1,037 units",Worldwide Distribution,Terminated,"July 27, 2012",324,1037,Not_Computer,N/A,N/A,N/A
Z-3172-2011,59453,"kit, wound dressing",MCY,Elastic bandage.,General Hospital,General & Plastic Surgery,Enforcement Discretion,"Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061.Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118","Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain",2,"September 08, 2011", 2011,Medela Inc,"Medela determined that some of the individual kits or bags of lot #370118 of ""0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain"", were labeled incorrectly as ""0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain"". The outside label on the case is correctly labeled as ""0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain"".",PRODUCTION CONTROLS: Labeling Mix-Ups,"Medela Inc. sent an ""Urgent Device Recall"" letter dated July 26, 2011 to all affected customers.The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.",N/A,3000,"3,000 kits","Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.",Terminated,"February 16, 2012",161,3000,Not_Computer,N/A,N/A,N/A
Z-3164-2011,59798,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),"DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable StaplesReference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.",DUET TRS Loading Units,2,"September 08, 2011", 2011,Covidien LP,Sterility of the device is compromised due to a breach in the sterile packaging,PRODUCTION CONTROLS: Storage,"The firm, Covidien, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated August 15, 2011, to its customers via federal express. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (Note: Units from the affected lots may have been incorporated into Covidien BEST PRACTICE KITS. If you have purchased BEST PRACTICE KITS, please evaluate whether these kits contain units from the affected lots.); complete and return the DUET TRS Universal Loading Unit Recalled Product Return form via fax to (203) 822-6009; and return all inventory from the affected lots (note: All affected units must be returned) with the complete form to: Field Returns Department, located at 195 McDermott Road, North Haven, CT 06473. Questions or concerns, contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.",N/A,4362,4362 units,"Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.",Open,N/A,N/A,457461,Not_Computer,N/A,N/A,N/A
Z-3173-2011,59830,N/A,N/A,N/A,N/A,N/A,N/A,BardPort Titanium Implanted Port.Bard Access Systems.Assembled in Mexico.A totally implantable vascular access device designed to provide long term repeated access to the vascular system,BardPort Titanium Implanted Port.,3,"September 08, 2011", 2011,Bard Access Systems,Implanted port has discrepant product information on package labeling.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Bard Access System, Inc. sent a ""Label Discrepancy Notification dated August 30, 2011 to all affected customers.The letter included affected product and informed them of the labeling discrepancy. Customers could either use the device or return it to Bard for replacement. For information on this recall call (801) 595-5568.",Contact the recalling firm for information,1375,1375 units,"Worldwide Distribution: Nationwide Distribution including the states of; AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, KY, LA, MA, MD, MI, MO, NJ, NV, NY, OK, PA, RI, SC, TN, TX, UT, VA, WI, and WV; and the countries of Canada and Belgium.",Terminated,"March 30, 2012",204,1375,Not_Computer,N/A,N/A,N/A
Z-3175-2011,58425,arthroscope,HRX,Arthroscope.,Orthopedic,Orthopedic,510(k),"Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CADesigned to reduce kyphosis that results from vertebral body collapse due to osteoporosis.","KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System",2,"September 09, 2011", 2011,Medtronic Spine LLC (formerly Kyphon Inc.),Device was shipped past the labeled expiration date.,TRAINING: Employee Error,"On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.",N/A,44,44,Nationwide Distribution,Terminated,"September 09, 2011",0,44,Not_Computer,N/A,N/A,N/A
Z-3182-2011,59677,immunohistochemistry reagents and kits,NJT,Immunohistochemistry reagents and kits.,Hematology,Pathology,510(K) Exempt,"Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.",Leica Bond ReadytoUse Primary Antibody Epithelial Membrane Antigen (GP1.4) ,3,"September 09, 2011", 2011,"Leica Microsystems, Inc.",There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.,TRAINING: Employee Error,"Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.",No consumer action necessary,3,3 units,Nationwide Distribution-in the states of Indiana and Kentucky.,Terminated,"September 09, 2011",0,4,Not_Computer,N/A,N/A,N/A
Z-3176-2011,59455,"accessory equipment, cardiopulmonary bypass",KRI,Cardiopulmonary bypass accessory equipment.,Cardiovascular,Cardiovascular,510(K) Exempt,Terumo Sarns Level Sensor II Pads.Terumo Cardiovascular Systems Corporation.Used to attach level sensors to the sides of the venous reservoir.,Terumo Sarns Level Detect II Mount Pads,2,"September 09, 2011", 2011,Terumo Cardiovascular Systems Corporation,Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.,PRODUCTION CONTROLS: Error in Labeling,"Terumo Cardiovascular Systems Corp. sent an ""Urgent Medical Device Removal"" notice dated August 10, 2011 to all affected customers.The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product.For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST.",Contact the recalling firm for information,1531440,"1,531,440 devices","Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.",Terminated,"June 20, 2012",285,1531440,Not_Computer,N/A,N/A,N/A
Z-3183-2011,59421,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"LATITUDE¶_ Patient Management System Communicator, Model 6482.The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.",LATITUDE Patient Management System Communicator,2,"September 09, 2011", 2011,Boston Scientific CRM Corp,"Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed, the pertinent data will not be available on the",DESIGN: Device Design,"Boston Scientific notified all affected customers by telephone on May 25, 2011. The customers were informed that there was an interrogation for one of their patients that was not able to be displayed on the website. Boston Scientific detected that a payload failure had occurred, but could not conclude what information was contained within the payload. Each patient has had previous and subsequent payloads that have processed and displayed on the LATITUDE website.",N/A,2,2,Nationwide Distribution-in the states of Florida and Texas.,Terminated,"December 04, 2012",452,2,Software,Display/Image,Notification,Safety Notice/Insructions
Z-3177-2011,59759,"suture, nonabsorbable, synthetic, polyamide",GAR,Nonabsorbable polyamide surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes.The products are labeled in parts.These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.",Monomid NonAbsorbable Suture,2,"September 09, 2011", 2011,C P Medical Inc.,Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.,PRODUCTION CONTROLS: Process Control,"CP Medical sent a ""RECALL NOTICE"" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return.Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.",Contact the recalling firm for information,776,776 dozens boxes,"Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.",Terminated,"May 24, 2012",258,776,Not_Computer,N/A,N/A,N/A
Z-3174-2011,59564,"collector, ostomy",EXB,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.)Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2"" -3 7/8""/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2"" -2 3/4""/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark.These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.",SenSura and Assura Postop Pouches,2,"September 09, 2011", 2011,"Coloplast Manufacturing US, LLC","On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determined that all affected lots be recalled and quarantined. This affects lots manufactured and distributed from January 2010 until July 19, 2011.",PRODUCTION CONTROLS: Process Control,"Coloplast sent a ""RECALL OF STERILE SENSURA AND ASSURE POST-OP POUCHES"" letter dated July 27, 2011 to all affected customers. An enclosed Field Safety Notice described the product, problem, and actions to be taken by the customers.Contact your Customer Service representative at 800-533-0464 for questions regarding this recall.",Contact the recalling firm for information,4020,4020,"Nationwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, GA, LA, MA, MD, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, and WI.",Terminated,"June 05, 2012",270,4020,Not_Computer,N/A,N/A,N/A
Z-3179-2011,59656,"evacuator, gastro-urology",KQT,Gastroenterology-urology evacuator.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.",Olympus Fluid Aspiration Set,2,"September 09, 2011", 2011,"Northgate Technologies, Inc.",The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump.,TRAINING: Employee Error,"The firm, Northgate Technologies, sent an ""URGENT: MEDICAL DEVICE RECALL"" letters dated August 18, 2011 to the Olympus America customers who ordered the Aspiration Tubing Set, 72-00114-0. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall for subsequent return to Northgate Technologies; if they further distributed this product, they were to identify and notify their customers of the recall, and complete and return the enclosed Return Response Form via fax to (847) 608-9405 or mail to: Northgate Technologies Inc., 1591 Scottsdale Court, Elgin, IL 60123. If you have any questions, please call (224) 856-2222 or e-mail to: ckurek@northgate-tech.com.",Discard product or return to place of purchase for a full refund or exchange,10680,"10,680 sets","Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.",Terminated,"December 14, 2011",96,10680,Not_Computer,N/A,N/A,N/A
Z-3185-2011,55319,"stimulator, vestibular acceleration, therapeutic",MHZ,N/A,N/A,Neurology,Contact ODE,"The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display.The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.","Spacelabs Medical Vital Signs Monitor, Model 91220",2,"September 12, 2011", 2011,"Spacelabs Healthcare, Incorporated","There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries.",DESIGN: Component Design/Selection,"SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.",N/A,614,614 units,"Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.",Terminated,"September 12, 2011",0,614,Not_Computer,N/A,N/A,N/A
Z-3187-2011,59764,"staple, implantable",GDW,Implantable staple.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ENDOPATH¶_ ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.",ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters,2,"September 12, 2011", 2011,Ethicon Endo-Surgery Inc,Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH¶_ ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.,PRODUCTION CONTROLS: Packaging,"Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.",N/A,27582,"27,582 instruments","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREECE, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, POLAND, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, THAILAND and UNITED ARAB EMIRATES",Terminated,"February 15, 2013",522,27582,Not_Computer,N/A,N/A,N/A
Z-3186-2011,59477,"catheter, steerable",DRA,Steerable catheter.,Cardiovascular,Cardiovascular,510(k),"Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP, Kirkland, Quebec H9H 5H3, Canada.Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.",Medtronic FlexCath 3FC12,2,"September 12, 2011", 2011,Medtronic Inc. Cardiac Rhythm Disease Management,"Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood and saline solution leaking out of, and air ingress into the hemostatic valve. This includes reported instances of the introduction of air bubbles through the valve during aspiration of the side port",N/A,"Medtronic Sales Reps began on July 15, 21011 hand delivering an ""IMPORTANT MEDICAL DEVICE iNFORMATION"" letter dated July 2011 to consignees. The letter identified the product, the problem, and the actions needed to be taken. The letter stated the rate of occurrence, described the potential clinical implications, and reinforced the importance of following the information found in the instructions for use as consignees continue to use the device. The letter also stated that Medtronic CryoCath is working urgently on a number of fronts to mitigate this observation and will continue to communicate with consignees as appropriate.For further information, please contact Medtronic VP of Quality at (763) 526-0576.",Contact the recalling firm for information,6712,6712,"Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MN, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI. and the countries of: Australia, Austria, Belgium, Canada, Czech, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Qatar, South Africa, Spain, Switzerland, and United Kingdom.",Terminated,"June 07, 2012",269,6712,Not_Computer,N/A,N/A,N/A
Z-3188-2011,58478,"dispenser, cement",KIH,Cement dispenser.,Orthopedic,Orthopedic,510(K) Exempt,Orthovita(R) Cortoss(TM) Delivery GunProduct Usage: Used for the application of Cortoss(TM) Bone Augmentation Material,Orthovita(R) Cortoss(TM) Delivery Gun,2,"September 12, 2011", 2011,"Orthovita, Inc.","Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report",PRODUCTION CONTROLS: Packaging,"Orthovita sent an ""URGENT FIELD SAFETY NOTICE"" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost. For any questions regarding this notice call 484-323-8860.",Contact the recalling firm for information,3174,3174,"Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. Government accounts include Bethesda Naval Center, 8901 Rockville Pike, Bethesda, MD; Lackland Air Force Base, 2200 Berquist Drive, Suite 1, Lackland AFB, TX; Hunter Holmes McGuire VA Hospital 1201 Broad Rock Blvd., Richmond, VA; Madigan Army Medical Center, Madigan Army Medical Center, Tacoma, WA; Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC; VA Medical Center, 1481 W. 10th St., Indianapolis, IN; VA Hospital of Palo Alto, 3801 Miranda Ave., Palo Alto, CA; VA Loma Linda Healthcare System, 11201 Benton Street, Loma Linda, CA; and VA Medical Center/NY Harbor Healthcare, NY, NY.",Terminated,"September 25, 2012",379,3174,Not_Computer,N/A,N/A,N/A
Z-3178-2011,59331,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures.Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70",EPShuttle/Stockert J50/Stockert J70,2,"September 12, 2011", 2011,"Biosense Webster, Inc.","Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.",DESIGN: Software Design (Manufacturing Process),"The recall communication was initiated on 7/8/11 and 7/11/11 with Biosense Webster forwarding A Customer Notification Letter, Acknowledgement Form and Software Release Note (Attachments 3, 4 and 1) via FedEx to all U.S. customers who purchased the Stockert 70 Radio Frequency Generator. Two letters and forms were sent to U.S. customers via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively.The Release Note provides tips for the avoidance of potential events when working with the EP-SH UTTLE, STOCKERT 70, STOCKERT J50 or STOCKERT J70 RF generators with SW versions 1.035 / 1.035J /1.035J70 to 1.037/1.037J70.",N/A,3397,"3,397 units total (1,217 in U.S.)","Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.",Terminated,"October 12, 2012",396,3397,Software,Physical Safety Hazards,Notification,Safety Notice/Insructions
Z-3200-2011,59175,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.",GEMINI TF64 Diagnostic Imaging System,2,"September 13, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.",DESIGN: Software Design,"The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place.For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5 for ""All Imaging Systems"". Enter your site ID number. If you do not know your site ID, please hold and then select option 5 for ""Nuclear Medicine"" and finally select option 2 for ""PET"" support. In all other countries, the local Philips Healthcare office should be contacted at 440-483-3000.",N/A,6,6 units,"Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.",Terminated,"February 22, 2013",528,19,Computer,N/A,N/A,N/A
Z-3191-2011,58985,"motor, drill, electric",HBC,Electric cranial drill motor.,Neurology,Neurology,510(k),"Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049563***.Cutting and Shaping bone including bones of the spine and cranium.","Anspach Single Use, Sterile Bone Cutting Burrs model QD84OVD ",2,"September 13, 2011", 2011,"The Anspach Effort, Inc.","The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to",TRAINING: Employee Error,"The Anspach Effort, Inc. sent an ""URGENT: MEDICAL DEVICE REMOVAL"" letter dated May 27, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers.The letter instructs customers to check their inventory and to segregate any affected product found. A Customer Response Form was attached for customers to complete and return to the firm via fax at 1-800-327-6661.Contact Anspach Customer Support at 800-327-6887 for questions regarding this recall.",No consumer action necessary,17,17,"Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.",Terminated,"February 15, 2012",155,114,Not_Computer,N/A,N/A,N/A
Z-3198-2011,59690,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"TSX-101A: AQUILION 16; System, X-Ray, Tomography, ComputedX-Ray Tomography","TSX101A: AQUILION 16; System, XRay, Tomography, Computed",2,"September 13, 2011", 2011,Toshiba American Medical Systems Inc,"Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed,TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed,TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr",DESIGN: Software Design,"Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available.Customers were requested to take temporary measures until corrective measures were taken.1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy.2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy.3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list.4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility.Customers were asked to complete and return the attached form and fax it to 877-349-3054.For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.",N/A,155,155 units total,Nationwide Distribution,Open,N/A,N/A,155,Computer,N/A,N/A,N/A
Z-3184-2011,59797,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill.Imaging processing System",Straumann coDiagnostiX,2,"September 13, 2011", 2011,Straumann Manufacturing Inc.,"Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.",DESIGN: Software Design,"Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service.The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.",Contact the recalling firm for information,272,272,Nationwide Distribution,Terminated,"May 23, 2012",253,272,Software,Device Operation,Software update,Software Update
Z-3076-2011,59760,industrial x-ray,RBS,N/A,N/A,N/A,N/A,Hamamatsu model L10951-35 Micro Focus x-ray generator.The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.,Micro Focus XRay generator,2,"September 13, 2011", 2011,Hamamatsu Corporation,It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator.,RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act,"Hamamatsu Corporation sent a letter dated July 19, 2011, to the manufacturer and their subcontractor informing them of the affected product and what they propose to do. They will repair the units both in the field and those returned to our plant by installing additional lead shielding in the units. The lead shielding will be fixed to the unit by soldering the addition to the existing lead shield (see attachment 2). We expect to complete the repair of all units in the field by October 1, 2011. All new units to be shipped from our plant will be repaired before shipment.For further questions, please call (908) 231-0960 X 2300.",N/A,8,8,"Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.",Open,N/A,N/A,8,Not_Computer,N/A,N/A,N/A
Z-3206-2011,57889,"oximeter, ear",DPZ,Ear oximeter.,Cardiovascular,Anesthesiology,510(k),"DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)",DATEXOHMEDA TRUSAT PULSE OXIMETER ,2,"September 14, 2011", 2011,"GE Healthcare, LLC","The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for system or components to start on fire or explode (general case).",DESIGN: Device Design,"On 4/8/11 GE Healthcare sent consignees an ""Urgent Medical Device Correction"" letter dated March 30, 2011. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering & Home Healthcare Provider.The letter listed the Safety Issues, Safety Instructions, Affected Product Details, Product Correction and Contact Information.",N/A,31846,"31,846","Worldwide distribution: USA, ZAMBIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UGANDA, TURKEY, TUNISIA, TRINIDAD & Tobago, THAILAND, UNITED REPUBLIC OF TANZANIA, PROVINCE OF CHINA TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SUDAN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, NEPAL, MOZAMBIQUE, MEXICO, MALTA, MALAYSIA, MACEDONIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GUADELOUPE, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, KOREA, EL SALVADOR, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE , CANADA, BRITISH INDIAN OCEAN TERRITORY, BRAZIL, BOLIVIA, BENNIN, BELGIUM, BANGLADESH, BAHAMAS, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.",Open,N/A,N/A,31846,Not_Computer,N/A,N/A,N/A
Z-3213-2011,58820,"laryngoscope, rigid",CCW,Rigid laryngoscope.,Anesthesiology,Anesthesiology,510(K) Exempt,Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647Disposable laryngoscope blades,Crystal Metal Miller Disposable Blades,2,"September 14, 2011", 2011,"Penlon, Ltd. (Fmly East Healthcare)",Disposable laryngoscope blades incorrectly labeled with wrong size.,MISBRANDING: Labeling False and Misleading,"Penlon Ltd ( frmly East Healthcare ) sent an "" Urgent Field Safety Notice"" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match.Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and contact Penlon using the information below.For further questions please call 44 1235 547093.",N/A,5,5 cartons (20 blades each),"Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China.",Terminated,"September 21, 2012",373,5,Not_Computer,N/A,N/A,N/A
Z-3211-2011,59438,"vehicle, motorized 3-wheeled",INI,Motorized three-wheeled vehicle.,Physical Medicine,Physical Medicine,510(k),"Victory 10, 3 Wheel (SC610)Mobility medical device","Victory 10, 3 Wheel (SC610)",2,"September 14, 2011", 2011,Pride Mobility Products Corp,Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Pride Mobility Products Corp. sent a ""RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES"" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .",N/A,N/A,N/A,"Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Australia, Canada, France, and United Kingdom.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-3202-2011,59182,"motor, drill, electric",HBC,Electric cranial drill motor.,Neurology,Neurology,510(k),"Cutting Burr labeled in part:""***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***"". Cutting and shaping bone including bones of the spine and cranium.","Anspach Single Use, Sterile Bone Cutting Burs",2,"September 14, 2011", 2011,"The Anspach Effort, Inc.","The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the screw.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.",N/A,599,599,"Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.",Terminated,"October 11, 2011",27,628,Not_Computer,N/A,N/A,N/A
Z-3210-2011,59826,"massager, powered inflatable tube",IRP,Powered inflatable tube massager.,Physical Medicine,Physical Medicine,510(k),"Game Ready Professional Therapy System,a cryotherapy device.Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.",Game Ready Professional Therapy System,3,"September 14, 2011", 2011,"CoolSystems, Inc.",It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped.,TRAINING: Employee Error,"The firm, CoolSystems, Inc., contacted customers by phone on August 23, 2011. The customers were informed that some Game Ready Professional Therapy System units have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped. Instructions were given to immediately cease fulfilling orders from that inventory. Loaners were shipped to the customers overnight. The customers were instructed to replace the shipped device with the loaner that was sent and return it to the company ASAP. If you have any questions, contact the Vice President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.",N/A,26,26 units,"Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.",Terminated,"November 14, 2011",61,26,Not_Computer,N/A,N/A,N/A
Z-3205-2011,59473,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc.A computed radiography image processing system.",Philips Healthcare PCR Eleva Radiological Image Processing System ,2,"September 14, 2011", 2011,Philips Healthcare Inc.,The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis,DESIGN: Software Design,"Philips Healthcare Inc. sent out ""Urgent --Medical Device Correction"" notices dated June 10, 2011 to all affected customers.The letter described the product and problem. Customers were informed the ""burned-in Mirror-Icon"" may be misinterpreted as a Right marker. Customers are advised to preferably use lead markers during each X-ray acquisition or alternatively electronic annotations on each image for side indication. The presentation of these markers within each image will clearly show the difference between the intended Left/Right indication and the little mirror ICON. Philips will install improved software that prevents the misinterpretation of the symbol and will schedule the installation of the updated software.For questions on this recall call Phillips Healthcare Inc. at 978-687-1501.",N/A,197,197 units,"Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.",Open,N/A,N/A,197,Software,Display/Image,Software update,Software Update
Z-3208-2011,59681,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011.The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",Brilliance iCT CT XRay System,2,"September 14, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors.,OTHER/UNDETERMINED: Pending,"Philips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action.For further questions please call (440) 483-7000.",N/A,5,5 units,"Worldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.",Terminated,"February 22, 2013",527,8,Software,Device Operation,Software update,Software Update
Z-3204-2011,58474,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.","Millennium and HD120 MultiLeaf Collimators (MLC), Clinac",2,"September 14, 2011", 2011,"Varian Medical Systems, Inc.","An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.",DESIGN: Component Design/Selection,"On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps.",N/A,3791,3791 units,"Worldwide distribution including USA, Australia, Argentina, Italy, Morocco, South Korea, Belgium, Canada, Netherlands, Denmark, Japan, Hong Kong, Malaysia, Hungary, New Zealand, Sweden, Taiwan, Switzerland, Romania, Brazil, Slovakia, India, Colombia, UK, Ireland, Spain, Singapore, Martinique, Reunion, Venezuela, Iceland, Portugal, Turkey, Israel, Bahrain, Macau, Chile, Saudi Arabia, Latvia, China, Finland, Kazakhstan, Thailand, France, Poland, and Germany.",Terminated,"June 20, 2012",280,3791,Not_Computer,N/A,N/A,N/A
Z-3194-2011,59586,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3;Varian Medical Systems, Palo Alto, CADesigned to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.",4D Integrated Treatment Console ,2,"September 14, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system.,N/A,"Urgent Medical Device Correction/Field Safety Notification letters were sent to all US consignees by Certified Mail on July 21, 2011., as well as Varian Sales, Marketing and Service Organizations. Varian International Customer Support managers will notify international customers by appropriate methods. The letter informed customers of the issue and the corrective action steps. Letters request that all appropriate personnel working in the radiotherapy department be notified of the contents of the letter. A new release version is being created to correct the issue. All sites will be notified when it is available.Questions or concerns should be directed to 1-888-827-4265. Contact information for international customers is also provided as well as a list of all affected serial numbers.",Contact the recalling firm for information,1125,1125,"Worldwide Distribution -- USA, China, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guadeloupe, Ireland, Italy, Latvia, Lithuania, Martinique, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom, Singapore, Algeria, Bangladesh, Belarus, Egypt, Guam, Hong Kong, India, Indonesia, Iraq, Israel, Kenya, Kuwait, Macau, Malaysia, Philippines, Qatar, Russia, South Africa, South Korea; Taiwan, Thailand, Tunisia, Ukraine, United Arab Emirates, Japan, Brazil, Chile, Columbia, Dominican Republic, Ecuador, Mexico, Peru, Venezuela, New Zealand, and Australia.",Terminated,"August 01, 2013",687,1125,Not_Computer,N/A,N/A,N/A
Z-3214-2011,59528,"pump, blood, cardiopulmonary bypass, roller type",DWB,Roller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.",8K Cardioplegia Monitor,2,"September 15, 2011", 2011,Terumo Cardiovascular Systems Corporation,The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.,DESIGN: Software Design (Manufacturing Process),"Terumo Cardiovascular Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated August 29, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter advises customers to make sure all users are aware of the notice. Customers are instructed to complete and return an attached Customer Response Form. Terumo will replace the software on all monitors of the affected product.Customers with questions or concerns should call Terumo CVS Customer Service 1-800-521-2818.",Contact the recalling firm for information,85,85,"Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan.",Terminated,"March 08, 2013",540,85,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-3207-2011,59290,"orthosis, spinal pedicle fixation, for degenerative disc disease",NKB,Pedicle screw spinal system.,Orthopedic,Orthopedic,510(k),"Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000.Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.",Synthes Matrix System T1 Matrix Locking Cap,2,"September 15, 2011", 2011,"Synthes USA (HQ), Inc.","Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Consultant.",Contact the recalling firm for information,N/A,N/A,"Nationwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-3221-2011,59519,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.",TSX101: Aquilion 32/64,2,"September 16, 2011", 2011,Toshiba American Medical Systems Inc,"There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.",DESIGN: Software Design,"Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.",N/A,528,528 units,Nationwide Distribution.,Terminated,"March 18, 2013",549,528,Software,Output/Calculation,Firmware update,Software Update
Z-3217-2011,59359,"system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen",NQX,Antimicrobial susceptibility test powder.,Microbiology,Microbiology,510(k),"BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits",BD MAX DNA Extraction Kit DNA2 (Whole Blood),2,"September 16, 2011", 2011,Becton Dickinson & Co.,"Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BD Diagnostic Systems sent an ""URGENT PRODUCT RECALL"" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.",Contact the recalling firm for information,9,9 kits,"Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.",Terminated,"October 12, 2011",26,392,Not_Computer,N/A,N/A,N/A
Z-3254-2011,59770,"clamp, circumcision",HFX,Obstetric-gynecologic specialized manual instrument.,Obstetrics/Gynecology,Obstetrics/Gynecology,510(k),"Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican RepublicLot Numbers: 20854003, 22892644(2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USALot Number 20012949Circumcision Clamp",Circumcision trays and packs ,2,"September 16, 2011", 2011,"Deroyal Industries, Inc. Lafollette",The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.,OTHER/UNDETERMINED: Pending,"DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.",N/A,390,390 units,"USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.",Terminated,"January 30, 2013",502,490,Not_Computer,N/A,N/A,N/A
Z-3255-2011,59683,cardiac ablation percutaneous catheter,LPB,N/A,N/A,Cardiovascular,N/A,"7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH.St Jude Medical CompanyA sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.",Therapy Ablation Catheter,2,"September 16, 2011", 2011,St Jude Medical,"The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.",PRODUCTION CONTROLS: Process Control,"St. Jude Medical sent an ""important Medical Device Safety Information"" letter dated February 22, 2011 to all affected customers.The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form.For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.",Discard product or return to place of purchase for a full refund or exchange,179,179 units total,"Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.",Terminated,"April 03, 2012",200,179,Computer,N/A,N/A,N/A
Z-3215-2011,59743,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EOThe Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.,Expect Endoscopic Ultrasound Aspiration Needle,3,"September 16, 2011", 2011,Boston Scientific Corporation,The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga.,OTHER/UNDETERMINED: Pending,"Boston Scientific Corporation sent a ""URGENT MEDICAL DEVICE RECALL letter dated August 11, 2010, to all affected customers. The letter identified the product, the problem and the action needed to be taken by customer.Customers were instructed to immediately remove the affected lot of Recall products from your inventory ( whether in Labs, Central Supply, Shipping and Receiving or any other location). Also, segregate this product in a secure location for return to Boston Scientific. Complete and return the Reply Verification Tracking Form ( even if you do not have any product to return) following the directions on this page and Reply Verification Tracking Form. Fax the Form to (508) 683-5578. Further questions please call (508) 683-4678.",N/A,30,30 units,"Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.",Terminated,"November 10, 2011",55,30,Not_Computer,N/A,N/A,N/A
Z-3222-2011,59704,"cpb check valve, retrograde flow, in-line",MJJ,Cardiopulmonary bypass blood reservoir.,Cardiovascular,Cardiovascular,510(k),"Cardiovascular Custom Procedure Kits, REV OAPERFUSION W/4:1 CARDIOPLEGIAItem Number 72990Terumo Cardiovascular Systems Corp.The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.",Terumo 3T L. V. Control Valve ,2,"September 16, 2011", 2011,Terumo Cardiovascular Systems Corp,"3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.For questions on this recall contact Terumo Customer Service at (734) 525-9580.",Discard product or return to place of purchase for a full refund or exchange,34,34 units,"Nationwide Distribution, including the states of FL and MI.",Terminated,"March 20, 2012",186,4233,Not_Computer,N/A,N/A,N/A
Z-3259-2011,59794,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804Angiographic catheter",SoftVu Angiographic Catheter,2,"September 16, 2011", 2011,Angiodynamics Worldwide Headquarters,The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.,TRAINING: Employee Error,"The firm ANGIODYNAMICS, Inc., sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number XXXXXXXXXX on the outside of the shipping box and include a copy of the Soft-Vu Angiographic Catheter Recall Reply Form with your shipment. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to customerservice@angiodynamics.com.",Contact the recalling firm for information,30,Domestic - 25 units; Foreign - 5 units,"Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain.",Terminated,"October 18, 2012",398,30,Not_Computer,N/A,N/A,N/A
Z-3266-2011,59820,"catheter, continuous flush",KRA,Continuous flush catheter.,Cardiovascular,Cardiovascular,510(k),"ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 10 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804",UNIFUSE INFUSION SYSTEM ,2,"September 19, 2011", 2011,Angiodynamics Worldwide Headquarters,The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.,PRODUCTION CONTROLS: Packaging Process Control,"URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.",Contact the recalling firm for information,23,23 units,Worldwide Distribution -- USA and The Netherlands.,Terminated,"October 18, 2012",395,47,Not_Computer,N/A,N/A,N/A
Z-3268-2011,59467,"glucose dehydrogenase, glucose",LFR,Glucose test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Contour, Contour TS Blood Glucose Test Strips and Bonus PacksIntended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood","Contour, Contour TS Blood Glucose Test Strips and Bonus Packs",2,"September 19, 2011", 2011,"Bayer Healthcare, LLC","All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour"" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood",PRODUCTION CONTROLS: Packaging,"Bayer sent an ""URGENT DIABETES TEST STRIP RECALL"" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.",Contact the recalling firm for information,58172747,"3,617,287 vials/ 54,555,460 test strips",Nationwide Distribution and Puerto Rico,Terminated,"July 02, 2012",287,3617287,Not_Computer,N/A,N/A,N/A
Z-3263-2011,59726,"products, red-cell lysing products",GGK,Red cell lysing reagent.,Hematology,Hematology,510(K) Exempt,"COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L).The COULTER¶_ DxH Cell Lyse is an erythrocyte lytic agent used for quantitativedetermination of hemoglobin, enumeration of NRBC, and counting and sizingleukocytes on UniCel¶_ DxH 800 Coulter¶_ Cellular Analysis System.",COULTER DxH Cell Lyse,2,"September 19, 2011", 2011,Beckman Coulter Inc.,The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts;could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/¶_L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.,N/A,"The recall communication was initiated on 08/01/2011 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US customers) to all customers, who purchased Coulter DxH Cell Lyse. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact Beckman Coulter for product replacement. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their Beckman Coulter representative.",Contact the recalling firm for information,4913,4913 units total (2245 in US),"Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.",Terminated,"June 04, 2012",259,4913,Not_Computer,N/A,N/A,N/A
Z-3261-2011,59831,"catheter, percutaneous",DQY,Percutaneous catheter.,Cardiovascular,Cardiovascular,510(k),"ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 Cardiovascular catheterization",Profiler Balloon Catheter,2,"September 19, 2011", 2011,Angiodynamics Worldwide Headquarters,The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.,TRAINING: Employee Error,"Angiodynamics, Inc sent a ""Urgent Medical Device Recall letter"" dated February 25, 2011 to all affected customers via Certified Mail Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer.The customer was instructed the following steps1. Identify and segregate the recalled lot that is in your possession.2. Complete the enclosed Profiler PTA Balloon Catheter Recall Reply Form and fax it to the attention of the Profiler PTA Balloon Catheter Recall Coordinator at 518-798-1360.The form lists the catalog numbers, lot numbers, and quantity our records indicate your facility has received.For further questions please call 1-800-772-6446.",Contact the recalling firm for information,15,15 units,"Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.",Terminated,"October 18, 2012",395,29,Not_Computer,N/A,N/A,N/A
Z-3265-2011,59303,automated external defibrillators (non-wearable),MKJ,Automated external defibrillator.,Cardiovascular,Cardiovascular,510(k),"Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy.Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440.Brand names: Powerheart AED, G3, CardioVive AED, GE ResponderAED, Nihon Kohden CardioLife AED.","Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED",2,"September 19, 2011", 2011,Cardiac Science Corporation,"Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state.CSC remind owners/operators of the Powerheart AED devices to verify the ""Rescue Readiness"" of their equipment and follow maintenance pro",OTHER/UNDETERMINED: Pending,"Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly.CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED ""Operator and Service Manual"" provided with every AED.Customers can call Cardiac Science at 800-426-0337 or e-mail at aed205@cardiacscience.com.",N/A,195739,"195,739 units in US",Worldwide Distribution - US (nationwide)This action applies only to domestic,Terminated,"February 13, 2014",878,195739,Not_Computer,N/A,N/A,N/A
Z-3270-2011,59865,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"VASOVIEW 6 Endoscopic Vessel Harvesting SystemManufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134.Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.",VASOVIEW 6 Endoscopic Vessel Harvesting System,2,"September 20, 2011", 2011,"Maquet Cardiovascular, LLC","During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"MAQUET Cardiovascular, LLC, sent an ""Urgent Device Removal/Immediate Action Required"" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.",Contact the recalling firm for information,141,141 units,"Nationwide Distribution (USA) including the states of: AL, AZ, CA, CT, FL, KS, KY, IL, IN, MI, MO, ND, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI.",Terminated,"September 21, 2011",1,390,Not_Computer,N/A,N/A,N/A
Z-3269-2011,59664,autonomous extracorporeal blood leak detector/alarm,ODX,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"CombiSet¶_ True Flow"" 2008K@home BloodlinesFresenius Medical Care.Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient","Fresenius Medical CombiSet True Flow"" ",2,"September 20, 2011", 2011,"Fresenius Medical Care Holdings, Inc.",Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions,DESIGN: Device Design,"Fresenius Medical Care sent out an ""Urgent"" recall notice dated August 11, 2011 to all affected customers .The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius.For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.",N/A,118,118 cases,Nationwide Distribution.,Open,N/A,N/A,118,Not_Computer,N/A,N/A,N/A
Z-3273-2011,57865,"syringe, piston",FMF,Piston syringe.,General Hospital,General Hospital,510(k),"Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)Indicated for aspirating bone marrow","Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)",2,"September 21, 2011", 2011,"Synthes USA (HQ), Inc.",Firm became aware that some systems were released to stock without going through the sterilization process.,N/A,"Synthes (USA) sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated February 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. Affected product removed from inventory will be replaced by Synthes. Contact the Synthes Spine Sale Consultant at 1-800-620-7025 ext.6883 for questions concerning this recall.",Contact the recalling firm for information,96,96 parts,"Nationwide Distribution-including the states of AR, CO, FL, GA, ID, LA, MA, MD, MO, MT, NY, NC, OH, SC, SD, TN, TX, and VA.",Open,N/A,N/A,96,Not_Computer,N/A,N/A,N/A
Z-3274-2011,59791,"tourniquet, pneumatic",KCY,Pneumatic tourniquet.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Stryker SmartPump Extension Tubing (Pneumatic tourniquet).Sterile tubing extension 40"" and 60"", set, luer lock. Rx only.Stryker Instruments Div. of Stryker Corporation.Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.",Stryker SmartPump Extension Tubing ,3,"September 21, 2011", 2011,Stryker Instruments Div. of Stryker Corporation,Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description.,N/A,"Stryker Instruments sent out ""Urgent Medical Device Recall"" notices dated August 22, 2011 to all affected customers.The letter included the name of the recalled product, lot numbers, and the reason for the recall. Customers were instructed to send back any product to Stryker that is within the affected lots. The letter further stated Stryker will quarantine the product and replace any product that is returned. For information on this recall contact Stryker Instruments at (269) 389-4534.",N/A,11848,5920-000-003 (30 bx) and 5920-000-005 (30 bx),"Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE",Terminated,"October 12, 2011",21,60,Not_Computer,N/A,N/A,N/A
Z-3277-2011,53897,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,"CareSuite"" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data.This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.","CareSuite"" Critical Care Manager, PACU Manager and Anesthesia Manager ",2,"September 23, 2011", 2011,Picis Inc.,"Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders, as entered by the attending physician",DESIGN: Software Design,"Picis Inc. sent a customer notification letter dated August 11, 2009 to all affected customers. The letter describes the product, problem, and action to be taken. Customers informed of the potential patient safety error were advised to make the appropriate configuration change, within current software versions 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.",N/A,8576,8576 UNITS,"Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.",Terminated,"September 27, 2011",4,8576,Software,Display/Image,Instructions on changing configurations,Safety Notice/Insructions
Z-3275-2011,59908,"microscope, surgical",EPT,Surgical microscope and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"OPMI¶_ Pentero¶_, OPMI¶_ Pentero¶_ C, OPMI¶_ Pentero¶_ 900,OPMI¶_ Vario/S8, OPMI¶_ Vario/S88, OPMI¶_ Neuro Multivision/NC4, OPMI¶_ Vario/NC33, OPMI¶_ Neuro/NC4, OPMI¶_ Neuro/NC4 Ceiling Mount.A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.","Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro",2,"September 23, 2011", 2011,"Carl Zeiss Meditec, Inc.",Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.,N/A,"The firm, Zeiss, sent an ""IMPORTANT SAFETY ALERT FOR ZEISS SURGICAL MICROSCOPES"" letter dated September 7, 2011, to all affected customers. The letter described the product, problem and action to be taken. The customers were instructed to use surgical drapes compatible with ZEISS surgical microscopes and always follow the instructions for use of the third party navigation system manufacturer for calibration, calibration verification and operation. In addition, the firm supplied customers with a supplement to their Zeiss surgical microscope user documentation and requested that they read the information and keep a copy with their original instructions also the customers were instructed to complete and return the Acknowledgement of Receipt form within 5 business days via fax to 1-866-809-6044 or USPS to Stericycle, Inc., Attn: Event 2480, 2670 Executive Dr. Suite A, Indianapolis, IN 46241.Should you have any questions about this Safety Alert, please contact your Carl Zeiss Customer Care representative at 1-888-871-7120.",Contact the recalling firm for information,1677,1677 consignees,Nationwide distribution: USA only.,Terminated,"February 24, 2012",154,1677,Not_Computer,N/A,N/A,N/A
Z-3276-2011,59734,"set, i.v. fluid transfer",LHI,Intravascular administration set.,General Hospital,General Hospital,510(k),"LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.",Logix Order Entry (OE) Software,2,"September 23, 2011", 2011,Baxter Healthcare Corp.,"There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order, the user can accept the pre-populated ""per units"" of ""Bag"" or select other ""per units"". A dosing error may occur if the user does not select the prescribed ""per units"" for the added ingredient.",DESIGN: Software Design,"Baxter Healthcare Corp. sent an ""Urgent Device Correction"" letters dated August 15, 2011 which included LOGIX OE screen illustrations of a representative neonate and adult patient, via first class mail to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed to follow safe compounding practice, which includes verifying that the ingredient per units entered match the TPN prescription prior to preparation. Baxter requests that customers communicate this issue to all personnel responsible for LOGIX order entry and order authorization at their facility. Customers are instructed to retain a copy of the letter at each computer on which LOGIX OE software is installed. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.",Contact the recalling firm for information,95,95 units,Worldwide Distribution - USA (nationwide) including Puerto Rico and the country of Canada.,Open,N/A,N/A,95,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-3260-2011,59877,"tray, start/stop (including contents), dialysis",FKG,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,"Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A.Product Usage: custom dialysis prep kits",Custom Dialysis prep kits ,1,"September 23, 2011", 2011,Lee Medical International Inc,The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pads were subsequently recalled due to possible bacterial contamination.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Lee Medical International Inc., notified their consignees by email and telephone on August 17, 2011. Consignees were instructed to remove the affected product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.",N/A,4075,"4,075 units","Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.",Terminated,"January 30, 2012",129,4075,Not_Computer,N/A,N/A,N/A
Z-3258-2011,59825,low energy direct current thermal ablation system,OAB,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),"ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).",NANOKNIFE,2,"September 23, 2011", 2011,"Angiodynamics, Inc.","Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a ""GOMe"" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.",DESIGN: Component Design/Selection,"AngioDynamics, Inc. sent a ""NOTIFICATION OF MEDICAL DEVICE CORRECTION"" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.",Contact the recalling firm for information,21,21 units,"Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,",Open,N/A,N/A,21,Hardware,Treatment/Delivery/Therapy,Notification,Safety Notice/Insructions
Z-3278-2011,59862,"nitrophenylphosphate, alkaline phosphatase or isoenzymes",CJE,Alkaline phosphatase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31.Used for the quantitation of alkaline phosphatase in human serum or plasma.",Abbott Clinical Chemistry Alkaline Phosphatase Assay,2,"September 26, 2011", 2011,"Abbott Laboratories, Inc","The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.",N/A,"The firm decided to recall and notified consignees by a Product Recall - Immediate Action Required letter on 08/26/11. The letter identified the affected product, the reason for the recall, the patient impact, and necessary actions to be taken by the customer. Customers are to determine if they are using or have the affected product in their inventory. Customers are to discontinue use and destroy any remaining product of the specified lots in accordance with their facility's policies and procedures. Alternative lots of the product should be ordered and the enclosed Customer Reply form should be completed and returned. The letter also states that customers may want to decontaminate their systems by following the steps in Attachment A. If the product from the affected lots were further distributed, a copy of the letter should be provided to those customers as well. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service.",Contact the recalling firm for information,6269,6269 units,Worldwide Distribution,Terminated,"August 17, 2012",326,6269,Not_Computer,N/A,N/A,N/A
Z-3280-2011,58556,"walker, mechanical",ITJ,Mechanical walker.,Physical Medicine,Physical Medicine,510(K) Exempt,"Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box.Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.",wheeled adult and junior walkers,2,"September 27, 2011", 2011,Invacare Corporation,"The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would res",DESIGN: Device Design,"The firm, Invacare Corporation notified their customers of this recall/corrective action via an 'URGENT RECALL INFORMATION' letter dated April 7, 2011. The letter was sent to the customers by registered mail or Federal Express. The letter informs the customer(s) of the component defect involved and the inherent possibility that over time, a walker wheel(s) could fall off resulting in instability of the product and potential for serious injury to the user of the device. The letter provides a list of the affected units sold to each facility on an enclosed tracking sheet. It also asks that the customer: 1) Examine their stock for the presence of any of the affected walkers and to quarantine any such products found; 2) Complete an attached recall response form indicating the customers receipt and understanding of the instructions provided in the letter and to fax the completed form to the telephone number listed on the bottom of the form. The letter goes on to state that once the faxed back form is received by Invacare, the company will send the customer replacement wheels kits for all affected walkers purchased; 3) the customer is asked upon receipt of the replacement wheel kits to replace the wheels of any units still in stock and discard all of the old wheel parts removed; 4) Lastly, the customer is asked to contact their sub-account customers and notify them of the recall. If the customer have any questions concerning the instructions, call the recall support line at 1-866-567-7899.",N/A,12764,"12,764 walkers were distributed.","Worldwide Distribution - USA (nationwide: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, including Puerto Rico and countries of Canada, Columbia, and Israel.",Terminated,"July 02, 2013",644,12764,Not_Computer,N/A,N/A,N/A
Z-3282-2011,59527,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTIONGE Medical Systems, SCS.A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.",ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION,2,"September 27, 2011", 2011,"GE Healthcare, LLC",GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.,DESIGN: Software Design,"GE Healthcare sent ""Urgent Medical Device Correction"" letters dated August 18, 2011 to all affected customers.The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade.For question of this recall contact the GE Service Representative at (800) 437-1171.",Contact the recalling firm for information,697,697,"Worldwide Distribution: Nationwide distribution including the states of AZ, CA, CT, DC, FL, ID, IL, KY, LA, MD, MI, MN, NJ, NY, OR, PA, PR, TN, TX, VA, WA, and WI; and the countries of VIETNAM, MEXICO, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, ST HELENA, SPAIN, SLOVENIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¶_D¶_RATION, ROMANIA, REUNION, REPUBLIC OF CHINA, QATAR, PORTUGAL POLAND, PARAGUAY, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LUXEMBOURG, LIBYA, KUWAIT, KOREA, JAPAN, ITALY, ISRAEL, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, CZECH REPUBLIC, CROATIA, COSTA RICA, COLOMBIA, CHILE, CANADA, BELARUS, BRAZIL, BOSNIA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.",Terminated,"August 09, 2012",317,697,Software,Display/Image,Software update,Software Update
Z-3281-2011,59383,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592.The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",Brilliance CT XRay System,2,"September 27, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS,OTHER/UNDETERMINED: Pending,"Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011.For questions regarding this recall call 1-440-483-7000.",N/A,1,1 unit,Nationwide Distribution including PA,Terminated,"March 15, 2013",535,1,Not_Computer,N/A,N/A,N/A
Z-3279-2011,59503,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty.The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.",Zimmer Trabecular Metal Modular Acetabular System ,2,"September 27, 2011", 2011,Zimmer Inc.,"Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. Th",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Zimmer, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.",N/A,62255181,24 devices lot 61132689; 1 device lot 001122467,"Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.",Terminated,"August 29, 2013",702,25,Not_Computer,N/A,N/A,N/A
Z-3283-2011,59686,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"Boston Scientific, LATITUDE¶_ Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798Boston Scientific, LATITUDE¶_ RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798LATITUDE Communicator REF 6468 (only distributed outside the US)The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.","Boston Scientific, LATITUDE Patient Management System Communicator",3,"September 28, 2011", 2011,Boston Scientific CRM Corp,"A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.",DESIGN: Software Design (Manufacturing Process),"Boston Scientific CRM Corporation sent a "" Dear Patient"", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally.1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator.2. We also ask that you return the original communicator previously delivered to you:"" Place the original equipment in the shipping box used for the new equipment."" Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box."" Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label."" Call Federal Express at 1.800.463.3339 to schedule a pick-up.We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.",N/A,470,470,"Worldwide Distribution -- (USA) nationwide including the states of AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE,NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY., and the countries of United Kingdom, France",Terminated,"November 06, 2012",405,470,Other,Device Operation,N/A,Other
Z-3286-2011,59953,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005.Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur.",Plum A Hyperbaric Single Channel Infusion Pumps,2,"September 29, 2011", 2011,Hospira Inc.,"Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur.",N/A,"Hospira, Inc. sent an ""URGENT DEVICE RECALL"" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. The letter instructs customers on how to prevent occurrences of continuous recycling/rebooting during start-up. A reply form was attached to the letter for customers to complete and return via fax to 1-888-345-5358. Contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance or information regarding this notice.",Contact the recalling firm for information,120,120 pumps,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the U. S. Virgin Islands and countries of Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.",Open,N/A,N/A,290217,Not_Computer,N/A,N/A,N/A
Z-3288-2011,59312,"spirometer, monitoring (w/wo alarm)",BZK,Monitoring spirometer.,Anesthesiology,Anesthesiology,510(k),FloTrak Elite modulesFloTrak Elite P/N 1044971FloTrak Elite P/N 1051005,Philips,2,"September 30, 2011", 2011,"Respironics Novametrix, LLC.",Pressure lines maybe occluded and display incorrect tidal volumes.,PRODUCTION CONTROLS: Manufacturing Material Removal,"Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.",N/A,41,41 units,"Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.",Terminated,"May 23, 2012",236,295,Not_Computer,N/A,N/A,N/A
Z-3289-2011,59724,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"Comprehensive Reverse Humeral Fracture InserterREF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1.Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.",Biomet Reverse Humeral Inserter,2,"September 30, 2011", 2011,"Biomet, Inc.","Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 8/3/11 Biomet Orthopedics sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" letter to all affected customers.The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form.For information or questions on this recall call Biomet at (574) 372-1570.",Contact the recalling firm for information,6,6 units (internationally),"International Distribution Only: Canada, Australia, and Columbia.",Terminated,"October 26, 2011",26,6,Not_Computer,N/A,N/A,N/A
Z-0001-2012,57858,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),"Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation,Louisville, CO 80027.Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.",Left Long Tactile Probe,2,"October 03, 2011", 2011,"Medtronic Navigation, Inc",Distal end of tactile probe may break off during use.,DESIGN: Labeling Design,"Medtronic sent an ""Urgent Product Safety Notice"" to all affected customers dated Jan 20, 2011.The letter included affected product and updated instructions for use. On-site training was given for the use of the probes by Medtronic Representatives.For information on this recall call Medtronics at (720) 890-3409.",Contact the recalling firm for information,6,6 probes,Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea,Terminated,"October 03, 2011",0,6,Not_Computer,N/A,N/A,N/A
Z-0007-2012,59847,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ESB. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.",Outlook ES Safety Infusion System,2,"October 03, 2011", 2011,"B Braun Medical, Inc",The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.,DESIGN: Software Design,"The firm, B. Braun Medical Inc., sent an ""URGENT: FIELD CORRECTION"" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned.Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).",Contact the recalling firm for information,11525,"11,525 pumps","Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.",Open,N/A,N/A,11525,Software,Device Operation,Software update,Software Update
Z-0003-2012,59979,"implant, cochlear",MCM,N/A,N/A,Ear Nose & Throat,N/A,"Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia.The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.",Cochlear Nucleus CI512 Cochlear Implant,2,"October 03, 2011", 2011,Cochlear Americas Inc.,Cochlear implant may shut down and cease to function.,DESIGN: Component Design/Selection,"Cochlear Americas, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.",Contact the recalling firm for information,60902,"33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.",Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.,Terminated,"July 10, 2012",281,33645,Not_Computer,N/A,N/A,N/A
Z-0006-2012,59139,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,N/A,"Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page.Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.",Cyberonics,2,"October 04, 2011", 2011,"Cyberonics, Inc",An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.,DESIGN: Software Design (Manufacturing Process),"The firm, Cyberonics Inc., initiated containment actions on March 17, 2011 to prevent additional affected devices from being shipped. The firm initiated contact with implanting facilities in the United States on May 6, 2011 and international facilities and distributors on May 10, 2011 to remove product from the field that has not yet been implanted. Additionally, a ""Field Safety Alert"" letter was sent to all affected medical professionals. The letter identifies the affected product, the issue, and the action(s) to be taken by the physicians. Consignees are instructed to complete and return an attached Effectiveness Check Form. If assistance is needed physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.",N/A,13,13 units,"Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.",Terminated,"December 04, 2012",427,105,Software,N/A,N/A,N/A
Z-0008-2012,59213,"system, facet screw spinal device",MRW,N/A,N/A,Orthopedic,510(k),"OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001",OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft ,2,"October 04, 2011", 2011,"Osteomed, Lp",Two of the Implant Driver Assembly tips were reported to break during surgery.,DESIGN: Device Design,"OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to:OsteoMed LPAttan: Rebecca Ellis3885 Arapaho RoadAddison, Texas 75001If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address.Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.",N/A,20,20 units,"Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO",Terminated,"December 04, 2012",427,20,Not_Computer,N/A,N/A,N/A
Z-0004-2012,58823,"pump, infusion, pca",MEA,Infusion pump.,General Hospital,General Hospital,510(k),"Smiths Medical, CADD¶_-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.",CADDSolis ambulatory infusion pumps.,2,"October 04, 2011", 2011,"Smiths Medical ASD, Inc.","Reports of non-delivery/ significant under-delivery of fluids when the CADD¶_ Medication Cassette Reservoir is not correctly latched to the pump.EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Smiths Medical sent a customer's bulletin notice dated April 11, 2011, only to the customers who reported this issue. Smiths Medical will work directly with the five Consignees who have reported complaints for this issue.The customer was instructed to read the attached Customer Information Bulletin. If you have additional questions on how to correctly latch a cassette to the pump, than please visit the following website: https://www.smiths-medical-education.com.Smiths Medical will also provide replacement pumps, as requested. This also will be considered an extension of Smiths Medical's investigation into this issue and to further validate the effectivity of the corrective and preventative actions in actual use.For further questions please call (651) 628-7280.EXPANDED:Consignees were sent a Smith Medical "" Urgent Safety Alert"" letter dated June, 30, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians/ Biomedical Engineering, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Medical Equipment Rental Companies,Distributors and other users of these devices. The letter described the problem and the product. It provided ""Advice on Action to be Taken by the User"". This included to read the attached Customer information Bulletin and to complete and return the attached Confirmation Form.",No consumer action necessary,4536,"4536 (3792 USA, 744 OUS)","Worldwide Distribution -- (USA) nationwide including the states of AR, CA, MO, NY and WI., and the countries of BELGIUM, CANADA, SWITZERLAND, GERMANY, DENMARK, FRANCE, UNITED KINGDOM, IRELAND, ITALY, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE. *** EXPANDED*** AL, AK, AZ, CO, DC, FL, GA, ID, IL, IN, KY, LA, MD,MA, JI, MN, MT, NE, NH, NJ, NM, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WY. UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA.",Terminated,"July 19, 2012",289,4536,Not_Computer,N/A,N/A,N/A
Z-0011-2012,59956,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.",Plum A Hyperbaric Single Channel Infusion Pumps,2,"October 04, 2011", 2011,Hospira Inc.,Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.,DESIGN: Software Design,"The firm, Hospira sent ""URGENT DEVICE RECALL"" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***.",No consumer action necessary,120,120 pumps,"Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.",Open,N/A,N/A,290217,Software,N/A,N/A,N/A
Z-0013-2012,59952,"collector, ostomy",EXB,Ostomy pouch and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(K) Exempt,Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm)Required for application to a patient immediately after ostomy surgery.,Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm),3,"October 05, 2011", 2011,Convatec Inc.,Post-operative kits 57 mm may contain 70 mm pouches.,PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, ConvaTec, sent a ""MEDICAL DEVICE RECALL"" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in inventory; call the toll free number 1-800-582-6514 for return instructions and RGA number-(recall product must be returned in a separate container from any other product returns); mark all return shipments ""Recalled Product"" and provide supplied RGA number, and forward this letter to customers, if they distributed the product.Should you have any questions, call 1-800-582-6514.",Contact the recalling firm for information,283,283 units,"Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.",Terminated,"January 11, 2012",98,283,Not_Computer,N/A,N/A,N/A
Z-0012-2012,59943,"band, elastic, orthodontic",ECI,Orthodontic appliance and accessories.,Dental,Dental,510(K) Exempt,"Biomet Microfixation outer packaging labeled in part:""REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16"" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***.""Inner Vendor/Manufacturer Label labeled in part:""H4 Elastics 4mm (3/16"") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***""Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.",Latex Free Rubber Band,2,"October 05, 2011", 2011,"Biomet Microfixation, Inc.","On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as ""LATEX FREE"" although it contains ""LATEX"". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies.",PRODUCTION CONTROLS: Error in Labeling,"Biomet Microfixation, Jacksonville, FL sent a Urgent Medical Device letter dated August 19, 2011, to all affected customers. They were also notified by phone, and followed-up by e-mails starting on 08/18/2011. The letter identified the product the problem and the action needed to be taken by the customer.The customer was instructed If you have any of the affected products in your facility, please remove it and return it immediately to Biomet Microfixation for credit. In order to return these products, please utilize the Return Goods Authorization (RGA) number provided on the reconciliation form.Please follow the instructions on the form and fill out the attached Inventory Reconciliation sheet and FAX to (904) 741-9425. If you have any further questions, please call 1-800-874-7711 or (904) -741-4400, extension 9468, Monday through Friday, 8am-4pm ET.",N/A,22,22 packs,"Worldwide Distribution-- USA (nationwide) including the states of FL, KY, MN, NJ, SD, and VA., and the country of Australia.",Terminated,"February 06, 2012",124,22,Not_Computer,N/A,N/A,N/A
Z-0016-2012,59854,catheter introducer kit,OFD,Catheter introducer.,Cardiovascular,Cardiovascular,Enforcement Discretion,"DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.",DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits,2,"October 06, 2011", 2011,"Deroyal Industries, Inc. Lafollette","The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, DeRoyal, sent a ""URGENT: MEDICAL DEVICE RECALL"" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers.Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.",N/A,200,200 units,"Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.",Terminated,"January 30, 2013",482,1140,Not_Computer,N/A,N/A,N/A
Z-0020-2012,59868,"assay, glycosylated hemoglobin",LCP,Glycosylated hemoglobin assay.,Hematology,Hematology,510(k),"VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States.Kit contains:1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges.4. CD-ROM 1 - CD Rom with program parameters5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water.6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative,7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps.8. Instruction Manual.Bio-Rad Laboratories, Hercules, CA 94547.Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)","VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, ",3,"October 07, 2011", 2011,"Bio-Rad Laboratories, Inc.",A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.,PRODUCTION CONTROLS: Process Control,"Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product.Customers were asked to please translate (if necessary) the attached ""Customer Medical Device Correction Response Form,"" customers should add their local contact information and distribute to all affected customers in their region by mail or fax.Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter.Complete the ""SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM"" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD.Customers would be issued credits for the affected products based on their request. For questions call (510) 741-3954.",N/A,82,82,"Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.",Terminated,"May 11, 2012",217,287668114,Not_Computer,N/A,N/A,N/A
Z-0030-2012,59957,fibrin split products,GHH,Fibrinogen/fibrin degradation products assay.,Hematology,Hematology,510(k),"Minutex D-Dimer ; Trinity Biotech plc,Bray,Co. Wicklow,Ireland.Tel: (353) 1 276 9800,Fax: (353) 1 276 9888,Web: www.trinitybiotech.comMinutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.",Minutex DDimer ,2,"October 07, 2011", 2011,"Tcoag Us, Incorporated",There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm,Tcoag US, Incorporated, sent an ""Urgent Device Recall"" letter dated June 13, 2011 via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products subject to recall; complete and return the attached Product Recall Notification Response Form by June 22, 2011 via fax at 973-775-3085; scrap the products consistent with their laboratory policy and if they have further distributed these products, notify their customers to quarantine and scrap the recalled product.For questions or technical assistance, please call the Tcoag hotline at 1-888-291-0415, option 2 (7.30 am to 6.00 pm Eastern Time).",N/A,4409,4409 Units,Worldwide distribution: USA (nationwide) and country of: Canada.,Terminated,"December 11, 2012",431,4409,Not_Computer,N/A,N/A,N/A
Z-0032-2012,59853,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"MDC PACS - release R2.3 SP1 .Phillips HealthcareAndover, MassachusettsA software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).",Philips Medical,2,"October 07, 2011", 2011,Philips Healthcare Inc.,Clinical measurements on true size printouts may be inaccurate,DESIGN: Software Design,"Philips Medical notified all affected customers with a ""Field Safety Notice"" dated August 2011.The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377.",Contact the recalling firm for information,20,20 units,"Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.",Open,N/A,N/A,20,Software,Output/Calculation,Software update,Software Update
Z-0029-2012,59787,biopsy needle kit,FCG,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),OLYMPUS ViziShot EBUS Aspiration NeedleEndobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.,OLYMPUS ViziShot EBUS Aspiration Needle,2,"October 07, 2011", 2011,Olympus America Inc.,Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n,DESIGN: Device Design,"OLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention.Customers were instructed to examine their inventory to determine if they have the affected product.To share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred.Complete and return the enclosed questionnaire even if they do not have affected product. Customers were instructed to fax the completed questionnaire to 484-896-7128.For any question call 484-896-5688.",N/A,22498,"22,498","Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.",Terminated,"September 28, 2012",357,22498,Not_Computer,N/A,N/A,N/A
Z-0031-2012,59746,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.",Dimension Vista(R) Cuvettes ,2,"October 07, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.","Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the Cuvette flange or ""wing"" breaking, resulting in an error condition. Therefore, patient results are not impacted.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Siemens Healthcare Diagnostics sent a Urgent Field Safety Notice letter dated August 2011, to all affected customers. The letter identifed the product the problem and the action needed to be taken by customer.Customers were instructed to discard all cuvette cartridges of the identified lots. Customers were also informed that until a replacement lot is available, if an error is encountered, they may contact the Technical Solutions Center for assistance at (800) 441-9245. For replacement product , please call the Siemens Atlanta Customer Service Center at (800) 241-0420.",N/A,1786,"1,786","Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.",Terminated,"December 24, 2013",809,1786,Not_Computer,N/A,N/A,N/A
Z-0028-2012,59535,"station, pipetting and diluting, for clinical use",JQW,Pipetting and diluting system for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700.Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.",Coulter PrepPlus 2,2,"October 07, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter Representative.",No consumer action necessary,391,391 units total (193 in US),Worldwide distribution.,Terminated,"April 04, 2012",180,391,Not_Computer,N/A,N/A,N/A
Z-0036-2012,59937,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA",CyberKnife Robotic Radiosurgery System,2,"October 11, 2011", 2011,Accuray Incorporated,"A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly.",PRODUCTION CONTROLS: Process Control,"Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.",Contact the recalling firm for information,236,236 total devices,Worldwide Distribution,Terminated,"February 27, 2012",139,236,Not_Computer,N/A,N/A,N/A
Z-0034-2012,59756,"curette, surgical, general use",FZS,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144The Axle Torque Driver Handle is used to lock the set screw into the locking plate.",Axle Interspinous Fusion System Torque Driver Handle,2,"October 11, 2011", 2011,X Spine Systems Inc,The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.,DESIGN: Component Design/Selection,"X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle ""click."" The ""click"" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again.If the product was distributed further, they should contact their accounts, and advise them of this recall.The firm will send replacement handles.For any questions call (937) 847-8400, ext 115.",Contact the recalling firm for information,39,39 Torque Driver Handles,"Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.",Terminated,"March 01, 2013",507,39,Not_Computer,N/A,N/A,N/A
Z-0033-2012,59879,"adaptor, y",FJP,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KYSystem is used to mix and distribute bicarbonate as a part of a clinical dialysis system.",Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model MD380,3,"October 11, 2011", 2011,Isopure Corp,"Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.",DESIGN: Software Design,"Isopure sent a letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Isopure devised an immediate solution which must be implemented at their faclity in conjunction with the disinfection procedure. Customers were asked to inform all appropriate personnel, clinical and technical, who may be involved in operating the system during the normal disinfection schedule.On 5/19/2011, the firm sent letters to their customers via US mail and email. They also telephoned their customers to notify them of the problem.",Contact the recalling firm for information,11,11 units,"Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.",Terminated,"February 19, 2013",497,11,Software,Device Operation,Instructions,Safety Notice/Insructions
Z-0043-2012,58746,"stains, hematology",KQC,Dye and chemical solution stains.,Hematology,Pathology,510(K) Exempt,"Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342Made in India.The product is a Class I, IVD dye and chemical stain for use in Hematology.",Harleco Giemsa Stain ,3,"October 12, 2011", 2011,EMD Chemicals Inc.,Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.,TRAINING: Employee Error,"EMD Chemicals Inc. sent an ""IMPORTANT PRODUCT RECALL"" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. An attached response form is included for customers to complete and return via fax to EMD Chemicals at 856-423-6314. Any questions concerning this recall notice should be directed to EMD Chemicals Technical Service Department at 1-800-222-0342.",Contact the recalling firm for information,36,36 units,USA Distribution in the states of PA and NY.,Terminated,"October 13, 2011",1,36,Not_Computer,N/A,N/A,N/A
Z-0037-2012,59898,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"LATITUDE¶_ Paceart Integration Software, version 1.00 Model 6472.LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493.When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.",LATITUDE Paceart Integration Software,2,"October 12, 2011", 2011,Boston Scientific CRM Corp,"Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) softwaremay not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.",DESIGN: Software Design,"Consignees were sent on 8/12/11 a Boston Scientific letter dated August 2011. The letter was addressed to ""Dear Doctor"". The letter described the product and problem. It also gave Background Information, Description of Potential Data Translation Error, and Additional Information and Action information.A letter, including an HRS form, was also sent to all US LATITUDE Clinics that have active LPI software to notify them of the need to install the corrected LPI Software.",Contact the recalling firm for information,398,398,"Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT DE, DC, FL, GA, IL,IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OJ, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV, WI, and WY.",Terminated,"November 06, 2012",391,398,Software,Device Operation,Software update,Software Update
Z-0042-2012,59891,"test, urea (breath or blood)",MSQ,Campylobacter fetusserological reagents.,Microbiology,Microbiology,510(k),"IDkit:HP"" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USAProduct Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.","IDkit:HP"" Two Test System",2,"October 12, 2011", 2011,Exalenz Bioscience Ltd,The product is in violation of the FD&C; Act in that it was illegally marketed without proper clearance (no 510(k) submitted).,N/A,"The firm, Exalenz Bioscience Ltd. notified consignees located in the United States of the recall by telephone, electronic mail, or written correspondence between June 9, 2011 and June 30, 2011. The letter informed consignees that Exalenz will immediately cease marketing the IDkit:HP TWO test in the United States. Consignees were instructed to return shipment of the IDkit:HP TWO test kits that they have in their possession to the companys US warehouse. For question call the VP of North American Sales at 704-770-6162 or VP of Marketing at 617-794-6936.",N/A,1240,1240 units,"Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.",Terminated,"July 06, 2012",268,1240,Not_Computer,N/A,N/A,N/A
Z-0039-2012,59316,"microtome, rotary",IDO,Tissue processing equipment.,Pathology,Pathology,510(K) Exempt,Thermo Scientific Microm: Rotary Microtome: REF HM355S-3Used for slicing tissue blocks.,Thermo Scientific Microm,2,"October 12, 2011", 2011,Richard-Allan Scientific Company,The firm has received two complaints of finger lacerations in operators of this device.,DESIGN: Device Design,"ThermoFisher Scientific sent ""URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice"" to all affected customers.The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.",No consumer action necessary,786,786,Worldwide Distribution: Nationwide distribution; including the country of Canada.,Terminated,"July 25, 2013",652,786,Not_Computer,N/A,N/A,N/A
Z-0038-2012,59888,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.,Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621),2,"October 12, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.","Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed.",OTHER/UNDETERMINED: Pending,"Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457.Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. For any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.",N/A,998,998,"Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland.",Terminated,"May 20, 2013",586,998,Not_Computer,N/A,N/A,N/A
Z-0040-2012,59712,"system, applicator, radionuclide, manual",IWJ,Manual radionuclide applicator system.,Radiology,Radiology,510(K) Exempt,"Prostrate Seeding Applicator Needle. Product code PSS1820ATPacked in boxes of (25) with five Single Packs and four five packs or as singles or five packs.Worldwide Medical Technologies, LLCUsed to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate","Prostate Seeding Needle, Applicator Technique",2,"October 12, 2011", 2011,"Worldwide Medical Technologies, LLC",Length of the cannula hub is longer and may not permit a fit with the Applicator,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"BrachySciences, a division of Biocompatibles, Inc., sent out ""Urgent Recall Device Recall"" letters Dated August 12, 2011 to all affected customers.The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm.For questions on this recall contact the firm at (203) 262-0571, extension 105.",Contact the recalling firm for information,1872,1872 units,"Worldwide Distribution: Nationwide distribution including the states of AR, CO, DE. FL, KY, MD, MI, MN, NY, TX, and VA; and the countries of Belgium, and Germany.",Terminated,"September 19, 2012",343,1872,Not_Computer,N/A,N/A,N/A
Z-0041-2012,59418,electrocardiograph,DPS,Electrocardiograph.,Cardiovascular,Cardiovascular,510(k),"ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.",ECG Cable,2,"October 12, 2011", 2011,"Edan Instruments, Inc.","The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control,"Edan Instruments, Inc. sent an Urgent - Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that wrongly labeled cable may lead to incorrect ECG waveforms during ECG test, customers were reminded to review previous diagnoses made from this cable to mitigate any inappropriate recordings or treatment made.Customers were instructed to replace the affected ECG Cables once they receive the new ECG Cable, and collect all the affected ECG Cables and then destroy and dispose of them according to local regulations. Questions or concerns were directed to the following numbers: Oceania and Asia: +86 (755) 2689 8322North America, South America:+86 (755) 2689 9914Europe: +86 (755) 2669 4684.",Contact the recalling firm for information,615,615 Ccables,"Worldwide Distribution - USA (nationwide) and the countries of Dominica, Ecuador, Colombia, Honduras, Peru, Mexico, El Salvador, Guatemala, Venezuela, Uruguay, Chile, Panama, Nicaragua, Ecuador, Australia, Philippines, Malaysia, Indonesia, Chinese Taipei, & Spain",Terminated,"October 13, 2011",1,615,Not_Computer,N/A,N/A,N/A
Z-0045-2012,58461,screwdriver,HXX,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc.A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.",PERPOS PLS System Single Use ,2,"October 13, 2011", 2011,Interventional Spine Inc,"This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone.Use of this product may result in a delay of the surgical procedure",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Interventional Spine, Inc. sent an ""Urgent Recall"" letter dated March 15, 2011 to all affected customers.The letter included; affected product, reason for recall and recommendations.Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain.For information on this recall contact the firm at (949) 472-0006.",N/A,2620,"2,620 units","Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.",Terminated,"February 05, 2013",481,2692,Not_Computer,N/A,N/A,N/A
Z-0055-2012,59526,"introducer, catheter",DYB,Catheter introducer.,Cardiovascular,Cardiovascular,510(k),"8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC.The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.",Safe Sheath ULTRALITE 8F Safe Sheath Introducer.,2,"October 13, 2011", 2011,"Angiodynamics, INC",The product may contain an incorrect size catheter and introducer.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"AngioDynamics, Inc contacted affected customers initially via telephone and a follow up ""Notification of Medical Device Correction"" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.",Contact the recalling firm for information,1095,1095 total units,"(USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.",Terminated,"March 07, 2012",146,1095,Not_Computer,N/A,N/A,N/A
Z-0048-2012,59768,real time nucleic acid amplification system,OOI,Instrumentation for clinical multiplex test systems.,Clinical Chemistry,Clinical Chemistry,510(k),"Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.",Abbott m2000rt System software,2,"October 14, 2011", 2011,Abbott Molecular,"The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the final results, which could cause an inval",DESIGN: Software Design,"Abbott Molecular Inc. sent a Field Correction Recall letter dated September 8, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until an upgrade to your m2000rt software can be installed. Abbott Molecular estimates that this software version will be available the first quarter of 2012.Please complete the enclosed reply sheet and fax it to (847) 775-6728 at your earliest convenience to acknowledge receipt. We appreciate your assistance in this matter.",N/A,926,926 units,"Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belgium, Benin, Bolivia, Bosnia and Herzegovia, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dem. Rep. of the Congo, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Gabon, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Libya, Lithuania, Malawi, Malaysia, Mali, Mauritius, Mexico, Moldova, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Venezuela, Vietnam, Zambia and Zimbabwe",Open,N/A,N/A,926,Software,Output/Calculation,Software update,Software Update
Z-0044-2012,60008,"lenses, soft contact, daily wear",LPL,Soft (hydrophilic) contact lens.,Ophthalmic,Ophthalmic,510(k),"AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736.Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.",AVAIRA,1,"October 14, 2011", 2011,CooperVision Inc.,"This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Corneal epithelial edema results",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm, CooperVision sent an ""Urgent: Company Initiated Voluntary Medical Device Recall - Contact Lenses"" notification letter to all affected consignees. The notice identified the product, the problem, and the actions to be taken. The letter includes an attached ""Recall Response Form"" that consignees are required to complete and fax to (585) 889-5688. Consignees were instructed to immediately examine their inventory, stop any further distribution, quarantine and return product subject to recall. In addition, consignees were told if they have further distributed the affected product to notify customers at once of this product recall. The letter states that accounts will either be credited or exchanged for an unaffected product. If you have any further questions, call 1-800-341-2020.",N/A,N/A,"At least ( 778,301 lenses: Domestic - 659,847 lenses; Foreign - 118,454 lenses; including EXPANSION: Domestic - 69,047 lenses) ( to be updated)","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0049-2012,59978,"screw, fixation, bone",HWC,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007;Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CAThe MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.",MiniMagnum Knotless Fixation Device,2,"October 14, 2011", 2011,ArthroCare Corporation,ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.,PRODUCTION CONTROLS: Packaging Process Control,"The firm, ArthroCare Corporation, sent a letter dated May 10, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were asked to immediately return the product; check their inventory, refer to the copy of the Mini Magnum outer label to help identify the product, and if the affected product lot is in their inventory, notify ArthoCare Product Support at (800) 797-6520, press 2 and return the product immediately. The letter also stated, ""In addition, if you do not have any product from this lot remaining in your inventory, we request that you contact ArthroCare at the number above, or by e-mail at ra@arthrocare.com, to inform us of the lack of remaining product. This will ensure that you will not be contacted again and that we have accounted for product shipments from this lot."" If you have any questions, please call the Chief Regulatory Officer and Senior Vice President, Quality Systems and Assurance at (408) 735-6229.",N/A,32,32 units,"Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.",Terminated,"October 24, 2011",10,32,Not_Computer,N/A,N/A,N/A
Z-0050-2012,53046,"visual, pregnancy hcg, prescription use",JHI,Human chorionic gonadotropin (HCG) test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Access Immunoassay Systems Total ¶_hCG.The Access Total ¶_hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ¶_hCG levels in human serum and plasma using the Access Immunoassay Systems.",Access Immunoassay Systems TOTAL hCG,2,"October 17, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed that certain Access Total ¶_hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total ¶_hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs.Customers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification.Finally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.",N/A,14764,"14,764","Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Zambia.",Terminated,"April 27, 2012",193,14764,Not_Computer,N/A,N/A,N/A
Z-0054-2012,59912,"sucker, cardiotomy return, cardiopulmonary bypass",DTS,Cardiopulmonary bypass cardiotomy return sucker.,Cardiovascular,Cardiovascular,510(k),"SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE","Sarns Adult Rigid Intracardiac Sucker; bulk, nonsterile",2,"October 17, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns"" Adult Rigid Intracardiac Sucker.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 9/13/2011 Terumo sent a letter entitled ""URGENT MEDICAL DEVICE REMOVAL"" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.",Contact the recalling firm for information,5700,5700,"Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.",Terminated,"December 10, 2012",420,15470,Not_Computer,N/A,N/A,N/A
Z-0052-2012,59961,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Impac Medical Systems SequencerProduct Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.",SEQUENCER,2,"October 17, 2011", 2011,Impac Medical Systems Inc,Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"""Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email support@impac.com or call. The letter provided consignees with a complete list of contact information..",N/A,11,11 devices,"Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.",Terminated,"March 06, 2012",141,11,Other,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0051-2012,59848,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES, 621-400ES, 621-400ESR.To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.",Outlook ES Safety Infusion System,1,"October 18, 2011", 2011,"B Braun Medical, Inc","B Braun Outlook ES Safety Infusion System ""Run"" Light Emitting Diodes (LEDs) pumps stop infusing and a backup alarm sounds, but the ""Run"" LEDs advance as if the pumps were infusing.",DESIGN: Software Design,"B. Braun Medical, Inc. sent an ""URGENT: FIELD CORRECTION"" letter dated September 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A firm representative will contact all affected customers in order to schedule the field correction. The correction consists of revising the Door and Main Processor software, inspecting the main board, and replacing the board, if warranted. A Field Correction Information Form was included in the letter for customers to complete and return. Contact Technical Product Support at 1-800-627-7867 for questions regarding this notice.",N/A,6321,6321,Nationwide Distribution,Open,N/A,N/A,6321,Software,Alarm/Message,Revise software/insepct and replace board if needed,Software Update
Z-0057-2012,59442,"system, imaging, pulsed doppler, ultrasonic",IYN,Ultrasonic pulsed doppler imaging system.,Radiology,Radiology,510(k),MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound.General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.,MicroMaxx ultrasound system and MTurbo ultrasound system,2,"October 18, 2011", 2011,"Sonosite, Inc.","This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment.",DESIGN: Software Design,"The firm SonoSite, Inc., sent an ""Urgent - Medical Device Correction"" letter dated September 29, 2011 to its foreign and domestic customers. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the three (3) steps provided in the letter to verify if the extended OB/GYN Calculations (EOBC) is enabled on their system. Additionally, SonoSite will perform a software upgrade to M-Turbo and/or MicroMax ultrasound system in order resolve the issue. The customers were instructed to contact Sonosite Technical Support via website: www.sonosite.com/sdratio; email: regulatory@sonosite.com (include contact information and address), or call in U.S. and Canada: 1-877-590-4982. If you have any questions or concerns regarding this matter, do not hesitate to contact in US and Canada at 1-877-657-8118, Monday-Friday, 6 am-5 pm PST. Customer can also send an email to Technical Support at service@sonosite.com.",No consumer action necessary,4236,4236 units (US) and 4089 units (internationally),"Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.",Terminated,"September 14, 2012",332,4236,Software,Output/Calculation,Software update,Software Update
Z-0060-2012,59998,"fastener, fixation, nondegradable, soft tissue",MBI,Smooth or threaded metallic bone fixation fastener.,Orthopedic,Orthopedic,510(k),"ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002Product Usage: The instrument is used as a soft tissue anchor",ANCHORLOK,2,"October 18, 2011", 2011,Wright Medical Technology Inc,The product is labeled with an expiration date without adequate justification.,EXPIRATION DATING: Incorrect or No Expiration Date,"The firm, Wright Medical Technology, Inc., sent an ""URGENT: PRODUCT RECALL NOTIFICATION"" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.",N/A,596,596 units,"Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.",Terminated,"July 17, 2012",273,11960,Not_Computer,N/A,N/A,N/A
Z-0071-2012,58302,"system, esophageal pacing",LPA,N/A,N/A,Cardiovascular,N/A,"***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101.***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.",TAPSCOPE 550,2,"October 19, 2011", 2011,Cardiocommand Inc.,"CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.",N/A,567,567 total,"Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.",Terminated,"August 28, 2012",314,567,Hardware,Device Operation,Replace,Remove or Replace
Z-0068-2012,60000,"drape, adhesive, aerosol",KGT,Drape adhesive.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.",STRIP T'S Sterile Adhesive Organizer,3,"October 19, 2011", 2011,Kapp Surgical Instrument Inc,"A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.",EXPIRATION DATING: Incorrect or No Expiration Date,"Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc) sent a notification letter dated March 5, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007. The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number 1-(800) 282-5277, to call in order to make arrangements for receive replacement labels for any misbranded packages received.",N/A,59,59 boxes (3540 units),"Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA",Terminated,"February 19, 2013",489,59,Not_Computer,N/A,N/A,N/A
Z-0070-2012,60007,"catheter, intravascular occluding, temporary",MJN,Vascular clamp.,Cardiovascular,Cardiovascular,510(k),"LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-portThe Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion",9F Pruitt F3 Outlying Carotid Shunt with Tport,2,"October 19, 2011", 2011,"Lemaitre Vascular, Inc.","Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05",PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, LeMaitre Vascular, Inc., sent an ""URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice"" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.",Contact the recalling firm for information,144,144 units,"Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.",Terminated,"March 14, 2012",147,144,Not_Computer,N/A,N/A,N/A
Z-0069-2012,59889,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges",Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges,2,"October 19, 2011", 2011,"Siemens Healthcare Diagnostics, Inc.",Firm has confirmed customer complaints for low recovery of QC and patient samples.,PRODUCTION CONTROLS: Process Control,"Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.",N/A,6072,"6,072 cartons","Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.",Terminated,"January 14, 2014",818,6072,Not_Computer,N/A,N/A,N/A
Z-0076-2012,59911,"guide, surgical, instrument",FZX,Manual surgical instrument for general use.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA.This device is used to mark the femoral neck resection level",BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE,2,"October 20, 2011", 2011,"Biomet, Inc.","Biomet has initiated this action following an investigation which identified that the blueprint calls forengraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. Theabove lots, as supplied to Biomet by a vendor, are engraved on only one side. To date, Biomet hasreceived 2 reports involving 2 units where the instrument was missing the engraving on one side.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Biomet sent an ""URGENT MEDICAL DEVICE RECALL NOTICE"" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM.",N/A,22,22,"Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.",Terminated,"March 07, 2013",504,22,Not_Computer,N/A,N/A,N/A
Z-0075-2012,59968,"prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate",MEH,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Total Hip Joint ReplacementAccolade TMZF Plus 127 Neck Angle V40 Hip Stem #3Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A subsidiary of Stryker Corp.Stryker FranceZAC Satolos Green PusignanAv de Staolas Green 69881 MetziaeCedex FranceThe TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.",Total Hip Joint Replacement,2,"October 20, 2011", 2011,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Stryker Orthopaedics sent an ""URGENT: PRODUCT RECALL"" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.",N/A,21,21 units,Nationwide Distribution,Terminated,"November 15, 2013",757,21,Not_Computer,N/A,N/A,N/A
Z-0079-2012,59948,"gauge, pressure, coronary, cardiopulmonary bypass",DXS,Cardiopulmonary bypass coronary pressure gauge.,Cardiovascular,Cardiovascular,510(k),"Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.",Medtronic Disposable Pressure Display Set,2,"October 20, 2011", 2011,Medtronic Perfusion Systems,"Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure.",DESIGN: Software Design,"Medtronic Perfusion Systems, sent an ""Urgent Medical Device Notification letter dated September 9, 2011, via UPS 2-day delivery to all affected customers. The letter identified the affected devices, described the issues, and the actions needed to be taken. The letter indicates when approved, the updated Directions for Use for the Pressure Display Box and Pressure Display Sets will be sent to customers. Customers were asked to complete the Customer Confirmation Certificate and return to Medtronic per the instructions on the form. The letter states that if the recalled products have been further distributed, forward this letter immediately to all customers who received the affected products, and gather proof of notification. For further questions concerning this notification, contact Medtronic Cardiovascular Technical Support at 877-526-7890 or Medtronic Sales Representative.",Contact the recalling firm for information,74804,"74,804","Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.",Terminated,"October 11, 2012",357,270088,Software,N/A,N/A,N/A
Z-0083-2012,52105,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09.It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.",Instrument Manager software,2,"October 21, 2011", 2011,"Data Innovations, Inc.","The ""previous result"" retrieved from the Specimen Management Database may not be the most recent ""previous result"".",DESIGN: Software Design,"Data Innovations sent an ""IMPORTANT PRODUCT NOTICE"" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.",N/A,188,188,USA (nationwide) and the country of Canada.,Terminated,"October 25, 2011",4,188,Software,Output/Calculation,Software update,Software Update
Z-0084-2012,59892,"tray, catheterization, sterile urethral, with or without catheter (kit)",FCM,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:""***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***""Case of Catheter Kits labeled in part:""***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: gomedic@linet.net.au Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***""This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.",O'Neil Sterile Field Intermittent Urinary Catheter Kit,2,"October 21, 2011", 2011,"Go Medical Industries Pty., Ltd.",O'Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P; Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Go Medical Industries Pty Ltd, sent an e-mail on September 3, 2011 and follow-up with an ""URGENT: MEDICAL DEVICE RECALL"" letter dated September 07, 2011 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and not sell the product in the market place; immediately perform a sub-recall and notify their customers and complete and return the RETURN RESPONSE FORM via fax at 716-883-8099 or mail to: American Australian Medical Inc, 1083 Delaware Avenue, Buffalo, NY 14209.For further details you can contact QA Manager at Go Medical Industries at +61 89 381 3226 or pmoretta@gomedical.com.au.",N/A,203743,"203,743 (189,043 English; 14,700 Spanish)",Nationwide distribution.,Terminated,"January 30, 2012",101,235243,Not_Computer,N/A,N/A,N/A
Z-0104-2012,60004,"intervertebral fusion device with bone graft, cervical",ODP,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.,Synthes Spine ZeroP Instruments and Implants,2,"October 21, 2011", 2011,"Synthes USA (HQ), Inc.","LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.",MISBRANDING: Labeling False and Misleading,"Synthes (USA) sent an ""URGENT: MEDICAL DEVICE LABELING CORRECTION"" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.",Contact the recalling firm for information,N/A,N/A,"USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0100-2012,59837,"burr, orthopedic",HTT,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"""***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***""Lot numbers: 309600 and 315857.Product Usage: Cutting and shaping bone including bones of the spine and cranium.","Anspach Single Use, Sterile Bone Cutting Burrs",2,"October 21, 2011", 2011,"The Anspach Effort, Inc.","The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.",TRAINING: Employee Error,"The firm, Anspach sent an ""URGENT PRODUCT REMOVAL"" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached ""Product Replacement Form."" Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the ""Product Replacement Form"" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the ""Product Replacement Form."" 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed ""Product Replacement Form."" Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.",Contact the recalling firm for information,40,40,"Worldwide Distribution - USA (nationwide) including the states of: CA, CO, FL, GA, IA, ID, SC, MA, MD, MI, MO, MN, MS, NY, OH, OR, PA, TN, TX, and WI, and the countries of: Africa, Netherlands, Panama, South Korea, Spain, and United Kingdom.",Terminated,"October 24, 2011",3,905,Not_Computer,N/A,N/A,N/A
Z-0103-2012,60047,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NVThe F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.",Disposable Syringe Pack for use with Microlab F.A.M.E,3,"October 21, 2011", 2011,Hamilton Co,"Certain lots of syringes have caused an increase in error message ""DIS541"", which indicates ""improper dispensation"".",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Hamilton, sent an ""Urgent: Product Recall Notification"" letter dated September 26, 2011 to its customers. The letter describes the product, problem and action to be taken. The customers were instructed to return the syringes with a completed Hamilton Company Product Recall Questionnaire form via fax to: (775) 856-7259 or with an emailed signed pdf copy to wayne.mcauliffe@hamiltoncompany.com. The firm's Customer Service Department will contact customers with complete Returned Material Authorization information. If you have any questions, please do not hesitate to contact the Director of Quality at (775) 858-3000.",N/A,1096,1096 units,"Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.",Terminated,"March 06, 2012",137,1096,Not_Computer,N/A,N/A,N/A
Z-0082-2012,60054,"laparoscope, general & plastic surgery",GCJ,Endoscope and accessories.,Gastroenterology/Urology,General & Plastic Surgery,510(k),"Smith & Nephew, HD1200 Autoclavable Camera HeadCatalog Number: 72203360Product Usage: Endoscope & Accessories",ENDOSCOPIC Camera ,2,"October 21, 2011", 2011,"Smith & Nephew, Inc. Endoscopy Division",HD1200 camera heads may cause image issues,N/A,"Smith Nephew sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. For questions call 405-917-8556.",N/A,15,15 units,"Nationwide Distribution (USA) including the states of: MI, NH, OK.",Open,N/A,N/A,15,I/O,Display/Image,Replace,Remove or Replace
Z-0080-2012,59984,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"""***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Sriracha, Chonburi 20230, Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***""Packed 24 units per case.The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.",Elastomeric Infusion Pump,1,"October 24, 2011", 2011,"Victus, Inc.","Victus, Inc. Miami, FL is recalling Vipat Brand Elastomeric Infusion Pump, Model H0020-100, Lot 100533. The product may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to patients.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Victus, Inc. sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated July 15, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use, remove the products from inventory and quarantine the products. Additionally, the firm indicated that their customer service department would contact customers to coordinate the return of affected products. Customers are directed to call 305-663-2129 ext. 110 for questions regarding this notice.",Contact the recalling firm for information,63,63 units,USA (nationwide) including Puerto Rico and the states of FL and PA.,Terminated,"January 12, 2012",80,63,Not_Computer,N/A,N/A,N/A
Z-0081-2012,59981,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore.The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.",Medpro AccuFlo Elastomeric Infusion Device,1,"October 24, 2011", 2011,Progressive Medical Inc,The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Progressive Medical, sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question.Should you have any questions, please call 800-969-6331 or email to dsullivan@progressivemedinc.com.",Contact the recalling firm for information,180,180 units,"Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.",Terminated,"December 19, 2011",56,180,Not_Computer,N/A,N/A,N/A
Z-0105-2012,60017,"microscope, surgical",EPT,Surgical microscope and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"OPMI VARIO 700 Surgical Microscope.Manufactured by: Carl Zeiss Meditec AG,Oberkochen, Germany.Provide a magnified view of the surgical field.",OPMI VARIO 700 Surgical Microscope,2,"October 24, 2011", 2011,"Carl Zeiss Meditec, Inc.",An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616.,Contact the recalling firm for information,3,3,"USA (nationwide) including the states of FL, GA, and LA .",Terminated,"November 04, 2011",11,3,Not_Computer,N/A,N/A,N/A
Z-0106-2012,58984,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"""***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***"".Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.",MRI Patient Monitoring System,2,"October 25, 2011", 2011,Invivo Corporation,"Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall.",PRODUCTION CONTROLS: Process Control,"Philips Invivo Corporation issued a Field Safety Notice ""URGENT - MEDICAL DEVICE RECALL"" letter to all affected customers notifying them that the Expression MRI Patient Monitoring System could pose a risk for patients and users. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the user in order to prevent risks for patients or users and the actions planned by Philips Invivo to correct the problem. This notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. Customers were instructed to contact Philips Invivo Customer Support at (877) 468-4861 (option 1, then option 3) for questions or support concerning this issue.",N/A,285,285 units,"Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI., SC, SD, TN, TX, VA, WA, and WI and the countries of: Australia, Austria, Canada, Denmark, Germany, Israel, Malaysia, Netherlands, Norway, Singapore, Spain, Switzerland and, United Kingdom.",Terminated,"November 15, 2012",387,285,Not_Computer,N/A,N/A,N/A
Z-0089-2012,59969,"pump, infusion, enteral",LZH,Infusion pump.,General Hospital,General Hospital,510(k),"CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500.Intended to deliver formula to patients requiring tube feedings.",CORFLO 300 Enteral Pump,2,"October 25, 2011", 2011,CORPAK MedSystems,"Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.",PRODUCTION CONTROLS: Process Control,"Corpak MedSystems sent Recall Notification letters dated September 19, 2011 to all CorFlo 300 Enteral Pump customers on the same date. The customers were informed that there is a possibility that with fluid ingress the keypad may become inoperable, and that there is a possibility of motor mount failure. Either event could possibly affect the rate at which formula is delivered to the patient, and fluid ingress could cause a potential of audible alarm failure. Corpak determined that the removal of the pumps from the market was the best option for their customers, and requested the return of all CorFlo 300 pumps to Corpak by no later than December 1, 2011. The customers were requested to contact Corpak at 1-800-323-6305 to arrange for the return of the pumps, and to complete and return the enclosed acknowledgement form, indicating the number of pumps on hand, via fax at 847-541-9526 or e-mail to questions@corpak.com. Dealers/distributors were requested to notify their customers of the recall.",Contact the recalling firm for information,13000,"13,000 pumps",Nationwide Distribution,Open,N/A,N/A,13000,Not_Computer,N/A,N/A,N/A
Z-0115-2012,59326,"full field digital,system,x-ray,mammographic",MUE,Full-field digital mammography system.,Radiology,Radiology,N/A,"GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM.The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.",GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM.,2,"October 26, 2011", 2011,"GE Healthcare, LLC",GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety.,DESIGN: Software Design,"GE Healthcare sent an "" URGENT MEDICAL DEVICE CORRECTION"" letter dated September 21, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter provides safety instructions and advises customers to complete and return a Customer Reply Form via fax to +33(0)1 30 70 39 30. A GE Healthcare service representative will contact customers if the updated software version is required. Contact the Call Center at 800-437-1171.",N/A,1344,1344,"Worldwide Distribution-USA (nationwide) including Puerto Rico and Washington, D.C. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA,GERMANY, GREECE, GUADELOUPE, GUYANA, HONDURAS, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF KOREA, RUSSIAN FEDERATION SAINT PIERRE AND MIQUELON, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE FORMER YUGOSLAV REPUBLIC OF MECEDONIA, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VENEZUELA.",Terminated,"October 16, 2012",356,3457,Software,N/A,N/A,N/A
Z-0112-2012,58454,"mask, oxygen, low concentration, venturi",BYF,Venturi mask.,Anesthesiology,Anesthesiology,510(K) Exempt,"Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs;Salter Labs, Arvin, CA 93203Intended usage: respiratory therapy.","Mask adult, elastic strap style, PercentO2 Lock air entrainment system",2,"October 26, 2011", 2011,"Salter Laboratories, Division of Regulatory Affairs",A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.,PRODUCTION CONTROLS: Equipment Maintenance,"The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an ""URGENT PRODUCT RECALL"" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.Should you have any questions, please contact Salter Labs at 1-800-235-4203.",N/A,800,800 all varieties,"Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.",Terminated,"October 26, 2011",0,800,Not_Computer,N/A,N/A,N/A
Z-0107-2012,59522,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000.The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.","GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000",2,"October 26, 2011", 2011,"GE Healthcare, LLC","GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock, which may impact service personnel safety. This issue does not impact patient or operator safety.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"GE Healthcare LLC sent a ""Urgent Medical Device Correction letter"" dated August 29, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to please ensure that all potential service personnel at your facility are made aware of this safety notification and the recommended actions.Contact your local service representative if you have any questions concerning this notification. For further questions please call ( 262 ) 513-4122.",Contact the recalling firm for information,52,52,"Worldwide Distribution -- USA (nationwide) including the states of AL, CA, FL, ID, NY, NH, NJ, NV, OH, PA, TX, VA and WI., and countries of UNITED ARAB EMIRATES, UKRAINE, UNITED KINGDOM, SWITZERLAND",Terminated,"May 29, 2012",216,52,Not_Computer,N/A,N/A,N/A
Z-0074-2012,59933,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).",EnVe Ventilator,1,"October 26, 2011", 2011,"CareFusion 203, Inc.",CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions.,DESIGN: Device Design,"The firm, CareFusion, sent an ""URGENT PRODUCT RECALL"" letter dated September 12, 2011 to its customers.The letter identified affected product, described the 3 issues providing the description of the event, potential risk, and provided required action for Users. The letter also stated that CareFusion would be contacting the facility to coordinate the corrective action.If you have any questions and/or need support, please contact CareFusion Technical Support at 1-800-554-8933 from Mon. - Fri. 8:00am -5:00pm Pacific Time.",N/A,128,128 units,"Nationwide distribution: USA including states of: CA, CO, FL, IL, MI, MN, MT, ND, NJ, NM, NY, OK, PA, TX, UT, WI, and WV.",Terminated,"November 22, 2012",393,128,Not_Computer,N/A,N/A,N/A
Z-0124-2012,59147,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SYNCHRON CX4 Clinical System Part #: 758300Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine",SYNCHRON CX4,2,"October 27, 2011", 2011,Beckman Coulter Inc.,"The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.",DESIGN: Software Design,"Beckman Coulter sent an ""URGENT: PRODUCT CORRECTIVE ACTION"" letter dated September 20, 2010 with an attached Fax Back Response Form (via US Postal Service for US Customers) to all customers who purchased the Synchron¶_ CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems. The letter provides the customers wtih an explanation of the problem identified and actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected product listed above to another laboratory, they were asked to provide a copy of this letter to them. Questions regarding this Product Corrective Action letter, were directed to Customer Support Center (Call Center) on the Beckman Coulter website athttp://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada. Outside the United States and Canada, they were directed to their local Beckman Coulter Representative.",N/A,1070,1070 systems total in US,Worldwide Distribution - USA (nationwide) and the country of Canada,Terminated,"June 28, 2012",245,1070,Software,N/A,Instructions,Safety Notice/Insructions
Z-0119-2012,60041,first aid kit with drug,LRR,N/A,N/A,General & Plastic Surgery,Enforcement Discretion,"Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces.The kit is labeled in parts: ""***BASE CAMP FIRST AID KIT***171 PIECE***6 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***"".First aid kit.",Base Camp First Aid Kit ,2,"October 27, 2011", 2011,Lifeline First Aid LLC,The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Lifeline First Aid, LLC sent a "" PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES"" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P; Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721.Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.",Contact the recalling firm for information,6072,6072 kits,Nationwide Distribution,Terminated,"March 29, 2012",154,26150,Not_Computer,N/A,N/A,N/A
Z-0117-2012,60064,"system, x-ray, fluoroscopic, image-intensified",JAA,Image-intensified fluoroscopic x-ray system.,Radiology,Radiology,510(k),"Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.",Philips BV Endura ,2,"October 27, 2011", 2011,Philips Healthcare Inc.,Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Philips Healthcare Inc., sent an ""URGENT - Field Safety Notice"" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support.",N/A,12,12 units in the US,"Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.",Open,N/A,N/A,266,Not_Computer,N/A,N/A,N/A
Z-0113-2012,60025,"monitor,physiological,patient(without arrhythmia detection or alarms)",MWI,Cardiac monitor (including cardiotachometer and rate alarm).,Cardiovascular,Cardiovascular,510(k),"Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits).Label located on the back of the WPU. Product is labeled in part: ""***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***"" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***"" Display Controller Unit (DCU) is labeled in part: ""***Invivo***PRECESS***"". Wireless Processing Unit (WPU) is labeled in part: ""***Invivo***"". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS.The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.",Precess MRI Patient Monitoring System,2,"October 27, 2011", 2011,Invivo Corporation,Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication between the wireless Processing Unit and the Display Controller Unit.,DESIGN: Device Design,"A Field Safety Notice entitled Urgent - Medical Device Correction letter, dated September 2011, with attached Field Safety Notice for customers were sent to distributors. The letter described the reason for the recall and the intention of the Field Safety Notice. Also, the hazards involved and instructions on how to identify units that are affected by the recall were provided . The actions to be taken by the user and the actions planned by the Philips Invivo were explained. Users were to follow the instructions provided on how to safely use the device until the unit can be serviced by Philips Invivo. For further information or support concerning this issue, customers are to contact Philips Invivo Customer Support at (877)-468-4861 or their local Philips Invivo representative.",N/A,875,875,"Worldwide Distribution -- Australia, Austria, Brazil, Canada, China, France, Germany, Malaysia, Norway, Portugal, Spain, Sweden, The Netherlands, United Arab Emirates, United Kingdom, and US.",Terminated,"August 07, 2013",650,875,I/O,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0073-2012,59536,"table, surgical with orthopedic accessories, ac-powered",JEA,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,Mizuho OSI Modular Table System;Product Usage: For use in orthopaedic surgery to provide support to a patient.,Modular Table System,1,"October 27, 2011", 2011,Mizuho Orthopedic Systems Inc,Reports of injury related incidents while using the Mizuho OSI Modular Table System.,N/A,"Mizuho Orthopedic Systems Inc sent a ""Field Advisory Notice (Recall)"" letters dated July 29, 2011 to all customers using the Modular Table System via Federal Express. The Field Advisory Notice reference the devices involved and explain that there is no need to return any product or to discontinue the use. The letter provides WARNINGS and RECOMMENDATIONS for all users to consider when using the devices and request that the response form be completed as instructed in the advisory communication. The letters also recommend that awareness, training, inspection prior to use, and proper maintenance be established and practiced. The letter recommend that the Field Advisory Notices be posted in prominent areas and communicated to all staff and potential users of this device. Additional support and training can be obtained by contacting Mizuho OSI's Customer Resource Group at 1-800-777-4674. For further questions concerning this notification, contact the Director of Customer Resource Group for assistance (1-800-777-4674, outside the USA 00+1-510-476-8199).Revised letters were approved by CDRH and sent out in January 2012.",Contact the recalling firm for information,15011,"15,011 units",Worldwide Distribution - Nationwide USA,Terminated,"August 27, 2013",670,15011,Not_Computer,N/A,N/A,N/A
Z-0135-2012,60175,"system, gastrointestinal motility (electrical)",FFX,Gastrointestinal motility monitoring system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"AR ManoShield, MSS-3599, 10 pack.FGS: MSS-3599,Individual package label: LBL-110275-03,Box label: LBL-110282-03,Package Inserts: DOC-3682,User Manual: DOC-1332-12.Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.",Sierra Scientific Motility Visualization System (MVS),2,"October 28, 2011", 2011,Sierra Scientific Instruments Inc,"The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Given Imaging sent an ""Urgent Product Recall 1st Notice"" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at karla.guerrero@givenimaging.com.",N/A,292,292 units,"Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.",Terminated,"August 30, 2012",307,292,Not_Computer,N/A,N/A,N/A
Z-0133-2012,59521,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"GE Healthcare, Innova¶_ 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System.Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.",Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System ,2,"October 28, 2011", 2011,"GE Healthcare, LLC",A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"A GE Healthcare ""Urgent Medical Device Correction"" letter dated August 22, 2011 was sent out 8/24/11. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were told to operate the suspension without excessive force. If one of the end-stops breaks, then the system should not be used and their local GE Healthcare Service Representative should be contacted. GE will contact customers to replace all end-stops at no cost to the customer. Questions or concerns should be directed to 800-437-1171 in the US and 0120-055-919 in Japan. For other countries, customers can contact their local GE Healthcare Service Representative.",Contact the recalling firm for information,15,15,"Worldwide Distribution -- USA, including the states of TX & NC and the countries of TURKEY, POLAND, MEXICO, CHINA, CAMBODIA, BRAZIL, BOLIVIA, and SAUDI ARABIA.",Terminated,"May 29, 2012",214,15,Not_Computer,N/A,N/A,N/A
Z-0136-2012,59866,"light, surgical, ceiling mounted",FSY,Surgical lamp.,General & Plastic Surgery,General & Plastic Surgery,510(k),"SwitchPoint Infinity Control SystemStryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208The SwitchPoint Infinity (SPI) Control System is an integrated voice, video, data router and teleconferencing interface for operating rooms. The SwitchPoint Infinity is used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.",SwitchPoint Infinity Control System,2,"October 28, 2011", 2011,Stryker Communications Corp,"Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.",PRODUCTION CONTROLS: Process Control,"Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services.For questions regarding this recall call 972-410-7310.",Contact the recalling firm for information,N/A,N/A,"Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.",Terminated,"August 20, 2012",297,N/A,Not_Computer,N/A,N/A,N/A
Z-0134-2012,60168,"pump, infusion",FRN,Infusion pump.,General Hospital,General Hospital,510(k),"Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064.The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.",Baxter FloGard 6301 Volumetric Infusion Pump,2,"October 28, 2011", 2011,Baxter Healthcare Corp.,The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.,TRAINING: Employee Error,"A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable.",N/A,1,1 unit,Distributed only in Puerto Rico.,Terminated,"October 31, 2011",3,1,Not_Computer,N/A,N/A,N/A
Z-0140-2012,59909,general surgery tray (kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act:a) Split Dressing - 2""x 2"", Yellow, component C-033-0022, vendor part number S1072; b) Tubing Extension Sets and IV Sets component C-FG711297CP, vendor pn FG711297CP;component C-FG711093CP, vendor pn FG711093CP; component C-FG711298CP, vendor pn FG711298CP; component C-FG711092CP, vendor pn FG711092CP; c) Cast Padding component C-9046, vendor pn 9046; component C-9044, vendor pn 9044;component C-9043, vendor pn 9043;component C-9062, vendor pn 9062;d) Scalpel Holder component C-DD1628-6, vendor pn DD1628-6; e) Latex Tubing component C-806-12, vendor pn 806-12;component C-808R, vendor pn 808R;component C-606R, vendor pn 606R;component C-122BA10, vendor pn 122BA10;component C-122BA12, vendor pn 122BA12;component C-122BA07, vendor pn 122BA07;component C-102BA12, vendor pn 102BA12;component C-099BA10, vendor pn 099BA10;component C-102BA10, vendor pn 102BA10;component C-103BA10, vendor pn 103BA10;component C-124BA10, vendor pn 124BA10;component C-140BA10, vendor pn 140BA10;f) Clinic Dropper component C-12548, vendor pn 10-871-00; g) Tongue Blade (depressor) component C-11820-010, vendor pn 07-920-00; h) Catheter Clamp component C-043-0497, vendor pn 033403-887;i) Gillette Good News Razorcomponent C-P4417A, vendor pn 4417GN; j) Prepsicle Round Short Blue Swabstickcomponent C-051-0401, vendor pn SBR20035;k) Tubingcomponent C-SFM3-3050, vendor pn SFM3-3050;component C-SFM3-3650, vendor pn SFM3-3650;l) Specimen Containercomponent C-B9021YN, vendor pn B9021YN;component C-C8846-18, vendor pn 15706-806;The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.",Presource Custom Sterile Surgical and Procedure Kits,2,"October 31, 2011", 2011,Cardinal Health,Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product.,DESIGN: Component Design/Selection,"Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 2, 2011 to all affected consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. If the consignee does not wish to accept overlabeled product or to overlabel the product in their possession, they were asked to contact Presource Sales Operations at 800-766-0706 or their Sales Representative for further instructions. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact the following: Hospitals - Presource Sales Operations at 800-766-0706, Distributors - Distributor Management Group at 800-635-6021, and Federal Government facilities - Government Service at 800-444-1186.For questions regarding this recall call 847-887-6412.",N/A,N/A,N/A,Nationwide Distribution,Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0139-2012,60006,"software, transmission and storage, patient data",NSX,N/A,N/A,General Hospital,Enforcement Discretion,"Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data)This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.",Picis Anesthesia Manager,2,"October 31, 2011", 2011,Picis Inc.,Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view.,DESIGN: Software Design,"Picis Inc. sent a ""Safety Notification letter"" dated August 12, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed until this service pack is applied, we recommend: * For patients who have been transferred from other facilities within the same VISN, you should discontinue the use of these Picis applications. Manually check the patient's name with that displayed in the Picis patient blue banner to ensure you catch all of these cases. * For all other patients, you may safely continue the use of these Picis applications.For further questions please call (781) 557-3000.",Contact the recalling firm for information,10,10,"Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.",Terminated,"March 23, 2012",144,10,Software,Output/Calculation,Software update,Software Update
Z-0142-2012,59582,"monitor, blood-gas, on-line, cardiopulmonary bypass",DRY,Cardiopulmonary bypass on-line blood gas monitor.,Cardiovascular,Cardiovascular,510(k),"CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module.Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.",CDI 500 Monitor,2,"October 31, 2011", 2011,Terumo Cardiovascular Systems Corporation,"Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.",DESIGN: Component Design/Selection,"Terumo Cardiovascular Systems Corporation sent an ""URGENT MEDICAL DEVICE CORRECTION"" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.",No consumer action necessary,432,432,"Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.",Terminated,"April 11, 2013",528,432,Hardware,Device Operation,Replace component,Remove or Replace
Z-0143-2012,55537,"plate, bone",JEY,Bone plate.,Dental,Dental,510(k),"Bioplate Titanium Fixation System, Sterile Kit.The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.","Bioplate Titanium Fixation System, Sterile Kit.",2,"November 01, 2011", 2011,Bioplate Inc,There is potential defect in seal of the sterile barrier containing the device.,DESIGN: Process Design,"BIOPLATE sent an URGENT - PRODUCT RECALL NOTIFICATION letter dated March 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.Customers were instructed to return any recalled product they have at their siteand if distributed further they should forward the information contained in the letter to all customers. If a device from one of the lots noted above has already been used, Bioplate would like to be advised of that use.They asked that consignees complete the enclosed Fax form and transmit the requested information to them as soon as possible at (310) 815-2126.Returned recalled product was to be sent to: Bioplate3643 Lenawee AvenueLos Angeles, CA 900163643 Lenawee Avenue, Los Angeles, CA 90016For any questions regarding this recall call (310) 815-2100.",N/A,18246,"16,020 Individual Kits; 2,226 Boxes.","Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.",Terminated,"April 04, 2012",155,18246,Not_Computer,N/A,N/A,N/A
Z-0144-2012,60057,"mesh, surgical, polymeric",FTL,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Bard¶_ Ventralex"" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5"", Catalog Number: 5950008.Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars.","Bard Ventralex"" ST Medium Circle with Strap Hernia Patch",2,"November 01, 2011", 2011,"Davol, Inc., Sub. C. R. Bard, Inc.","Mislabeled: Bard¶_ Ventralex"" ST Medium Circle was packaged in a pre-printed carton identified for a Bard¶_Ventralex"" ST Large Circle.",PRODUCTION CONTROLS: Packaging Process Control,"Davol Inc. issued an Urgent; Medical Device Recall letter on 10/4/11 for the mislabeled Bard Ventralex ST Medium Circle. The letter identified the affected product and explained the reason for recall. Customers are to immediately examine their inventory and quarantine any affected product. In addition, if any product was further distributed then those customers should be notified of the recall as well. Accounts are to contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. The attached recall effectiveness check form should be completed and returned. Questions should be directed towards Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.",N/A,96,96 units,Nationwide Distribution,Terminated,"September 20, 2013",689,96,Not_Computer,N/A,N/A,N/A
Z-0146-2012,58162,orthopedic stereotaxic instrument,OLO,Stereotaxic instrument.,Neurology,Orthopedic,510(k),"Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317.RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.",RIO Robot Arm Interactive Orthopedic System,2,"November 01, 2011", 2011,Mako Surgical Corporation,MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,"The firm, MAKO Surgical Corp., sent an ""RECALL NOTICE 2.4. SITES"" letter dated February 1, 2011 to its customers. The letter describes the product, problem, actions to be taken which includes a workaround and an updated user guide identifying the appropriate workflow. The customers were instructed to follow the user guide and workflow and to complete and return the enclosed confirmation memo to their MAKOplasty Specialist or return it in the pre-addressed, pre-paid envelope provided. MAKOplasty included with the letter new steps in the surgical workflow in the use of the RIO system to ensure error value accuracy; worked on a software update that will not allow the user to proceed with error values that do not support the required accuracy-this software was to be supplied to customers in February 2011, and trained MAKOplasty Specialist will make available written updates to the RIO use instructions as well.If you have any questions or concerns, please do not hesitate to speak with your MAKOplasty Specialist or contact the Manager of Customer Relations at 954.927.4022 x447.",Contact the recalling firm for information,70,70,"Worldwide distribution: USA including states of: AZ, CA, CO, FL, GA, IA, IL, LA, MI, MO, MS, NC, NJ, NV, NY, OK, OH, OR, PA, RI, TX, UT, VA, WA, WI, and WV; and countries of: Scotland, Italy and Korea.",Terminated,"December 13, 2011",42,70,Software,Physical Safety Hazards,Software update,Software Update
Z-0145-2012,60046,"implant, dermal, for aesthetic use",LMH,N/A,N/A,General & Plastic Surgery,N/A,"MERZ AESTHETICS, Radiesse¶_ Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY.Part Number 8071M4K1 distributed in CanadaPart Number 8071M5 distributed in Europe/Middle East/AfricaPart Number 8071M9 distributed in Hong Kong, Korea, Malaysia.",Radiesse,2,"November 01, 2011", 2011,"Merz Aesthetics, Inc.","There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On 8/18/11, consignees were sent a Merz Aesthetics ""Urgent Medical Device Recall"" letter dated August 15, 2011. The letter was addressed to ""Dear Health Care Professional"". The letter described the product and the problem and listed the details regarding this issue.",Contact the recalling firm for information,311582,"311,582","Worldwide distribution including USA, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada.",Terminated,"May 01, 2012",182,311582,Not_Computer,N/A,N/A,N/A
Z-0147-2012,60240,"injector and syringe, angiographic",DXT,Angiographic injector and syringe.,Cardiovascular,Cardiovascular,510(k),"Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.",Medrad(R) Sterile Disposable Stellant Syringe Kit,2,"November 02, 2011", 2011,Medrad Inc,Packaging may exhibit open seals - sterility compromised,PRODUCTION CONTROLS: Packaging Process Control,"Medrad sent a "" Urgent Medical Device Recall letter"" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall.Complete and sign the attached response form and fax it back to MEDRAD at (412) 406-0942.Please complete and fax this form even if you do not have any of the referenced product so we can maintain proper accountability for all syring kits that have been shipped.",N/A,17380,"17,380","Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, and WI.",Open,N/A,N/A,17380,Not_Computer,N/A,N/A,N/A
Z-0149-2012,60034,"catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",OAE,N/A,N/A,Cardiovascular,N/A,"Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US)Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50¶_C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety.",Medtronic CryoCath Arctic Front CryoAblation Catheter,2,"November 02, 2011", 2011,Medtronic Inc. Cardiac Rhythm Disease Management,"Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributedwith incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571,25375, 25376, 25377, and 25381 of the Arctic Front Catheter Model Number 2AF282. Medtronic CryoCathis communicating this information to the FDA.On affected catheters, the incor",TRAINING: Employee Error,"Medtronic sent an ""Important Device Recall"" letter dated August 2011, hand delivered by Medtronic Field Representatives on August 29, 2011 to all affected customers. The letter described the product affected, the problem, and the actions needed to be taken. The customers were instructed to return all unused catheters from affected lots for credit and replacement. The letter states that Medtronic AF Solution representative will assist customers with the return of affected product. For further questions contact your local Medtronic AF Solutions representative.",Contact the recalling firm for information,263,263,"Worldwide Distribution - USA (nationwide) including the states of: AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MN, MS, MO, NE, NY, NC, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. and the countries of: Austria, United Kingdom.",Terminated,"June 07, 2012",218,263,Software,Alarm/Message,Return,Remove or Replace
Z-0150-2012,59991,orthopedic manual surgical instrument,LXH,Orthopedic manual surgical instrument.,Orthopedic,Orthopedic,510(K) Exempt,"RSP Humeral Socket Reamer (Size 32 SML):DJO Surgical Instruments and Instrument CasesDJO surgicalEncore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696.The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.",RSP Humeral Socket Reamer (Size 32 SML) ,2,"November 02, 2011", 2011,"Encore Medical, Lp",DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU.,DESIGN: Component Design/Selection,"DJO Surgical sent an URGENT FIELD SAFETY NOTICE letter dated September 28, 2011, to all affected customers. The letter identified the product. the problem, and the action to be taken by the customer. Customers were instructed to return the RSP Humeral Socket Reamers and RSP Baseplate Rim Planers. The RSP Humeral Socket Reamers will be reworked and returned to the customer. The Baseplast Rim Planer will be replaced when a suitable design is available. During the interim until instruments are returned, the use of FMP acetabular reamers size 42mm, 43mm, 45mm (DJO PIN 803-05-226, 227, 200) for the humeral preparation was validated to be effective to prepare the humerus for the implant.Customers were instructed to immediately notify the hospitals and surgeons using these devices and document it on the Field Safety Notice Response Form. For questions regarding this recall call 512-832-9500.",Contact the recalling firm for information,399,399 Reamers,"Worldwide Distribution - USA including AR, AZ, CA, CO, FL,GA, ID, IN, IL, LA, MA, MD, ME, MI, MO, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, and WI and Internationally toGermany, South America, Italy, Saudi Arabia, United Kingdom, and Canada.",Terminated,"March 29, 2013",513,532,Not_Computer,N/A,N/A,N/A
Z-0158-2012,60254,"abutment, implant, dental, endosseous",NHA,Endosseous dental implant abutment.,Dental,Dental,510(k),"""***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***"".Attach an implant to an implant restoration.",Conical Angled Abutment,2,"November 03, 2011", 2011,"Biomet 3i, LLC","On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment.",TRAINING: Employee Error,"Biomet 3i, LLC sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated September 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to inspect their inventory and return any affected product for replacement.A Product Recall Response Form was attached for customers to complete and return via fax to 561-514-6316. Customers are directed to call 1-800-342-5454 for questions regarding this recall.",Contact the recalling firm for information,122,122,"Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.",Terminated,"March 09, 2012",127,130,Not_Computer,N/A,N/A,N/A
Z-0152-2012,60100,"enzyme immunoassay, amphetamine",DKZ,Amphetamine test system.,Toxicology,Toxicology,510(k),"ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M WaivedProduct Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.",Us Diagnostic ProScreen Drugs of Abuse Cup,2,"November 03, 2011", 2011,Ameditech Inc,"The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics' customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use",PRODUCTION CONTROLS: Packaging Process Control,"The recall communication was initiated on June 9, 2011 with Ameditech Inc. forwarding an Urgent Medical Device Recall notification with an attached Verification Form (via phone and written notification) to the affected distributor. The letter provides the distributor with an explanation of the problem identified and actions to be taken. The distributor was required to: cease distribution of the affected lot and provide remaining inventory count to Ameditech; destroy any remaining inventory of these lots and document destruction per site requirements; and ensure that all user of the device have received a copy of the Urgent Medical Device Recall. In addition, the distributor was instructed to complete and return the enclosed Verification Form with in 10 days.For any questions about the information contained in this notice, contact Ameditech at amd.complaint@alere.com or call 858-535-1968.",N/A,2000,2000 test cups (800 kits),Nationwide Distribution (USA) including the state of Alabama.,Terminated,"January 18, 2012",76,2000,Not_Computer,N/A,N/A,N/A
Z-0154-2012,60114,"material, tooth shade, resin",EBF,Tooth shade resin material.,Dental,Dental,510(k),"37% Etching Gel-1ml syringe 20 pk, part # T06AThe intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.",37 Etching Gel1ml syringe,3,"November 03, 2011", 2011,Kerr/pentron Dba Kerr Corporation And Pentron Clinical,"Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Pentron Clinical, sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken.All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015.Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.",N/A,41744,"41,744 units","Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.",Terminated,"August 09, 2012",280,41744,Not_Computer,N/A,N/A,N/A
Z-0160-2012,57234,gutta-percha,EKM,Gutta percha.,Dental,Dental,510(K) Exempt,Microseal Master Cone Part Number: 815-9033Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.,Microseal Master Cone Part Number: 8159033,3,"November 04, 2011", 2011,Ormco Corporation,The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.,PRODUCTION CONTROLS: Error in Labeling,"Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product ""RECALLED PRODUCT Attention: Customer Returns""SybronEndo 1332 South Lone Hik AvenueGlendora, CA 91740ADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN.Customers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers.For questions regarding this recall call 909-962-5600.",N/A,200,200 units,"Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.",Terminated,"November 21, 2011",17,200,Not_Computer,N/A,N/A,N/A
Z-0161-2012,60003,"intervertebral fusion device with bone graft, lumbar",MAX,Intervertebral body fusion device.,Orthopedic,Orthopedic,510(k),Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system.Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.,Synthes Spine TPAL Spacer System.,2,"November 04, 2011", 2011,"Synthes USA (HQ), Inc.",LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All,PRODUCTION CONTROLS: Error in Labeling,"SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the packageCustomers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link:http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover.To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods:Mail provided postage paid envelopeFax 610-251-9005Scan/e-mail to FieldAction@synthes.comFor any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.",N/A,N/A,N/A - Labeling Correction,"Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, HI, KS, KY, LA, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. and Puerto Rico and Washington, D.C; Internationally to Canada and Japan",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0162-2012,60094,cyclosporine,MKW,Cyclosporine test system.,Clinical Chemistry,Toxicology,510(k),"ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25.The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.",ARCHITECT Cyclosporine,2,"November 04, 2011", 2011,Abbott Laboratories,The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Abbott Laboratories sent a ""PRODUCT RECALL"" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.",N/A,8913,"8,913 kits","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.",Terminated,"November 07, 2012",369,8913,Not_Computer,N/A,N/A,N/A
Z-0165-2012,60241,"keratome, ac-powered",HNO,Keratome.,Ophthalmic,Ophthalmic,510(k),"Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.",INTRALASE FS Laser,2,"November 04, 2011", 2011,"AMO Manufacturing USA, LLC",The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 ¶_m or deeper) created using the Laser System.,DESIGN: Process Design,"Abbott Medical Optics Inc. (AMO) issued an ""ADVISORY NOTICE"" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375.",Contact the recalling firm for information,1226,1226 total laser systems,Worldwide Distribution - USA (nationwide),Terminated,"May 01, 2013",544,1226,Not_Computer,N/A,N/A,N/A
Z-0164-2012,60143,"prosthesis, hip, semi-constrained, metal/polymer, cemented",JDI,Hip joint metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),"BioPro Femoral Head 28 mm +18, Item 19010.Orthopedic femoral head for implantation",BioPro Femoral Head 28 mm 18,2,"November 04, 2011", 2011,"Biopro, Inc.","BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.",PRODUCTION CONTROLS: Packaging,"Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up ""RECALL NOTICE"" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.",N/A,8,8 units,"USA (nationwide) including the states of FL, MI, and TX.",Terminated,"February 15, 2013",469,12,Not_Computer,N/A,N/A,N/A
Z-0174-2012,60255,"introducer, syringe needle",KZH,Syringe needle introducer.,General Hospital,General Hospital,510(k),"1.0mL 28 G x 1/2"" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920Intended use: Subcutaneous injection of insulin.","Becton Dickinson 1.0mL 28 G x 1/2"" blister packaged insulin syringe",2,"November 07, 2011", 2011,Becton Dickinson & Company,Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.,PRODUCTION CONTROLS: Labeling Mix-Ups,"The firm, BD, sent an ""PRODUCT RECALL NOTIFICATION"" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853.If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.",Contact the recalling firm for information,10230,"10,230 shelf cartons (1,0230,000 syringes)",Nationwide Distribution.,Open,N/A,N/A,10230,Not_Computer,N/A,N/A,N/A
Z-0173-2012,60183,"dialyzer, high permeability with or without sealed dialysate system",KDI,High permeability hemodialysis system.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis",Baxter System 1000 Tina Hemodialysis Instrument,2,"November 07, 2011", 2011,Baxter Healthcare Renal Div,The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.,TRAINING: Employee Error,"Baxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results.",Contact the recalling firm for information,1,1 unit,Distributed in Puerto Rico only.,Terminated,"November 07, 2011",0,1,Not_Computer,N/A,N/A,N/A
Z-0169-2012,60069,general surgery tray (kit),LRO,Surgical drape and drape accessories.,General & Plastic Surgery,General & Plastic Surgery,Enforcement Discretion,"Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: a) 24"" Infant Tape Measure, component 30942P; b) Silicone Tubing, component SFM3-4450; c) Triple Dye Drug, 10 unit dose, component PM1022; d) Assembly Swabstick, component PS004; e) 18x26 Poly Lined Towel, component 8580Z; f) Disposable Vein Stripper, component 63-0431;g) Cotton Glove, Large, White, PR, NS, component 1051; h) Cotton Glove, Medium, White, PR, NS, component 1051M; i) 6 Inch Metric-Inch Ruler, component 18C-Thru; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.",Presource Custom Sterile Surgical and Procedure Kits,2,"November 07, 2011", 2011,Cardinal Health,Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components.,DESIGN: Component Design/Selection,"Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above.For questions regarding this recall call 800-292-9332.",N/A,N/A,N/A,"Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin",Open,N/A,N/A,N/A,Not_Computer,N/A,N/A,N/A
Z-0171-2012,58766,"implant, endosseous, root-form",DZE,Endosseous dental implant.,Dental,Dental,510(k),"***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.",OSSEOTITE Certain Implant ,2,"November 08, 2011", 2011,"Biomet 3i, LLC","The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.",PRODUCTION CONTROLS: Process Control,"The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.",N/A,241,241,"Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.",Terminated,"November 09, 2011",1,241,Not_Computer,N/A,N/A,N/A
Z-0176-2012,59684,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients.",BD Microtainer MAP Microtube for Automated Process.,3,"November 08, 2011", 2011,Becton Dickinson & Company,BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.,DESIGN: Device Design,"A Becton Dickinson Sales Consultant conducted a ""on-site"" visit to the single Customer account, Florida Hospital, on February 11, 2011. All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed. If you have any questions or request additional information please do not hesitate to call (201) 847-5636.",Contact the recalling firm for information,10800,"10,800 units",Distributed only to Florida.,Terminated,"November 10, 2011",2,10800,Not_Computer,N/A,N/A,N/A
Z-0175-2012,59996,"rod, fixation, intramedullary and accessories",HSB,Intramedullary fixation rod.,Orthopedic,Orthopedic,510(k),"Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter ShaftUsed to facilitate insertion and delivery of a Mantis rod.",Mantis Rod Inserter ,2,"November 08, 2011", 2011,Stryker Spine,There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.,DESIGN: Device Design,"Stryker notified branches/agencies, surgeons and hospitals beginning June 24, 2011 with an Urgent Product Recall letter, dated June 24, 2011, via Fed Ex. The letter identified the affected product, the issue, potential hazards, risk mitigations, and the return process. Customers were asked to examine their inventory and reconcile any inserters and shafts with the catalog numbers provided using the Customer Response Form. Customers are to fax the form to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should be retrieved and returned. Questions should be directed to 201-760-8298.",N/A,471,"471 units US, 667 units international",Nationwide Distribution,Terminated,"November 13, 2012",371,471,Not_Computer,N/A,N/A,N/A
Z-0177-2012,59425,"calibrator, dose, radionuclide",KPT,Radionuclide dose calibrator.,Radiology,Radiology,510(k),"Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02PET dose calibrator",Capintec CRC 25 PET,2,"November 09, 2011", 2011,Capintec Inc,Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET,DESIGN: Software Design,"Capintec, Inc. sent a Software Error Alert letter dated July 8, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contac their Capintec Customer Support Representative to receive a software upgrade. For questions call Capintec Customer Support at 1-800-631-3826.",N/A,69,69,"Worldwide distribution - United States including CA, FL, IL, MA, NJ, OK, PA, and VA; and internationally to Brazil, China, India, Indonesia, Italy, Japan, Korea, South Korea, and Turkey.",Terminated,"December 10, 2013",762,69,Software,N/A,Software update,Software Update
Z-0181-2012,60022,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators.Manufactured by Varian Medical System, Palo Alto, CA.Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.","Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators",2,"November 09, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.",DESIGN: Device Design,"The firm, Varian Medical Systems, sent an ""URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE"" letter dated September 9, 2011 to all affected customers via Federal Express with attached instructions. The letter provides the description of problem; references, details, recommended user actions, and varian actions.***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***In addition, the letter also states ""THIS LETTER IS NOT A SUBSTITUTE FOR THE CAREFUL REVIEW OF ALL USER DOCUMENTATION ASSOCIATED WITH YOUR PARTICULAR EQUIPMENT AND SOFTWARE.""If you have any questions, contact Varian Oncology Help Desk at USA and Canada: 1.888.VARIANS (888.827.4265); Europe +41 41 749 8844 and/or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.",N/A,5823,5823 devices,Worldwide Distribution.,Terminated,"July 24, 2012",258,5823,Not_Computer,N/A,N/A,N/A
Z-0179-2012,59918,"needle, hypodermic, single lumen",FMI,Hypodermic single lumen needle.,General Hospital,General Hospital,510(k),"Quick Shield with Snappy Safety Holder, Greiner bio-one.The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.",Quick Shield with Snappy Safety Holder,2,"November 09, 2011", 2011,"Greiner Bio-One North America, Inc.",Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Greiner Bio-One sent a ""QUICKSHIELD WITH SAFETY HOLDER"" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall.",Contact the recalling firm for information,443950,"443,950 pieces","Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.",Terminated,"March 20, 2012",132,443950,Not_Computer,N/A,N/A,N/A
Z-0178-2012,60104,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"LifeCell Strattice Reconstructive Tissue Matrix for Stoma ReinforcementCatalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm).Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.",Strattice Reconstructive Tissue Matrix for Stoma Reinforcement,2,"November 09, 2011", 2011,LifeCell Corporation,The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.,PREMARKET APPROVAL: No Marketing Application,"LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.",N/A,2651,2651 sublots (of 42 lots),Nationwide Distribution,Terminated,"March 04, 2013",481,2651,Not_Computer,N/A,N/A,N/A
Z-0172-2012,59829,"massager, therapeutic, electric",ISA,Therapeutic massager.,Physical Medicine,Physical Medicine,510(K) Exempt,"Shoulder Flex Massage DeviceDevice is an electric personal massage device labeled in part: ""ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China.""Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.",Shoulder Flex Massage Device,1,"November 10, 2011", 2011,King International,"The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and a strangulation associated with using the device.",DESIGN: Component Design/Selection,"An Urgent Product Recall letter was sent via regular mail to customers. The letter identified the affected product and described the reason for the recall. Customers were asked to stop using Shoulderflex massagers immediately and to safely dispose of them in the trash. The device components should be disposed of separately so that the device cannot be reassembled and used. This means that the power supply should be separated from the massager unit, and the massage fingers should also be removed and disposed of separately. Customers are to complete and return the enclosed the postage-paid card to King International in order to confirm receipt of the recall letter. If additional information is needed regarding this recall, customers are to contact King International LLC at 503-524-7046 or visit their website at www.shoulderflex.com or via mail to PO Box 2384, Beaverton, Oregon 97075.On 8/25/2011 FDA published a health alert on the FDA website. On 8/31/2011 the firm issued a nationwide press release.",N/A,11934,11934,Nationwide Distribution,Open,N/A,N/A,11934,Not_Computer,N/A,N/A,N/A
Z-0180-2012,60048,"immunoassay method, troponin subunit",MMI,Creatine phosphokinase/creatine kinase or isoenzymes test system.,Clinical Chemistry,Clinical Chemistry,510(k),i-Stat cTnI cartridgesIs an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.,iStat cTnI cartridges,2,"November 10, 2011", 2011,Abbott Point Of Care Inc.,"i-Stat cTnI cartridges beginning with letter ""T"" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees. The letter identified the affected product and explained the background of the problem. Customers are to discontinue use of the cartridges from the lots identified. All unused product will be credited and should be returned as instructed on the attached Business Reply Card. If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well. APOC shipped replacement product in order to minimize any disruption. If replacement product has not been received then customers should contact Customer Service at 1-800-366-8020, option 5. Questions regarding this information should be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1 or customers' local APOC representative.",Contact the recalling firm for information,1688755,"1,688,755 cartridges",Worldwide Distribution,Terminated,"March 11, 2013",487,1688755,Not_Computer,N/A,N/A,N/A
Z-0182-2012,60036,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),"Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test PeriodA nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.",Extended Brilliance WorkstationNM (EBWNM) ,2,"November 10, 2011", 2011,Philips Medical Systems,A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.,DESIGN: Software Design,"Philips sent all affected sites an Urgent Medical Device Correction Letter on September 27, 2011 for the MUGA issue. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy of the communication with the equipment instruction for use. Additionally, a field change order was released on September 26, 2011, customers will be receiving release notes as part of their correction informing them of the changes and corrections to the software. The new software will be installed on affected units by Philips Field Service Engineers.For customers in North America contact Customer Care Solutions Center at 1-800-722-9377. Select option 5. In all other countries contact the local Philips Healthcare office.",N/A,1181,1181 systems,Worldwide Distribution - USA (nationwide) and Canada.,Terminated,"January 30, 2013",447,1181,Software,Output/Calculation,Software update,Software Update
Z-0187-2012,59461,"bed, therapeutic, ac-powered, adjustable home-use",LLI,AC-powered adjustable hospital bed.,General Hospital,General Hospital,510(K) Exempt,"Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG.",Invacare bariatric bed,2,"November 14, 2011", 2011,Invacare Corporation,"Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.",DESIGN: Labeling Design,"On 9/19/11, Invacare sent Recall Notificaiton Letters to their customers. They instructed their customers to quarantine the product, complete and return a response form.",Contact the recalling firm for information,35747,"35,747","Distribution Nationwide and to United Arab Emirates, Dominican Republic, Egypt, Guam, Mexico, & Virgin Islands.",Terminated,"July 02, 2013",596,35747,Not_Computer,N/A,N/A,N/A
Z-0186-2012,60242,"cement, dental",EMA,Dental cement.,Dental,Dental,510(k),"Breeze Self-Adhesive Resin Cement, Part Number: N97A,Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.",Breeze SelfAdhesive Resin Cement,2,"November 14, 2011", 2011,Kerr/pentron Dba Kerr Corporation And Pentron Clinical,Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.,N/A,"Pentron Clinical sent an ""Urgent: Medical Device Recall"" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification.Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.",N/A,336,336 units,"Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.",Terminated,"June 28, 2013",592,336,Not_Computer,N/A,N/A,N/A
Z-0183-2012,60122,"sleeve, limb, compressible",JOW,Compressible limb sleeve.,Cardiovascular,Cardiovascular,510(k),"Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC.Prevention of DVT.",Pulstar(R) DVT PREVENTION SYSTEM,2,"November 14, 2011", 2011,Albahealth LLC,The wrap portion of the device was tearing at the seam.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Albahealth, L.L.C. sent an ""URGENT: MEDICAL DEVICE RECALL"" letter dated September 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to quarantine all affected product. A response form was enclosed for customers to complete and return. The firm provide information on how to return the affected product and receive replacement product. Questions concerning this recall are directed to call 865-354-5229 for assistance.",Contact the recalling firm for information,2582,"2,582 pairs","Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.",Terminated,"March 30, 2012",137,2582,Not_Computer,N/A,N/A,N/A
Z-0184-2012,59919,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.",Vacuette 4ml EDTA DK2 tube,2,"November 14, 2011", 2011,"Greiner Bio-One North America, Inc.",Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.,PRODUCTION CONTROLS: Process Control,"Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach¶_ and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.",N/A,504000,"504,000 pieces",Nationwide.,Terminated,"March 12, 2012",119,504000,Not_Computer,N/A,N/A,N/A
Z-0188-2012,60370,"pad, alcohol, device disinfectant",LKB,N/A,N/A,General Hospital,510(k),"PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box.Alcohol Prep Pads, packaged in the Alere INRatio¶_ 2 PT/INR Home Monitoring Kit; or Hemosense INRatio¶_ 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio¶_ Prothrombin Time/INR Testing Kit, Self-Test System;Alcohol Prep Pads, packaged in the INRatio Starter Kit ProductModel Number: 0200086, 0200432, 0100007, 0100072The Alere INRatio¶_2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio¶_2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio¶_2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio¶_2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio¶_ system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you.",PDI Alcohol Prep Pads packaged in the INRatio kit. ,2,"November 16, 2011", 2011,Alere San Diego,Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"Alere sent a recall notification letter dated October 6, 2011, and Verification Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an alternate prep pad that is not involved with the PDI recall, or use a sterile gauze pad with isopropyl alcohol. If customers purchase alcohol pads from a store or pharmacy, customers can confirm with their pharmacist that the pads they are purchasing are not associated with the PDI recall. INRatio/INRatio2 kits at Alere are currently being reworked to include a sterile PDI alcohol pad.Customers were instructed to complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of the notice and to indicate the number of discarded/required replacement alcohol prep pads.Customers with questions about INRatio¶_/ INRatio¶_ 2 were instructed to consult their healthcare provider, or call Alere Technical Service at 877-866-5313 (24 hours a day, 7 days a week).",Contact the recalling firm for information,14248,"Estimated 14,248 Total units",Nationwide Distribution,Terminated,"February 29, 2012",105,14248,Not_Computer,N/A,N/A,N/A
Z-0190-2012,60366,dialysate concentrate for hemodialysis (liquid or powder),KPO,Hemodialysis system and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step","Step 2, 300022000 GPD (Sodium Hydroxide 2.0N)",3,"November 16, 2011", 2011,Isopure Corp,"The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components,"Isopure sent a Product Recall Notice dated October 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue the use of any Step 2 chemical from the affected product, place any remaining chemical into the original box, seal it with tape, and segregate the product to prevent it from being placed back into stock. The firm will pick up the product for return on a call tag. Customers would receive replacement product for all affected cases of the Step 2 chemical the firm received.For questions call 502-722-1000.",N/A,107,91cs/12/4 oz plastic bottles,"Nationwide Distribution including the following states: AL, AZ, CA, FL, GA, IN, KS, LA, MA, MO, MS, NC, NH, NJ, NM, NV, OH, OR, PA, SC, TN, TX, and VA",Terminated,"February 24, 2012",100,91,Not_Computer,N/A,N/A,N/A
Z-0192-2012,60097,"prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented",LZO,Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex FranceThe MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.",Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert;,2,"November 16, 2011", 2011,Stryker Howmedica Osteonics Corp.,Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.,DESIGN: Labeling Design,"The firm, Stryker, sent an ""URGENT PRODUCT CORRECTION"" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069.If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.",N/A,1951,1951 units,Nationwide distribution.,Terminated,"November 13, 2013",728,16891,Not_Computer,N/A,N/A,N/A
Z-0195-2012,60145,"driver, wire, and bone drill, manual",DZJ,Bone cutting instrument and accessories.,Dental,Dental,510(k),"IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.",Stryker,2,"November 16, 2011", 2011,Stryker Instruments Div. of Stryker Corporation,"There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli",DESIGN: Device Design,"The firm, Stryker, sent an ""URGENT MEDICAL DEVICE RECALL NOTIFICATION"" letter dated October 18, 2011 to Risk Managers, Office Managers, and Oral Surgeons. The letter described the products under recall, the problem and a series of actions to be taken. Customers were asked to immediately locate recalled products and quarantine. Products were to be shipped back to Stryker. The letter included a Business Reply Form to be faxed back to Stryker Instruments Regulatory Department, 866-521-2762. The letter instructs to forward this notification to all affected locations if the recalled products were further distributed. Customers with questions can call Stryker at 1-800-253-3210.",N/A,5691,"5,691","Worldwide Distribution - USA (nationwide) and the countries of Brazil, Canada, China, Germany, Greece, Hong Kong, India, Jordan, Miramar, Saudi Arabia, Singapore, Spain, Switzerland, United Kingdom.",Terminated,"July 12, 2013",604,12631,Not_Computer,N/A,N/A,N/A
Z-0189-2012,60059,"urease and glutamic dehydrogenase, urea nitrogen",CDQ,Urea nitrogen test system.,Clinical Chemistry,Clinical Chemistry,510(k),"Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.",Abbott Clinical Chemistry Urea Nitrogen,2,"November 16, 2011", 2011,"Abbott Laboratories, Inc",The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.,PRODUCTION CONTROLS: Process Control,"The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.",N/A,5704,5704 units of Urea Nitrogen,Worldwide Distribution.,Terminated,"May 11, 2012",177,5704,Not_Computer,N/A,N/A,N/A
Z-0191-2012,60174,"separator, automated, blood cell and plasma, therapeutic",LKN,N/A,N/A,Gastroenterology/Urology,510(k),"Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215.A blood component separator used for therapeutic plasma exchanges.",Spectra Optia Apheresis System,2,"November 16, 2011", 2011,"Caridian BCT, Incorporated",Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.,DESIGN: Software Design,"CaridianBCT sent a ""Safety Alert"" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm will be sending a recall letter to consignees in November 2011, stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved.If you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT ( US Toll free 1-877-299-4228 ) or (303) 231-HELP ) ( 1 (303) 231-4357, or your local CaridianBCT Customer Service office.",N/A,852,852 units (US: 333; Foreign: 519),"Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.",Terminated,"February 01, 2013",443,852,Software,N/A,Software update,Software Update
Z-0200-2012,60118,"bracket, plastic, orthodontic",DYW,Orthodontic plastic bracket.,Dental,Dental,510(k),"Spirit MB Brackets, part #494-1210.The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.",Spirit MB Brackets,3,"November 16, 2011", 2011,Ormco Corporation,Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.,DESIGN: Device Design,"Ormco Corporation sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.",Contact the recalling firm for information,10,10 packs,"Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.",Terminated,"April 24, 2012",160,145,Not_Computer,N/A,N/A,N/A
Z-0185-2012,60202,"dc-defibrillator, low-energy, (including paddles)",LDD,DC-defibrillator (including paddles).,Cardiovascular,Cardiovascular,510(k),"The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings.Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.",LIFEPAK 20 defibrillator,2,"November 16, 2011", 2011,"Physio Control, Inc.","When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.",TRAINING: Employee Error,"Physio Control sent a "" Urgent Medial Device Safety Alert"" letter dated January 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.The letter instructed the customers to follow the Operating Instructions for AED and Manual Defibrillation mode (Section 4-Therapy, pages 58 and 61) that instructs users to ""Connect therapy electrodes to the therapy cable and confirm cable connection to the defibrillator"" to prevent users from mistakenly leaving the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.Recommendations to users who use a Therapy Cable:-Disconnect the QUIK-COMBO test plug prior to patient use-Confirm therapy electrodes - to - therapy cable connection-Confirm therapy cable - to - defibrillator connection-Confirm therapy electrodes - to - patient connectionAdding 2005 American Heart Association software that includes audible and visual prompts to LIFEPAK 20 defibrillators manufactured prior to January 2007 is optional and not required. If the customers would like to have this optional kit installed in your defibrillators, please contact Physio Control, Inc.Customers can call Technical Support at 1-800-442-1142 for any questions about this recall or or visit our website at www.physio-controlnotices.com/LP20testplug.",Contact the recalling firm for information,23467,"23,467 units worldwide","Worldwide Distribution--USA ( nationwide ) and the countries of Bahrain, Lebanon , Cyprus, Netherlands, Egypt, Pakistan, Germany, Saudi Arabia, India, South Africa, Iran, Syria, Israel, Turkey, Jordan, UAE,Kuwait,Yemen, Asia Pacific, Australia, New Caledonia, Guam, New Zealand, Hong Kong, Latin America, Anguilla, Jamaica, Argentina, Mexico, Bahamas, Nicaragua, Brazil, Panama, Chile, Peru, Colombia, Trinidad, Costa Rica,Uruguay, El Salvador, Venezuela, Guatemala, Virgin Islands and Canada.",Terminated,"November 21, 2011",5,23467,Other,N/A,N/A,Other
Z-0209-2012,60420,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.",SoftPath GUI ,2,"November 17, 2011", 2011,SCC Soft Computer,"Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.",DESIGN: Software Design,"The firm, SCC Soft Computer, sent a ""CORRECTION COMMUNICATION"" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to ""Y"". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed.If you have any questions, contact the Director of Quality Management at (727)789-0100.",N/A,142,142,"Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.",Terminated,"July 17, 2012",243,142,Software,N/A,N/A,Other
Z-0207-2012,59990,"transmitters and receivers, electrocardiograph, telephone",DXH,Telephone electrocardiograph transmitter and receiver.,Cardiovascular,Cardiovascular,510(k),"LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard, 2 Pekeris St, Rehovot, 76100, Israel; Model FG-00084LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms.",LifeStar ACT III Platinum Sensor,2,"November 17, 2011", 2011,Lifewatch Services Inc,LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, LifeWatch, sent an "" Urgent Device Recall"" letter dated September 27, 2011 to the affected customers. The letter describes the product, problem and action to be taken. The customers were instructed to immediately refrain from providing these devices to their customers; stop using the affected sensors, return their entire kit in the pre-paid mailer, and use the new device kit included with the recall letter. In addition, the letter informed the users that the replacement device has upgraded software and firmware that allows for detection of shorts in the cable, and if detected, cuts off current flow to the patient to prevent minor shocks and burns.If you have any questions, please call (847) 813-4258.",N/A,442,442 sensors,Nationwide distribution.,Terminated,"May 15, 2012",180,1094,Computer,N/A,N/A,N/A
Z-0202-2012,59960,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),Medtronic MiniMed paradigm mio Infusion Sets MMT-921The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.,Medtronic MiniMed paradigm mio Infusion Sets ,2,"November 17, 2011", 2011,Medtronic Minimed,The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insulin Pump among other items.The mio infusion sets were not authorized to be shipped to the consignee based on Medtronics internal product handling procedures and they may not function properly.T,TRAINING: Employee Error,"The firm, Medtronic, sent an ""IMPORTANT RECALL INFORMATION"" letter dated May 16, 2011 to consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use right away; use the replacement mio infusion sets provided to them in this package; return all unused Lot 3700255 mio infusion sets using the emailed pre paid return label, and drop the package off at any UPS location or call UPS at 800.742.5877 to schedule a pick up.""Please note that only the Lot 3700255 mio infusion sets were shipped in error. The other products included in the package were not shipped in error and do not need to be returned.""If you have any additional questions relating to this notification or any questions in general call 800.999.9859 ext.63704.",Discard product or return to place of purchase for a full refund or exchange,4,4 boxes,Nationwide distribution: AL only.,Terminated,"December 14, 2011",27,4,Not_Computer,N/A,N/A,N/A
Z-0203-2012,60124,"enzyme linked immunoabsorbent assay, rubella",LFX,Rubella virus serological reagents.,Microbiology,Microbiology,510(k),"EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealersThe Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections.",Premier EHEC Kit ,2,"November 17, 2011", 2011,Meridian Bioscience Inc,"Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Meridian Bioscience, Inc. sent an Urgent Medical Device Recall letter dated October 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, evaluate testing performed with the affected product., and segregate and destroy remaining inventory.Customers were asked to contact Meridian's Technical Service Department by phone or facsimile as necessary. For replacement product phone 800-343-3858, outside North America 513-271-3700, Fax 513-272-5432.Customers were also asked to complete and return the attached Customer Response Form. In the event that they have no remaining inventory, customers were instructed to indicate such on the Customer Response Form and return to Meridian Technical Service. For questions phone 800-343-3858, outside North America 513-271-3700.",N/A,3236,3236 Kits,"Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI and WV and the countries of AUSTRALIA, CANADA, CHILE, COSTA RICA, ITALY, JAPAN and NEW ZEALAND.",Terminated,"February 19, 2012",94,3236,Not_Computer,N/A,N/A,N/A
Z-0204-2012,60392,"catheter, intravascular, diagnostic",DQO,Diagnostic intravascular catheter.,Cardiovascular,Cardiovascular,510(k),"SUPER TORQUE MB Angiographic Catheter product is labeled in part: ""***5F (1.65 mm)***110 cm .038"" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson; company***""UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6.UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10.Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.",SUPER TORQUE MB Angiographic Catheter ,2,"November 17, 2011", 2011,Cordis Corporation,"Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB are affected by the Cordis Correction.",PRODUCTION CONTROLS: Error in Labeling,"Cordis Corporation sent a Correction letter dated November 21, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are instructed to read the ""Description"" and ""Recommendations"" sections, sign and return an enclosed Acknowledgement Form, and to maintain awareness of the communication until the information has been incorporated into the Cordis Super Torque MB Catheter labeling. Contact Cordis at 800-781-0282 for questions regarding this notice.",N/A,118690,"118,690 units",Worldwide Distribution-USA (nationwide) including Puerto Rico.,Terminated,"July 23, 2013",614,119000,Not_Computer,N/A,N/A,N/A
Z-0214-2012,57585,catheter care tray (kit),OHR,Urological catheter and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,Enforcement Discretion,"Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2"" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6""); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8""); 1 Extension Tubing (30""); 2 - 3""x3"" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30""x30"")***Catalog Number: 660005000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com.HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.",HSG Procedure Tray 5Fr,2,"November 18, 2011", 2011,"Medical Device Technologies, Inc.","Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity.",PRODUCTION CONTROLS: Packaging,"The firm, Angiotech, sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product.If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.",N/A,2902,2902 boxes,"Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.",Terminated,"November 30, 2011",12,32491,Not_Computer,N/A,N/A,N/A
Z-0213-2012,60101,"densitometer, bone",KGI,Bone densitometer.,Radiology,Radiology,510(k),"DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers.The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.",DICOM Option for the Norland Illuminatus Software Revs ,2,"November 18, 2011", 2011,"Cooper Surgical, Inc.","The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record.",DESIGN: Software Design,"The firm, CooperSurgical, sent a ""Notice of RECALL-URGENT"" letter dated September 23, 1011 to its customers. The letter described the product, ""Problem/Situation"", and ""When can this problem occur?"". CooperSurgical will send a new revision of Illuminatus software to the customers once available.If you have any concerns about your existing database of patients, please contact our Norland Technical Support team at (203) 601-5200 Extension 9888 or 9889.",N/A,184,184,"Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, FL, GA, IN, KS, KY, LA, MD, MA, MI, MO, NJ, NY, NC, OK, PA, TN, TX, UT, and WI ; and countries of: ARGENTINA, AUSTRALIA, BELGIUM SPAIN, CANADA, CHINA, DENMARK, EMIRATES, ENGLAND, FRANCE, GERMANY, GREECE, IRELAND, MALTA, POLAND, SAUDI ARABIA, SOUTH KOREA, and TAIWAN.",Terminated,"April 09, 2013",508,184,Software,Output/Calculation,Software update,Software Update
Z-0210-2012,59818,"stimulator, autonomic nerve, implanted for epilepsy",LYJ,N/A,N/A,Neurology,N/A,"VNS Therapy Aspire HC Generator and VNS, Model 105Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058For implantation in humans to treat Epilepsy and Depression.",VNS Therapy Aspire HC Generator and VNS,2,"November 18, 2011", 2011,"Cyberonics, Inc",The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of:Lack or loss of efficacyPain, inflammation, swelling/edema in the neck area; and/orPatient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.For questions regarding this recall call 281-228-7323.",N/A,340,340 units,"Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.",Terminated,"August 20, 2012",276,340,Not_Computer,N/A,N/A,N/A
Z-0211-2012,60154,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.,Results Management (RM) Reporting Module,2,"November 18, 2011", 2011,AGFA Corp.,Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.,DESIGN: Software Design,"AGFA Healthcare sent an ""URGENT FIELD SAFETY NOTICE"" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions:Amend the report through the RM interface, orCall AGFA Service to change the status of the report to ""preliminary"" and then proceed with the finalization of the report.AGFA issued an Acknowledgment, via FAX- Back that the information was received and understood to affected customers. For any questions customers were instructed to contact their AGFA Healthcare Service at 877-777-2432.",N/A,323,323,Worldwide Distribution - USA (nationwide) and Canada,Terminated,"July 02, 2013",592,323,Not_Computer,N/A,N/A,N/A
Z-0212-2012,60165,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.,IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) ,2,"November 18, 2011", 2011,AGFA Corp.,Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).,N/A,"The firm, AGFA HealthCare"" sent an 'URGENT FIELD SAFETY NOTICE"" dated May 27, 2011 via FED-EX by June 6, 2011 to all customers using the affected product. The letter describes the product, problem and actions to be taken. The customers were instructed to distribute this information within their facility to all those who need to be aware and to complete and return the attached FEEDBACK FORM via fax to 864-421-1668 or email to debbie.norris@agfa.com. AGFA will provide software corrections to all affected sites and will contact the customers to schedule the analysis and provide any corrections if required.If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.",Contact the recalling firm for information,280,280,"Worldwide distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV; and country of: Canada.",Open,N/A,N/A,280,Software,Output/Calculation,Software update,Software Update
Z-0247-2012,60021,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"SKYLight Gamma Camera System;SKYLIGHT 8FT, 3/8"" SPECTManufactured by Philips Medical Systems (Cleveland), Inc.595 Miner Road, Cleveland, OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.",SKYLight Gamma Camera System,2,"November 19, 2011", 2011,Philips Medical Systems,A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.,DESIGN: Device Design,"Philips Medical Systems sent a ""Customer Information"" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.",Contact the recalling firm for information,658,658 - all units in recall,Worldwide Distribution-USA (nationwide) including Puerto Rico.,Terminated,"December 21, 2012",398,658,Not_Computer,N/A,N/A,N/A
Z-0259-2012,60173,"suture, surgical, absorbable, polydioxanone",NEW,Absorbable polydioxanone surgical suture.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}).Product is labeled in part: ""***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***"".Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.",MonoDox Synthetic Absorbable Suture,2,"November 19, 2011", 2011,C P Medical Inc.,The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"CP Medical, Inc. sent a ""RECALL NOTICE"" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.",Contact the recalling firm for information,13632,13632 sutures,Nationwide Distribution,Terminated,"December 13, 2011",24,13632,Not_Computer,N/A,N/A,N/A
Z-0261-2012,60405,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.",SoftLab,2,"November 21, 2011", 2011,SCC Soft Computer,"On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0",DESIGN: Software Design,"SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue. Each client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail.SCC recommended to the customer until Live on the correction avoid making edits in the instrument menu.For further questions please call (727) 789-0100.",N/A,255,255,Worldwide Distribution - USA ( nationwide) and Canada.,Terminated,"November 22, 2013",732,255,Not_Computer,N/A,N/A,N/A
Z-0265-2012,60301,"electrosurgical, cutting & coagulation & accessories",GEI,Electrosurgical cutting and coagulation device and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(k),Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;,SERFAS,2,"November 21, 2011", 2011,Stryker Endoscopy,An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.,DESIGN: Component Design/Selection,"Stryker Endoscopy Urgent Medical Device Removal notifications datyed October 25, 2011, were sent to all consignees via traceable mail. Sales representatives and regional managers were notified by e-mail. Product is to be returned to Stryker Endoscopy using the pre-paid shipping label. Replacement product may be obtained by calling Stryker at 1-800-624-4422. The enclosed Acknowledgement receipt form is to be completed and returned. Questions or comments may be directed to Stryker at 1-800-624-4422 or e-mail at 90S@stryker.com.",Contact the recalling firm for information,6307,6307,"Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom",Terminated,"February 29, 2012",100,6307,Not_Computer,N/A,N/A,N/A
Z-0262-2012,60205,"degreaser, skin, surgical",KOY,Surgical skin degreaser or adhesive tape solvent.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows:Aria, Kit Part number 23189-010, Kit, Basic hookup, AA;CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall;Aria, Kit Part number 23189-106, Kit, Aria Hookup;Aria, Kit Part number 23189-110, Kit, Aria Hookup;Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup;Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode;LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual;Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA;LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard;483, Kit Part number 23189-117, Kit, Holter Hookup 483;Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode;Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC;EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch;EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch;EVO, Kit Part number SK10456, Sample Kit, Disposables.A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.",Spacelabs Healthcare HookUp kits,2,"November 21, 2011", 2011,"Del Mar Reynolds Medical, Ltd.","The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI).",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"SpaceLabs Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the affected product and dispose of them per their hospital or clinic protocol. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2for Technical Support.",N/A,25015,"25,000 pieces of PDI alcohol prep pads-15 different Spacelabs hook-up kits","Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait",Terminated,"February 23, 2012",94,25015,Not_Computer,N/A,N/A,N/A
Z-0264-2012,60365,"dilator, vessel, for percutaneous catheterization",DRE,Vessel dilator for percutaneous catheterization.,Cardiovascular,Cardiovascular,510(k),"Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA.Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9.Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8.Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6.The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.",Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths,2,"November 21, 2011", 2011,Boston Scientific Corporation,"Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035"" ID dilator may be labeled incorrectly as a 0.038"" ID dilator.",MISBRANDING: Labeling False and Misleading,"Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers.For questions regarding this recall call 763-494-1133.",N/A,2660,2660,"Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE.",Terminated,"January 15, 2013",421,2660,Not_Computer,N/A,N/A,N/A
Z-0270-2012,60278,"chair, adjustable, mechanical",INN,Mechanical chair.,Physical Medicine,Physical Medicine,510(K) Exempt,"""***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***""Labeling on product: ""***1C0101 and K0061014***"".A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis, post-operative conditions, degenerative joint disease, Parkinson's disease or other neuromuscular disorders.",Uplift Commode Assist,2,"November 22, 2011", 2011,Uplift Technologies Inc.,"On June 26, 2011 Uplift Technologies Inc. Nova Scotia, Canada initiated a recall of the Uplift Commode Assist Model No. CA200, Lot No. 1C0101. The plastic seat does not meet manufacturing specifications. The seat may not fit the unit properly and may interfere with the unit's normal locking mechanism.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Uplift Technologies, Inc. sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated June 27, 2011 to all affected customers The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and to quarantine the affected product. Customers are to call Uplift's Customer Service Department at 1-800-387-0896 to request a Return Materials Authorization number in order to return the product..",Contact the recalling firm for information,219,219 chairs,Worldwide Distribution-USA (nationwide) and the country of Canada.,Terminated,"May 31, 2012",191,219,Not_Computer,N/A,N/A,N/A
Z-0266-2012,60005,"source, brachytherapy, radionuclide",KXK,Radionuclide brachytherapy source.,Radiology,Radiology,510(k),"Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000.RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.",Rapid Strand Rx,2,"November 22, 2011", 2011,Medi-Physics Inc. dba GE Healthcare,There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.,PRODUCTION CONTROLS: Process Control,"GE Healthcare/Oncura sent a ""Urgent Medical Device Correction"" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have.Please call if you have any further questions (847) 398-8400 and 011-44-1494-737251 (Amersham, United Kingdom, GMT).",No consumer action necessary,23,23 orders,"Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom",Terminated,"January 20, 2012",59,23,Not_Computer,N/A,N/A,N/A
Z-0271-2012,60374,"tubes, gastrointestinal (and accessories)",KNT,Gastrointestinal tube and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage",TUMEVAC ,3,"November 22, 2011", 2011,"Ethox International, Inc.","Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.",TRAINING: Employee Error,"Ethox International, Inc. sent an ""URGENT DEVICE RECALL"" letter dated March 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine if they have the affected product. Customers are to return the affected product to the firm by using UPS account 128959. Customers will be reimbursed for the returned goods. Additionally, a response form was enclosed for customers to complete and return. Contact the firm at (716) 842-4000 for questions regarding this recall.",Contact the recalling firm for information,130,130 units,"Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.",Terminated,"November 28, 2011",6,130,Not_Computer,N/A,N/A,N/A
Z-0263-2012,60155,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring SolutionNetworked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.",Infinity(R) Acute Care System (IACS) Monitoring Solution (M540),1,"November 22, 2011", 2011,"Draeger Medical, Inc.","During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition, a misalignment of ECG and ART waveforms delivered from an Infinity(RO Acute Care System (IACS) Monitoring Solution (M540) was observed on the Infinity Central Station.",N/A,"The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, ""Check the patient and treat if necessary"".If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).",N/A,476,476,Nationwide distribution - IL,Terminated,"April 01, 2013",496,476,Other,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0268-2012,60316,"pump, infusion, elastomeric",MEB,Infusion pump.,General Hospital,General Hospital,510(k),"Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.",WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP,1,"November 23, 2011", 2011,Wolf Medical Supply Inc.,Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).,PRODUCTION CONTROLS: Process Control,"On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.",N/A,8,8 cases (192 units),"Nationwide distribution, including Puerto Rico.",Terminated,"April 25, 2012",154,40,Not_Computer,N/A,N/A,N/A
Z-0272-2012,60164,"system, image processing, radiological",LLZ,Picture archiving and communications system.,Radiology,Radiology,510(k),IMPAX CardioVascular (CV) Admin ToolThe IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.,AdminTool2,2,"November 23, 2011", 2011,AGFA Corp.,Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.,DESIGN: Software Design,"An 'URGENT FIELD SAFETY NOTICE"" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the ""merge"" function should be utilized. The letter also states that a software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an ""URGENT FIELD SAFETY NOTICE"" was sent on October 12, 2012.",N/A,323,323 units,"Worldwide Distribution -- USA, Virgin Islands and Canada",Terminated,"June 26, 2012",216,323,Software,Output/Calculation,Software update,Software Update
Z-0273-2012,60123,"sucker, cardiotomy return, cardiopulmonary bypass",DTS,Cardiopulmonary bypass cardiotomy return sucker.,Cardiovascular,Cardiovascular,510(k),"IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.",IBC Suction Wand,2,"November 23, 2011", 2011,International Biophysics Corp,Potential for the sterility to be compromised.,PRODUCTION CONTROLS: Packaging,"International Biophysics Corp. sent a"" Medical Device Recall Notice"" dated October 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use of the product in the referenced lot number should cease immediately. Customers were asked to follow the instructions in the letter to return the affected product.If you have any further questions please call (512) 814-0070.",Contact the recalling firm for information,1200,1200 units,"Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX",Terminated,"March 23, 2012",121,1200,Not_Computer,N/A,N/A,N/A
Z-0282-2012,59913,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)",Flexible Probe with Blocking Washer,2,"November 23, 2011", 2011,"Varian Medical Systems, Inc.",The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control,"Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.",Contact the recalling firm for information,81,81 parts,"Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India",Terminated,"December 05, 2011",12,81,Not_Computer,N/A,N/A,N/A
Z-0278-2012,60430,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.",Softlab,2,"November 23, 2011", 2011,SCC Soft Computer,"Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.",CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control,Clients were notified through SCC Soft Computer's proprietary Task Management System On 03/22/201. All clients have received a hot fix that corrected the issue or made the hosparam change that prevents the issue.,N/A,12,12,Sold throughout US and Canada.,Terminated,"October 29, 2012",341,12,Software,Output/Calculation,Software update,Software Update
Z-0279-2012,60305,"table, operating-room, ac-powered",FQO,Operating tables and accessories and operating chairs and accessories.,General & Plastic Surgery,General & Plastic Surgery,510(K) Exempt,"STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.",STERIS 5085 and 5085SRT surgical tables ,2,"November 23, 2011", 2011,Steris Corporation,Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s).",N/A,10504,167 tables were distributed - 5085=108 and 5085SRT=59,Nationwide distribution.,Terminated,"March 19, 2013",482,167,Not_Computer,N/A,N/A,N/A
Z-0281-2012,60269,"monitor, physiological, patient(with arrhythmia detection or alarms)",MHX,Arrhythmia detector and alarm (including ST-segment measurement and alarm).,Cardiovascular,Cardiovascular,510(k),"Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).","Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors",2,"November 23, 2011", 2011,"Draeger Medical, Inc.",Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.,DESIGN: Software Design,"Firm initiated their recall of this device on October 25, 2011 by sending an ""Urgent Medical Device Recall"" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.",N/A,14894,"14,894","Worldwide distribution- USA including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WI and WV and International distribution including the countries of Algeria, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brasilien, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Deutschland, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Finland, France, Frankreich, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indien, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Jordanien, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Madagascar, Malaysia, Malta, Mauritius, Mayotte, Mexico, Moldavia, Moldova, Morocco, Netherlands, Norway, Norway, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Rumania, Russian Fed., Saudi Arabia, Serbia, Seychelles, Singapore, Slovenia, Slowenien, South Africa, South Korea, Spain, Sri Lanka, S¶_dafrika, Sweden, Switzerland, Syria, Taiwan, Thailand, Tschechische Republic, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and White Russia.",Terminated,"July 01, 2013",586,14894,Software,Alarm/Message,Software update,Software Update
Z-0276-2012,59980,intraocular lens,HQL,Intraocular lens.,Ophthalmic,Ophthalmic,N/A,Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter.The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.,Sensar Foldable IOL with OptiEdge,2,"November 23, 2011", 2011,Abbott Medical Optics Inc (AMO),The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.,TRAINING: Employee Error,"Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. For any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative.For any questions regarding this recall call 714-247-8656.",N/A,96,96,"Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia",Terminated,"January 08, 2014",777,179,Not_Computer,N/A,N/A,N/A
Z-0274-2012,60328,"mesh, surgical",FTM,Surgical mesh.,General & Plastic Surgery,General & Plastic Surgery,510(k),"Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024.The device is intended to be used as a staple line buttress",PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV),3,"November 23, 2011", 2011,Synovis Surgical Inovation Div. of,Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.,PRODUCTION CONTROLS: Labeling Mix-Ups,"Synovis Surgical Inovation sent a ""Recall Notification"" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.",Contact the recalling firm for information,132,132 units,"Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.",Terminated,"April 24, 2012",153,132,Not_Computer,N/A,N/A,N/A
Z-0284-2012,60142,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.",Symbia T Series SPECTCT System,2,"November 23, 2011", 2011,"Siemens Medical Solutions USA, Inc.",Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control,"Siemens Medical Solutions USA, Inc. sent an ""Urgent Field Correction Recall"" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.",Contact the recalling firm for information,3,3 units,"Florida, Illinois and Texas",Terminated,"October 16, 2012",328,5,Software,Physical Safety Hazards,Software update,Software Update
Z-0280-2012,60219,"antinuclear antibody, indirect immunofluorescent, antigen, control",DHN,Antinuclear antibody immunological test system.,Immunology,Immunology,510(k),"Inova Diagnostic Inc., NOVA Lite ANA KSL KitPart Number: 708390. in vitro diagnostic.",NOVA Lite ANA KSL Kit,3,"November 23, 2011", 2011,Inova Diagnostics Incorporated,The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume.,CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control,"On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.",N/A,500,500 kits,"Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.",Terminated,"April 04, 2012",133,500,Not_Computer,N/A,N/A,N/A
Z-0277-2012,60436,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.",SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4. ,2,"November 23, 2011", 2011,SCC Soft Computer,"On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03",DESIGN: Software Design,"SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a ""valcheck"" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix.If you have any further questions please call ( 727 ) 789-0100.",N/A,69,69,Worldwide Distribution-- USA ( nationwide) and Canada.,Terminated,"August 07, 2013",623,69,Software,Output/Calculation,Software update,Software Update
Z-0285-2012,60166,"film, radiographic",IWZ,Radiographic film.,Radiology,Radiology,510(K) Exempt,"Curix Opthos H, size 35x43 cmA radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.",Curix Opthos H,3,"November 25, 2011", 2011,AGFA Corp.,The film notch was located in the wrong position.,PRODUCTION CONTROLS: Process Control,"An ""URGENT SAFETY NOTICE"" letter was sent via email to the dealers on October 7, 2011. The letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the dealer sites. Included in each dealer letter, Agfa also provided a customer notification letter to be sent to their end-use customers. Agfa has requested dealers and end-use customers to file a complaint at 1-877-777-2432 for any identified product still in their inventories. Agfa will replace product and arrange for return shipment.",N/A,125,125,"Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.",Terminated,"December 22, 2011",27,125,Not_Computer,N/A,N/A,N/A
Z-0292-2012,60413,"set, administration, intravascular",FPA,Intravascular administration set.,General Hospital,General Hospital,510(k),"Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 19208-01Intended use: for the administration of fluids",Hospira LifeShield LatexFree 150 mL Burette Set,2,"November 25, 2011", 2011,Hospira Inc.,The float valve in the burette sticks to the burette wall and does not open or close properly.,TRAINING: Employee Error,"The firm, Hospira, sent an ""URGENT DEVICE RECALL"" letter dated November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: hospira2530@stericycle.com; return affected product to Stericycle using the label provided with this letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.",Contact the recalling firm for information,12580,"12,580 units","Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin, and internationally to Canada",Open,N/A,N/A,12580,Not_Computer,N/A,N/A,N/A
Z-0289-2012,60355,"tubes, vials, systems, serum separators, blood collection",JKA,Blood specimen collection device.,Clinical Chemistry,Clinical Chemistry,510(k),"ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 test (with lancet),Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.","MyAllergyTest, Specimen Collection Kit",2,"November 25, 2011", 2011,Immunetech Inc,"ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination,"The firm, IMMUNETECH, sent an ""URGENT PRODUCT RECALL NOTIFICATION"" letter dated November 4, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory and quarantine all affected kits; if they have further distributed the affected kits, contact Immunetech to accurately identify and immediately notify their customers and facilitate the return and exchange of all remaining kits. If you have any questions, call (650) 312-1066, Monday-Friday, 9:00am -5:00pm (pacific) or email: customersupport@immunetech.com.",N/A,50,50,Worldwide distribution.,Terminated,"June 14, 2012",202,3340,Not_Computer,N/A,N/A,N/A
Z-0294-2012,60031,"scale, stand-on, patient",FRI,Stand-on patient scale.,General Hospital,General Hospital,510(K) Exempt,"Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KLModel 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).",Health o Meter Professional ,2,"November 28, 2011", 2011,"Pelstar, Llc","There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst.",DESIGN: Device Design,"Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.",N/A,2498,"2,498 units","Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.",Open,N/A,N/A,2498,Hardware,Physical Safety Hazards,Remove,Remove or Replace
Z-0293-2012,60304,"system, nuclear magnetic resonance imaging",LNH,Magnetic resonance diagnostic device.,Radiology,Radiology,510(k),"Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.",Ingenia 1.5T and 3.0T MRI Systems,2,"November 28, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil.",DESIGN: Software Design,"Philips Medical Systems ( Cleveland) Inc. sent a Urgent Field Safety Notice dated August 3, 2011, to all affected customers. Philips Field Service Engineers were dispatched to the affected customer sites to deliver the recall notification and to perform the necessary software corrections. The letter lists the affected MRI systems; describes the problem; the actions to be taken by the customer/user; it also informs the customer of the upcoming software correction which will be applied to each unit by the Philips Field Service Engineers in order to address this issue. If any additional information is required, the customer is instructed to contact their local Philips Field Service Engineer. For further questions please call (440) 483-7000.",N/A,26,26 units - 12 units distributed in U.S. & 16 distributed to foreign customers,"Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, GA, OR, MI, NJ and TX., and the countries of AU, BE, CH, DE, FR, JP, NL and SE.",Terminated,"February 22, 2013",452,26,Software,Physical Safety Hazards,Software update,Software Update
Z-0297-2012,60233,"calibrators, drug specific",DLJ,Clinical toxicology calibrator.,Toxicology,Toxicology,510(k),"Multigent Vancomycin Calibrators;Manufactured by Microgenics Corp, Fremont, CA.Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage:The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycinVancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.",Multigent Vancomycin Calibrators,2,"November 28, 2011", 2011,Microgenics Corp,"Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.",COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342.Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.",N/A,118839963,809 kits lot 59446762; 651 kits lot 59391741,Nationwide Distribution (USA) in the state of ILLINOIS,Terminated,"February 17, 2012",81,1460,Not_Computer,N/A,N/A,N/A
Z-0305-2012,60121,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Elekta Synergy XVI 4.5Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.",Medical linear acelerator (with patient imaging),2,"November 29, 2011", 2011,"Elekta, Inc.","If ""Confirm"" or ""Unconfirm"" settings are clicked during the ""Terminated Checking"" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.",DESIGN: Software Design,"Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.",N/A,56,56,"Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico",Terminated,"August 09, 2012",254,56,Software,N/A,N/A,Other
Z-0303-2012,59479,"pump, blood, cardiopulmonary bypass, roller type",DWB,Roller-type cardiopulmonary bypass blood pump.,Cardiovascular,Cardiovascular,510(k),"Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.","Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module",2,"November 29, 2011", 2011,Terumo Cardiovascular Systems Corporation,Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.",Contact the recalling firm for information,10,10 units,"Nationwide Distribution (USA) including the state of San Antonio, TX",Terminated,"February 17, 2012",80,10,Not_Computer,N/A,N/A,N/A
Z-0306-2012,60192,"dressing, wound, drug",FRO,N/A,N/A,General & Plastic Surgery,510(k),"ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4"" x 4.5"" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026.The product is labeled in parts: ""***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***"".Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.",ONQ Silver Dressing,2,"November 29, 2011", 2011,Acrymed Incorporated,"The Silver Dressing, lot H0705J and H0706J may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.",PRODUCTION CONTROLS: Process Control,"On June 30 2008, the firm e-mailed all affected customers with an Important Product Recall Notification letter.The customers were notified that two lots of SilverDressing may contain dressings that are not properly seated in the foil pouch.The customers were instructed to inspect the inventory, ceased distribution of the affected lots and quaratine the remaining inventory and notify AcryMed.Customers can call AcryMed at 503-624-9830 for any questions about this recall.",Discard product or return to place of purchase for a full refund or exchange,41061,"14,125 units from lot # H0706J and 25,525 units from lot # H0705J","Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.",Terminated,"December 20, 2011",21,41061,Not_Computer,N/A,N/A,N/A
Z-0298-2012,59581,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 VProduct Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.",Advanced Perfusion System 1,2,"November 29, 2011", 2011,Terumo Cardiovascular Systems Corporation,"1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer.",DESIGN: Device Design,"Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).",N/A,12,12 units,Worldwide Distribution - (USA) Nationwide Distribution,Terminated,"August 22, 2012",267,12,Not_Computer,N/A,N/A,N/A
Z-0302-2012,60289,"console, heart-lung machine, cardiopulmonary bypass",DTQ,Cardiopulmonary bypass heart-lung machine console.,Cardiovascular,Cardiovascular,510(k),"Terumo Advanced Perfusion System 1- 4"" Roller Pump for Terumo System 1Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.",Terumo Advanced Perfusion System 1,2,"November 29, 2011", 2011,Terumo Cardiovascular Systems Corporation,Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.",N/A,3,3 units,"Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.",Terminated,"September 06, 2012",282,9,Not_Computer,N/A,N/A,N/A
Z-0304-2012,60204,"system, measurement, blood-pressure, non-invasive",DXN,Noninvasive blood pressure measurement system.,Cardiovascular,Cardiovascular,510(k),"Ambulatory Blood Pressure (ABP) Monitor, Model 90217A.The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.",Ambulatory Blood Pressure (ABP) Monitor,2,"November 29, 2011", 2011,"Del Mar Reynolds Medical, Ltd.","If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code.",DESIGN: Device Design,"On October 21, 2011, a Medial Device Correction customer letter was mailed to all US customers. A return receipt was requested.The letter identified the affected devices and described the problem. If the device displays an EC75 error code, customers can cycle the power off and then on to restore normal functionality. Please advise patients of this mitigation to avoid a delay in obtaining results. The firm is in the process of upgrading their software to avoid the issue and will contact customers to arrange for an update to their monitors.Customers can call Spacelabs Healthcare at 1-800-522-7025, select 2 for Technical support for any question about this recall.",N/A,785,785 units worldwide (83 in US and 702 outside US),Worldwide Distribution,Terminated,"May 30, 2012",183,785,Software,Device Operation,Software update,Software Update
Z-0311-2012,60146,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"Roche Cobas c 111 AnalyzerThe Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.",Roche Cobas c111 Analyzer,2,"November 30, 2011", 2011,"Roche Diagnostics Operations, Inc.","Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. The missing number of characters can be in any position, therefore it could be in the middle of a result, (e.g. 48.53 mmol in",DESIGN: Software Design,"Roche Diagnostics Operations, Inc sent a Urgent Medical Device Correction dated October 18, 2011, via UPS Ground (receipt required) to all affected customers and one distribution center, with instructions to disable the Auto Print Result feature until new software is available. All printed results will need to be confirmed against the results indicated on the display screen. Questions are to be directed to Roche Diagnostics Technical Support at 1-800 428-2336,.",N/A,135,135,Worldwide Distribution - USA including West Virginia and Texas.,Terminated,"February 21, 2013",449,135,Software,Output/Calculation,Software update,Software Update
Z-0314-2012,60287,"fastener, fixation, biodegradable, soft tissue",MAI,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.","Panalock Loop, Lupine Anchor ",2,"November 30, 2011", 2011,"DePuy Mitek, Inc., a Johnson & Johnson Co.",Incorrect suture configuration,TRAINING: Employee Error,"The firm, DePuy Mitek Inc., sent an ""URGENT VOLUNTARY PRODUCT RECALL""letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.",Contact the recalling firm for information,298,298 units,"Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia.",Open,N/A,N/A,1768,Not_Computer,N/A,N/A,N/A
Z-0309-2012,60314,anesthesia conduction kit,CAZ,Anesthesia conduction kit.,Anesthesiology,Anesthesiology,Enforcement Discretion,"Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours","Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH",2,"November 30, 2011", 2011,Arrow International Inc,"Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.",PRODUCTION CONTROLS: Packaging,"The firm, Arrow International, sent an ""URGENT MEDICAL DEVICE RECALL"" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account.If you have questions or concerns, please call this toll free number 800-233-3187.",Contact the recalling firm for information,17,17 kits,Nationwide distribution: CT,Terminated,"October 01, 2012",306,17,Not_Computer,N/A,N/A,N/A
Z-0319-2012,60150,neurological stereotaxic instrument,HAW,Stereotaxic instrument.,Neurology,Neurology,510(k),Stereotactic Circular CollimatorProduct Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions.,Stereotactic Circular Collimator,2,"November 30, 2011", 2011,"Elekta, Inc.",Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.,N/A,"Elekta sent an IMPORTANT NOTICE letter dated March 25, 2011 to all affected customers. The letter identified the affected product, the problem, key safety procedures and information to users for safe operation of the Stereotactic Circular Collimator. Elekta will issue a Mandatory Action Field Change Order which will include an updated Circular Collimator Instructions for Use - 102022201 and new labels. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. Also, Elekta is offering some free WebEx sessions which will include the procedures and recommended operation of these types of accessories. Customers are instructed to register at www.elekta.com/SafeAccessories.",N/A,89,89 devices,"Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV",Terminated,"October 02, 2012",307,89,Not_Computer,N/A,N/A,N/A
Z-0310-2012,60282,"analyzer, chemistry (photometric, discrete), for clinical use",JJE,Discrete photometric chemistry analyzer for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"cobas c 311 Analyzer, Part Number: 04826876001In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.",cobas c 311 Analyzer,2,"November 30, 2011", 2011,"Roche Diagnostics Operations, Inc.",The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.,DESIGN: Software Design,"October 26, 2011 Urgent Medical Device Corrections were sent to all direct accounts in the USA that have installed the cobas c 311 analyzer and included a faxback form to be completed and faxed to 1-877-766-7452. Consignees were instructed to temporarily replace the ISE Reference Electrolyte bottle based upon the frequency calculated from the maximum number of ISE samples run per day and activate the yellow threshold alarm on the system. Customers with question and concerns are directed to call Roche Diagnostics Technical Support at 1-800-428-2366, available 24-hours, 7 days a week.",N/A,940,940 worldwide,Worldwide Distribution -- USA including the states of Maryland and Texas.,Terminated,"July 09, 2012",222,940,Software,Output/Calculation,Instructions,Safety Notice/Insructions
Z-0313-2012,60323,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Philips Digital Diagnost Rel 3, a radiographic system, digitalIntended use: Radiographic system, digital",Digital Diagnost Rel 3,2,"November 30, 2011", 2011,Philips Healthcare Inc.,"Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit",PRODUCTION CONTROLS: Process Control,"The firm, Philips Healthcare, sent a ""URGENT - Field Safety Notice"" letter dated October 25, 2011, to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed: Do not place your hand in the open slot below the Control Handle and ensure that no patient places his/her hands the opening; review the following information with all members of their staff who need to be aware of the contents of this communication, and retain a copy with the equipment instruction for use. Philips has issued a Field Change order instructing Service Engineers to check affected systems and install the cover where it is missing free of charge.If you need any further information or support concerning this issue call 978-659-4519.",Contact the recalling firm for information,28,28 (7 US; 2 Canada; 19 OUS),"Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.",Open,N/A,N/A,28,Not_Computer,N/A,N/A,N/A
Z-0295-2012,59856,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.",GammaMed Flexible Applicator Probe,2,"November 30, 2011", 2011,"Varian Medical Systems, Inc.",GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.,PRODUCTION CONTROLS: Process Control,"Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.",Contact the recalling firm for information,653,653 parts,"Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.",Terminated,"December 07, 2011",7,653,Not_Computer,N/A,N/A,N/A
Z-0312-2012,60128,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),"Elekta Leksell Gamma Knife C 1.2, 4 and 4CProduct Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.",Radionuclie radiation therapy system,2,"November 30, 2011", 2011,"Elekta, Inc.","Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.",N/A,"Elekta sent an IMPORTANT NOTICE: Urgent Field Safety Notice letter dated May 12, 2011 to affected customers. The notice identified the affected product, problem, and actions to be taken by the user. The letter describes special care to be used in operating the helmet changer actuator LMR03. The letter states that Elekta will replace all actuators LMRO3. For more details contact your local Elekta representative..",N/A,44,44,"Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico",Open,N/A,N/A,44,Not_Computer,N/A,N/A,N/A
Z-0307-2012,60125,"system, radiation therapy, radionuclide",IWB,Radionuclide radiation therapy system.,Radiology,Radiology,510(k),Elekta Leksell Gamma PlanProduct Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.,Elekta Leksell Gamma,2,"November 30, 2011", 2011,"Elekta, Inc.","There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.",MISBRANDING: Labeling False and Misleading,"Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.",N/A,2,2,Nationwide Distribution (USA) - including the states of: NM and WA,Terminated,"January 31, 2012",62,2,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0326-2012,59779,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany.The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.",GammaMed Plastic Needle with Mandrin,2,"December 01, 2011", 2011,"Varian Medical Systems, Inc.",Plastic needle tip could possibly crack or separate.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"Varian Medical Systems sent a ""CUSTOMER TECHNICAL BULLETIN"" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.",Contact the recalling firm for information,1716,1716 parts,"Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.",Terminated,"December 07, 2011",6,1716,Not_Computer,N/A,N/A,N/A
Z-0339-2012,59767,"incubator, neonatal",FMZ,Neonatal incubator.,General Hospital,General Hospital,510(k),"Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033Usage: An incubator for infants.",Rabee Incu i,2,"December 01, 2011", 2011,Atom Medical Corporation,The caster with lock on the incubator may become loose or break.,DESIGN: Device Design,"The firm, Atom Medical, sent an ""Urgent: Field Safety Notice"" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.",N/A,32,32 units,"Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.",Terminated,"September 09, 2013",648,270,Not_Computer,N/A,N/A,N/A
Z-0331-2012,60229,solid state x-ray imager (flat panel/digital imager),MQB,Stationary x-ray system.,Radiology,Radiology,510(k),"Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System.These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.",Model CAT850B Catheterization Table,2,"December 01, 2011", 2011,Toshiba American Medical Systems Inc,"The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.",DESIGN: Device Design,"Toshiba America Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION"" letter dated October 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to follow the user instructions by positioning the tabletop at the foot-end position, and ensuringsufficient assistance is available, when transferring a patient from the gurney to the CAT-850B catheterization table. Customers were also instructed to follow the instructions for transferring a patient to the CAT-850B that are included in the operation manual. A Customer Reply Form was included with the letter for customers to complete and return via fax to (877) 349-3054. The customer reply form can also be sent via e-mail to raffairs@tams.com. Questions regarding the recall letter can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.",Contact the recalling firm for information,300,300 units,Nationwide Distribution.,Terminated,"March 18, 2013",473,300,Not_Computer,N/A,N/A,N/A
Z-0329-2012,60231,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH,Bergische Strasse 16, D-42781 Haan, Germany.The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.",GammaMed 12i Accessory,2,"December 01, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",The Product Models 1 & 2 have a design flaw problem where the clamping adapter canobstruct movement of the source cable in the event the bronchial catheter is dislodgedfrom the connector.,DESIGN: Component Design/Selection,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE"" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.",Contact the recalling firm for information,N/A,N/A,Worldwide Distribution--USA (nationwide).,Terminated,"October 22, 2012",326,N/A,Not_Computer,N/A,N/A,N/A
Z-0325-2012,59885,"system, applicator, radionuclide, remote-controlled",JAQ,Remote controlled radionuclide applicator system.,Radiology,Radiology,510(k),"VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.","Brachytherapy System, Remote Afterloader",2,"December 01, 2011", 2011,"Varian Medical Systems, Inc.",VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.,DESIGN: Software Design,"Varian Medical Systems sent a ""MEDICAL DEVICE RECALL"" letter dated April 1, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to conduct a simple test to establish if their machine is affected by the problem. Device users were requested to complete an attached receipt verification form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.",N/A,72,72 worldwide/50 in U.S.,Worldwide Distribution-USA (nationwide),Terminated,"May 30, 2013",546,72,Software,Treatment/Delivery/Therapy,Instructions,Safety Notice/Insructions
Z-0336-2012,60286,"plate, fixation, bone",HRS,Single/multiple component metallic bone fixation appliances and accessories.,Orthopedic,Orthopedic,510(k),"10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202.The product is labeled in parts: ""***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE""The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.","RibLoc System, Standard Screw",2,"December 01, 2011", 2011,Acute Innovations Llc,RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.,PRODUCTION CONTROLS: Process Control,"The firm, ACUTE Innovation, sent an ""URGENT NOTICE: DEVICE RECALL"" letter dated February 21, 2011, to all consignees/customers via FED-EX on February 28, 2011. The letter describes the product, problem and actions to be taken. The customers were instructed to identify product having the lot code(s) and quarantine them; return all product from this lot to Acute Innovations immediately using shipping labels provided or return to: Acute Innovations, LLC, 21421 NW Jacobson Rd, Suite 700, Hillsboro, OR, 97124, and if they further distributed this product, notify those customers of this recall and request return of product(s).Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.",Discard product or return to place of purchase for a full refund or exchange,299,299 units (267 in US and 32 to South Africa),"Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, GA, IL, MN, NC, NY, UT, and WA; and countries of: South Africa.",Terminated,"December 06, 2011",5,299,Not_Computer,N/A,N/A,N/A
Z-0343-2012,60302,"system, tomography, computed, emission",KPS,Emission computed tomography system.,Radiology,Radiology,510(k),"Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.",GEMINI TF 16 PET/CT Xray Diagnostic Imaging System,2,"December 01, 2011", 2011,Philips Medical Systems (Cleveland) Inc,"In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.",DESIGN: Software Design,"Philips Healthcare sent a ""CPE CUSTOMER LETTER"" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.",N/A,9,9 units,"Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.",Terminated,"February 22, 2013",449,19,Software,N/A,N/A,N/A
Z-0345-2012,59934,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),OdysseyA radiation treatment planning system,Odyssey,2,"December 01, 2011", 2011,"PerMedics, Inc.","Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files:During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values t",DESIGN: Device Design,"PerMedics sent an Odyssey TPS URGENT NOTICE OF CORRECTION letter dated November 4, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:Anomaly 1 User Corrective Action:Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations were provided if they planned to use Odyssey RT Ion Plan, DICOM RT Image, and/or RTP Link export:Workaround for the invalid exported table and/or collimator angle errors: If, prior to the software correction, any of these affected file types were exported from Odyssey, manually verify that the table and collimator angles are correct. Additionally, apply appropriate changes to any angles deemed incorrect that were obtained from Odyssey's DICOM RT Ion Plan, DICOM RT Image, and/or RTP Link files.Only those machines with table and/or collimator angles that increase in the clockwise direction will have the incorrect angles.Anomaly 2 User Corrective Action:Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations are provided if the user- Changes the patients scheduled start date prior to the software correction:Workaround for Incorrect Monitor Unit Values when Changing Treatment Start Date: If, prior to the software correction, the user changes the patient's treatment start date on any fully-computed IMRT plan, IMAT plan or plan containing a ""Region DVH"" prescription, the user should force a full recommendation oft hose patient plans prior to fixing and exporting the plan.The following procedure can be used to force a full re-computation of the plan:- Open the patient's plan worksheet- Change the algorithm type of the plan- Change the algorithm type back to its original value- Close t.",No consumer action necessary,15,15,"Worldwide Distribution - USA including NY, GA, CA and the countries of Hungary, Brazil, China, India, Italy, and Mexico",Terminated,"March 02, 2012",92,15,Software,Treatment/Delivery/Therapy,Software update,Software Update
Z-0323-2012,59814,"prosthesis, hip, semi-constrained, metal/polymer, porous uncemented",LPH,Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.,Orthopedic,Orthopedic,510(k),"ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies.Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.",ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis,2,"December 01, 2011", 2011,Zimmer Inc.,This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.,PRODUCTION CONTROLS: Error in Labeling,"The firm Zimmer, sent an ""URGENT DEVICE CORRECTION"" letter dated August 26, 2011 to Marketing Personnel, Distributors, Sales Representatives, Distribution Operation Managers, and Surgeons. The letters identified the reason for the recall, the product, and required actions to be taken. The letter also included Medwatch reporting information and a Certificate of Acknowledgement form to fax back to the recalling firm to confirm receipt of the recall notice. For questions contact Zimmer at 1-877-946-2761.",Contact the recalling firm for information,119284,"119,284 total devices","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,",Terminated,"August 29, 2013",637,119284,Not_Computer,N/A,N/A,N/A
Z-0320-2012,60250,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Elekta Synergy XVI R.4.5 and R4.6ProducT Usage: To be used as part of radiation therapy treatment process.,XVI R4.5 Xray Volume Imaging System,2,"December 01, 2011", 2011,"Elekta, Inc.",The software did not operate as expected.,DESIGN: Software Design,"Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative.",N/A,77,77,"Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico",Open,N/A,N/A,77,Software,N/A,Instructions,Safety Notice/Insructions
Z-0333-2012,60244,implantable cardioverter defibrillator (non-crt),LWS,N/A,N/A,Cardiovascular,N/A,"LATITUDE¶_ Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA).There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the USThe LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1.Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements.",LATITUDE Patient Management System,2,"December 01, 2011", 2011,Boston Scientific CRM Corp,"Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the mea",DESIGN: Software Design,"Boston Scientific sent an ""IMPORTANT DIAGNOSTIC INFORMATION"" letter dated October 2011 to all affected customers. The letter described the product, problem and actions to be taken by the customers.",Contact the recalling firm for information,25300,"25,300 (14,700 US; 10,600 OUS)","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GUADELOUPE, HUNGARY, BANGLADESH, CHINA, COCOS ISLAND, HONG KONG, INDIA, INDONESIA, KOREA, MALAYSIA, PHILIPPINES, SINGAPORE, SOUTH KOREA, SRI LANKA, THAILAND, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, NEW CALEDONIA, POLAND, PORTUGAL, QATAR, REUNION,IRAN, ISRAEL, JORDAN, KUWAIT, LATVIA, LEBANON, LUXEMBOURG, MONACO, MOROCCO, JAPAN, ARGENTINA, ARUBA, BAHAMAS, BARBADOS, BELIZE, BERMUDA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, FALKLAND ISLANDS, HAITI, HONDURAS, JAMAICA, MEXICO, PANAMA, PERU, TRINIDAD & Tobago, URUGUAY, VENEZUELA, AND NETHERLANDS ANTILLES.",Terminated,"December 04, 2012",369,25300,Not_Computer,N/A,N/A,N/A
Z-0332-2012,60238,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices.Varian Medical Systems, Palo Alto, CA 94304.The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions.",Head Ring Posts; of the Optical Guidance Platform and Floorstand devices ,2,"December 01, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems",An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.,DESIGN: Device Design,"Varian Medical Systems sent an ""URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE"" letter dated October 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are advised to verify that they are using the current design of the head ring posts (part # 970.284) and to contact Varian if replacements are needed. Customers may contact the Varian Help Desk for questions regarding this notice at 1-888-827-4265.",No consumer action necessary,205,205 kits ( Each kit contains 4 Head Post Rings) 820 HPR's,Worldwide Distribution.,Terminated,"July 25, 2012",237,205,Not_Computer,N/A,N/A,N/A
Z-0335-2012,60228,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.",Brilliance CT XRay System,2,"December 01, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.,DESIGN: Software Design,"Philips Healthcare released a 'Field Change Order' (FCO #72800531) on September 12, 2011. Philips sent an - URGENT Medical Device Correction letter dated October 17, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to this situation. The letter informed customers on how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update is installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. Customers were instructed to contact their Philips representative or local Philips Healthcare Office for further information or support for this issue. For North America and Canada customers were instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).",N/A,3,three (3) units were distributed.,"Worldwide Distribution - USA including Texas and the countries of Italy, India and China.",Terminated,"February 22, 2013",449,5,Software,N/A,Softwarae update,Software Update
Z-0341-2012,60153,"monitor, carbon-dioxide, cutaneous",LKD,Cutaneous carbon dioxide (PcCO2) monitor.,Anesthesiology,Anesthesiology,510(k),"TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).",transcutaneous pCO2 electrodes,2,"December 01, 2011", 2011,Radiometer America Inc,"Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.",TRAINING: Employee Error,"Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.",N/A,4,4 units were distributed.,"Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.",Terminated,"February 19, 2012",80,4,Not_Computer,N/A,N/A,N/A
Z-0342-2012,60497,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),Elekta Synergy XVI X-ray Volume Imaging SystemTo be used as part of radiation therapy treatment process.,Synergy XVI kV Generator,2,"December 01, 2011", 2011,"Elekta, Inc.",A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"The firm, Elekta, issued a ""FIELD CHANGE ORDER MANDATORY ACTION"" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator.If you have any questions, call 770-300-9725.",N/A,123,123,"Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC.",Terminated,"August 09, 2012",252,123,Hardware,Physical Safety Hazards,Instructions,Safety Notice/Insructions
Z-0363-2012,60458,"calculator/data processing module, for clinical use",JQP,Calculator/data processing module for clinical use.,Clinical Chemistry,Clinical Chemistry,510(K) Exempt,"SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.",SoftPath GUI ,2,"December 02, 2011", 2011,SCC Soft Computer,"On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011.",DESIGN: Software Design,"SCC Soft Computer sent a ""CORRECTION COMMUNICATION"" dated July 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. SCC personnel will review the customized Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss with them the irregularities requiring change or reconfigure macros as necessary.",N/A,97,97,Worldwide Distribution-USA (nationwide) and the country of Canada.,Terminated,"May 21, 2013",536,97,Software,Output/Calculation,Upgrade,Repair
Z-0355-2012,60451,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.","SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. ",2,"December 02, 2011", 2011,SCC Soft Computer,"On 06/13/2011, SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. A client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. Parts A through D were present as well as Part F, however, Part E diagnosis was missing for one of the patient reports. All affected clients wer",DESIGN: Device Design,"SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue.SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions: 1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction. 2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border. For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.",No consumer action necessary,14,14,Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.,Terminated,"May 31, 2012",181,14,Software,Output/Calculation,Software update,Software Update
Z-0359-2012,60409,"system,planning,radiation therapy treatment",MUJ,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.comRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.",RayStation ,2,"December 02, 2011", 2011,RAYSEARCH LABORATORIES AB,"The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.",DESIGN: Device Design,"The firm, RaySearch Laboratories, sent an email with an ""Urgent Field Safety Notice Medical Device Correction"" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct values upon request.For further information please contact RaySearch Laboratories AB Quality and Regulatory Affairs Manager at +46 722 366 110 or david.hedfors@raysearchlabs.com; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearchlabs.com.",Contact the recalling firm for information,19,19 units,"Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands",Terminated,"May 11, 2012",161,19,Software,Display/Image,Software update,Software Update
Z-0346-2012,60335,"filler, bone void, calcium compound",MQV,Resorbable calcium salt bone void filler device.,Orthopedic,Orthopedic,510(k),"Product is labeled in part - Pouch label: ""***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***"" Product is labeled in part - Carton label: ""***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***""Origen DBM with Bioactive Glass Catalog #:22-2002 (2cc size) 22-2005 (5cc size)22-2010 (10cc size)""Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation.""Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).",Origen DBM with Bioactive Glass,2,"December 02, 2011", 2011,"Nanotherapeutics, Inc","On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011",N/A,"Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached. Recall Instructions:Immediately examine inventory and quarantine product subject to recall.Return all quarantined product subject to recall to:Nanotherapeutics, Inc.Attn: Receiving Department13859 Progress Blvd, Suite 300Alachua, Florida 32615For questions call 386-462-9663.",N/A,6276,6276 units,"Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.",Terminated,"April 03, 2012",123,6407,Not_Computer,N/A,N/A,N/A
Z-0348-2012,60237,"instrument, surgical, orthopedic, ac-powered motor and accessory/attachment",HWE,Surgical instrument motors and accessories/attachments.,General & Plastic Surgery,Orthopedic,510(K) Exempt,"Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive.This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.",Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive,2,"December 02, 2011", 2011,"Synthes USA (HQ), Inc.","The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.",N/A,"Synthes sent a ""NOTICE: MEDICAL DEVICE RECALL"" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.",Contact the recalling firm for information,5,5,"Nationwide Distribution including the states of CO, LA, NY, and OK.",Open,N/A,N/A,5,Not_Computer,N/A,N/A,N/A
Z-0349-2012,60245,"prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer",JWH,Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.,Orthopedic,Orthopedic,510(k),Foundation Tibial Broach P/N 801-01-013Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013,Foundation Tibial Broach,2,"December 02, 2011", 2011,"Encore Medical, Lp",The strike plate may dislodge from the broach stem handle during impaction of the device.,COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component,"DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.",N/A,30,30 units,"Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy",Terminated,"September 05, 2012",278,30,Not_Computer,N/A,N/A,N/A
Z-0351-2012,60347,"instrument, biopsy, suction",FCK,Gastroenterology-urology biopsy instrument.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),"The EnCor¶_ biopsy probe, designed for use with EnCor¶_ and EnCor¶_ Enspire Vacuum Assisted Biopsy (VAB) driver systems.The EnCor¶_ Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.",The EnCor biopsy probe,2,"December 02, 2011", 2011,Bard Peripheral Vascular Inc,"This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked.",PRODUCTION CONTROLS: Packaging,"The firm sent the customer notification letter on 11/07/11, via FedEx with proof of delivery notice. The letter notified customers of the reason for recall that units from the affected lot may have packaging damage resulting from transportation. The letter instructed customers to check all inventory locations , remove any identified product, to not use the affected product, and return the affected product to Bard Peripheral Vascular, Inc., 1415 W. 3rd Street, Tempe, Arizona 85281. The letter also instructed customers to fill out the recall and effectiveness check form and fax it to 1-800-894-6772. Customers were instructed to call 1-800-321-4254, Option #2 Ext 2727 for a return authorization number to facilitate the expedient return of the product.For questions regarding this recall call 480-894-9515.",No consumer action necessary,64570,64570 units,"Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia",Terminated,"March 29, 2012",118,64570,Not_Computer,N/A,N/A,N/A
Z-0362-2012,60416,medical computers and software,LNX,N/A,N/A,General Hospital,510(k),"SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.",SoftReports ,2,"December 02, 2011", 2011,SCC Soft Computer,"On 10/25/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page. All affected clients were notified on the issue on",DESIGN: Software Design,"SCC Soft Computer sent a ""Correction Notification"" letter dated October 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The hot fixes that were previously loaded which introduced this issue were corrected and delivered to all affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.",No consumer action necessary,5,5,Nationwide Distribution.,Terminated,"March 16, 2012",105,5,Software,Output/Calculation,Software update,Software Update
Z-0364-2012,60411,"accelerator, linear, medical",IYE,Medical charged-particle radiation therapy system.,Radiology,Radiology,510(k),"TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.","TrueBeam and TrueBeam STx,",2,"December 02, 2011", 2011,"Varian Medical Systems, Inc. Oncology Systems","An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.",DESIGN: Device Design,"On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.",No consumer action necessary,N/A,N/A,Worldwide distribution including the US and Internationally.,Terminated,"July 25, 2012",236,N/A,Other,N/A,Software update,Software Update
Z-0360-2012,59886,"system, x-ray, tomography, computed",JAK,Computed tomography x-ray system.,Radiology,Radiology,510(k),"Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157.The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.",Brilliance CT XRay System,2,"December 02, 2011", 2011,Philips Medical Systems (Cleveland) Inc,Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.,DESIGN: Software Design,"Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts.For questions regarding this recall call 440-483-4918.",N/A,5,5 units,"Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden",Terminated,"March 15, 2013",469,7,Software,N/A,Software update,Software Update
Z-0353-2012,60338,"ventilator, continuous, facility use",CBK,Continuous ventilator.,Anesthesiology,Anesthesiology,510(k),"Maquet Servo-S ventilator systemDevice Part number 66 40 440Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.",ServoS ventilator system,2,"December 02, 2011", 2011,Maquet Inc.,Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).,N/A,"The firm, Maquet Getinge Group, sent an "" PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION"" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment. If you have any questions, call technical support at our toll free number at 1-888-627-8383.",Contact the recalling firm for information,26,26 units,Nationwide distribution.,Open,N/A,N/A,202,Not_Computer,N/A,N/A,N/A
Z-0356-2012,60300,"light source, fiberoptic, routine",FCW,Endoscope and accessories.,Gastroenterology/Urology,Gastroenterology/Urology,510(k),Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXProduct Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.,Integra LifeSciences,2,"December 02, 2011", 2011,Integra LifeSciences Corp.,A loose screw may result in shifting of components and improper function of the turret or actuator assembly.,PRODUCTION CONTROLS: Process Control,"Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Service at 1-800-431-1123.",N/A,66,66 units,"Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan, Sweden, Switzerland, and Turkey.",Terminated,"March 08, 2012",97,97,Not_Computer,N/A,N/A,N/A
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